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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 | Metabolic Profile and Anthropometric Changes in Schizophrenia | Completed | Metabolic Syndrome, Diabetes, Obesity | Drug, Drug, Drug - Olanzapine, Risperidone, Haloperidol | Central Institute of Psychiatry, Ranchi, India, Other | 18 Years - 40 Years | N/A | Interventional | "No clinical differences will be found between the three antipsychotics under study - olanzapine, risperidone and haloperidol - on the patients' metabolic profile and weight. " | ||
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Clinicaltrials.gov | Effect of Diet Plus Sibutramine on Hormonal and Metabolic Features in Overweight and Obese Women With PCOS | Completed | Obesity, Polycystic Ovary Syndrome | Drug - Sibutramine | Hippocration General Hospital, Other | Female | 18 Years - 40 Years | Phase 4 | Interventional | Studies on the effect of sibutramine, an anti-obesity drug, on hormonal and metabolic features of women with polycystic ovary syndrome (PCOS) are lacking. The objective of this study is to examine the effect of sibutramine plus hypocaloric diet on body composition, hormonal and metabolic parameters and insulin resistance in obese patients with PCOS. Overweight and obese women with PCOS were placed in a hypocaloric diet plus sibutramine (10 mg/day) for the first month and then on a hypocaloric diet plus sibutramine (10 mg/day) or hypocaloric diet only for the subsequent 6 months. The main outcome measures are: Body composition, hormonal and metabolic features and insulin sensitivity (OGTT) at baseline, at 3 and 6 months of treatment. | |
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Clinicaltrials.gov | Food Rheology and Feeding in Lean and Obese Humans | Completed | Obesity, Overweight, Diabetes | Other, Other - food in fluid form, food in solid form | Purdue University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | 18 Years - 40 Years | N/A | Interventional | The 2010 National Health Objectives call for a reduction in the prevalence of obesity. The marked recent increase in overweight and obesity prevalence implicates behavioral factors in the etiology of the epidemic. The present proposal hypothesizes the trend is attributal, in part, to increasing consumption of energy-yeilding beverages since they are a significant and increasing source of dietarty energy and they elicit weaker appetitive and dietary responses than solid foods. | ||
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Clinicaltrials.gov | Functional Lipids and Appetite Regulation | Completed | Obesity | Behavioral - SALATRIM | University of Copenhagen, Danisco, Other, Industry | Male | 18 Years - 40 Years | N/A | Interventional | To evaluate the short-term effects of structured lipids on appetite regulation. | |
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Clinicaltrials.gov | Obesity and Weight Loss on Reproductive Function | Terminated | Obesity | Milton S. Hershey Medical Center, Tobacco Settlement Grant, Other, Other | 18 Years - 40 Years | Observational | The purpose of this study is to examine how obesity and weight loss following bariatric surgery affect reproductive function. The study is particularly interested in how changes in hormones (those produced in the stomach and fat tissue) following weight loss affect reproductive function. Specifically, we, the researchers at Penn State University, propose to characterize reproductive abnormalities in morbidly obese men and women. We hypothesize that morbid obesity leads to reproductive abnormalities in men and women. We plan to examine the short-term effects of alteration in GI hormones after bariatric surgery on reproductive function. We hypothesize that bariatric surgery radically alters GI hormone expression, resulting in immediate changes to the hypothalamic-pituitary-gonadal axis in men and women. Lastly, we, the researchers, plan to examine the long-term effects of weight loss and changes in adipokines on reproductive function. We hypothesize that the changes in adipokine levels resulting from fat mass reduction lead to substantial long-term improvements in reproductive function and fertility. We also hypothesize that there are sexual dimorphisms in adipokine levels following weight loss, with women experiencing larger changes than men. | ||||
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Clinicaltrials.gov | Placebo Breakfast Consumption, Appetite and Food Intake | Completed | Obesity | Dietary Supplement, Dietary Supplement, Dietary Supplement - Placebo breakfast, Typical whole-food breakfast, Water-only control | Nottingham Trent University, Loughborough University, Other, Other | Male | 18 Years - 40 Years | N/A | Interventional | The purpose of this study was to examine the effects of a very low-energy, viscous placebo breakfast meal on subjective appetite sensations during the morning, and food intake at lunch, compared to a typical whole-food breakfast meal and a water-only control. Participants will not be told that the placebo breakfast contains nearly no energy until the end of the study. The breakfasts will be provided in a randomised order, with a period of at least four days separating the trials. Blood samples will be taken before and after the breakfast is eaten to see how appetite-regulating proteins and blood sugars respond during the morning. Appetite questionnaires will also be completed throughout the morning, and a pasta-based lunch meal will be provided so that voluntary food intake can be measured. | |
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Clinicaltrials.gov | Regulation of Muscle Protein Phenotype in Humans With Obesity | Recruiting | Obesity | Other, Other - Exercise, Infusion of Amino Acids | Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | 18 Years - 40 Years | N/A | Interventional | Maintenance of protein homeostasis is impaired in skeletal muscle of humans with obesity. A hallmark of this defect is distorted expression of isoforms of the myosin heavy chain (MHC) protein, and this defect is linked to obesity-associated adverse health outcomes. By employing exercise and increase in plasma amino acids as investigational tools the investigators intend to modulate the metabolism of muscle MHC isoforms in order to unravel the biological mechanisms that sustain distorted MHC protein metabolism in muscle of humans with obesity. | ||
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Clinicaltrials.gov | Study of the Effect of Testosterone and Estradiol on NP Responses to Acute and Chronic Salt Loading | Withdrawn | Hypertension | Drug, Drug - leuprolide acetate, Anastrozole | Massachusetts General Hospital, Other | 18 Years - 40 Years | Early Phase 1 | Interventional | There is gender dimorphism in cardiovascular risk, with men at higher risk than women. However, the fundamental basis for the protective effect of female sex remains unclear. Recent data implicate the natriuretic peptide (NP) system as an important determinant of blood pressure. Also, NP levels are twice as high in women of reproductive age than in men, and gonadal steroids are important determinants of circulating NPs. These are the marked, but poorly understood differences in the NP status between men and women. The investigators hypothesize that gonadal steroids regulate NP release, specifically that testosterone inhibits and estrogen activates the NP axis, leading to differences in both resting NP levels and dynamic responses of the NP, RAAS, and kidneys to acute and chronic salt loading. Understanding the basis for gender differences in NP function should provide important insights regarding mechanisms underlying hypertension in men versus women. | ||
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Clinicaltrials.gov | Carbohydrate Intake and Gut Hormone Release During Exercise | Active, not recruiting | Obesity | Dietary Supplement, Other, Other, Other - Maltodextrin (carbohydrate), Exercise, Rest, Water | Imperial College London, Other | Male | 18 Years - 40 Years | N/A | Interventional | It is well known that following a single session of moderate-to-high intensity exercise individuals experience a temporary suppression of hunger and a delay in the commencement of eating. This effect is believed to be due to changes in blood concentrations of specific hormones released from the gut that influence appetite. Individuals undertaking physical activity often consume foods immediately before exercise in order to improve their performance. However, it is currently unknown whether this eating practice influences the gut hormone response to exercise as well as how hungry an individual feels post-exercise. Therefore, the aim of this study is to investigate the effect of consuming a sugary (carbohydrate) drink immediately before starting an exercise session on the concentration of these gut hormones as well as the amount of food eaten in the hours following exercise completion. | |
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Clinicaltrials.gov | AVACEN Hand Heating on Fasting Blood Glucose | Completed | Hyperglycemia, Hypertension | Device, Device, Device - AVACEN 100, AVACEN 100 Heat Only, AVACEN Sham | Jeff Moore, Other | 18 Years - 40 Years | N/A | Interventional | A double-blind crossover randomized controlled trial to investigate the effects of the AVACEN device on fasting blood glucose. The AVACEN device creates negative pressure around the hand while heating the palm. Two sham devices, one providing heat but no vacuum and one providing neither heat nor vacuum were also used. Each subject was tested while using each of these three devices on separate visits. Subjects arrived in the morning following an overnight fast. Fasting blood glucose, blood pressure, tympanic temperature, and subjective thermal ratings were measured before and throughout the 30 minutes that the device was used. | ||
Clinicaltrials.gov | The Diurnal Rhythm in Natriuretic Peptide Levels | Completed | Natriuretic Peptides, Obesity, Nocturnal Blood Pressure | Other - standardized Study Diet | University of Alabama at Birmingham, Other | Male | 18 Years - 40 Years | N/A | Interventional | The purpose of the study to assess the diurnal rhythm in natriuretic peptide levels and its temporal relationship with nocturnal blood pressure in obese and African-American individuals as compared with lean and white individuals. | |
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Clinicaltrials.gov | Comparison of Low GI and High GI Potatoes in Relation to Satiety (POSAT) | Completed | Obesity | Other, Other - Low glycaemic potato, High glycaemic potato | Anne Birgitte Raben, Other | Male | 18 Years - 40 Years | N/A | Interventional | The study is a single-blind, randomised crossover study, investigating how a high glycaemic potato affects satiety in humans compared to a low glycaemic potato. This is done to shed further light on the discussion about whether potatoes with a high glycaemic index increases the risk of overweight and obesity and thus indirectly type 2 diabetes and cardiovascular disease. | |
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Clinicaltrials.gov | Effects of Salt on Serum Osmolarity and Hemodynamics Parameters | Completed | Hypertension, Sodium Excess, Oxidative Stress, Inflammation | Other - High salt (NaCl) intake | Koç University, Other | 18 Years - 40 Years | N/A | Interventional | Diets containing excessive salt (>12 g/day) have negative effects on kidney and cardiovascular system. Considering this known fact, the investigators aimed to study if the amount of the water taken with excessive salt had any part on these negative effects by testing the blood pressure, serum osmolality, endothelial functions, cardiac function, inflammatory parameters and sympathetic nervous system. Excessive dietary salt raises the serum osmolality, which triggers the protection mechanisms of the body. The first mechanism is the secretion of vasopressin from posterior pituitary and the second one is the polyol mediated aldose reductase enzyme activation in renal tubules. In the beginning, water and a little amount of salt is reabsorbed from the kidneys for keeping the serum osmolality in normal ranges by the elevation of vasopressin. Besides the high levels of vasopressin for long durations may have a role in both developments of hypertension and the progression/development of chronic kidney disease. Polyol mediated aldose reductase enzyme turns glucose into sorbitol, which is turned to fructose by sorbitol dehydrogenase activity. Fructose is degraded by fructokinase activity into toxic substances. With this pathway, the acute energy need is satisfied, yet uric acid, local oxidative stress, and inflammatory mediators rise while nitric oxide levels decreasing. These facts are independent risk factors for both kidney disease progression and hypertension. In addition, excessive salt intake may elevate the transforming growth factor beta-1 (TGF-B1) levels, which activates the sympathetic system, inflammation, and endothelial dysfunction. According to these data, the investigators speculate that if they increase the amount of water intake while eating the high salt diet they may decrease the toxic effect of salt with less increase in serum osmolarity. To test this hypothesis, by regulating the salt and water amount in healthy people's diets, the investigators aimed to evaluate the following these parameters; biochemical parameters that could affect the blood and urine osmolality, blood pressure, vascular endothelial functions with the non-invasive flow-mediated dilatation technique and arterial stiffness, systolic and diastolic functions of the heart by transthoracic echocardiography. In addition, it was planned to evaluate the hormonal effects of arginine vasopressin, a long peptide with 39 amino acids, which is longer and easier to measure than vasopressin levels in serum by measuring the pituitary hormone-derived copeptin. Although, decreasing the salt intake is the first step of the treatment in hypertension, and kidney diseases, the compliance rate to less sodium intake is very low (<20%). The investigators aim is to evaluate the effects of water, which is taken acutely with the excessive salt intake on cardiovascular system and kidney. The findings of the study will important for public health. If the investigators prove their hypothesis, they may recommend increasing high water intake before feeling thirst of which may contribute to decreasing the prevalence of hypertension and kidney disease. | ||
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Clinicaltrials.gov | Weight Gain and Adipose Tissue | Completed | Obesity | Behavioral - overfeeding induced weight gain | Mayo Clinic, Other | 18 Years - 40 Years | N/A | Interventional | This study aims to examine the role of weight gain in adipose tissue immune cell influx and development of obesity related cardiometabolic disorders. Adipose tissue-mediated chronic systemic inflammation is implicated in the development of cardiometabolic disorders in obesity. Therefore, resolution of adipose tissue inflammation may be key to ameliorating obesity-associated dyslipidemia, insulin-resistance, and cardiovascular disease. Proinflammatory cytokines contribute to the initial influx of immune cells into adipose tissue during weight gain. However, mechanisms regulating these cytokines in the adipose tissue milieu and the effects of weight gain on adipose tissue are not completely understood. The study proposes to investigate the molecular events contributing to increased infiltration of macrophages and T-cells into adipose tissue during weight gain. The central hypothesis is that in lean subjects (with low body fat mass), healthy fat gain which is associated with decreased expression of proinflammatory cytokines. However, in obesity (high body fat mass), adipose tissue is altered, which permits increased expression of inflammatory cytokines and further fat gain results in influx of immune cells. To test the hypothesis, adipose tissue from well characterized lean (control, with low body fat) and obese individuals (with high body fat) at baseline and after a modest 5% weight gain will be used. Adipose tissue samples after subsequent weight loss will also be examined. For this study, obesity will be defined by body composition rather than body mass index (BMI), as several studies have shown that BMI does not adequately define obesity and several individuals with normal BMI may indeed have high body fat mass. Individuals with body fat content ≤25% for men, & <35% for women) will be considered lean and individuals with body fat content >25% for men, ≥35% for women will be considered obese. | ||
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Clinicaltrials.gov | Newborns of Obese Mothers | Completed | Obesity | Procedure - Obstetric management | Assistance Publique - Hôpitaux de Paris, Other | 18 Years - 40 Years | N/A | Interventional | This was a prospective bi-centric study, exposed-unexposed. In an effort to better understand the potential independent effect of maternal obesity on fetal growth, investigators designed a prospective study, comparing fetal growth between normal weight (18.5 ≤ BMI < 25 kg/m2) or obese pregnant women (BMI ≥ 30 kg/m2), while maternal diabetes and hyperglycaemia was screened and treated throughout pregnancy. | ||
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Clinicaltrials.gov | Metabolic Effects of Non-nutritive Sweeteners | Completed | Obesity | Dietary Supplement, Other, Dietary Supplement - Sucralose, Water, glucose load | University of Illinois at Urbana-Champaign, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | 18 Years - 40 Years | N/A | Interventional | The purpose of this research study is to examine whether sugar-replacement sweeteners that are currently on the market (ex. Sucralose, which is in Splenda) change how well the body works to control blood sugar. | ||
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Clinicaltrials.gov | High-fat Overfeeding, Hepatokines and Appetite Regulation | Completed | Insulin Resistance, Type2 Diabetes Mellitus, Non-Alcoholic Fatty Liver Disease, Obesity | Dietary Supplement - High-fat diet | Loughborough University, Nottingham Trent University, Nottingham University Hospitals NHS Trust, Other, Other, Other | Male | 18 Years - 40 Years | N/A | Interventional | The present study will investigate the effect of high-fat overfeeding on a group of liver-secreted proteins linked to worsened blood sugar control, as well as proteins involved in appetite control. Participants will consume both a high-fat diet, consisting of 50% extra calories above their daily required intake, and a control diet, consisting of their normal 'habitual' diet, with each diet lasting seven days. The diets will be undertaken in a randomised order, with a period of three weeks separating the two diets. Blood samples will be taken before and after each diet to measure blood sugar control. Further blood samples will also be taken 24 hours and 72 hours into each diet to see how levels of the liver and appetite-regulating proteins change over the course of the seven days. It is expected that blood sugar control will be worsened by the high-fat diet and this will be accompanied by increases in levels of the liver-secreted proteins and an impaired release of the appetite-regulating proteins into the blood. | |
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Clinicaltrials.gov | Effect of rTMS in Combination With a Low-carbohydrate Diet in Patients With Obesity | Completed | Obesity, Anxiety | Device, Device, Other - rTMS, sham rTMS, Diet | Hospital General Ajusco Medio, Other | 18 Years - 40 Years | N/A | Interventional | In the present study the investigators want to evaluate if the application of rTMS can reduce the anxiety and craving in patients with obesity helping them to follow a low carb-diet, as well as, to assess the changes in weight, body mass index and quality of life before and after rTMS or sham rTMS. | ||
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Clinicaltrials.gov | Maternal Metabolic and Molecular Changes Induced by Preconception Weight Loss and Their Effects on Birth Outcomes | Recruiting | Obesity, Familial, Pregnancy Related | Dietary Supplement, Other - Very-low energy Diet (VLED), Standard of care (SOC) | University of Michigan, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | Female | 18 Years - 40 Years | N/A | Interventional | Our hypothesis is that aggressive preconception weight loss in obese women will improve the metabolic health of the mother and the intrauterine environment. An optimized developmental environment will normalize fetal growth and improve clinical fetal and infant outcomes, and theoretically reduce future susceptibility to obesity and cardiometabolic disease. | |
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Clinicaltrials.gov | Hypoxic Training in Obese Patients | Unknown status | Obesity | Other - Training | University of Lausanne, CHUV - Centre des Maladies Osseuses - Département de l'Appareil Locomoteur (DAL), Centre Hospitalier Universitaire Vaudois, Other, Other, Other | 18 Years - 40 Years | N/A | Interventional | By analyzing energetic and biomechanical basis of walking, and the subsequent changes induced by hypoxic vs normoxic training in obese individuals, it may optimize the use of walking in hypoxia to gain perspective for exercise prescription to set up training programs that aim to induce negative energy balance and to deal with weight management. However to the investigators knowledge, the analysis of changes in mechanics, energetics and efficiency of walking after continuous hypoxic training (CHT) has not been performed yet. The aims of the present study were: 1. Comparing the changes in body composition between continuous hypoxic training (CHT) and similar training in normoxia; e.g. continuous normoxic training (CNT) in obese subjects. 2. Comparing the metabolic and energetics adaptations to CHT vs CNT. 3. Finally, comparing the associated body-loss induced gait modification since walking intensity at spontaneous walking speed (Ss) is lower in CHT than in CNT. |
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