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Integrated Clinical Trials is a virtual database currently indexing clinical trials from: EU Clinical Trials Register and ClinicalTrials.gov.
(last updated: Nov 28, 2022)
Clinical Trials Information| Database | Title | Recruitment | Conditions | Intervention | Sponsored By | Gender | |||||
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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. | |||
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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. | ||
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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. | ||
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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. | |
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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. | |
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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. | ||
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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. | ||
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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. | ||
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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. | ||||
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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. | ||
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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. | ||
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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 | ||||
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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. | ||
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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. | ||
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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. | |||
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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. | ||||
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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. | ||
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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 | ||||
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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. |
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