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Obesity clinical trials

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NCT ID: NCT04837586 Recruiting - Adolescent Obesity Clinical Trials

Self-Weighing for Adolescents Seeking Obesity Treatment

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

99 patients age 12 to <18 years old with obesity (BMI >/=95th percentile), will be randomized to one of three treatment interventions: 1. Usual Care 2. Usual Care plus advice to weigh daily on simple scale 3. Usual Care plus advice to weigh-daily on an EHR-connected scale Survey data collected at baseline, 2, 4, 6, and 12-weeks, and qualitative interviews at 12 weeks, will assess acceptability, safety, self-efficacy, and BMI. Recruitment will also be assessed (% eligible patients who consent). In order to understand real-world feasibility of this intervention, the clinic staff will work with patients to connect the scales to Epic.

NCT ID: NCT04820036 Recruiting - Obesity Clinical Trials

A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)

Start date: May 6, 2021
Phase: N/A
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Affecting approximately one-third of the United States (U.S.) population, the prevalence of NAFLD increases to 90% in patients with obesity. In 25% of patients, NAFLD progresses to a more severe form-non-alcoholic steatohepatitis (NASH)-which further increases the risks of cirrhosis and hepatocellular carcinoma. In 2017, the lifetime costs of caring for NASH patients in the U.S. were estimated at $222.6 billion, with the cost of caring for the advanced NASH (fibrosis stage ≥ 3) being $95.4 billion. It is projected that the number of NASH cases will increase by 63% from 2015 to 2030. Given the weight loss efficacy of Endoscopic Bariatric and Metabolic Therapies (EBMTs), it has been suggested that EBMTs may serve as a novel treatment category for NASH. Previously, the PI and Co-Is studied the effect of Intragastric balloons (IGB)-the oldest EBMT device-on NASH. EUS liver biopsy performed at the time of IGB removal revealed resolution of all NASH histologic features including fibrosis. A follow-up study by a different group showed similar findings. Furthermore, studies have showed the benefits of S-ESG and Aspiration Therapy (AT) on non-histologic features of NASH. Given the greater weight loss experienced after P-ESG compared to IGB (20% vs 10% TWL) and the more reproducible technique and shorter learning curve of the current P-ESG compared to S-ESG, we aim to assess the effect of P-ESG on NASH.

NCT ID: NCT04819308 Recruiting - Obesity Clinical Trials

Differences in Nutrient Use During Exercise Between Children of Varying Body Mass Indices and Fitness Levels

SUPERkids
Start date: March 18, 2021
Phase:
Study type: Observational

Children who have previously participated in the study "MI Energy" will be invited to participate in "SUPER kids". Investigators want to better understand differences in nutrient use (e.g., fatty acid and carbohydrate) during rest and exercise in children of varying body types and activity levels.

NCT ID: NCT04818177 Recruiting - Obesity Clinical Trials

Immunoglobulin G Therapy Dose Optimization

Start date: April 2, 2021
Phase:
Study type: Observational [Patient Registry]

The overall goal of this proposal is to investigate effects of obesity on pharmacokinetics of immunoglobulin G (IgG) and to develop strategies for optimization of dosing of IgG in obese patients. There is an ongoing debate regarding the most appropriate dosing of IgG formulations in obese patients. Obesity poses significant health risks; and evidence supporting dosing strategies of IgG in obese patients is inadequate. Some of the adverse reactions have been attributed to a relative overdosing in these patients, due to a limited distribution of IgG into fat tissue.

NCT ID: NCT04815122 Recruiting - Obesity Clinical Trials

Correlation Between COMT Val158Met Polymorphism and Dopaminergic Transporter Density (DAT) in Obese Women

Start date: April 2021
Phase:
Study type: Observational

The present study aims to evaluate the correlation between the presence of COMT Val158Met polymorphism and the density of dopaminergic transporters (DAT) in young obese women.

NCT ID: NCT04814147 Recruiting - Obesity Morbid Clinical Trials

Role NLRP3 Inflammasome in Weight Loss Following Sleeve Gastrectomy in Morbidly Obese Patients

BARIAMITRI
Start date: March 13, 2021
Phase:
Study type: Observational

Epidemiological studies show a very rapid increase in the epidemic of obesity in the Caribbean population. 6 out of 10 adults are overweight and 1 out of 4 is obese. Most are women. Consequences : harm to health and possible reduction in life expectancy due to the association with many cardiovascular comorbidities. Adverse effects of obesity on the cardiovascular and endocrine systems are attributed a chronic low-grade inflammatory state in obese patients. Visceral adipose tissue is largely responsible for the inflammatory syndrome. Obesity can also induce the formation of multi-protein platforms called inflammasomes also activated by mitochondrial production. Morbid obesity treatment with sleeve gastrectomy is an effective long term therapeutic for weight loss but also beneficial in terms of insulin resistance and cardiovascular complications. Some patients nevertheless remain resistant to the beneficial cardio-metabolic effects of bariatric surgery. However, the mechanisms that regulate the extent of weight loss and its stabilization after bariatric surgery are still poorly understood. Our study aims to describe the evolution of postoperative weight loss and the place of preoperative inflammation in its amplitude. The hypothesis is that the level of inflammation in visceral fat before surgery determines the extent of postoperative weight loss in obese women who have undergone sleeve gastrectomy.

NCT ID: NCT04812314 Recruiting - Obesity Clinical Trials

Exercise Effects on Adipose Tissue Structure and Function

LG
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.

NCT ID: NCT04812132 Recruiting - Obesity Clinical Trials

RCT Comparing OAGB and Long Limb Roux Gastric Bypass

OAGBvsLLbypass
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass. We plan to enroll up to 500 patients from three different clinics in Estonia. Outcomes are excess weight loss %, impact on type 2 diabetes, hypertension, hyperlipidemia and obstructive sleep apnea. Other outcomes are nutritional deficiencies, occurrence of reflux disease and impact on quality of life. There are planned outpatient visits 1, 5 and 10 years after the surgery to measure the impacts. There are a lot of studies comparing OAGB to standard Roux gastric bypass but non comparing it to long biliary limb gastric bypass.

NCT ID: NCT04808206 Recruiting - Obesity Clinical Trials

A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy

STAP-JOLI
Start date: June 1, 2022
Phase:
Study type: Observational

The purpose of this observational registry is to evaluate the safety and the clinical efficacy of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical). The goal of the study will be achieved by reporting peri- and postoperative complications and the clinical outcome after surgery in a prospectively maintained database.

NCT ID: NCT04805502 Recruiting - Pregnancy Clinical Trials

Pregnancy Exercise Mode Effect on Childhood Obesity

Start date: October 18, 2021
Phase: N/A
Study type: Interventional

The overall objective of this proposal is to conduct a longitudinal prospective study of overweight/obese (OW/OB) pregnant women and their offspring to determine which prenatal exercise mode will have the greatest impact on maternal and infant cardiometabolic health. This information may lead to clinical practice recommendations that improve childhood health. This randomized controlled trial will recruit 284 OW/OB pregnant women randomized to an exercise intervention (aerobic (AE), resistance (RE), or aerobic+resistance exercise (AERE)) or to no exercise; their infants will be measured at 1, 6, and 12 months of age. This design will test our central hypothesis that AERE and RE training during pregnancy will improve maternal and offspring cardiometabolic outcomes to a greater extent than AE alone. This hypothesis will be tested with two specific aims: Aim 1. Determine the influence of different exercise modes during OW/OB pregnancy on infant cardiometabolic health and growth trajectories. Hypothesis: AE, RE, and AERE by OW/OB pregnant women will improve offspring neuromotor and cardiometabolic measures at 1, 6, and 12 months postpartum (e.g. decreased %body fat, BMI z-score, heart rate [HR], non-HDL, and C-Reactive Protein (CRP); increased insulin sensitivity) compared to infants of OW/OB pregnant women that do not exercise; AERE and RE will have the greatest impact on improving infant measures. Aim 2. Determine the most effective exercise mode in OW/OB pregnancy on improving maternal cardiometabolic health outcomes. Hypothesis: AE, RE, and AERE by OW/OB pregnant women will improve both maternal cardiometabolic health measures (e.g. decreased BMI z-score, non-HDL, % body fat, HR, weight gain) across pregnancy (16-36 weeks' gestation) and overall pregnancy outcomes (e.g. lower incidence of gestational diabetes, pre-eclampsia, hypertension during gestation) compared to OW/OB pregnant women that do not exercise; AERE and RE will have the greatest impact on improving maternal health measures, with the AERE group having the highest compliance. The proposed study will be the first to provide an understanding of the influence of maternal exercise modes on the cardiometabolic health and growth trajectories of offspring who are at increased risk due to maternal OW/OB. This work will have a significant impact on reducing the cycle of OB, potentially providing the earliest and most efficacious intervention to decrease or prevent OB in the next generation.