Bariatric Surgery Versus Diet Alone in the Bile Acid Pathway and Weight Loss
Effect of Weight Loss Through RYGB Versus Weight Loss Through Caloric Restriction on the Bile Acid Pathway
2 other identifiers
interventional
21
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started May 2019
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2017
CompletedFirst Posted
Study publicly available on registry
August 3, 2017
CompletedStudy Start
First participant enrolled
May 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 11, 2027
February 11, 2026
February 1, 2026
7.7 years
August 1, 2017
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Bile Acid (BA) excretion
Total Fecal BA excretion change measured in mcmoles/48 hours
baseline, 12 weeks
Study Arms (2)
Roux-En-Y Gastric Bypass (RYGB)
ACTIVE COMPARATORParticipants will have elected to have RYGB surgery per standard of care.
Low-calorie Diet
ACTIVE COMPARATORParticipants will have a low-calorie diet prescribed by a registered dietitian.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andres J Acosta, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 1, 2017
First Posted
August 3, 2017
Study Start
May 17, 2019
Primary Completion (Estimated)
January 11, 2027
Study Completion (Estimated)
January 11, 2027
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share