Clinicaltrials.gov
 | Incretin Physiology and Beta-cell Function Before and After Weight-loss | Terminated | Obesity | Other - Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rate | Glostrup University Hospital, Copenhagen, University of Copenhagen, European Foundation for the Study of Diabetes, Novo Nordisk A/S, Other, Other, Other, Industry | | 18 Years - N/A | | Observational | To evaluate the impact of laparoscopic adjustable gastric banding (LAGB) on beta-cell
function, insulin sensitivity, incretin function, postprandial secretion of incretin hormones
(glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) in
morbidly obese patients and to describe the pathophysiological mechanisms involved in the
amelioration of glucose homeostasis during long-term weight loss. | |
Clinicaltrials.gov
| A Study of the Safety and Effectiveness of JNJ-16269110 (R256918) in Overweight and Obese Patients | Completed | Obesity, Nutritional and Metabolic Diseases, Metabolic Diseases, Nutrition Disorders, Overweight | Drug, Drug, Drug, Drug - placebo, R256918, R256918, R256918 | Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry | | 18 Years - 65 Years | Phase 2 | Interventional | This study investigates the effectiveness and safety of 12 weeks of treatment with
JNJ-16269110 (R256918), in overweight and obese patients. The primary measure of
effectiveness is the change in body weight at a clinically relevant dosage level during
treatment. Additional measures include body mass index (BMI), DEXA (dual X-ray absorptiometry
which is a specialized x-ray test that measures body composition), fasting glucose, lipid
levels, and blood pressure. Safety assessments performed during the trial include laboratory
tests, vital sign measurements, and adverse event reporting. | |
Clinicaltrials.gov
| Energy Expenditure & Activity During & After Exercise-Induced Weight Loss | Completed | Obesity | Behavioral - Walking exercise | University of Colorado, Denver, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | | 18 Years - 55 Years | N/A | Interventional | This project is aimed at determining whether an exercise-based weight loss intervention
causes a compensation in some component of energy expenditure such that the increase in
measured energy expenditure is less than the added exercise. The study will compare two
separate exercise interventions to determine if this is influenced by exercise intensity. | |
Clinicaltrials.gov
| Impact of Trans Fatty Acids From Natural and Industrial Origin in the Induction of Insulin Resistance Development | Completed | Insulin Resistance, Obesity | Dietary Supplement, Dietary Supplement, Dietary Supplement - vaccenic acid enriched diet, Elaidic acid enriched diet, control diet | Institut National de la Recherche Agronomique, Other | Female | 18 Years - 50 Years | N/A | Interventional | The investigators' project has as for principal objective to understand the impact of trans
fatty acids from dairy products and industrial origin on the development of insulin
resistance in obese woman. Because of the different isomeric position of the double bound
those trans fatty acids may have different metabolic effects. | |
Clinicaltrials.gov
| Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome | Completed | Obesity | Dietary Supplement, Dietary Supplement - Synergy 1, maltodextrin | Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Other | Female | 18 Years - 65 Years | N/A | Interventional | Obesity is constantly increasing, causing an important risk to develop diseases such as heart
disease, diabetes,... Some recent studies have shown that obese people present modifications
of colon microflora and a low-grade inflammation.
In our laboratory, we have demonstrated that the intake of fructans lessens dietary intake,
body weight gain, adipose tissue accumulation and steatosis in rodents. These effects lead to
an improvement of insulin resistance and hyperglycemia in diabetic rats and mice. Fructans
are also able to restore the microflora disturbed by a high fat diet and to prevent
endotoxemia. Moreover, studies have shown that fructans intake promotes satiety (Cani et al,
Diabetes 2007) and or decreases fat mass (Abrams et al, Journal of Pediatrics 2007) in
healthy human. An intervention study in obese patients is thus needed to study the effects of
fructans in the target population. | |
Clinicaltrials.gov
| Lap-Band Surgery on Adolescents for Safety and Efficacy | Active, not recruiting | Obesity, DM | Device - Lap-Band | NYU Langone Health, Hope Foundation, Other, Other | | 14 Years - 17 Years | N/A | Interventional | This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in
the morbidly obese adolescent population. | |
Clinicaltrials.gov
| FB4 (Framingham, Boston, Bloomington, Birmingham, and Baylor) | Terminated | Obesity | Behavioral - Feeding Study | Boston Children's Hospital, Indiana University, University of Alabama at Birmingham, Framingham State University, Baylor University, Other, Other, Other, Other, Other | | 18 Years - 50 Years | N/A | Interventional | This study will evaluate the effects of dietary carbohydrate and sugar consumption,
independent of energy content, on body fatness and metabolism in a rigorous feeding study. | |
Clinicaltrials.gov
| Effect of Discontinuation of Sugar Sweetened Beverages | Completed | Type 2 Diabetes, Obesity | Behavioral - discontinuation of sugar sweetened beverages | Duke University, Other | | 18 Years - N/A | N/A | Interventional | Purpose The purpose of this study is to investigate the effects of discontinuation of sugar
sweetened beverages on hemoglobin A1c (HbA1c) and plasma fasting and post-prandial blood
glucose in a population with type 2 diabetes.
Hypothesis Elimination of sugar sweetened beverages from the diet for a 4 week period will
lead to a decrease in HbA1c and plasma fasting and 2 hour post prandial blood glucose in a
population with a history of type 2 diabetes and high consumption of sugar sweetened
beverages.
Specific aims to test hypothesis
1. Investigate how elimination of sugar sweetened beverages from the diet affects HbA1c and
plasma fasting and two hour post prandial blood glucose.
2. Test the feasibility of carrying out a simple diet intervention in an outpatient
population with type 2 diabetes. | |
Clinicaltrials.gov
| Exercise Changes to Peripheral Blood Mononuclear Cells in Children | Withdrawn | Physical Fitness, Obesity, Child Development, Growth | | University of California, Irvine, Other | | 8 Years - 18 Years | | Observational | The goal of this research is to determine how the peripheral immune system is altered by
exercise and differences related to gender, pubertal status and health. | |
Clinicaltrials.gov
| Study Of The Safety And Pharmacokinetics Of CE-326,597 In Patients With Asymptomatic Gallstones | Completed | Obesity | Drug, Drug - CE-326,597, Placebo | Pfizer, Industry | | 18 Years - 65 Years | Phase 1 | Interventional | The study is designed to assess whether repeated dosing with CE-326,597 will cause patients
with asymptomatic gallstones (as detected on screening abdominal ultrasound) to become
symptomatic. In addition, the study will characterize the pharmacokinetics of CE-326,597. | |
Clinicaltrials.gov
| Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S): A Prospective Cohort Study | Recruiting | Obesity, Morbid Obesity | Procedure, Procedure - BPD-DS, SADI-S | McGill University Health Centre/Research Institute of the McGill University Health Centre, Other | | 18 Years - 60 Years | N/A | Interventional | The prevalence of morbid obesity in Canada has risen almost 5 fold in the past three decades.
Surgery remains the cornerstone of treatment of obesity and related comorbidities such as
type-2 diabetes. Bariatric/metabolic procedures can be classified into 2 main categories: a)
those that cause restriction, and b) those that add a malabsorptive component to restriction.
Currently sleeve gastrectomy (SG), which is a purely restrictive operation, is the most
frequently performed procedure in North America.
Interestingly, combined restrictive/malabsorptive procedures such as Roux-en-Y gastric bypass
(RYGB) or biliopancreatic diversion with duodenal switch (BPD-DS) are more effective
procedures when compared to purely restrictive ones. Moreover, the conventional BPD-DS
procedure has been shown to be significantly more effective than RYGB in achieving durable
weight loss and resolving comorbidities such as type-2 diabetes. Despite superior outcomes,
the performance of BPD-DS is highly institution dependant and comprises less than 5% of the
annual bariatric procedures performed worldwide.
Common reservations against BPD-DS are related to the side effects of the procedure, and
include frequent bowel movements, flatulence, fat, micronutrient and protein malnutrition.
Furthermore, longer operative times and surgical technical challenges are also reasons for
lower prevalence of the BPD-DS procedure.
Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) is a modification of
the conventional BPD-DS that potentially addresses many of these concerns. In addition, it is
a suitable second-stage or salvage procedure for severely obese patients with inadequate
weight loss or resolution of obesity-related comorbidities after SG. Despite showing
excellent results of up to 5 years with acceptable postoperative morbidity, all the
literature on SADI-S originates from a single center and has not been compared directly with
BPD-DS. Hence, the investigators aim to evaluate the feasibility, safety, and postoperative
outcomes of SADI-S as it compares to conventional BPD-DS in morbidly obese patients.
This project has three specific aims:
1. To evaluate feasibility and short-term safety of SADI-S.
2. To evaluate short and long-term beneficial outcomes.
3. To evaluate and compare long-term morbidity. | |
Clinicaltrials.gov
| Mitochondrial Function in Pediatric Obesity | Unknown status | Obesity, Insulin Resistance | | Massachusetts General Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Lawson Wilkins Pediatric Endocrine Society, Boston Children's Hospital, Other, NIH, Other, Other | | 8 Years - 18 Years | | Observational | The prevalence of pediatric obesity is increasing at an unprecedented rate. Obese children
are at risk for the development of insulin resistance, relative insulin deficiency and type 2
diabetes mellitus. However, the cause of insulin resistance remains an area of scientific
interest. The study of type 2 diabetes in children is limited by the lack of a non-invasive
method to evaluate insulin resistance. Recent studies have suggested that mitochondrial
dysfunction is associated with, and perhaps predictive of insulin resistance in adult
relatives of individuals with type 2 diabetes. Mitochondria generate energy in muscle tissue
through the production of ATP, and are important in the metabolism of both glucose and fat.
This study evaluates a novel, non invasive, safe method for predicting insulin resistance and
diabetes in children using a magnetic resonance imaging (MRI) based technique to measure
mitochondrial function. We propose to investigate mitochondrial function and glucose
metabolism in obese and non-obese children in early, mid and late puberty. Analyses will be
conducted to investigate the presence of mitochondrial dysfunction in obese children, to
evaluate the contribution of mitochondrial dysfunction to insulin resistance, and to
determine the contribution of pubertal status to mitochondrial dysfunction and insulin
resistance. The successful completion of this study would provide evidence to support the
hypothesis that mitochondrial dysfunction plays a role in insulin resistance and diabetes in
children. In addition, it would provide a new technique for the prediction of disease states
and perhaps lead to the development of preventative therapeutics for insulin resistance and
type 2 diabetes in children.
We hypothesize that mitochondrial dysfunction will mirror the progression of insulin
resistance and precede and predict abnormal glucose metabolism in a population with pediatric
obesity | |
Clinicaltrials.gov
| Low Carbohydrates in Obese Adolescents | Completed | Obesity | Behavioral - dietary intervention | Rabin Medical Center, Other | | 12 Years - 18 Years | N/A | Interventional | A three arms open,randomized interventional study in order to compare the impact of low
carbohydrate diets with different protein and fat ratios versus a standard balanced diet on
BMI and metabolic parameters in obese adolescents.
55 obese adolescents (12-18y, BMI > 95th percentile) were randomly allocated to one of three
12-weeks diet regimens: low-carbohydrate low-fat, low-carbohydrate high-fat or balanced
low-fat diet, followed by 9-months follow-up. Weight, Height, waist circumference, lipid
profile, glucose, insulin, liver enzymes, renal functions, C-reactive protein, leptin,
ghrelin and resting energy expenditure were measured in the morning after over-night fast at
baseline, during the 12-weeks of intervention and after 9-months of follow-up. | |
Clinicaltrials.gov
| Dietary Modulation of Gene Expression and Metabolic Pathways in Glucose Metabolism | Completed | Metabolic Syndrome, Obesity, Impaired Glucose Tolerance, Impaired Fasting Glucose | Dietary Supplement, Dietary Supplement, Dietary Supplement - Diet with increased intake of rye bread, berries and fish, Increased intake of whole grain and rye bread, Control diet with decreased intake of rye bread, berries and fish | Marjukka Kolehmainen, VTT Technical Research Centre, Finland, Wageningen University, Other, Other, Other | | 40 Years - 65 Years | Phase 2 | Interventional | Professor Matti Uusitupa, University of Kuopio, Department of Clinical Nutrition (www.uku.fi)
Docent Matej Oresic, VTT (www.vtt.fi) Ursula Schwab, PhD, Docent, Marjukka Kolehmainen, PhD,
Docent, Leena Pulkkinen, PhD, Docent, David Laaksonen, MD, PhD, MPH, Docent, Kaisa Poutanen,
DSc (Tech), Research Professor
ABSTRACT
The metabolic syndrome (MS) and type 2 diabetes (T2DM) are the most important health problems
worldwide. In Finland the prevalence of T2DM is 12-15% among middle-aged people. The
prevalence of less marked disturbances in glucose metabolism and MS is 30-40%. Because MS and
T2DM are important risk factors for cardiovascular diseases (CVD), the leading cause of death
in western countries, all efforts to reverse the epidemic increase in the incidence of MS and
T2DM are warranted. The investigators have focused for years on the prevention and
non-pharmacological treatment of T2DM and its complications including studies on genetic
regulation of glucose and lipid metabolism after dietary modifications. In the investigators'
recent projects, the investigators have studied the effects of long-term dietary
interventions on gene expression profiles of fat tissue in subjects who are at risk of T2DM.
The ultimate goal of these projects has been to identify genes and gene clusters and their
biological pathways that respond to dietary modification and modulate glucose and lipid
metabolism, and to develop dietary strategies for prevention of T2DM. The main goal of this
project is to find nutrition related early biomarkers for progression of MS to T2DM by using
modern technologies of systems biology (transcriptomics, metabolomics) of carefully conducted
dietary interventions involving subjects with MS. The data will be analysed by using
bioinformatics. The investigators reflect these new data to well-known risk factors for T2DM
and CVD, e.g., insulin sensitivity, insulin secretion, serum lipids and inflammatory factors
among others. In addition to interventions conducted earlier, a new intervention with a whole
grain-berry-fish diet and a whole grain diet compared to a control diet with refined foods
will be performed. The aim is to increase the investigators' understanding on the synergistic
effects of these foods, because the investigators' previous interventions have shown that
these individual foods have beneficial effects on glucose and lipid metabolism. On the
contrary, diets with refined foods may be harmful in long-term due to its high insulin
response, which may through chronic stress lead to both insulin resistance and beta-cell
damage.
The significance of this project is to increase understanding of the pathophysiology of MS,
T2DM and CVD in physiological, cellular and genetic systems, which may lead to more effective
and individualised strategies for treatment and prevention, and better identification of
high-risk individuals responsive to specific dietary modifications. Increasing knowledge of
dietary factors involved in the progression of MS to T2DM and CVD offers new opportunities to
individually tailored diets in the management and prevention of these disorders. The results
will also be beneficial for the food industry in developing new functional foods. These
results and actions may help delay or even stop the epidemic of MS and T2DM and their
negative effect on public health currently seen in Finland and worldwide. | |
Clinicaltrials.gov
| Mechanisms of Diabetes Control After Weight Loss Surgery | Completed | Gastric Bypass Surgery, Obesity | Procedure, Other - gastric bypass surgery, Diet induced weight loss | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH | | 21 Years - 60 Years | | Observational | Obesity and type 2 diabetes (T2DM) are increasing in the US. One third of patients seeking
bariatric surgery have T2DM. Although all surgeries result in significant weight loss and
often 'cure' the T2DM, the rapid onset and the magnitude of the benefits of gastric bypass
(GBP) on T2DM has thus far baffled clinical scientists. Limited data suggest that the
improvement in T2DM after GBP occurs very rapidly, and may not be wholly accounted for by
weight loss. Secretion of incretins (gut peptides secreted in response to meals which enhance
insulin secretion) is impaired in T2DM and improves after GBP, possibly due to the specific
anatomical changes after this surgery. While some determinants of impaired insulin secretion,
such as glucotoxicity, improve equally after diet or surgical weight loss, the improvement in
the incretin effect after GBP might be specific to this surgery. The aim of this study is to
determine whether the magnitude of the incretin effect on insulin secretion is greater after
GBP than after an equivalent diet-induced weight loss. We will compare, in obese patients
with diabetes, randomized to very low calorie diet or to GBP, the effect of an equivalent
weight loss on the incretin effect (difference in insulin secretion after comparable oral and
intravenous (IV) glucose loads). As more obese diabetic patients undergo GBP, understanding
the mechanisms that produce improvement in their diabetes is increasingly important. | |
Clinicaltrials.gov
| Prevalence and Cardiovascular Effects of Growth Hormone Deficiency in Abdominal Obesity | Completed | Obesity, Growth Hormone | | Massachusetts General Hospital, National Heart, Lung, and Blood Institute (NHLBI), Other, NIH | | 18 Years - 55 Years | | Observational | Obesity is one of the leading causes of cardiovascular-related diseases, including diabetes
and heart disease. Obesity, and more specifically abdominal obesity, may cause decreased
growth hormone (GH) levels. It is believed that GH deficiency may contribute to increased
cardiovascular risk by affecting insulin resistance, inflammatory markers, and blood
cholesterol levels. This study will determine the occurrence of GH deficiency in abdominal
obesity and whether GH deficiency is associated with increased cardiovascular risk beyond
traditional risk factors. | |
Clinicaltrials.gov
| Intraoperative Goal-directed Fluid Management | Withdrawn | Obesity, Abdominal Surgery, Hysterectomy, Genital Prolapse | Procedure - Esophageal probe | The Cleveland Clinic, Other | | 18 Years - 85 Years | N/A | Interventional | The investigators propose to determine esophageal Doppler goal-directed fluid requirements in
lean, overweight, obese, and morbidly obese patients with the goal of developing a body mass
index (BMI)-specific fluid replacement strategy. Specifically, th investigators will test the
hypothesis that perioperative fluid requirements on a per-kg basis varies as a function of
BMI. Individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or
genital prolapse repair will be eligible to participate | |
Clinicaltrials.gov
 | Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy) | Completed | Metabolic Syndrome, Obesity | Procedure - Stress Echocardiography | University of Missouri-Columbia, Other | | 18 Years - 65 Years | N/A | Interventional | We plan to test the hypothesis that patients with metabolic syndrome will have impaired left
ventricular diastolic parameters. These parameters will be measured before and after a stress
test at the end of a 3 month period of exercise training and a 10% weight loss. | |
Clinicaltrials.gov
| Observational Non-interventional Study (Anwendungsbeobachtung) With Telmisartan in High-risk Hypertensives | Completed | Hypertension, Obesity | | Boehringer Ingelheim, Industry | | 18 Years - N/A | | Observational | This observational non-interventional study will assess (under conditions of clinical
practice in daily routine) the antihypertensive efficacy of telmisartan treatment with or
without active promotion of lifestyle changes in hypertensive patients at high cardiovascular
risk | |
Clinicaltrials.gov
| Treatment for Obesity and Binge Eating Disorder | Completed | Binge Eating Disorder, Obesity | Behavioral, Behavioral, Behavioral - Cognitive Behavior Therapy, CBT and BWL, Behavioral Weight Loss Treatment | Yale University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | | 18 Years - 60 Years | N/A | Interventional | This study is a test of cognitive behavioral therapy(CBT) and behavioral weight loss (BWL)
treatments for obese patients with binge eating disorder (BED). The study involves a
comparison of three treatment conditions: (1) CBT; (2) BWL, and (3) a sequential (two-part)
treatment consisting of CBT followed by BWL. | |
Clinicaltrials.gov
| A Study of Nasal PYY3-36 and Placebo for Weight Loss in Obese Subjects | Completed | Obesity | Drug, Drug, Drug, Drug, Drug, Drug - Nasal Placebo, Placebo Capsule, PYY3-36, PYY3-36, PYY3-36, Sibutramine | Nastech Pharmaceutical Company, Inc., Industry | | 18 Years - 65 Years | Phase 2 | Interventional | The purpose of this study is to determine the effect of nasal PYY3-36 on weight loss post 24
weeks of treatment. | |
Clinicaltrials.gov
| Metabolic Profile and Anthropometric Changes in Schizophrenia | Completed | Metabolic Syndrome, Diabetes, Obesity | Drug, Drug, Drug - Olanzapine, Risperidone, Haloperidol | Central Institute of Psychiatry, Ranchi, India, Other | | 18 Years - 40 Years | N/A | Interventional | "No clinical differences will be found between the three antipsychotics under study -
olanzapine, risperidone and haloperidol - on the patients' metabolic profile and weight. " | |
Clinicaltrials.gov
| Efficacy of MK0557 in Combination With Sibutramine or Orlistat (0557-015)(COMPLETED) | Completed | Obesity | Drug - MK0557 | Merck Sharp & Dohme Corp., Industry | | 18 Years - 65 Years | Phase 2 | Interventional | Study medicine will be given alone, or in combination with either sibutramine or orlistat, to
obese subjects to compare the effect on body weight over a six month period. | |
Clinicaltrials.gov
| Obesity and Memory, mRNA, Body Composition, Comorbidity Scale | Terminated | Obesity, Memory Deficits | | Oregon Health and Science University, Other | | 18 Years - N/A | | Observational | 1. Briefly describe the purpose of this protocol. First purpose of the study is to
understand the inheritance of morbid obesity.
2. Briefly summarize how participants are recruited. Volunteers will first learn of LABS-2a
research opportunity at the Bariatric Surgery Informational meetings.
3. Briefly describe the procedures subjects will undergo.
Participants will be asked to complete a set of memory tests. Fat and Liver samples will
be removed during their weight loss surgery, specifically for this research study.
4. If applicable, briefly describe survey/interview instruments used. Memory tests will be
performed to assess cognition.
5. Briefly describe how the data will be analyzed to address the purpose of the protocol.
The memory test data collected and compared against well established norms. Tissue samples
will stored in a repository to be genetically studied for an indefinite amount of time.
Genetic studies will be related to the disease of obesity and associated comorbidities
brought on by the disease. | |
Clinicaltrials.gov
| Team PLAY (Positive Lifestyles for Active Youngsters) | Completed | Obesity | Behavioral - Team PLAY | University of Tennessee, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Other, NIH | | 4 Years - 7 Years | Phase 2/Phase 3 | Interventional | The purpose of this study is to determine whether an intense family-centered program to help
children, 4 to 7 years old, control their weight is more effective than the advise and
referrals their health provider gives in the primary care office. | |
Clinicaltrials.gov
| Effects of Rosiglitazone on Serum Ghrelin and Peptide YY Levels | Completed | Type 2 Diabetes Mellitus, Obesity | Drug - rosiglitazone | Baskent University, Other | Female | 45 Years - 65 Years | Phase 4 | Interventional | We aimed to evaluate the effects of rosiglitazone on serum ghrelin and peptide yy levels in
diabetic women. | |
Clinicaltrials.gov
| A Controlled Trial of Protein Enrichment of Meal Replacements for Weight Reduction With Retention of Lean Body Mass | Completed | Weight Loss, Obesity | Dietary Supplement, Dietary Supplement - high protein, standard protein | University of California, Los Angeles, National Institutes of Health (NIH), Other, NIH | | 30 Years - N/A | N/A | Interventional | Study hypothesis: High protein diets have been shown to make people full and and help to
retent of muscle mass. This study was designed to determine effects of a protein- enriched
meal replacement (MR) on weight loss and muscle mass retention by comparison to an equal
calorie carbohydrate-enriched MR.
Methods: Single blind, placebo-controlled, randomized outpatient weight loss trial in 100
obese men and women comparing two equal calorie meal plans.,1) 2.2 g protein/kg of LBM per
day [high protein diet (HP)] or 2) 1.1 g protein/kg LBM/day standard protein diet (SP). Body
weight, body composition, and lipid profiles were measured at baseline and 12 weeks. | |
Clinicaltrials.gov
| Promotion of Exercise and Health in Obesity | Unknown status | Obesity | Behavioral - SDT and Motivational Interviewing in Obesity Treatment | Technical University of Lisbon, Other | Female | 25 Years - 50 Years | N/A | Interventional | The primary objectives of this randomized clinical trial are a) to implement and test the
impact of a 1-year lifestyle obesity treatment program based on Self-Determination Theory on
3-year change in physical activity and motivation for exercise/physical activity, body weight
and fat, and selected eating variables, b) to identify behavioral and psychosocial
theory-based moderators or mediators of primary outcomes, especially physical activity and
body weight. | |
Clinicaltrials.gov
| Melatonin Metabolism Abnormality in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine | Active, not recruiting | Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Obesity, Metabolic Syndrome | Drug - olanzapine and melatonin | Seattle Institute for Biomedical and Clinical Research, Eli Lilly and Company, Other, Industry | | 18 Years - 65 Years | N/A | Interventional | Atypical antipsychotic medications, such as olanzapine, cause metabolic side effects,
including weight gain, extra fat around the middle of the body, high blood sugar, and high
cholesterol. One of the mechanisms by which these medications may cause these effects is by
reducing plasma melatonin. This study is a pilot project to evaluate 1) the effect of
olanzapine on melatonin secretion levels and 2) the effect of melatonin on olanzapine-induced
changes in melatonin secretion in patients with schizophrenia, schizoaffective, or bipolar
disorder. | |
Clinicaltrials.gov
| A Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers | Completed | Obesity | Drug - trodusquemine | Genaera Corporation, Industry | | 18 Years - 55 Years | Phase 1 | Interventional | The purpose of this study is to evaluate the safety and tolerance of single intravenous
(through a vein) doses of trodusquemine. Different amounts of trodusquemine will be given to
each volunteer group throughout the study. Another purpose is to evaluate the
pharmacokinetics (PK - the study of the way the drug enters and leaves the blood and tissues
over time) of trodusquemine. Finally, this study will also determine whether trodusquemine
has any effect on appetite, mood or behavior, and selective biomarkers (substances in your
blood that may change in response to the study drug). | |
Clinicaltrials.gov
| Epidemiology of Body Mass Index Rebound | Completed | Cardiovascular Diseases, Heart Diseases, Obesity | | National Heart, Lung, and Blood Institute (NHLBI), NIH | | 3 Years - 7 Years | | Observational | To investigate the relationship between obesity, body mass index (BMI) rebound, body
composition changes, associated factors (e.g., diet, physical activity), and cardiovascular
risk factor status in a longitudinal study of young children, age three at the beginning of
the study. | |
Clinicaltrials.gov
| A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients | Completed | Obesity | Drug, Drug - exenatide, placebo | AstraZeneca, Eli Lilly and Company, Industry, Industry | | 18 Years - N/A | Phase 2 | Interventional | This is a multicenter study designed to compare the effect of exenatide plus a lifestyle
modification plan versus placebo plus a lifestyle modification plan on weight loss in
non-diabetic, obese subjects. | |
Clinicaltrials.gov
| Investigation of Cardiac Function and Cardiovascular Risk Factors in Marathon Runners- The Munich Marathon Study | Completed | Modes of Exercise and Myocardial and Endothelial Function, Microcirculation, Subclinical Endorgan Damage, Obesity | | Technische Universität München, Ludwig-Maximilians - University of Munich, Other, Other | Male | 30 Years - 60 Years | | Observational | The purpose of this study is to determine the cardiovascular risk involved in the exertional
exercise of marathon running. The researchers aim to investigate the beneficial effects of
regular well-dosed exercise on health and compare these findings with the effects of the
extreme strains of marathon running. Subclinical injuries to heart and arteries are being
investigated in different groups of runners, including obese participants. | |
Clinicaltrials.gov
| Adipose Secretory Function in Patients Before & After Laparoscopic Surgery | Completed | Obesity | Procedure - Cytokines assessed from fat tissue | Vanderbilt University, Other | | 18 Years - 65 Years | Phase 3 | Interventional | The central hypothesis of our study is that metabolic and hemodynamic improvements following
gastric bypass surgery are mediated by downregulation of inflammation-related adipokines
produced by the intra-abdominal adipose tissue such as Visfatin. | |
Clinicaltrials.gov
| Vitamin D Effects in Overweight Patients | Completed | Overweight, Obesity | Dietary Supplement - vitamin D | Heart and Diabetes Center North-Rhine Westfalia, Other | | 18 Years - 70 Years | N/A | Interventional | The purpose of the study is to investigate in overweight patients who are on a telemedically
guided weight loss program the influence of a daily vitamin D supplement on
- weight loss and body composition,
- selected inflammation markers and biochemical parameters of lipid and glucose metabolism
.
- selected clinical parameters such as blood pressure, heart rate | |
Clinicaltrials.gov
| Behavioral Self-Regulation | Completed | Obesity | Behavioral - self-regulation | The Miriam Hospital, Other | | 18 Years - 35 Years | N/A | Interventional | The purpose of this pilot study is to determine whether incorporating self-regulation
training using daily weighing is efficacious within a behavioral weight loss program
specifically targeting young adults. | |
Clinicaltrials.gov
| Lifestyle Intervention in Primary Health Care - the Björknäs Study | Completed | Hypertension, Type 2 Diabetes, Obesity, Dyslipidemia | Behavioral - Exercise and diet - based on DPS and DPP | Umeå University, County Council of Norrbotten, Sweden, Other, Other | | 18 Years - 65 Years | Phase 3 | Interventional | The purpose of this study is to determine whether a short group intervention programe aiming
at lifestyle changes at a local health centre can improve risk factors for cardiovascular
disease | |
Clinicaltrials.gov
| Effects of Chromium Picolinate on Food Intake | Completed | Obesity, Atypical Depression | Drug - Chromium Picolinate | Pennington Biomedical Research Center, Nutrition 21, Inc., Other, Industry | Female | 18 Years - 50 Years | N/A | Interventional | The purpose of this study is to test the effects of chromium picolinate on food intake, food
cravings, eating attitudes, and appetite. If chromium picolinate is found to have a
beneficial impact on satiety and food intake, then this supplement may be an alternative or
adjunctive treatment for overweight people desiring to modify their food intake. The primary
hypothesis of this study is that among individuals who report being carbohydrate cravers,
chromium picolinate supplementation will reduce food intake during a test lunch meal and
produce greater satiety in comparison to a placebo. | |
Clinicaltrials.gov
| Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise | Terminated | Obesity, Diabetes Mellitus Type 2 | Drug, Drug, Other - Rimonabant, placebo (for Rimonabant), Diet and exercise | Sanofi, Industry | | 20 Years - N/A | Phase 3 | Interventional | The primary objective of this study is to assess the efficacy of Rimonabant (SR141716)
compared to placebo on change in HbA1c and on relative change in body weight over 36 weeks in
obese type 2 diabetic patients inadequately controlled with diet and exercise alone.
The secondary objectives are:
- To evaluate the effect of Rimonabant compared to placebo on other parameters related to
the glucose control, waist circumference, Body Mass Index and metabolic parameters;
- To evaluate the safety and tolerability of Rimonabant compared to placebo;
- To evaluate the pharmacokinetics of Rimonabant. | |
Clinicaltrials.gov
| Effect of Weight Loss on Prostate Cancer Pathology | Completed | Obesity, Prostate Cancer | Behavioral, Other - Weight Loss, No Weight Loss Group | VA Office of Research and Development, U.S. Fed | Male | N/A - N/A | N/A | Interventional | The purpose of this study is to determine if weight loss prior to radical prostatectomy
effects chemical substances in the blood stream and prostate tissue that may affect prostate
cancer development and progression. | |
Clinicaltrials.gov
| Correlation of Hyperghrelinemia With Carotid Artery Intima-Media Thickness in Children With Prader-Willi Syndrome | Completed | Prader Willi Syndrome, Obesity | | Samsung Medical Center, Other | | 1 Year - 18 Years | | Observational | Prader-Willi syndrome (PWS) is a genetic disorder characterized by childhood-onset obesity
and endocrine dysfunction that leads to cardiovascular disability and early death within the
first 3 decades of life.To assess the significance of risk factors for future disabilities,
carotid artery intima-media thickness (IMT) was measured and correlated with known
atherosclerotic risk factors in 27 children with PWS and 24 age-, sex-, and body mass index
(BMI)-adjusted controls. | |
Clinicaltrials.gov
| Multi-Center Pre-Bariatric Weight Loss Study | Completed | Obesity | Device, Procedure - GI Sleeve Implantable weight loss device (EndoBarrier), Sham Procedure | GI Dynamics, Industry | | 18 Years - 55 Years | Phase 2 | Interventional | The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients
who require weight loss prior to their Bariatric surgery. | |
Clinicaltrials.gov
| Optimizing Image Quality in Obese Patients Undergoing Coronary Computed Tomography (CT) Angiography | Completed | Coronary Angiography, Obesity, Coronary Disease | | William Beaumont Hospitals, Other | | 18 Years - N/A | | Observational | The purpose of this cardiovascular imaging research is to look at ways to improve the way we
can look at the pictures of the heart. Patients undergo CT scans of the heart for a variety
of reasons, including symptoms and/or tests suggestive of coronary artery disease (chest
pain, shortness of breath, abnormal stress test, follow up exam of known/existing coronary
disease, abnormal calcium score, etc.) This study involves finding ways to optimize quality
of the scan in persons of size. This is because in patients with a BMI (body mass index) of
greater than 40, it is usually difficult to "see" all the arteries around the heart
satisfactorily. Body mass index is a number that we can get by putting your height and weight
in a formula. The purpose of this study is to use a new computer software program to help us
interpret your heart study. | |
Clinicaltrials.gov
| Effect of Diet Plus Sibutramine on Hormonal and Metabolic Features in Overweight and Obese Women With PCOS | Completed | Obesity, Polycystic Ovary Syndrome | Drug - Sibutramine | Hippocration General Hospital, Other | Female | 18 Years - 40 Years | Phase 4 | Interventional | Studies on the effect of sibutramine, an anti-obesity drug, on hormonal and metabolic
features of women with polycystic ovary syndrome (PCOS) are lacking.
The objective of this study is to examine the effect of sibutramine plus hypocaloric diet on
body composition, hormonal and metabolic parameters and insulin resistance in obese patients
with PCOS.
Overweight and obese women with PCOS were placed in a hypocaloric diet plus sibutramine (10
mg/day) for the first month and then on a hypocaloric diet plus sibutramine (10 mg/day) or
hypocaloric diet only for the subsequent 6 months.
The main outcome measures are: Body composition, hormonal and metabolic features and insulin
sensitivity (OGTT) at baseline, at 3 and 6 months of treatment. | |
Clinicaltrials.gov
| Family Lifestyle Overweight Prevention Program | Completed | Overweight, Obesity | Behavioral, Behavioral - FLOW, SelfHelp | Baylor College of Medicine, Other | | 10 Years - 16 Years | Phase 3 | Interventional | The purpose of the study was to design a weight management program for Mexican American youth
and to determine the effectiveness of the program for weight management compared to a self
help program.
1. At the end of 6 months, individuals randomly assigned to Intensive Intervention (II)
(instructor/trainer led intervention) will lose more weight than individuals assigned to
Self Help (SH) only.
2. At the end of 1 year, individuals randomly assigned to II will maintain their weight
losses better than individuals assigned to SH.
Secondary hypotheses will include examination of main effects and interactions at the end of
6 months with the following secondary dependent measures: treatment adherence (e.g.,
attendance, food diaries, exercise diaries), blood levels, changes in percent body fat,
overall psychological functioning (PEDS-QL 4.0), and eating behaviors as assessed by food
frequency checklists. | |
Clinicaltrials.gov
| Mechanism of Growth Hormone Effects on Adipose Tissue | Completed | Obesity | Drug - rhGH | Pennington Biomedical Research Center, Other | Male | 40 Years - 70 Years | Phase 4 | Interventional | Growth hormone treatment in humans has been shown to decrease body fat. This study aims to
determine what adipose tissue depots are affected by GH and what is the mechanism. | |
Clinicaltrials.gov
| Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101) | Unknown status | Obesity | Drug - oleoyl-estrone (MP 101) | Manhattan Pharmaceuticals, Industry | | 18 Years - 65 Years | Phase 2 | Interventional | The purpose of this study is to evaluate the safety, preliminary efficacy, and
pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult
subjects. | |
Clinicaltrials.gov
| Effect of Short-Term Beta-Cell Rest in Adolescents and Young Adults With Type 2 Diabetes Mellitus | Completed | Obesity, Overweight, Diabetes Mellitus, Type 2 | | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH | | 8 Years - 25 Years | | Observational | This study will determine whether resting beta cells (cells in the pancreas that produce
insulin) for 2 weeks will improve the ability of patients with Type 2 diabetes mellitus
(T2DM) to make insulin. Beta cells can rest by giving patients insulin shots. The study will
also examine how teenagers with T2DM feel about having diabetes and explore differences
between young people with and without T2DM.
This study includes patients 12 to 25 years of age with T2DM who are overweight and who were
diagnosed within 2 years of enrolling in the study. Healthy individuals of normal weight or
who are overweight are also eligible. Candidates are screened with a medical history,
physical examination and laboratory tests.
Participants with T2DM are assigned to one of two groups. Group 1 takes an anti-diabetes
medicine called metformin and follows a diet prescribed by a study staff dietitian for 2
weeks. Group 2 takes metformin, follows the prescribed diet, and receives insulin through a
pump under the skin for 2 weeks. During these two weeks, all participants have the following
tests:
- Frequent blood sugar checks.
- Oral glucose tolerance test (routine diabetes test in which blood samples are drawn
before and several times after the subject drinks a sugary solution).
- Arginine stimulation to test the response of the body to arginine, a normal ingredient
of food that stimulates the release of insulin. Two catheters are placed into veins in
the arms, one to administer a liquid containing arginine, the other to draw the blood
samples.
- Ultrasound of the blood vessels in the neck to check for hardening of the arteries.
- Metabolism test to measure the amount of oxygen used during rest. The subject breathes
normally during rest while wearing a canopy over his or her head for about 20 minutes.
- MRI scans of the abdomen to examine the amount of fat in the belly (at the beginning and
end of the study)
- DEXA scan to determine percent body fat.
- Tests to explore quality of life and feelings about health, work or school, friends and
family.
- Exercise testing on a treadmill or stationary bicycle.
- Genetic studies for information on diabetes and obesity.
Normal volunteers have blood draws, oral glucose tolerance testing, MRI scan, DEXA scan,
psychological testing, exercise testing, and genetic testing. | |
Clinicaltrials.gov
| Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children | Completed | Obesity | Behavioral, Behavioral - Parents and children group, Parent's group | Rabin Medical Center, Pfizer, Other, Industry | | 5 Years - 10 Years | N/A | Interventional | Randomized, controlled, open, comparative intervention study in 270 children at risk for
obesity.Patients will be randomly allocated into one of two behavior intervention groups or
control group in ratio of 1:1:1.The study will consist of two main periods: an intervention
period of 3 months followed by 21 months of a follow up period. During the intervention
period, participants (parents or both parents and children, depending on randomization) will
attend a behavior intervention program once a week, each session will last one hour and would
be guided by dietician and psychologist. Follow up visits will be performed at the clinic
(for participants in al 3 groups) at months 0, 3, 12 and 24. | |
Clinicaltrials.gov
| Obesity Intervention "Obeldicks" for Obese Children, Adolescents and Their Parents | Active, not recruiting | Obesity | Behavioral - obesity intervention | University of Witten/Herdecke, Other | | 6 Years - 18 Years | | Observational | The intervention program "Obeldicks" was developed for obese children aged 6 to 16 years.
This intervention is gender- and age specific. The 12-months intervention is based on
nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality
of structure, process and results of the intervention. Primary outcome measure is change of
weight status as standard deviation score of BMI. Furthermore, cardiovascular risk factor
profile, hormones (e.g. iGF-I, thyroid hormones, vitamin D status)adipocytokines, GI-
hormones, intima media thickness are measured prior to and after the one-year intervention.
The changes of these hormones and adipocytokines will allow to answer the questions whether
the alterations of these hormones are a cause or consequence of overweight. Additionally, a
genetic screening is performed to characterize the participants to probably predict response
to intervention. | |
