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

NCT02735564 | Completed

• 1 other identifier: PBRC 2015-064
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Bariatric Surgery Candidate

Keywords

Weight Loss; Magnetic Resonance Imaging; gut microbiota

Outcome Measures

Primary Outcomes (2)

• Neural reward sensitivity

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

  baseline, 6 months

• gut microbiota

  Determine if gut microbiota, as analyzed via stool sample collection, changes from baseline (prior to surgery) to 6 months follow-up (post-surgery) among the groups.

  baseline, 6 months

Study Arms (3)

RYGB

EXPERIMENTAL

Bariatric Surgery:Roux-en-y

Procedure: Bariatric Surgery

SG

EXPERIMENTAL

Bariatric Surgery: Sleeve Gastrectomy

Procedure: Bariatric Surgery

Control

PLACEBO COMPARATOR

BMI matched control

Procedure: Bariatric Surgery

Interventions

Bariatric Surgery PROCEDURE

Control; RYGB; SG

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who qualify for Heads Up and would like to participate in this ancillary study
• Be willing to participate in additional procedures including: 4 brains scans (2 before surgery and 2 after surgery), 2 meal challenges (1 before surgery and 1 after surgery), and 2 microbiota collections (1 before surgery and 1 after surgery).
• Be willing to archive microbiota samples
• Control Group:
• Males and females age 21-70 years
• Body Mass Index ≥40 kg/m2 without type 2 diabetes or ≥35 kg/m2 and ≤ 60kg/m² with type 2 diabetes
• Agree to receive frequent contacts from investigators and communicate with program staff for up to 6 months
• Able to give written informed consent
• Able to comply with study procedures

You may not qualify if:

• Unable or unwilling to give informed consent
• Pregnant or planning on becoming pregnant during the 6 months you participate in the study
• History or presence of unremoveable metal objects (medical or dental) or electronic devices or other contraindication to MRI scanning.
• Unwillingness to complete an MRI due to confined space or other related phobias
• Unable or unwilling to give informed consent
• Hospitalization for psychiatric illness or substance use/abuse within the past year
• Diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, or personality disorder as determined by the medical staff
• Travel plans that do not permit participation
• Pregnant or planning on becoming pregnant during the 6 months you participate in the study
• History of prior bariatric surgery, extensive bowel resection, or hiatal hernia repair (unless approved by the medical staff)
• History of eating disorder such as anorexia nervosa, bulimia, or binge eating (unless approved by program staff)
• Current major depressive episode or history of suicidal behaviors
• Severe congestive heart failure (NYHA class III, IV)
• Second degree or greater heart block
• Other medical, psychiatric, or behavioral limitations that in the judgement of the investigator may interfere with program participation or the ability to follow the intervention protocol

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808-4124, United States

Location

MeSH Terms

Conditions

Weight Loss

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Keely Hawkins, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 12, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: April 1, 2018
• Last Updated: January 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)