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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03065426
Other study ID # BIO-XXX
Secondary ID
Status Recruiting
Phase N/A
First received February 22, 2017
Last updated May 12, 2017
Start date May 11, 2017
Est. completion date September 2021

Study information

Verified date May 2017
Source North Dakota State University
Contact Carrie Nelson, BSN
Phone 701-365-4918
Email cnelson@nrifargo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 144
Est. completion date September 2021
Est. primary completion date September 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio
United States Neuropsychiatric Research Institute Fargo North Dakota

Sponsors (3)

Lead Sponsor Collaborator
North Dakota State University Neuropsychiatric Research Institute, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight trajectory Weight outcomes following bariatric surgery 24 months
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