Microbiome and Bariatric Surgery (Biobehavioral)

Mechanisms That Predict Weight Trajectory After Bariatric Surgery: The Interactive Roles of Behavior and Biology

This is a prospective, 24-month, longitudinal study of patients planning to undergo bariatric surgery (Roux-en-Y Gastric Bypass or Sleeve Gastrectomy) in which we aim to identify correlates and predictors of observed weight loss trajectories following bariatric surgery. This approach will expand current knowledge by examining the combined impact of empirically supported behavioral and biological data in a large sample over time. Intensive measurement of problematic eating behaviors, mood, and compliance with diet and exercise regimens post-surgery will be analyzed in the context of lterations in parallel with, or in response to, changes observed in the gut microbiota. Identifying these post-surgical predictors of weight loss and comorbidity resolution will allow for the development of individualized interventions to optimize surgery-related outcomes.

Study Overview

• Status: Unknown
• Conditions: Weight Change, Body

• Study Type: Observational
• Enrollment (Anticipated): 144

Contacts and Locations

• Study Contact: Name: Carrie Nelson, BSN; Phone Number: 701-365-4918; Email: cnelson@nrifargo.com

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Recruiting
      • Neuropsychiatric Research Institute
      • Contact: Brian Peterson
      • Principal Investigator: Kristine Steffen
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Leslie Heinberg
      • Principal Investigator: Leslie Heinberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants planning to undergo Roux-en-Y Gastric Bypass or Sleeve Gastrectomy.

Description

Inclusion Criteria:

1. In evaluation for Roux-en-Y Gastric Bypass or Sleeve Gastrectomy.
2. Age 18-65, inclusive

Exclusion Criteria:

1. Alcohol or substance use disorder in past year
2. Severe psychiatric disorder that may affect ability to complete the protocol
3. Regular tobacco use during the last year
4. Current medication taken routinely and known to impact factors that may affect the gut microbiome
5. Use of any oral or injectable antibiotic in the past month
6. Use of commercially available pre/pro biotic in the past month
7. History of significant disease/disorder that would be expected to impact the microbiome of the gut
8. Inability to engage in physical activity or dietary monitoring
9. Nonprescribed/illicit drug use
10. Pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Roux-en-Y Gastric Bypass; Patients planning to undergo Roux-en-Y Gastric Bypass will be invited to participate in this study.
Sleeve Gastrectomy; Patients planning to undergo Sleeve Gastrectomy will be invited to participate in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight trajectory	Weight outcomes following bariatric surgery	24 months

Collaborators and Investigators

• Sponsor: North Dakota State University
• Collaborators: The Cleveland Clinic; Neuropsychiatric Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2017
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 12, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes
• Other Study ID Numbers: BIO-XXX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: To the extent required by NIH and permitted by appropriate laws and rules. It will be available after the conclusion of the study and when the data have been cleaned.