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Microbiome and Bariatric Surgery (Biobehavioral)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2017 by North Dakota State University
Sponsor:
Collaborators:
Neuropsychiatric Research Institute
The Cleveland Clinic
Information provided by (Responsible Party):
Kristine Steffen, North Dakota State University
ClinicalTrials.gov Identifier:
NCT03065426
First received: February 22, 2017
Last updated: NA
Last verified: February 2017
History: No changes posted
  Purpose
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
Weight Change, Body

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanisms That Predict Weight Trajectory After Bariatric Surgery: The Interactive Roles of Behavior and Biology

Resource links provided by NLM:


Further study details as provided by North Dakota State University:

Primary Outcome Measures:
  • Weight trajectory [ Time Frame: 24 months ]
    Weight outcomes following bariatric surgery


Biospecimen Retention:   Samples With DNA
Fecal

Estimated Enrollment: 144
Anticipated Study Start Date: March 1, 2017
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Participants planning to undergo Roux-en-Y Gastric Bypass or Sleeve Gastrectomy.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03065426

Contacts
Contact: Carrie Nelson, BSN 701-365-4918 cnelson@nrifargo.com

Sponsors and Collaborators
North Dakota State University
Neuropsychiatric Research Institute
The Cleveland Clinic
  More Information

Responsible Party: Kristine Steffen, Associate Professor, North Dakota State University
ClinicalTrials.gov Identifier: NCT03065426     History of Changes
Other Study ID Numbers: BIO-XXX 
Study First Received: February 22, 2017
Last Updated: February 22, 2017
Individual Participant Data  
Plan to Share IPD: Yes
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.

Additional relevant MeSH terms:
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 27, 2017