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Morbid Obesity clinical trials

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NCT ID: NCT05000996 Recruiting - Hypertension Clinical Trials

Gut Microbiota in Metabolic Surgery

Start date: August 19, 2021
Phase:
Study type: Observational [Patient Registry]

Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. Longitudinal studies that examined pre- to post-surgery changes in gut microbiota and its relation to cardiometabolic health after surgery are limited. Furthermore, few studies have included African Americans, a population with high rates of cardiometabolic diseases. The investigators aim to fill these research gaps by establishing a longitudinal, observational study of metabolic surgery patients and applying multi-omics to identify stool, blood, and/or tissue microbial features related to post-surgery cardiometabolic outcomes. In the current study, the investigators plan to enroll up to 300 patients who undergo metabolic surgery at Vanderbilt University Medical Center and follow them for up to 10 years after surgery. Fasting blood and stool samples will be collected at pre-surgery and 3-month, 1-year, 2-year, and 3-year post-surgery clinical visits. Tissue samples (e.g., biopsies of the liver and adipose and remnants of the stomach) will be collected during operation. Meanwhile, participants will complete a REDCap survey at baseline and 1-year, 2-year, and 3-year post-surgery. Participants' electronic medical records will be used to obtain additional information and facilitate long-term follow-up. The investigators will evaluate pre- to post-surgery changes in the fecal microbiome and fecal and blood levels of metabolites and proteins and the associations of microbiome, metabolites, and proteins with cardiometabolic improvements after surgery. This study will advance our understanding of the role of gut microbiota in metabolic surgery, which may translate into novel approaches to identify and treat obese patients for better cardiometabolic health.

NCT ID: NCT04993651 Recruiting - Morbid Obesity Clinical Trials

Effect of CPAP on Fetal pH at Scheduled C-section in Morbidly Obese Women

Start date: October 11, 2021
Phase: N/A
Study type: Interventional

The objective of our study is to evaluate the effect of CPAP on umbilical cord acid base status in morbidly obese women at the time of scheduled cesarean delivery. We hypothesize that neonates born to mothers wearing CPAP during the cesarean section will have a higher umbilical artery pH.

NCT ID: NCT04945473 Recruiting - Morbid Obesity Clinical Trials

Gastric Recalibration After Endoscopic Sleeve Gastroplasty

ESG-IRM
Start date: July 13, 2021
Phase: N/A
Study type: Interventional

Endoscopic sleeve gastroplasty (ESG) is a technique used for bariatric surgery, with results comparable to conventional surgery, in order to treat morbid obesity. It has also less risks of complications, and it is not an irreversible technique. It can be repeated overtime, regarding the evolution of the gastroplasty. There is little data in the literature on the effectiveness of endoscopic "revision". This study will assess the benefits and costs of a revision during the follow-up endoscopy.

NCT ID: NCT04934826 Recruiting - Morbid Obesity Clinical Trials

Comparison of the Absorption of Hydrolyzed or Intact Proteins in Morbid Obese Patients After the Roux Y Gastric Bypass

RyDIGEST
Start date: September 7, 2021
Phase: N/A
Study type: Interventional

The gastric bypass can reduce the bioavailability of food proteins. The bioavailability of hydrolyzed proteins may be higher than intact proteins. Thus, the use of hydrolyzed proteins could compensate for the decrease in protein bioavailability observed after gastric By-pass in morbidly obese patients. The effectiveness of a hydrolyzed protein intake may be higher than that of an intact protein intake to improve the status of a By-pass. The hypothesis would be that the use of hydrolyzed proteins would compensate for the decrease in bioavailability of food proteins caused by gastric By-pass.

NCT ID: NCT04767490 Recruiting - Obesity Clinical Trials

Single Anastomosis Versus Standard Duodenal Switch

SADI
Start date: September 1, 2015
Phase: N/A
Study type: Interventional

Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS. The overall objective of this study is to assess in a prospective randomized blinded trial, the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.

NCT ID: NCT04701541 Recruiting - Morbid Obesity Clinical Trials

Perioperative Diaphragmatic Ultrasound as Predictive Index of Atelectasis in Bariatric Surgery

ECODIA
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

In this study the Authors assume that peri-operative changes in DIA are predictive of postoperative atelectasis, thus providing a clinically useful tool to stratify the need for high-intensity monitoring, including admission to intensive care. Aim of this prospective observational study, in obese patients undergoing sleeve gastrectomy, is to evaluate the relationship between pre to postoperative changes in US-DIA and PaO2/FiO2.

NCT ID: NCT04658134 Recruiting - Morbid Obesity Clinical Trials

Glycine "Deficiency" and the Kinetics of Acylglycine in Morbid Obesity

Start date: January 20, 2021
Phase: N/A
Study type: Interventional

This study aims to evaluate the effects of oral glycine supplementation on plasma glycine concentration, intracellular glutathione (GSH) concentration, plasma acylglycine concentration, urine acylglycine concentration, and insulin resistance in subjects with morbid obesity. This is an open-labelled trial. 20 adults with morbid obesity will be recruited. Following screening and baseline metabolic evaluations, eligible subjects will be given oral glycine supplements for 14 ± 5 days. Upon completing glycine supplementation, subjects will return for their post-supplement metabolic assessment. The investigators hypothesize that oral glycine supplementation in morbidly obese patients normalizes plasma glycine concentration, increases intracellular GSH concentration, increases plasma and urinary acylglycine concentration, and improves insulin resistance.

NCT ID: NCT04644445 Recruiting - Morbid Obesity Clinical Trials

Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery

Start date: November 3, 2020
Phase: N/A
Study type: Interventional

Postoperative nausea and vomiting are common occurrences following bariatric surgery, occurring in up to 80% of patients and contributing to increased healthcare utilization and delays in discharge. This study aims to evaluate the impact of a high-protein liquid diet on postoperative nausea, vomiting, and length of stay after laparoscopic or robotic sleeve gastrectomy.

NCT ID: NCT04619771 Recruiting - Insomnia Clinical Trials

M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER)

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

This study is a longitudinal clinical trial designed to assess the feasibility of sleep intervention (Cognitive Behavioral Therapy for Insomnia (CBT-I)) in individuals with insomnia following bariatric surgery.

NCT ID: NCT04613635 Recruiting - Morbid Obesity Clinical Trials

Stratafix vs. Vicryl OAGB / MGB Suture Study

Start date: November 6, 2020
Phase: N/A
Study type: Interventional

To compare shorttime (6 months) results of two competitive suture materials with regard to time demanded to perform the concerned surgical step and secondary to study anastomotic site safety and complications like leakage and hemorrhage as well as development of anastomotic strictures. Evaluation of cost-effectiveness.