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 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.

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Key information

Conditions

Bariatric Surgery Candidate Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808-4124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

Primary outcomes

Neural reward sensitivity

Time frame: baseline, 6 months

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

Time frame: baseline, 6 months

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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study 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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2018
First posted: Apr 12, 2016
Registry last updated: Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed