Biobehavioral: Microbiome and Bariatric Surgery

• Sponsor: North Dakota State University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03065426
• Collaborator: Neuropsychiatric Research Institute (Other), The Cleveland Clinic (Other)
• Enrollment: 144
• Locations: 2
• Anticipated Duration (Months): 51.7
• Patients Per Site: 72
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Change, Body

Study Design

• Study Type: Observational
• Anticipated Enrollment: 144 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Mechanisms That Predict Weight Trajectory After Bariatric Surgery: The Interactive Roles of Behavior and Biology
• Actual Study Start Date: May 11, 2017
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Weight trajectory [24 months]

   Weight outcomes following bariatric surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neuropsychiatric Research Institute	Fargo	North Dakota	United States	58103
2	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• North Dakota State University
• Neuropsychiatric Research Institute
• The Cleveland Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kristine Steffen, Associate Professor, North Dakota State University
• ClinicalTrials.gov Identifier: NCT03065426
• Other Study ID Numbers: BIO-XXX
• First Posted: Feb 27, 2017
• Last Update Posted: May 16, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Body Weight Changes

Study Results

No Results Posted as of May 16, 2017