Microbiome and Bariatric Surgery

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03065426

Acronym

Biobehavioral

Enrollment

144

Registered

2017-02-27

Start date

2017-05-11

Completion date

2021-09-30

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Change, Body

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Weight trajectory	24 months	Weight outcomes following bariatric surgery

Countries

United States

Contacts

Primary ContactCarrie Nelson, BSN

cnelson@nrifargo.com701-365-4918

Outcome results