Microbiome and Bariatric Surgery

NCT03065426 | Unknown

• 1 other identifier: BIO-XXX
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Weight Change, Body

Outcome Measures

Primary Outcomes (1)

• Weight trajectory

  Weight outcomes following bariatric surgery

  24 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• North Dakota State University: lead
• Neuropsychiatric Research Institute: collaborator
• The Cleveland Clinic: collaborator

Study Sites (2)

Neuropsychiatric Research Institute

Fargo, North Dakota, 58103, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Related Publications (1)

• Carroll I, Qian Y, Sorgen A, Steffen K, Heinberg L, Reed K, Malazarte A, Fodor A. Intestinal energy harvest is associated with post-bariatric surgery weight loss. Res Sq [Preprint]. 2024 Mar 29:rs.3.rs-4031151. doi: 10.21203/rs.3.rs-4031151/v1.

  PMID: 38586018 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fecal

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Carrie Nelson, BSN

CONTACT

701-365-4918; cnelson@nrifargo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: February 27, 2017
• Study Start: May 11, 2017
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)