
A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and...
Type 2 DiabetesObesityThe 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.

Probiotic Intervention Study
ObesityFood AddictionThe 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.

Effect of Timed-Restricted Eating on Metabolic Health
ObesityNon-Alcoholic Fatty Liver Disease1 moreWe aim to determine the effect of combined isocaloric time restricted eating and meal timing on metabolic health, liver fat, functional brain networks, inflammation, and sleep pattern/quality in subjects with obesity and insulin resistance.

Improving Dietary Habit and Weight Loss in Young Adults With Overweight and Obesity: The Healthy...
ObesityThis study aims to examining the effectiveness of a psychoeducational program (Healthy Eating in Young Adults; HEYA) on improving the dietary habits and body composition (e.g. weight and percentage fat mass) in young adults in Singapore.

Bimbingamba Zerosix Third Phase: Studying Communities
ObesityChildhood Obesity3 moreChildhood obesity is increasing in the last years especially in developed countries, and, as well as adult obesity, is related to the development of pathologies. Unfortunately, the restoration of a normal weight condition, if the ponderal excess rose in the first years of life, seems very difficult. Despite the importance of this issue, there is a paucity of evidence demonstrating effective interventions in reducing weight over time. The observation that in developed countries childhood obesity appears with evident social and geographical gradients justifies the implementation of inter-sectoral interventions of primary prevention, to be declined at the contextual level: family and community. Nowadays, there are numerous interventions for the promotion of lifestyle in pediatric age, in particular, those aimed at primary school and adolescence. On the other hand, few interventions were directed at the 0-7 age group. Therefore, this community intervention trial involved the pediatric population (aged 0-7 years) and their families, and it is aimed at the prevention of obesity and the restoring normal weight through community interventions aimed at improving lifestyles and with them the bio-metric parameters, health and well-being outcomes and soft skills in the population aged 0-7 years. The target population is children aged 0-7 years resident in the two municipalities (Mondovì and Savigliano), respectively selected as Intervention and Control Common. Totally, to conduct this study 2000 children, of both sex, will be enrolled (near 1000 for each of the two Municipalities).

Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity
Time Restricted FeedingExercise3 moreIn Spain, overweight and obesity prevalence is reaching 70% in men and 50% in women. Excess of triglycerides are usually stored in the subcutaneous adipose tissue (SAT), until a point where SAT is unable to expand further. Therefore, lipids are deposited in visceral and other peripheral organs and tissues that are not otherwise designed for adipose storage such as the liver, pancreas or the skeletal muscle, a process known as ectopic fat deposition. "Time-restricted eating" (TRE) is a recently emerged intermittent fasting approach which has the potential to maximize the beneficial metabolic effects extensively reported for energy intake restriction. Furthermore, exercise reduces hepatic steatosis and improves cardiometabolic health in humans. However, whether the effects of TRE combined with exercise on reducing hepatic steatosis are superior to TRE or exercise intervention alone remains unknown. The TEMPUS study will investigate the effects of a 12-week TRE combined with supervised exercise intervention, as compared with TRE or exercise alone, and usual-care control group, on hepatic fat (primary outcome) and cardiometabolic health (secondary outcomes) in adults with obesity; and to unveil the role of gut microbiota.

Daily Self-Weighing for Obesity Management in Primary Care
Overweight and ObesityMany adults with obesity continue to gain weight even though they do not want to. This project will test the effects of a primary care intervention in which people with obesity receive an electronic scale and recommendations to weigh themselves daily. This will help us understand whether daily self-weighing might be a way to prevent continued weight gain.

Project Health Intervention Among Latinx Adults in Primary Care
ObesityThe proposed study will examine acceptability/feasibility and establish initial estimates of effect sizes of an existing intervention (Project Health) on a sample of young adult Latinx individuals in a primary health care setting. Project Health intervention involves making small, participant-identified, gradually increasing improvements to their dietary intake and exercise.

EndoBarrier System Pivotal Trial(Rev E v2)
Diabetes type2ObesityA 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).

Simvastatin add-on Treatment to Standard Antidepressant Therapy in Patients With Comorbid Obesity...
Depressive DisorderMajor1 moreMajor depressive disorder (MDD) and obesity are major contributors to impaired health worldwide. Statins are among the most prescribed medications with well-established safety and efficacy. Statins are recommended in primary prevention of cardiovascular disease, which has been linked to both MDD and obesity. Moreover, statins are promising candidates to treat MDD because a meta-analysis of pilot randomized controlled trials has found antidepressive effects of statins as adjunct therapy to antidepressants. However, no study so far has tested the antidepressive potential of statins in patients with MDD and comorbid obesity. Therefore, we hypothesize that Simvastatin add-on to standard antidepressant Escitalopram will improve depression to a greater extent than add-on placebo in patients with comorbid obesity and major depression. We will randomize 160 obese MDD patients at 8 recruiting centers to either Simvastatin or placebo as add-on to Escitalopram for 12 weeks. If successful, our trial would have immediate impact on clinical practice given the fact that Simvastatin and Escitalopram are available as inexpensive generic drugs with established safety.