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Bariatric Surgery Versus Diet Alone in the Bile Acid Pathway and Weight Loss

Primary Purpose

Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Roux-En-Y Gastric Bypass
Low-calorie Diet
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Body Mass Index, gastric, bypass, bariatric surgery, bile acid, weight loss, diet, low calorie

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Roux-En-Y Gastric Bypass (RYGB)

Low-calorie Diet

Arm Description

Participants will have elected to have RYGB surgery per standard of care.

Participants will have a low-calorie diet prescribed by a registered dietitian.

Outcomes

Primary Outcome Measures

Change in Bile Acid (BA) excretion
Total Fecal BA excretion change measured in mcmoles/48 hours

Secondary Outcome Measures

Full Information

First Posted
August 1, 2017
Last Updated
February 2, 2023
Sponsor
Mayo Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03238794
Brief Title
Bariatric Surgery Versus Diet Alone in the Bile Acid Pathway and Weight Loss
Official Title
Effect of Weight Loss Through RYGB Versus Weight Loss Through Caloric Restriction on the Bile Acid Pathway
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 17, 2019 (Actual)
Primary Completion Date
January 11, 2024 (Anticipated)
Study Completion Date
January 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Body Mass Index, gastric, bypass, bariatric surgery, bile acid, weight loss, diet, low calorie

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roux-En-Y Gastric Bypass (RYGB)
Arm Type
Active Comparator
Arm Description
Participants will have elected to have RYGB surgery per standard of care.
Arm Title
Low-calorie Diet
Arm Type
Active Comparator
Arm Description
Participants will have a low-calorie diet prescribed by a registered dietitian.
Intervention Type
Procedure
Intervention Name(s)
Roux-En-Y Gastric Bypass
Other Intervention Name(s)
RYGB
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Low-calorie Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Bile Acid (BA) excretion
Description
Total Fecal BA excretion change measured in mcmoles/48 hours
Time Frame
baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres J Acosta, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Bariatric Surgery Versus Diet Alone in the Bile Acid Pathway and Weight Loss

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