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

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: Bariatric Surgery

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808-4124
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Surgical Groups (RYGB and SG) Inclusion criteria for the two surgery groups (n=16)

• 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:

Inclusion Criteria for the BMI matched control group (n=9):

• 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

Exclusion Criteria:

• Exclusion Criteria for the two surgery groups (n=16):

  • 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

Exclusion Criteria for the BMI matched control group (n=9):

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RYGB; Bariatric Surgery:Roux-en-y	Procedure: Bariatric Surgery
Experimental: SG; Bariatric Surgery: Sleeve Gastrectomy	Procedure: Bariatric Surgery
Placebo Comparator: Control; BMI matched control	Procedure: Bariatric Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Keely Hawkins, Ph.D., Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: April 6, 2016
• First Submitted That Met QC Criteria: April 6, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Weight Loss; gut microbiota
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: PBRC 2015-064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO