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Obesity clinical trials

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NCT ID: NCT05629858 Enrolling by invitation - Obesity Clinical Trials

Time Restricted Eating for the Treatment of PCOS

Start date: January 15, 2023
Phase: N/A
Study type: Interventional

Background: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility among young women. This syndrome is a reproductive and endocrinological disorder that affects up to 18% of reproductive-aged women. To date, the only strategy shown to reverse PCOS is sustained weight loss of 5-10%. At present, daily calorie restriction (CR) is the main diet prescribed to patients with PCOS for weight loss. However, some women find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day. Considering these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. Recent findings show that TRE significantly reduces body weight, insulin resistance, and inflammation in adults with obesity. However, no randomized controlled trials have studied the role of TRE in treating PCOS. Accordingly, this study will compare the effects of TRE vs CR in females with PCOS over 6 months on body weight, androgen markers, inflammatory markers and insulin sensitivity. Methods: A 6-month randomized, controlled, parallel-arm trial will be implemented. Females with obesity and PCOS will be randomized to 1 of 3 groups: (1) 6-h TRE (ad libitum food intake from 1-7 pm, fasting from 7pm-1pm); (2) CR (25% energy restriction daily); or (3) control group (ad libitum intake with no meal timing restrictions).

NCT ID: NCT05577325 Enrolling by invitation - OBESITY Clinical Trials

The Effect Of Planned Educatıon Based On The Health Improvement Model

Start date: January 13, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to determine the effect of planned education based on the health promotion model on lifestyle behaviors and weight management in obese secondary school students.

NCT ID: NCT05554601 Enrolling by invitation - Obesity Clinical Trials

A Randomized Trial of Behaviorally Designed Gamification and Social Incentives to Increase Physical Activity Among Overweight and Obese Veterans

STEP 4 Vets
Start date: July 17, 2023
Phase: N/A
Study type: Interventional

Despite the many associated health benefits, more than half of Veterans do not achieve enough regular physical activity. The investigators' prior work has demonstrated that gamification, a method commonly used for health promotion, can lead to sustained increases in physical activity if it is designed using insights from behavioral economics to enhance social incentives. In this study, the investigators will compare the effectiveness of behaviorally designed gamification that encourages Veterans to collaborate or compete on physical activity levels and examine clinical outcomes as well as costs, barriers and facilitators to implementation of the program within Veterans Affairs.

NCT ID: NCT05540314 Enrolling by invitation - Obesity Clinical Trials

Robotic Bariatric Database (RBD) Collaborative

Start date: August 10, 2022
Phase:
Study type: Observational

With increased prevalence of obesity in the general population over the past 30 years, researchers have been focused on the development of new treatment options to achieve long-lasting weight loss. In 1991, the National Institutes of Health Conference Statement on Gastrointestinal Surgery for Severe Obesity developed a consensus stating that bariatric surgery was the most effective treatment for obesity since it is associated with good long-term results in terms of weight loss, glycemic control and decreased mortality. To collect and store clinical data related to the treatment outcomes of robotic bariatric surgery in order to develop an evidence base such that physicians can provide the best possible care to patients undergoing surgical weight loss interventions.

NCT ID: NCT05530356 Enrolling by invitation - Obesity Clinical Trials

Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study

HEIRitage
Start date: September 30, 2022
Phase:
Study type: Observational

The current protocol plans to enroll participants with youth-onset Type 2 Diabetes (T2D) as well as obese and lean controls from the Renal-HEIR - Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study (n=100) [COMIRB #16-1752] in a prospective investigation that seeks to 1) define the changes in kidney function by gold standard techniques and energetics by functional Magnetic Resonance Imaging (MRI) in adolescents with and without T2D as they transition to young adulthood; 2) quantify kidney oxidative metabolism by 11C-acetate Positron Emission Tomography (PET) in a subset of participants who are ≥18 years of age with youth-onset T2D and/or obesity; 3) determine peripheral arterial stiffness by SphygmoCor. Mechanistic insight will be provided by transcriptomic analyses of repeat biopsies 3-years after their initial biopsy for eligible participants with youth-onset T2D, as well as molecular analysis of tissue obtained from J-wire endovascular biopsies. This study will also leverage this well-characterized cohort of youths to define youth-onset T2D-related changes in brain morphology and function by structural MRI and resting-state functional MRI and through the assessment of cognitive function (fluid and crystallized intelligence) using the NIH Toolbox Cognitive Battery (NIHTB-CB), as an exploratory objective. All enrollees in Renal-HEIR have consented to be contacted for future research opportunities.

NCT ID: NCT05503927 Enrolling by invitation - Obesity Clinical Trials

A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy

Start date: January 2, 2023
Phase:
Study type: Observational

This is an observational, retrospective, cohort study using administrative insurance claims data. The aim of this non-interventional study (NIS) is to compare maternal, fetal and infant outcomes of women exposed to Wegovy during pregnancy to a reference population not exposed to Wegovy, so that participants and healthcare providers can make informed treatment decisions.

NCT ID: NCT05459675 Enrolling by invitation - Obesity Clinical Trials

Effects of Very Low-calorie Diet Versus Bariatric Surgery on Body Composition and Gut Microbiota Pattern

Start date: July 20, 2022
Phase: N/A
Study type: Interventional

Obesity is a chronic disease characterized by the excessive accumulation of fat in body and it continues to be a major public health problem worldwide. Treatment options for obesity include lifestyle modification, pharmacotherapy and bariatric surgery. Bariatric surgery is a highly effective treatment for obesity and results in rapid and sustained weight loss. Also, it significantly alters gut microbiota composition and function. A very low-calorie diet (VLCD) is a rapid weight loss program which calorie intake is severely restricted (< 800 kcal/day). It has been shown to be very effective to induce rapid weight loss and result in comorbidities resolution similar to bariatric surgery. Therefore, this study was aimed to study the effects of 12-week VLCD compare to bariatric surgery (Laparoscopic Roux-en-Y gastric bypass (LRYGB) or Laparoscopic Sleeve Gastrectomy (LSG)) on weight loss, body composition, gut microbiota pattern and other metabolic parameters.

NCT ID: NCT05443620 Enrolling by invitation - Obesity Clinical Trials

Weight Load PET (WELPET)

WELPET
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Obesity related ailments, such as cardiovascular diseases (CVD) and metabolic disorders are major causes of death in the world. This trial may result in improved understanding of the causes of obesity and obesity-related disorders. Published data show that if a weight is carried by a rodent, this animal will lose body weight and gain an improved glucose control. Recently published data further show comparable results in humans when carrying an additional weight. The investigators aim to confirm and further investigate these findings in humans. The investigators plan to let obese participants carry weight vests and monitor their change in glucose uptake in different tissues. This to further examine the effects increased axial loading has on glucose metabolism in different parts of the body.

NCT ID: NCT05389618 Enrolling by invitation - Obesity Clinical Trials

Dietary Challenges in the Population of Nursing Homes' Residents

NUTRICARE
Start date: May 26, 2022
Phase:
Study type: Observational

To obtain up-to-date data on nutritional status of older adults, a national dietary survey will be conducted in 2022/2023, providing data on the consumption of foods and enabling the assessment intakes of energy and specific nutrients. Participating subjects will be also screened for micronutrient status using blood biomarkers (focusing into vitamin D, folic acid, vitamin B12, and iron).

NCT ID: NCT05328570 Enrolling by invitation - Adiposity Clinical Trials

Comparing the Effects of Exercise on the Structure and Function of Fat Tissue

CAT
Start date: June 4, 2020
Phase: N/A
Study type: Interventional

Assess differences in structure and biological function of abdominal subcutaneous adipose tissue samples collected from adults who exercise regularly vs. a well-matched cohort of non-exercisers.