Clinical Trials Directory

Trials / Completed

CompletedNCT02735564

Change in Reward System Activation and Gut Microbiota Following RYGB and Sleeve Gastrectomy for Weight Loss vs. Control-Heads Up Ancillary

Change in Reward System Activation and Gut Microbiota Following Roux-en-y and Sleeve Gastrectomy for Weight Loss as Compared to a Control- Heads Up Ancillary

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
Pennington Biomedical Research Center · Academic / Other
Sex
All
Age
21 Years – 70 Years
Healthy volunteers
Accepted

Summary

Bariatric surgery is considered an effective long-term intervention for the treatment of obesity and associated complications. While bariatric surgery has been shown to result in a large sustained weight loss, the degree of weight loss and maintenance thereafter varies greatly. The Heads Up Surgical Demonstration Project (Heads Up) is a 5 year project examining weight loss after an intensive medical intervention (IMI) and the 2 most widely used bariatric surgeries (roux-en-y gastric bypass or RYGB and sleeve gastrectomy or SG). Baseline data are collected prior to surgery and follow-up data are collected at 6 months and annually thereafter. A recent meta-analysis revealed that RYGB resulted in greater weight loss and is more effective in resolving obesity related comorbidities than SG, although SG has been shown to result in a reduction of perioperative complications and reoperations1. Full elucidation of the mechanisms leading to variation in success for weight loss interventions is crucial to understanding the most effective and reliable treatments for obesity and associated comorbidities.

Conditions

Interventions

TypeNameDescription
PROCEDUREBariatric Surgery

Timeline

Start date
2016-04-01
Primary completion
2017-11-01
Completion
2018-04-01
First posted
2016-04-12
Last updated
2020-01-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02735564. Inclusion in this directory is not an endorsement.