- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03238794
Bariatric Surgery Versus Diet Alone in the Bile Acid Pathway and Weight Loss
March 22, 2024 updated by: Andres J. Acosta, M.D., Ph.D., Mayo Clinic
Effect of Weight Loss Through RYGB Versus Weight Loss Through Caloric Restriction on the Bile Acid Pathway
It is unknown whether the bile acid pathway reacts differently to weight loss resulting from Roux-En-Y Gastric Bypass (RYGB) surgery than weight loss resulting from caloric restriction alone.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Participants will be placed into two groups.
The Roux-En-Y Gastric Bypass (RYGB) group will consist of participants who will have elected to have RYGB at the Mayo Clinic Bariatric Center of Excellence.
The Diet group will have a low-calorie diet prescribed by a registered dietitian.
Both groups will collect stool from every bowel movement 2 days before presenting for baseline testing.
Both group participants will present for baseline testing after an overnight fast and before intervention (RYGB or low calorie diet).
Participants will consume a standard breakfast provided by study staff and blood samples will be collected at -15, 0, 15, 30,45,60,90,120,150,180,210,240,300,360 minutes.
Appetite and satiation ratings will be recorded via questionnaires during that day every 15 minutes for the first 90 minutes, then every 30 minutes.
Participants will repeat this regimen again after losing 7% of their body weight after having RYGB or low calorie diet.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Women of childbearing potential will have negative pregnancy tests within 48 hours of enrolment.
- BMI: ≥ 40
- Individuals who have elected to have RYGB at the Mayo Clinic Bariatric Center of Excellence, and individuals with a BMI ≥40 who are otherwise healthy with controlled cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine disorders. The RYGB participants will be invited to participate when their surgery is scheduled at the Mayo Clinic Bariatric Center of Excellence.
- The non-RYGB participants (BMI ≥40) will be otherwise healthy individuals with no unstable psychiatric disease and no unstable cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine disorders.
Exclusion Criteria:
- 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 depression or anxiety 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.
- Any acute or chronic condition or other disease that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.Participant activities:
- If recruited for the investigation participants will be asked to refrain from donating blood; refrain from participating in other research studies; avoid taking any additional over the counter or prescription medications or herbal supplements that have not been reviewed and approved by the physician or the study coordinator until the study has been completed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Roux-En-Y Gastric Bypass (RYGB)
Participants will have elected to have RYGB surgery per standard of care.
|
Food will be consumed as directed by their doctor as standard of care.
A food log will be completed the week before visits 3 and 5.
Other Names:
|
Active Comparator: Low-calorie Diet
Participants will have a low-calorie diet prescribed by a registered dietitian.
|
Food will be consumed as Week one will be liquid 400 to 500 kcal/day, weeks 2,3, and 4 will consist of 500-600 kcal/day of pureed food, weeks 5-8 will consist of 600-800 kcal/day of mechanical-soft food, weeks 9-12 will consist of 800 to 1000 kcal/day of soft foods, and the remainder of the study participants will be given 1000 to 1200 kcal/day of regular food.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Bile Acid (BA) excretion
Time Frame: baseline, 12 weeks
|
Total Fecal BA excretion change measured in mcmoles/48 hours
|
baseline, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andres J Acosta, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 17, 2019
Primary Completion (Estimated)
January 11, 2025
Study Completion (Estimated)
January 11, 2025
Study Registration Dates
First Submitted
August 1, 2017
First Submitted That Met QC Criteria
August 1, 2017
First Posted (Actual)
August 3, 2017
Study Record Updates
Last Update Posted (Actual)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 22, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-008664
- K23DK114460 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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