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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. | |
Clinicaltrials.gov | Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes | Completed | Diabetes, Diabetes Mellitus, Type 2 | Drug, Drug, Drug, Drug, Drug, Drug, Drug - liraglutide, placebo, liraglutide, liraglutide, glimepiride, metformin, placebo | Novo Nordisk A/S, Industry | 18 Years - 80 Years | Phase 3 | Interventional | This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes | ||
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Clinicaltrials.gov | Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes | Completed | Diabetes, Diabetes Mellitus, Type 2 | Drug - biphasic insulin aspart | Novo Nordisk A/S, Industry | 30 Years - 70 Years | Phase 3 | Interventional | This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 50 three times a day to biphasic insulin aspart 70 three times a day in non-obese and obese with type 2 diabetes. | ||
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Clinicaltrials.gov | Efficacy and Safety of Insulin Detemir in Type 2 Diabetes Inadequately Controlled on OHA Therapy Alone | Completed | Diabetes, Diabetes Mellitus, Type 2 | Drug, Drug - insulin detemir, insulin NPH | Novo Nordisk A/S, Industry | 20 Years - N/A | Phase 3 | Interventional | This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in type 2 diabetes when added to current OHA treatment. | ||
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Clinicaltrials.gov | Yoga for the Treatment of Metabolic Syndrome | Completed | Metabolic Syndrome | Behavioral - Restorative yoga therapy | University of California, San Francisco, Cliff Lede Foundation, Other, Other | 30 Years - 65 Years | Phase 1 | Interventional | We tested the following hypotheses: 1. That a standardized yoga therapy will improve insulin sensitivity (primary outcome), and other features of the metabolic syndrome such as hypertension and dyslipidemia (secondary outcomes), we will perform a 2-hour oral glucose tolerance test, fasting blood tests, and a physical examination before and after randomization of subjects to a 10-week yoga therapy intervention or wait-list control group. 2. That a yoga therapy is feasible in overweight and underactive individuals with the metabolic syndrome, that adherence to a yoga intervention is acceptable, and that yoga therapy is associated with improved quality of life, we will assess the adherence to twice-weekly yoga group sessions (for weeks1-5) and weekly yoga group sessions (for weeks 6-10), frequency of home yoga therapy practice, and self-reported quality of life before and after the intervention in both treatment groups. 3. To elucidate a potential mechanism for the effect of yoga on changes in insulin resistance by evaluating markers of inflammation from adipose tissue (adipocytokines). We hypothesize that these biochemical parameters will show modest improvement with yoga therapy and that changes in these parameters will be associated with improvements in insulin sensitivity. | ||
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Clinicaltrials.gov | Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes | Completed | Diabetes, Diabetes Mellitus, Type 2 | Drug - biphasic insulin aspart | Novo Nordisk A/S, Industry | 18 Years - N/A | Phase 4 | Interventional | This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes failing OAD therapy. | ||
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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. | ||
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Clinicaltrials.gov | Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy | Completed | Diabetes, Diabetes Mellitus, Type 2 | Drug, Drug, Drug, Drug - biphasic insulin aspart, insulin glargine, metformin, pioglitazone | Novo Nordisk A/S, Industry | 18 Years - 75 Years | Phase 3 | Interventional | This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy. | ||
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Clinicaltrials.gov | Effect of Raised CBF During CEA on Cognition in DM Patients | Terminated | Carotid Artery Disease, Carotid Artery Stenosis, Diabetes, Cognitive Dysfunction | Procedure, Device - Carotid endarterectomy, Shunt | Columbia University, Other | 18 Years - N/A | N/A | Interventional | The purpose of this study is to determine if we can reduce the incidence of cognitive dysfunction - difficulty in performing certain pencil-paper, memory, finger dexterity and thinking type of tasks called neuropsychometric tests - in patients with adult onset diabetes mellitus (DM) undergoing surgery on the carotid artery (CEA). We hypothesize that cognitive dysfunction can be decreased in patients with type II DM by augmenting cerebral blood flow with a shunt during carotid endarterectomy compared to patients with Type II DM who are treated with "conventional" management in which a shunt is placed only if the electroencephalogram (EEG) indicates cerebral ischemia. | ||
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Clinicaltrials.gov | Pilot Study to Assess the Proteome in Human Atrial Tissue | Completed | Diabetes, Cardiomyopathy | National Heart, Lung, and Blood Institute (NHLBI), NIH | 18 Years - 80 Years | Observational | The concept of diabetic cardiomyopathy was initially defined more than 30 years ago, as cardiac failure in diabetic subjects in the absence of underlying coronary artery disease. Diabetes is also thought to contribute to earlier stage cardiac systolic dysfunction and/or to isolated diastolic dysfunction, in excess of underlying coronary artery disease and hypertension. More globally, it is recognized that subjects with type 2 diabetes have more extensive cardiovascular disease and a worse outcome for a similar level of disease than non-diabetic subjects. Despite this epidemiological evidence, the biological programming underpinning the myriad presentations of the diabetic heart' are poorly characterized in humans. Proteomics has emerged as an unbiased technology that enables the measurement of large numbers of steady-state protein levels. The potential to identify a diabetes associated proteomic signature in the heart would be a novel approach to identify putative biological programs altered by the diabetic state. A portion of the right atrial appendage is removed to insert the cardiac bypass machine cannula in certain cardiothoracic procedures. This tissue is usually discarded, however, we propose that it could be employed to examine whether otherwise similar subjects with and without diabetes have distinct atrial proteomic signatures. This pilot study may provide insight into potential biological pathways that orchestrate the worse cardiac prognosis in type 2 diabetic versus non diabetic control subjects. | ||||
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Clinicaltrials.gov | GLP1R Polymorphisms and Response to GLP1 | Completed | Diabetes | Drug - GLP-1 | Mayo Clinic, Merck Sharp & Dohme Corp., Other, Industry | 18 Years - 40 Years | N/A | Interventional | Glucagon-like Peptide-1 (GLP-1) is an important incretin hormone which acts as a powerful insulin secretagogue. Defects in GLP-1 synthesis and secretion are thought to be part of the pathogenesis of type 2 diabetes. Furthermore GLP-1 based therapy is an important part of the therapeutic armamentarium for the treatment of type 2 diabetes. The GLP-1 receptor (GLP1R) is the principal site of action of GLP-1 and GLP-1 receptor agonists like exenatide and liraglutide. The gene coding for this receptor, GLP1R, is highly polymorphic and contains numerous non-synonymous Single Nucleotide Polymorphisms (nsSNPs) which could potentially alter response to endogenous or exogenous GLP-1 or GLP-1R agonists. Indeed there is some in vitro data to support this concept. We propose to utilize a hyperglycemic clamp to test the insulin secretory response to infused GLP-1 in healthy volunteers to determine the effect of genetic variation in GLP1R on response to GLP-1. | ||
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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 | 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. |
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