Active clinical trials for "Obesity"

This study is an investigator-initiated, proof-of-concept, randomised, double-blind, placebo-controlled, parallel-group, single-centre clinical trial investigating the body weight loss potential of dapiglutide, a dual GLP-1R/GLP-2R agonist, administered subcutaneously once weekly. The study will investigate the efficacy of once-weekly subcutaneously administered of 4 mg and 6 mg dapiglutide versus placebo in 54 obese individuals (BMI >30 kg/m2) during a 12-week treatment period.

The growing obesity pandemic has a major impact on global cardiovascular (CVD)-related morbidity and premature mortality, severely compromising the quality of life of those affected and significantly increasing costs for the healthcare system. Numerous scientific evidences have demonstrated that a moderate weight loss (5-10% of the initial body weight) is already sufficient to determine the improvement of the cardiometabolic risk factors associated with overweight and obesity. With a view to obtaining a more significant weight loss in the initial stages of dietary treatment, in the last 10 years, the very low-calorie ketogenic diet (VLCKD) has become a strategy for the treatment of obesity and its comorbidities, also allowing to limit therapeutic failure and the high drop-out typical of traditional low-calorie diets. The present study aims to study the long-term efficacy (36 months) of VLCKD in patients with severe obesity and metabolic syndrome, on weight loss, on single factors of the metabolic syndrome compared to a restrictive Mediterranean diet. One hundred subjects with severe obesity and metabolic syndrome will be recruited and randomly assigned to VLCKD or to restrictive Mediterranean diet. Anthropometric parameters, metabolic status blood pressure, degree of arterial stiffness, prevalence and severity of snoring and OSA, cardiac systolic and diastolic function, the autonomic nervous control mode of the circulation will be evaluated at baseline, after one month and at the end of the study.

Sarcopenic obesity (SO) has synergistic detrimental effects on elderlies' health. It greatly increases the risk of cardio-metabolic diseases, physical impairment, institutionalization, and mortality when compared with sarcopenia or obesity alone. Effective interventions to simultaneously increase muscle mass and decrease fat mass are challenging but highly warranted. Research showed that exercise tends to produce better outcomes in SO than nutritional interventions. Inconsistent effects of nutritional interventions may be due to a short intervention duration and participants' poor compliance with nutritional advice. Participants' adherence to a dietary regimen is essential to the success of nutritional interventions. Behavior change techniques grounded in a tested effective theoretical model - the Health Action Process Approach [HAPA] model at improving participants' self-efficacy should be incorporated in a diet modification intervention.This project aims to investigate the effects of a HAPA-based individualized dietary behavior change (IDBC) intervention and exercise training, in combination and separately, for elderly with SO, to improve their body composition and physical functions. In this four-armed randomized controlled trial, investigators will recruit and randomize 380 elderly with SO to one of the following four groups: the combined (COMB) group, receiving the 24-week combined intervention consisting of the IDBC program and exercise training, the EXER-only group, receiving only the exercise training, the IDBC-only group, receiving a combination of the IDBC program and health talks, and the control group, receiving only health talks with no other intervention. Investigators will use health talks to control the group and social interaction effects of the group exercise training for the COMB and the EXER-only groups. Investigators hypothesize that participants in the COMB, EXER-only, and IDBC-only groups will have significantly better outcome measures middle of the intervention (T1), immediately (T2), at 3-months (T3), and 6-months (T4) post-intervention than those in the control group when compared to baseline (T0). Investigators will use mixed-effects modeling to compare changes in all outcome variables at the three post-tests among the four groups. If our intervention is effective at mitigating or preventing such occurrences, the impact on public health will be significant. A similar intervention for other populations.

The purpose of this study is to conduct a three-arm 52-week, randomized controlled trial with double blind treatment to evaluate the effects of a drug called tirzepatide in combination with an innovative, culturally-appropriate, intensive lifestyle intervention (ILI) delivered by community health workers (CHWs) in Latino adults with obesity. Participants will be randomized to 1) standard care (SC, n=25); 2) culturally-tailored dietary and behavioral intensive lifestyle intervention (ILI, n=25) provided by CHWs plus placebo; or 3) ILI plus tirzepatide (ILI-TRZ) for 52 weeks to evaluate the intervention's effect on: i) weight loss; ii) clinical efficacy (change in body fat mass, liver fat, intra-abdominal fat mass and intrahepatic triglyceride content, oral glucose tolerance, glycemic control, insulin sensitivity and b-cell function, plasma lipids, blood pressure, sleep duration, quality and behaviors, physical performance scores); iii) adherence and fidelity to the intervention (adherence to the intervention and barriers to long term adherence, quality-of-life, fidelity of the implementation by CHWs, CHW's and study participants' acceptability and satisfaction with the intervention and eating behaviors. Placebo or tirzepatide will be injected subcutaneously in the abdomen or thigh once a week for 12 months.

The current standard of care for obesity is the optimal management of comorbid conditions such as diabetes and hyperlipidemia, and counseling on diet, weight loss, or increased physical activity programs. However, lifestyle, diet, and behavioral interventions may provide between 7-10% reduction in initial weight and even fewer with long-term weight loss. In severely obese patients (BMI>40 or BMI>35 with comorbidities), bariatric surgery is also a potential treatment, but there is a high barrier for patients to undergo surgery for weight loss. These barriers include an aversion to major abdominal surgery, long recovery time, potential risk of vitamin deficiency, and risk for abdominal pain. For these reasons, there is a paramount need for other treatments for obesity and for food addiction. The current standard of care for obesity and food addiction is difficult to implement and lacks sustained efficacy. Most struggle to complete treatment, lose minimal weight, lack sustained weight loss, and engage in the well-known "YoYo" diet phenomenon. While bariatric surgery is currently the only effective treatment for obesity, there are several barriers associated with it such as eligibility requirements, invasiveness, difficult recovery, and cost making it not readily available for everyone. Some approved medications that help with obesity, such as orlistat, lorcaserin, or naltrexone-bupropion, have not been widely adopted by providers or patients due to their limited responses and adverse side effects. Probiotic cocktails have shown to be safe with little to no side effects. Preclinical models of probiotics demonstrate the ability to curb obesity in animal models. Therefore, a probiotic that is able to show significant weight loss along with lifestyle modifications would be highly adopted and desirable.

The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.

Overweight has become a critical issue in North America and the market value of weight loss products is expected to rise as the population becomes more health-conscious and aware of the risks associated with excess body weight. This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterium breve supplementation with exercise intervention on fat loss.

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.

This is a pilot study to evaluate the safety and efficacy of deep brain stimulation (DBS) of the lateral hypothalamic area (LHA) as a treatment for chronic refractory obesity. This study will include 6 individuals with chronic refractory obesity, that have failed other treatments including gastric bypass surgery.

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the EndoBarrier System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study. A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the EndoBarrier System plus moderate intensity lifestyle and dietary counseling compliant with 2019 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (EndoBarrier):1 (Sham).