Status:
COMPLETED
Characterization of Bile Acid Pathway in Obesity
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
It is unknown whether the bile acid pathway is altered in obesity. This study is designed to compare obesity and health to determine if the bile acid pathway differs depending on health state.
Detailed Description
This is a single center study involving diet intervention, including healthy obese and healthy normal weight participants. Participants will maintain their normal diet for 1 week, eat a high fat and h...
Eligibility Criteria
Inclusion
- Normal Weight Inclusion Criteria:
- Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment
- BMI: 18.5-25 kg/m2
- Obese Inclusion Criteria:
- Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment
- BMI: ≥ 30 kg/m2
- Exclusion Criteria for both Normal Weight and Obese Participants:
- History of abdominal surgery including cholecystectomy and other than appendectomy, Caesarian section or tubal ligation.
- Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat, phentermine.
- Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), a self-administered alcoholism screening test (AUDIT-C) and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a HAD score \>11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. The AUDIT-C is a 3-item alcohol screening questionnaire that reliably identifies participants who are hazardous alcohol drinkers or have active alcohol use disorders. In men, a score of 4 or more is above the recommended limits will be reviewed by study personnel. In women, a score of 3 or more is above the recommended limits will be reviewed by study personnel. However when the points are above recommended limits, the provider will review the patient's alcohol intake over the past few months to confirm accuracy and determine study eligibility..
- Intake of medication, whether prescribed or over the counter (except multivitamins), within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, and thyroxin replacement therapy.
Exclusion
Key Trial Info
Start Date :
November 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03341052
Start Date
November 14 2017
End Date
October 9 2021
Last Update
April 27 2023
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905