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Microbiome and Bariatric Surgery (Biobehavioral)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03065426
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : May 16, 2017
Sponsor:
Collaborators:
Neuropsychiatric Research Institute
The Cleveland Clinic
Information provided by (Responsible Party):
Kristine Steffen, North Dakota State University

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
Weight Change, Body

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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.



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


Biospecimen Retention:   Samples With DNA
Fecal


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065426


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

Locations
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United States, North Dakota
Neuropsychiatric Research Institute Recruiting
Fargo, North Dakota, United States, 58103
Contact: Brian Peterson         
Principal Investigator: Kristine Steffen         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Leslie Heinberg         
Principal Investigator: Leslie Heinberg         
Sponsors and Collaborators
North Dakota State University
Neuropsychiatric Research Institute
The Cleveland Clinic
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Responsible Party: Kristine Steffen, Associate Professor, North Dakota State University
ClinicalTrials.gov Identifier: NCT03065426    
Other Study ID Numbers: BIO-XXX
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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:
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Body Weight Changes
Body Weight