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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 InformationDatabase | 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. | |||
Clinicaltrials.gov | Exercise Changes to Peripheral Blood Mononuclear Cells in Children | Withdrawn | Physical Fitness, Obesity, Child Development, Growth | University of California, Irvine, Other | 8 Years - 18 Years | Observational | The goal of this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 | The Role of Leptin Receptors in NASH | Completed | Nonalcoholic Steatohepatitis, Metabolic Syndrome | Other - no interventions, only regular blood-draw | University of California, Davis, Other | 18 Years - 65 Years | Observational | NAFLD is a spectrum of liver diseases associated with varying degrees of hepatic steatosis, inflammation, and in some cases, fibrosis. NAFLD is a common observation in all demographics, but the prevalence of NAFLD and nonalcoholic steatohepatitis (NASH) is especially high in the morbidly obese population. Leptin is a cytokine that is encoded by the ob gene and primarily secreted by adipose tissue. The production of serum leptin increases with progressive obesity. Because of this observation, there has been significant interest in potential role of leptin in NAFLD. Our hypothesis is that we will find increased hepatic leptin and leptin receptor expression as the degree of hepatic injury worsens in NAFLD. | |||
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 | 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 of the Metabolic Syndrome in SPR Taking Antipsychotics | Unknown status | Metabolic Syndrome, Schizophrenia | Seoul National Hospital, Korea Otsuka Pharmaceutical Co., Ltd., Other, Industry | 18 Years - 65 Years | Observational | The purpose of this study is to assess the cross-sectional prevalence of the metabolic syndrome in patients with schizophrenia taking antipsychotics. | ||||
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 | Cardiovascular Risk Factors in an Ambulatory Urban Patient Population | Completed | Cardiovascular Risk Factors, Metabolic Syndrome, Lifestyle Modification, Coronary Artery Disease, Stroke | Behavioral, Behavioral, Behavioral, Behavioral, Behavioral - Dietary and nutritional modification, Stop smoking, Regular physical activities, Weight reduction to normal ranges, Regular intake of polyphenols, esp. from Ilex paraguayensis | Heidelberg University, Other | 18 Years - N/A | Observational | According to WHO estimations, cardiovascular diseases (CVDs) are the number one cause of death globally. More people die annually from CVDs than from any other cause. An estimated 17.5 million people died from CVDs in 2005, representing 30% of all global deaths. Of these deaths, an estimated 7.6 million were due to coronary heart disease and 5.7 million were due to stroke. Over 80% of CVD deaths take place in low- and middle-income countries and occur almost equally in men and women. In Paraguay, prevalence of classic risk factors, as well as new ones, like the metabolic syndrome are not completely known. Government health policies in industrialized countries are focusing on programs to modify cardiovascular risk factors. In developing countries, prevention of coronary heart disease and stroke through modification of cardiovascular risk factors are not playing a large role at the moment. The aim of this study is to define the effects of changes in lifestyle on cardiovascular risk factors, when added to optimized standard pharmacological therapy for arterial hypertension, diabetes mellitus and hyperlipidemia, in an ambulatory urban patient population. | |||
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 | 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 | 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 | 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 | 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 | 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 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 | 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. | |||
Clinicaltrials.gov | Gene Expression and Inflammation in Overweight Subjects | Completed | Obesity, Inflammation, Nutrition Therapy | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH | 25 Years - 45 Years | Observational | This study will look at gene expression (whether particular sets of genes are activated ["turned on"] or deactivated ["turned off"]) in overweight people as compared to non-overweight individuals. It will also investigate the potential role of inflammatory and protective substances that are produced naturally by the body within fat tissue. Findings from the study may lead to the development of ways to predict who will respond best to diet therapy. Healthy individuals between 25 and 45 years of age may be eligible for this study. Overweight subjects must have a BMI of 25 to 40, and non-overweight control subjects a BMI of 19 to 24.9. Candidates are screened with a medical history, physical examination, blood tests and electrocardiogram (EKG). They are instructed to record their dietary intake for a 3-day period and to collect their urine for a 24-hour interval. Participants have their food records reviewed a week after the screening visit. They are then scheduled for an overnight admission to the Clinical Center. Non-overweight subjects have one or two inpatient stays; overweight subjects have six inpatient stays plus frequent nutrition counseling sessions. During the 2-day hospital admissions, the following studies are performed: - DEXA scan to determine the percentage of body fat tissue. The subject lies on a table for about 15 to 60 minutes while the body composition is measured with very low-dose x-rays. - Single-slice CT scan to compare the amount of fat tissue under the skin with that in the abdomen. The subject lies on a table for about 5 to 10 minutes while the CT scanner measures body composition with very low-dose x-rays. - Subcutaneous fat microdialysis to investigate how weight loss affects the activity of fat tissue. A small tube (catheter) is placed into the fat tissue under the skin of the abdomen after numbing the skin with a local anesthetic. Fluid samples are collected through the tube. The procedure lasts overnight. In five non-overweight controls, a small amount of a substance called leukotriene B4 is put into their fat tissue to help adjust the instruments used in the study. - Air-displacement plethysmography to measure body composition. Subjects wear close-fitting clothing and enter a small capsule called a Bod-Pod. They breathe normally in the capsule while their body fat composition is studied. - Blood tests. Blood samples are drawn to analyze thyroid hormones, lipids, glucose, electrolytes, clotting factors, kidney function, red cells and DNA. - Euglycemic-hyperinsulinemic clamp to measure the effects of insulin in the body and to derive an index of insulin-sensitivity. Catheters are placed in a vein in an arm and in a vein in the hand on the other side of the body. Insulin and glucose are infused through the catheter in the arm, and blood samples are drawn from the catheter in the hand every 5 minutes to measure glucose levels. The test lasts about 2 hours. - Subcutaneous fat biopsy to find out how weight loss affects fat tissue characteristics, gene regulation and the ability to store glucose. A small sample of fat tissue is obtained from the skin of the abdomen after numbing the area with an anesthetic. - Nutrition counseling for overweight subjects. A nutritionist reviews the food record and designs a personalized diet for each participant. - Weight loss intervention for overweight subjects. In addition to individual nutritional counseling, group sessions are provided every 2 weeks during the first 3 months of the study and then every month. | ||||
Clinicaltrials.gov | Risk Assessment of Long-Haul Truck Drivers | Completed | Gonorrhea, Chlamydia Infections, Hepatitis B, Hepatitis C, Diabetes Mellitus, Hypertension, Obesity, HIV Infections, Hyperlipidemia | Wake Forest University Health Sciences, National Institute of Mental Health (NIMH), University of Alabama at Birmingham, Other, NIH, Other | 21 Years - N/A | Observational | International studies have repeatedly documented a substantial prevalence of sexual risk behaviors and high rates of human immunodeficiency virus (HIV) and other sexually transmitted infections (STI) ranging from 5%-56% amongst long-distance truck drivers ("truckers") living in diverse international settings including India, Bangladesh, South Africa, China, Laos and Thailand. The prevalence of sexual risk factors and STI/HIV in US drivers is unknown. This proposal will provide both qualitative and quantitative data on HIV risk behaviors by interviewing and testing truckers working for established long-distance trucking firms, the sector which accounts for most of the jobs in the trucking and warehousing industry in the United States. The data obtained from this study will be used to inform the development of an HIV prevention intervention for long-haul truck drivers. | ||||
Clinicaltrials.gov | Evaluating the Link Between Neighborhood Environments and Obesity Among African American Women | Completed | Obesity | Boston University, National Heart, Lung, and Blood Institute (NHLBI), Other, NIH | Female | 21 Years - 69 Years | Observational | African American women have higher rates of obesity than women of any other racial or ethnic group in the United States. Obesity can have many causes, including genetic and environmental factors. This study will examine how neighborhood environments influence the occurrence of obesity among African American women. | |||
Clinicaltrials.gov | Dallas Heart Study 2: Return Clinic Visit for the Dallas Heart Study Cohort | Completed | Atherosclerosis, Congestive Heart Failure, Left Ventricular Hypertrophy, Diabetes Mellitus, Hypertension, Obesity, Metabolic Syndrome X, Myocardial Infarction | University of Texas Southwestern Medical Center, Donald W. Reynolds Foundation, Other, Other | 35 Years - 70 Years | Observational | The Dallas Heart Study (DHS-1) is a large, multi-ethnic, population-based epidemiological study designed to identify determinants of atherosclerotic heart disease (ASHD) in a representative United States (US) urban environment. This study completed enrollment in 2003. Our objective is to pinpoint factors contributing to progression: 1. from health to ASHD risk; 2. from ASHD risk to subclinical ASHD; and 3. from subclinical to clinical ASHD. Identification of the critical factors in these transitions will enable targeted implementation of appropriate therapy to interdict before clinical ASHD develops. |
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