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Browse 4,295 clinical trials for obesity. Find studies that match your criteria and connect with research centers.
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NCT07253285
This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. The study has 2 parts: main and extension study. In the main study, participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to adolescents and adults) or placebo (a placebo looks like the treatment being tested, but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants who get semaglutide in the main study will not take part in the extension study. If participants take part in the extension study, they will get either CagriSema or cagrilintide in this part of the study. Like all drugs, the study drugs may have side effects. The total time participants will be in the main study is about 1 year and 6 months. If participants take part in the extension study, the total time is about 4 years and 10 months.
NCT06309563
The effectiveness of low-protein diets supplemented with essential aminoacid (EAA) formulas in genetic disorders of amino acid (AA) catabolism, such as maple syrup urine disease (MSUD), is widely recognized (Blackburn PR et al. 2017). The main aim of the present study is to evaluate a difference in the effectiveness of a multidisciplinary rehabilitation program in patients with high degree of obesity with and without supplementation of this new formula of amino acids (essential + tricarboxylic acids - EAA-AC). For this reason, patients of both sexes, aged between 45 and 65, suffering from high-grade obesity will be recruited in Piancavallo. The enrolled patients divided, randomly, into two groups will be given: EAA-AC group a low-calorie and low-protein diet integrated with 4 sachets of EAA-AC supplement per day; the control group will follow a low-calorie and low-protein diet only with placebo. The parameters considered, after two weeks of treatment, will be: weight loss; the maintenance/recovery of muscle mass assessed through changes in body composition and functional tests (Hand grip, 6MWT or TUG) but also through the analysis of mitochondrial function in PBMC and circulating levels of mtDNA; the improvement of the glucose picture and the lipid profile. 1 month after discharge, patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing.
NCT06325722
Background: In a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home. Objective: To test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks. Eligibility: Adults aged 19 to 50 years with a body mass index of 25 or more. Design: Participants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples. Participants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants' homes. They will eat only the foods delivered. Participants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period....
NCT00523627
This study, conducted at the NIH Clinical Research Unit at the Phoenix Indian Medical Center, will examine how the body s metabolism (energy expenditure) changes when people overeat and when they fast and how different diets (e.g., high-protein or high-fat) affect metabolism. The results may provide information about whether there are mechanisms that make some people more resistant than others to gaining weight when they eat more. Non-smoking healthy subjects between 18 and 55 years of age who weigh no more than 350 pounds may be eligible for this study. Participants undergo the following procedures: * Pregnancy test for women of childbearing age. * Oral glucose tolerance test. For this test, an I.V. line (needle attached to a plastic tube) is inserted into a vein to allow several blood draws without repeated needle sticks. After the first blood sample is drawn, the subject drinks a cola-flavored sugar solution. Five additional blood samples are then drawn over 3 hours. * Blood test for DNA (genetic) studies related to obesity, diabetes and related medical problems. * DEXA scan. This test measures body fat. The subject lies on a table while a very small dose of X-rays is passed through the body. * Respiratory chamber. This test measures how many calories the body burns a day and assesses energy balance between intake and expenditure. Subjects stay in a room with two windows, equipped with a sink, toilet, television and DVD player, desk, chair, telephone and bed for 24 hours. The test is repeated five times during the first 18-day admission and 3 times during the second 13-day admission. For the first two sessions, subjects are fed a diet equal to the amount of energy their body uses. For the next 6 stays they are fed double the amount of calories their body usually uses for 5 of the stays and fast (consume nothing but water and soda without caffeine or calories) during 1 stay. The overfeeding diets may be high or low in protein, normal in protein, or high in fat. Blood tests are done on the day of each respiratory chamber session and a 24-hour urine sample is collected for one day while in the chamber. * Eating behavior questionnaires. * Psychological performance tests. Some participants are asked to volunteer to repeat two of the chamber studies to validate the measurements. The repeat session includes only the fasting and the overfeeding with normal protein content. All participants are followed at 6 months with blood tests, a DEXA scan, and urine tests (including pregnancy test for women). At annual visits for years 1 through 7, participants have the 6-month tests plus an oral glucose tolerance test.
NCT02328599
Initially, 4 teams of investigators conducted randomized controlled trials (RCT) at their own site to evaluate the effectiveness of bariatric surgery compared to medical/lifestyle management of type 2 diabetes. Each study followed subjects for a duration of about 1 - 3 years. Following this, a consortium was created to pool data and continue to follow study participants. This early collaboration of the 4 groups of investigators was supported by Industry sponsors (Ethicon, Inc and Medtronic-MITG). Now, the investigators have successfully received a grant from the NIH, as the sole supporter of continued observational follow-up of study participants. The continuing aim of this study is to combine data from the 4 studies and follow the original randomized subjects for an additional 5 years of follow-up. The purpose of the study is to determine the longer term durability and effectiveness of bariatric surgery compared to medical/lifestyle intervention on the treatment of type 2 diabetes.
NCT07056842
This is a single-center, open-label, single-arm, fixed-sequence Phase I study in healthy participants to evaluate the effect of multiple doses of rifampin or itraconazole on the pharmacokinetics (PK) of VCT220 and its metabolite VCT289. Cohort 1 will assess the impact of rifampin (600 mg once daily) on VCT220 (160 mg single dose). Cohort 2 will assess the impact of itraconazole (200 mg once daily) on VCT220 (40 mg single dose). A total of 32 healthy subjects will be enrolled, 16 in each cohort.
NCT03538210
Obesity prevalence rapidly increased in the past decades in French population with multiple health consequences responsible for excess mortality. In the same period of time, the number of bariatric procedures have developed exponentially. Despite its great efficacy on weight loss but also on resolution of comorbidities, bariatric surgery is not without risks. Our hypothesis is that a better understanding of the physio-pathological consequences of obesity and bariatric surgery, notably on the gastrointestinal tract, may allow to improve the treatment of obesity and to find alternatives to bariatric surgery. The main objective of this cohort study is to systematize the collection and the conservation of biological samples (blood, stomach, liver, intestine, adipose tissue) obtained during bariatric surgery, in obese subjects undergoing surgery (including sleeve gastrectomy, Roux-en-Y gastric bypass, or revisional intervention for complication or weight regain) in the University Hospital group of Paris Nord Val de Seine (HYPNVS). The main projects that will build on this cohort will cover the physiopathology of obesity and its consequences, notably in the field of gastrointestinal tract including: modification of gastro-intestinal plasticity in severe obesity and after bariatric surgery and alterations of absorption of nutriments (lipids, proteins, carbohydrates) induced by obesity and bariatric surgery. The inclusion in this project of obese subjects before surgery, or lean or obese subjects after surgery will allow to distinguish the impact of weight loss and surgery on gastrointestinal remodeling. This cohort will also allow to characterize stomach and intestinal proteome in severe obesity and to precise the influence of tissue inflammation on metabolic disorders associated with obesity.
NCT07296861
The goal of this project is to evaluate an adapted health promotion program, HomeGrown, designed to improve the health of young children with Down syndrome by supporting families in making healthy home environmental changes. There is a significant need for evidence-based programs that address healthy eating and physical activity within this population, as most existing interventions have been developed for typically developing children. By tailoring the program to the unique needs of families of young children with Down syndrome, this project aims to advance inclusion and equity in health behavior promotion. This R61/R33 study will assess the feasibility (R61 Phase) and subsequent efficacy (R33 Phase) of the HomeGrown program in improving family practices related to nutrition and physical activity. During the R61 feasibility phase, 38 primary caregivers of children aged 2-6 years with Down syndrome will be enrolled in a 6-month randomized controlled trial. Families will be randomized 1:1 to either the HomeGrown intervention or a waitlist control group (6-month delayed start), stratified by the child's biological sex (male/female) and age (2-3 vs. 4-6 years). All measures will be collected at baseline and at 6-month follow-up. The R61 feasibility phase will address three specific aims: Accrual: Achieve an enrollment rate of 10 families per month, supporting feasibility for the R33 efficacy phase. Engagement: Demonstrate that families use at least 70% of available HomeGrown intervention components, measured using the digital behavior change interventions engagement scale. Data Collection \& Retention: Achieve at least 80% retention with completion of all outcome assessments. By addressing key gaps in nutrition and physical activity research for young children with Down syndrome, this study has the potential to improve health outcomes for an underserved population and inform future clinical and community health promotion efforts.
NCT04364282
Attrition from pediatric weight management programs is unacceptably high, with dropout ranging from 27-73%. This project will utilize a model that predicts dropout from treatment, increasing its power and accuracy through a multi-site observational study. This will result in a powerful tool that will be used to decrease attrition from pediatric weight management, with the potential for widespread dissemination to improve treatment outcomes.
NCT06800872
The main aim of the present study is to evaluate in a group of adolescents with obesity, hospitalized for a period of integrated metabolic rehabilitation (calorie restriction, aerobic physical activity, psychological counseling, nutritional re-education) lasting 3 weeks, the effects produced from a period of training with vibration stimulation on vibration platforms (Whole Body Vibration Exercise \[WBVE\]) on the resting energy expenditure (REE), assessed through indirect calorimetry. The results will be compared with those obtained in a control group, subjected to integrated metabolic rehabilitation alone. Secondary aims of the study are to evaluate the effects of training with WBVE also on cardiovascular and musculoskeletal parameters, evaluated through specific functional tests, comparing them with those obtained in the control group.
NCT03139305
The main purpose of this study is to examine the effect of prolonged (72 hour) administration of glucagon compared to placebo on energy expenditure in healthy, non-diabetic, obese subjects.
NCT07501377
People living with obesity have a higher risk of late-life cognitive decline and developing dementia. In women, the risk of cognitive decline may further raise during the menopausal transition, a period of substantial hormonal and metabolic changes. Recent studies suggest that a healthy diet could help to prevent neurocognitive disorders by reducing inflammatory processes in the body and brain. Emerging evidence further indicates that the gut-brain axis and the intestinal microbiome play a crucial role in mediating this effect, through metabolic, immune, neuronal and vascular routes. Modifying the gut microbiota may thus counteract the heightened systemic inflammation seen in obesity and during menopausal transition to eventually benefit brain health. Specifically, plant-based nutirents, such as fibre and polyphenols, have microbiome-changing, anti-inflammatory and neuroprotective properties that may slow brain aging and neuro-inflammation. However, evidence from human interventional studies and knowledge on the underlying mechanisms remain scarce. This randomized controlled trial will therefore test whether altering gut bacteria through six months of daily intake of a personalized "polybiotic" dietary formula, compared to placebo, improves markers of brain health in women during the perimenopausal transition that are living with overweight or obesity. We plan to enroll 120 women aged 35-60 with overweight/obesity and elevated inflammatory blood markers, randomized to: intervention (7.5 or 15 g inulin, plus 200 mg resveratrol and 320 mg quercetin per day in powder form with main meals) or control (isocaloric maltodextrin). Exclusions include type 1 diabetes, current psychiatric/gastrointestinal disorders, and magentic resonance imaging (MRI) contraindications. Before and after 26 weeks, participants will undergo brain MRI to assess inflammation-related brain markers, neuropsychological testing, anthropometric measurements, they will fill in a set of questionnaires and donate stool and blood. Gut bacteria will be profiled by next-generation sequencing; metabolites will be measured in blood and stool. The primary outcome is a proxy of neuroinflammation in the white matter assessed using diffusion-weighted MRI. Secondary analyses will examine blood-brain-barrier permeability and other functional and structural MRI measures, including MR spectoscropy. Mechanistic links among changes in inflammatory markers, microbiota composition, and short-chain fatty acids will be explored using path and network models. This study may help to develop novel prevention and treatment strategies to mitigate obesity-related cognitive decline via the gut-brain axis.
NCT02817659
To further understand the tolerability of glucagon.
NCT05567796
This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms. Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.
NCT07376655
The goals of this randomized trial is to learn: 1. If the Thrive AI Health app will help adults improve their everyday habits (diet, exercise, and sleep). 2. How often participants will use the Thrive AI Health app to which they will have free access The Thrive AI Health app uses artificial intelligence (AI) to give personalized advice. It is designed to help people eat better, exercise more, manage stress, and sleep well. Researchers will compare changes in diet, exercise and sleep in participants using the app to those participants not using the app. Participants will complete study questionnaires and an in-person visit at the beginning and end of the study.
NCT04036331
The purpose of this research is to determine the effectiveness of a coordinated program (Dyad Plus) that would help to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss. Participants of the Brenner FIT (Families In Training) pediatric weight management program and their parent/guardian will co-enroll in weight loss programs. Parents/guardians will receive the components of By Design Essentials.
NCT06782009
Nutritional interventions with dietary restrictions have become highly popular for promoting weight and body fat loss; In addition, they are largely associated with the improvement and preservation of mitochondrial function as well as the changes they generate in the composition of the gut microbiota and microbial metabolites. During obesity, mitochondrial dysfunction in monocytes can increase low-grade inflammation and contribute to alterations in various metabolic tissues. There have been many studies that have been dedicated to describing the benefits and mechanisms of the use of restrictive interventions, but few have focused on further monitoring and evaluating the metabolic changes that occur due to the lack of follow-up of the use of these interventions, where subjects resume eating patterns with energy overload. behavior that happens in the vast majority of patients, so keeping mitochondria in good condition is a key aspect of maintaining health. The present project aims to study the metabolic changes that are generated by the lack of follow-up of restrictive dietary interventions, focusing on the effects produced in mitochondrial function evaluated in monocytes isolated from peripheral blood and the impact that the composition of the intestinal microbiota is generated from the metabolites produced, affecting as a consequence the inflammatory state of the host. A randomized controlled clinical trial will be carried out where the selected participants will be assigned by lottery to one of the 3 nutritional interventions for 8 weeks, then the participants will be followed up at 8, 16 and 24 weeks after the intervention has ended. Anthropometric and biochemical parameters, resting energy expenditure, blood pressure, oxidative stress markers, metabolomics, gut microbiota composition, and mitochondrial function will be evaluated during follow-up.
NCT06280183
In obese individuals, increased adipose tissue and systemic inflammation play a key role in the development of cardiometabolic diseases, pulmonary system dysfunction, and many respiratory diseases. Existing research has demonstrated beneficial clinical outcomes of inspiratory muscle training or combined aerobic and resistance exercise training in obese individuals. However, this focused on the isolated effects of exercise on obesity. In the current literature, no study is evaluating the effectiveness of functional inspiratory muscle training in obese individuals. This study aims to investigate the effects of functional inspiratory muscle training on body composition, cardiometabolic markers, functional capacity, respiratory function, respiratory muscle strength, and respiratory muscle performance in obese individuals.
NCT06939296
The main purpose of this study is to assess how VCT220 tablets affect the bodyweight in obese or overweight adult participants. Participant will be randomly assigned to the high-dose group, low-dose group, or placebo group. Each participant will take the study drug orally once daily for 12 months.
NCT07457437
This study aims to investigate the effect that a structured, progressive resistance exercise program may have on maintaining the muscle mass and physical function of overweight/ obese females whilst they experience a tirzepatide (GLP-1/GIP receptor agonist) induced weight loss. Overweight and obese females aged 25-50 will be recruited for the study, they will require a BMI of \>30 or \>27 with one obesity related comorbidity (excluding diabetes). They will be screened, prescribed tirzepatide and then randomly assigned to either the intervention (GLP-1/GIP + Exercise) or the control group (GLP-1/GIP). Groups will then be split into pre and peri menopausal groups to provide a further exploratory pathway looking analysing if the menopause transition may have any effect on our outcome variables. This was proposed as in the UK females are more likely to begin GLP-1RA treatment. Both groups will be given an industry standard treatment of tirzepatide over 20 weeks starting at a dose of 2.5mg/week and following the dose titration process of +2.5mg/week every four weeks outlined by its manufacturers. The Exercise Group (GLP-1 +EXC) will be given the same tirzepatide prescription alongside following a progressive resistance exercise program. The exercise program will follow a similar structure to previous work in which participants will complete a propriety 20-wk whole body, low impact resistance exercise training program four times a week. The exercise sessions will be up to an hour and will be instructor lead by video and supervised by a member of the research team at The University of Exeter.
