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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 | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
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 | The Role of COX-2 Inhibition in Salt Sensitivity of Blood Pressure | Completed | Hypertension | Drug, Other - celecoxib (Celebrex), Placebo | University of Delaware, Christiana Care Health Services, Other, Other | 22 Years - 50 Years | Phase 4 | Interventional | The purpose of this study is to determine if the drug Celebrex changes the way the kidney gets rid of salt and maintains blood pressure. | ||
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 | Nice Morning- Safety and Efficacy Observational Study of Telmisartan in Hypertensive Patients in Multicenters | Completed | Hypertension | Boehringer Ingelheim, Industry | 20 Years - 80 Years | Observational | The purpose of this observational study is to survey the safety and effectiveness of the product under the real condition of usual practice in Taiwanese hypertensive patients. During the 8-week observation, the safety profiles and the clinical evaluation in between doses through blood pressure (BP) measurement for overall effectiveness of telmisartan therapy will be concluded. | ||||
Clinicaltrials.gov | The Japan-Combined Treatment With Olmesartan and a Calcium Channel Blocker Versus Olmesartan and Diuretics Randomized Efficacy Study (J-CORE) | Completed | Hypertension | Drug, Drug - Olmesartan medoxomil +Azelnidipine, Olmesartan medoxomil + Hydrochlorothiazide | Jichi Medical University, Other | 30 Years - 85 Years | Phase 4 | Interventional | The purpose of this study is to investigate which combination therapy is more effective for improving the blood pressure (BP) and reducing target organ damage in Japanese hypertensive patients: Angiotensin II receptor blocker (ARB) plus calcium channel blocker (CCB) or ARB plus diuretics. | ||
Clinicaltrials.gov | Comparison of Effects of Telmisartan and Valsartan on Neointima Volume in Diabetes | Completed | Hypertension, Diabetes, Coronary Artery Disease | Drug, Drug - telmisartan, valsartan | Korea University Anam Hospital, Other | 18 Years - 80 Years | Phase 4 | Interventional | People with diabetes mellitus are more prone to coronary heart disease, stroke, and peripheral vascular disease, and diabetes mellitus has been regarded as an independent risk factor for the progression of coronary artery disease. Several studies have been reported that diabetes increased the risk of cardiovascular mortality in both men and women. With the introduction of drug-eluting stents (DESs), the angiographic rates of restenosis at later months have reduced dramatically in several studies. However, even with DESs, diabetic patients showed increased rates of restenosis and late loss index compared with nondiabetic patients. Diabetes has been considered to be a predictor of poor prognosis after percutaneous coronary intervention with drug-eluting stents. Long-term clinical and angiographic outcomes after percutaneous coronary intervention (PCI) with drug-metal stents (DESs) have been demonstrated to be worse in diabetic patients compared with nondiabetic patients. In the era of DESs, no study has compared the effects of telmisartan and valsartan on neointima volume with intravascular ultrasound (IVUS) at 8 months after zotarolimus-eluting stent implantation in hypertensive type 2 diabetic patients. Telmisartan, which is well-known for its selective peroxisome proliferator-activated receptor (PPAR)-γ activity with its anti-inflammatory and antiproliferative properties, could be an appropriate therapeutic option for treating hypertensive diabetic patients with significant coronary artery diseases requiring stent implantation. In contrast, valsartan is an angiotensin receptor blocker with negligible PPAR-γ activity. Increasing interest remains in the identification of systemic pharmacological therapies to prevent coronary restenosis especially in diabetic patients. | ||
Clinicaltrials.gov | Randomized, Parallel, Comparison, Double-Blind Efficacy & Safety Study of APROVEL Versus Placebo in Chinese Patients With Hypertensive Type II Diabetic Patients With Microalbuminuria | Completed | Hypertension | Drug, Drug - Irbesartan, placebo | Sanofi, Bristol-Myers Squibb, Industry, Industry | 30 Years - 75 Years | Phase 3 | Interventional | To evaluate the effects and safety of irbesartan on proteinuria in hypertensive patients with type Ⅱdiabetes mellitus. | ||
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 | Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure | Completed | Hypertension, Pre-Hypertension | Behavioral, Other - DASH-4-Teens, Routine Care | University of Cincinnati, Other | 11 Years - 18 Years | N/A | Interventional | The purpose of this study is to examine the long term effects of a 24-week clinically-based behavioral nutrition intervention emphasizing the DASH diet compared to routine nutrition care on changing diet quality, blood pressure, hypertension status, and vascular function in adolescents with elevated blood pressure. | ||
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 | Vitamin D for Chemoprevention | Completed | Gastrointestinal Cancers, Prostate Cancer, Hypertension | Drug, Dietary Supplement - Vitamin D, Placebo | Dana-Farber Cancer Institute, Harvard School of Public Health (HSPH), Other, Other | 30 Years - 80 Years | Phase 1 | Interventional | This study will help us know the effects of Vitamin D pills in Blacks. The results of this study may be the first step in creating ways to prevent the risks of colon and prostate cancer. It will also help us develop ways to reduce colon cancer and prostate cancer among Blacks. This study will find out if Vitamin D pills can increase Vitamin D to healthy levels in our bodies. | ||
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 | Levels of Inflammatory Markers in the Treatment of Stroke-An SPS3 Ancillary Study | Completed | Hypertension, Stroke | Columbia University, National Institute of Neurological Disorders and Stroke (NINDS), Other, NIH | 30 Years - N/A | Observational | The goals of this trial are to determine the prognostic significance of an elevated level of inflammatory blood markers in people who have experienced small subcortical strokes and who are enrolled in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial. | ||||
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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