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NCT02735564 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Pennington Biomedical Research Center.

Completed
Registry status
NA
Development phase
6
Enrollment target

NCT02735564: Completed NA study, sponsored by Pennington Biomedical Research Center.

NCT02735564 is a NA study that has completed, run by Pennington Biomedical Research Center. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02735564, a NA study, has completed, sponsored by Pennington Biomedical Research Center.

COMPLETED
Registry status
NA
Development phase
6 participants
Enrollment target

Study 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.

Primary Outcome

Investigate change in reward activation patterns in the brain in response to food cues using fMRI.

Interventions

  • PROCEDURE Bariatric Surgery

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2016-04
Est. Completion 2018-04
Phase NA

What the finished NCT02735564 record still lists

NCT02735564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Bariatric Surgery is the first listed.

NCT02735564 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02735564 about?

NCT02735564 is a clinical study titled "Change in Reward System Activation and Gut Microbiota Following RYGB and Sleeve Gastrectomy for Weight Loss vs. Control-Heads Up Ancillary". 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...

What is the current status of trial NCT02735564?

This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2016-04. Estimated completion is 2018-04.

What interventions are being tested in trial NCT02735564?

The interventions under investigation include: Bariatric Surgery (PROCEDURE).

Who is sponsoring clinical trial NCT02735564?

This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02735564's enrollment target sits among peer trials

6 1983rd of 2000 higher than 13 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02735564, the US trial registry maintained by the National Library of Medicine. NCT02735564 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.