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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 | High Density Lipoprotein Turnover | Terminated | Obesity | Drug, Drug - Placebo, Rimonabant | Sanofi, Industry | 35 Years - 65 Years | Phase 3 | Interventional | The objective of the study is to evaluate the effect of Rimonabant 20mg in comparison to placebo, on HDL and VLDL lipoprotein kinetics, over a 12 months period. Primary objectives: - To assess effect of Rimonabant on HDL ApoA-I fractional catabolic rate (FCR). Secondary objectives: - To assess effect of Rimonabant on HDL ApoA-I production rate (PR) and on other lipoprotein kinetics. - To assess effect of Rimonabant on lipids, glycemic and inflammatory parameters - To assess effect of Rimonabant on body composition - To assess safety of Rimonabant | ||
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Clinicaltrials.gov | A 1-Year Study On The Effects Of CP-945,598 For The Treatment Of Obesity In Overweight Type 2 Diabetic Patients | Terminated | Obesity | Drug, Drug, Drug - Placebo, CP-945,598, CP-945,598 Treatment B | Pfizer, Industry | 18 Years - 70 Years | Phase 3 | Interventional | The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients. | ||
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Clinicaltrials.gov | A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus | Recruiting | Obesity, Type2 Diabetes | Drug, Drug - Placebo, CT-868 | Carmot Therapeutics, Inc., Industry | 18 Years - 75 Years | Phase 2 | Interventional | A Study to Assess the effect of CT-868 in hemoglobin A1c (HbA1c) in Overweight and Obese Participants with Type 2 Diabetes Mellitus. | ||
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Clinicaltrials.gov | Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment | Unknown status | Type 2 Diabetes, Obesity, Cardiovascular Disease | Drug, Drug - Placebo, Ephedrine, pioglitazone | Bayside Health, Baker Heart and Diabetes Institute, The Alfred, Other, Other, Other | Male | 19 Years - 35 Years | N/A | Interventional | Obesity is epidemic in Australia, and current preventative strategies have had limited success in alleviating this health crisis. While numerous options are available for treatment of obesity, most do not result in sustained weight reduction. Obesity results from an imbalance between energy intake and expenditure, therefore new methods that correct this imbalance are essential for effective long-term treatment. Rodent studies show that brown adipose tissue (BAT) can burn more energy than any other tissue in the body, therefore targeting BAT to increase its activity (energy burning rate) and quantity in humans is potentially a powerful tool for the treatment of obesity and related diseases. BAT has only recently been irrefutably identified in adult humans therefore little is known about how it functions in humans. | |
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Clinicaltrials.gov | Perioperative Systemic Lidocaine for Enhanced Bowel Recovery After Bariatric Surgery | Suspended | Obesity, Bariatric Surgery Candidate | Drug, Drug, Drug, Drug - Placebo, Lidocaine 1%, Lidocaine 1.5%, Lidocaine 2% | Mansoura University, Other | 18 Years - 65 Years | Phase 1/Phase 2 | Interventional | Increasing rates of obesity over the last few decades have led to growing demand for bariatric surgery, which may resulted in decreased comorbidities and improved patient outcomes. Laparoscopic bariatric surgery has several clinical benefits in terms of improved quality of analgesia, reduced pulmonary complications, enhanced recovery of bowel function, less immune suppression, and shortened duration of hospital stay than open laparotomies. Some investigators reported delayed return of bowel function for approximately two days after laparoscopic bariatric surgery, despite it occurred one day earlier than after open laparotomy. This potentially can lengthen the duration of hospital stay after bariatric procedures. With the impeding cost of health care in the developing countries, safely reducing length of stay is essential. Other investigators reported early return of bowel movements during the first postoperative day in 65% of patients undergoing laparoscopic gastric bypass surgery due to reduced morphine use with implementation of a multimodal analgesia strategy including ketorolac, and propoxyphene hydrochloride/acetaminophen. Lidocaine was investigated in several studies for its use in multi-modal management strategies to reduce postoperative pain and opioid use and enhance recovery. A recent Cochrane review including 45 trials demonstrated that systemic administration of lidocaine was associated with reduced pain scores at most of 'early time points' in patients undergoing laparoscopic abdominal surgery (MD -1.14, 95% CI -1.51 to -0.78; low-quality evidence), shorter times to first flatus (MD -5.49 hours, 95% CI -7.97 to -3.00; low-quality evidence) and first bowel movement (MD -6.12 hours, 95% CI -7.36 to -4.89; low-quality evidence), and less risk of paralytic ileus (risk ratio (RR) 0.38, 95% CI 0.15 to 0.99; low-quality evidence). However, no evidence of effect was found for lidocaine on shortening the time to first defecation. This low-quality evidence may be related to the heterogeneity between the studies in respect to the optimal dose, timing and duration of the administration of intravenous lidocaine. | ||
Clinicaltrials.gov | Effect of Fenofibrate on Sleep Apnea Syndrome | Terminated | Dyslipidemia, Sleep Apnea Syndrome, Overweight, Obesity | Drug, Drug - Placebo, Fenofibrate | Solvay Pharmaceuticals, Industry | 18 Years - 70 Years | Phase 2 | Interventional | Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome. | ||
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Clinicaltrials.gov | Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin | Completed | Obesity | Drug, Drug - Placebo, Pramlintide and Metreleptin | AstraZeneca, Industry | 18 Years - 65 Years | Phase 2 | Interventional | Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with randomized study medication. The purpose of the extension study is to examine the long-term (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide and metreleptin, administered as separate subcutaneous (SC) injections, in obese and overweight subjects. | ||
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Clinicaltrials.gov | Effects of Pioglitazone on Insulin Sensitivity in Healthy Overweight and Obese Males (MK-0000-170) | Completed | Healthy, Overweight, Obesity | Drug, Drug, Drug - Placebo, Comparator: Pioglitazone, Comparator: Hyperinsulinemic Euglycemic Clamp | Merck Sharp & Dohme Corp., Industry | Male | 18 Years - 45 Years | Phase 1 | Interventional | The purpose of this study is to evaluate whether 30 mg of pioglitazone administered once daily for up to 28 days to healthy overweight and obese subjects will lead to a significant change in insulin sensitivity, measured in the setting of a hyperinsulinemic euglycemic clamp | |
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Clinicaltrials.gov | The Effect of Pre-Operative Transversus Abdominis Plane (TAP) Block in the Post Operative Opioid Consumption in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study | Completed | Pain, Obesity, Surgery | Drug, Drug - Placebo, (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. | Northwestern University, Other | 18 Years - 65 Years | N/A | Interventional | The use of preoperative TAP block in laparoscopic bariatric surgery can improve the postoperative pain and quality of recovery in patients undergoing these procedures. | ||
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Clinicaltrials.gov | Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects | Completed | Diabetes Mellitus, Type 2, Obesity | Drug, Drug - Placebo, INCB013739 | Incyte Corporation, Industry | 18 Years - 70 Years | Phase 2 | Interventional | Purpose: A 28-day US study in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug. | ||
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Clinicaltrials.gov | A Pilot Trial of Nabilone for the Treatment of Obesity | Not yet recruiting | Obesity | Drug, Drug - Placebo, Nabilone | Centre for Addiction and Mental Health, Other | 25 Years - 45 Years | Phase 2 | Interventional | Obesity is a serious health problem which increases the likelihood of developing other life-changing medical conditions. Despite increasing knowledge about the neural and metabolic basis of obesity, the development of effective anti-obesity treatment strategies has been a challenge. Evidence shows an association between cannabis consumption and body weight. However, to date, no human trials have assessed the potential of cannabis-like compounds to reduce body weight in individuals who are obese. This pilot trial aims to determine the safety and feasibility of administering nabilone (a cannabinoid drug similar to the active component of cannabis) to patients who are obese. Our secondary aims are to determine if nabilone is effective in reducing weight in this population, and to probe potential mechanisms of the weight-loss-promoting effects of nabilone, such as neural reactivity to food stimuli, changes in gut bacteria, and changes in metabolic biomarkers. | ||
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Clinicaltrials.gov | A 26-Week, 2-Part Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity | Active, not recruiting | Obesity | Drug, Drug - Placebo, PF-06882961 | Pfizer, Industry | 18 Years - 75 Years | Phase 2 | Interventional | This study will assess the efficacy, safety, tolerability and pharmacokinetics (PK) of PF-06882961 in adults with obesity. The first part of the study, Part A, consists of study treatment dosing in Weeks 1 to 16. The second part of the study, Part B, is planned such that participants in Part A will continue dosing from Weeks 17 through 26. The planned End of Treatment is expected to be Week 26. | ||
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Clinicaltrials.gov | Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans | Not yet recruiting | Menopause, Prediabetes, Obesity | Other, Drug - Placebo, conjugated estrogens/bazedoxifene (CE/BZA) | VA Office of Research and Development, U.S. Fed | Female | 50 Years - 60 Years | Phase 2 | Interventional | The purpose of this study is to determine the effect of a novel menopause hormone therapy on blood sugar (glucose) and blood and liver fats (lipids) in obese menopausal women Veterans. | |
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Clinicaltrials.gov | Effects of RM-493 on Energy Expenditure in Obese Individuals | Completed | Obesity, Morbid Obesity | Drug, Drug - Placebo, RM-493 | Rhythm Pharmaceuticals, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Industry, NIH | 18 Years - 50 Years | Phase 1 | Interventional | Background: - RM-493 is a drug that stimulates parts of the brain that control eating and metabolism. It has helped to reduce body weight and improve insulin sensitivity in lab tests. However, it is not fully known whether RM-493 causes weight loss by just decreasing appetite or by increasing metabolism or both. Researchers want to see how RM-493 affects metabolism and hormones that affect the metabolic rate. They also want to see how RM-493 affects appetite by assessing feelings of hunger and fullness. They will study this drug in people who are obese but are otherwise in good health. Objectives: - To see how RM-493 affects metabolic rate and appetite in obese but otherwise healthy individuals. Eligibility: - Individuals between 18 and 50 years old who are obese (body mass index between 30 and 40 kg/m2) but are otherwise healthy. Design: - The study consists of three phases. The first phase is the screening visit. The second phase is an 8-day inpatient stay. The final phase is a follow-up phone call one week after the end of the second phase. - Participants will be divided into two groups. One group will receive the study drug first, followed by a placebo. The other group will receive the placebo followed by the study drug. The study drug and placebo will be given under the skin for 3 days each by a small device (OmniPod) that normally is used to give insulin to people with diabetes. - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will also meet with a dietitian. The OmniPod device will be demonstrated before use. - Participants will have the following procedures during their 8-day inpatient stay: - Daily exercise routine (walking on treadmill) after setting a comfortable pace (miles per hour) during an exercise test - Wear physical activity monitors - Body composition study to measure amounts of fat and muscle - Calorie controlled study diet - Study drug/placebo dose through the OmniPod (Days 2 through 4 and 5 through 7) - Metabolic rate studies using a cart or the metabolic chamber - Daily blood samples - Urine collection for 24 hours - Questions about weight history and appetite - About a week after the inpatient stay, participants will have a followup phone call to ask about any side effects from the study. | ||
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Clinicaltrials.gov | To Assess the Effect of Lorcaserin Hydrochloride on Energy Metabolism and Food Intake | Completed | Obesity | Drug, Drug - Placebo, Lorcaserin 10mg BID | Eisai Inc., Industry | 18 Years - 65 Years | Phase 1 | Interventional | The purpose of this study is to evaluate the effect of lorcaserin on energy metabolism and food intake in obese and overweight patients. | ||
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Clinicaltrials.gov | Testosterone, Metformin, or Both, for Hypogonadism in Obese Males | Completed | Hypogonadism, Obesity | Drug, Drug, Drug, Drug - Placebo, Metformin, Testosterone Undecanoate, Metformin + Testosterone Undecanoate | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud, Other | Male | 18 Years - 50 Years | Phase 3 | Interventional | The purpose of this study is to examine the effects of metformin, testosterone, or both, in males with obesity-related hypogonadism. This study will evaluate changes in insulin resistance, weight loss, body composition, testosterone levels,quality of life and erectile dysfunction. Obese men will receive diet and physical activity counselling, and be randomised to either testosterone, metformin, a combination of both or placebo | |
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Clinicaltrials.gov | Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin | Completed | Metabolic Syndrome | Drug, Drug - Placebo, Gymnema Sylvestre | University of Guadalajara, Other | 30 Years - 60 Years | Phase 2 | Interventional | Gymnema sylvestre has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Gymnema sylvestre has an excellent potential for the prevention and treatment of metabolic syndrome. | ||
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Clinicaltrials.gov | Effects of Intake of a Polysaccharides Mix on Metabolism, Hormones and Satiety in Obese Children. | Recruiting | Obesity | Drug, Drug - Placebo, Libramed | Azienda Ospedaliera Universitaria Integrata Verona, Other | 8 Years - 12 Years | Phase 1/Phase 2 | Interventional | AIMS Phase 1. Verify whether the intake of LibramedR is able to induce a better endocrine and metabolic profile. Phase 2. Verify whether treatment with LibramedR for 60 days produces a better glycaemic profile after oral glucose load. SUBJECTS Will be recruited 80 obese children for phase 1 and 40 obese children for phase 2. Subjects will be randomly assigned to treatment with placebo or LibramedR with a double blind clinical trial. METHODS Experimental protocol phase 1 Each child will arrive at the UOC at 8 a.m., in fasting. A blood sample will be taken. Then patients will be given two LibramedR tablets or placebo. After 20 minutes they will be given a mixed meal (equal to 15 kcal per kg of lean body mass). Blood samples will then be taken at 30-minute intervals for the first two hours and 60 minutes for the following two hours, for the determination of metabolites and hormones for a total of 4 hours. The level of satiety will be quantified through a visual analog scale. Experimental protocol phase 2 Based on the results of the OGTT performed in recruitment phase, children will be divided into two groups: group A, children with blood glucose 2 hours after oral load higher than the median and group B, children with blood glucose 2 hours after oral load below the median. The children of group A will be randomly assigned to LibramedR treatment or placebo for 60 days, after which they will repeat Anthropometric measurements, bioelectrical impedance, OGTT and blood chemistry. They will also repeat dietary and sport anamnesis . During the 60 days, the children of both groups will receive the same dietary treatment consisting of a low-calorie and balanced diet, and recommendations to practice more sport. Every 15 days a research assistant will contact the families to reinforce treatment adherence. EXPECTED RESULTS Phase 1 LibramedR intake should cause a lower increase in postprandial blood glucose, insulin, triglycerides and a greater decrease in ghrelin levels compared to placebo treatment; Phase 2 The treatment with LibramedR should be associated with a decrease in blood glucose and insulin secretion after OGTT compared to placebo treatment. | ||
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Clinicaltrials.gov | Resveratrol in Type2 Diabetes and Obesity | Unknown status | Type 2 Diabetes, Obesity, Insulin Resistance | Drug, Drug, Drug - Placebo, Resveratrol 40 mg oral three times a day, Resveratrol 500 mg oral once daily. | Kaleida Health, Other | 20 Years - N/A | Phase 2/Phase 3 | Interventional | The main objective of this study is to investigate the effect of resveratrol on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo. This research will investigate the hypothesis that resveratrol, when given orally to obese and type 2 diabetic subjects induces a decrease in reactive oxygen species (ROS) generation and the pro-inflammatory transcription factor nuclear factor-kB (NF-kB) and the inflammatory mediators regulated by it. The hypothesis that resveratrol suppresses the high fat, high carbohydrate (HFHC) meal induced inflammatory and oxidative response, will also be investigated. This research will also investigate the hypothesis that resveratrol intake for 12 weeks improves insulin sensitivity by lowering the Homeostasis model assessment of insulin resistance (HOMA-IR), an index of insulin resistance and, that resveratrol intake will cause an increase in incretins. | ||
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Clinicaltrials.gov | Effect of Sitagliptin and an ACE Inhibitor on Blood Pressure in Metabolic Syndrome | Completed | Metabolic Syndrome, Hypertension | Drug, Drug, Drug, Drug - Placebo, Enalapril 5mg, Enalapril 10mg, Sitagliptin | Vanderbilt University, Other | 18 Years - 70 Years | Phase 4 | Interventional | This study will measure the effect of the anti-diabetic agent sitagliptin on blood pressure in individuals with the metabolic syndrome. We will also measure the effect of sitagliptin on blood pressure in people already taking a blood pressure medication called an ACE inhibitor. |
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