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

Primary Purpose

Bariatric Surgery Candidate

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bariatric Surgery
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bariatric Surgery Candidate focused on measuring Weight Loss, Magnetic Resonance Imaging, gut microbiota

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

RYGB

SG

Control

Arm Description

Bariatric Surgery:Roux-en-y

Bariatric Surgery: Sleeve Gastrectomy

BMI matched control

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 6, 2016
Last Updated
January 3, 2020
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT02735564
Brief Title
Change in Reward System Activation and Gut Microbiota Following RYGB and Sleeve Gastrectomy for Weight Loss vs. Control-Heads Up Ancillary
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate
Keywords
Weight Loss, Magnetic Resonance Imaging, gut microbiota

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RYGB
Arm Type
Experimental
Arm Description
Bariatric Surgery:Roux-en-y
Arm Title
SG
Arm Type
Experimental
Arm Description
Bariatric Surgery: Sleeve Gastrectomy
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
BMI matched control
Intervention Type
Procedure
Intervention Name(s)
Bariatric Surgery
Primary Outcome Measure Information:
Title
Neural reward sensitivity
Description
Investigate change in reward activation patterns in the brain in response to food cues using fMRI.
Time Frame
baseline, 6 months
Title
gut microbiota
Description
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.
Time Frame
baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keely Hawkins, Ph.D.
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808-4124
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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