Bariatric Surgery vs Diet for Weight Loss

Recruiting in Palo Alto (17 mi)

Overseen ByAndres Acosta

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with severe obesity (BMI ≥ 40) who are healthy or have controlled health issues. Women must not be pregnant. Participants will either undergo Roux-En-Y Gastric Bypass surgery at the Mayo Clinic or follow a low-calorie diet if they're not having surgery. People with untreated psychiatric disorders, alcoholism, eating disorders, certain past surgeries, chronic gastrointestinal diseases, or conditions affecting study participation are excluded.

Inclusion Criteria

Women of childbearing potential will have negative pregnancy tests within 48 hours of enrolment

BMI: ≥ 40

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.

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Exclusion Criteria

If you have significant mental health issues like anxiety, depression, substance abuse, or eating disorders, you may be excluded from the study. A screening test will be used to check for these issues. If any problems are found, you will be referred to your primary care doctor for further evaluation and care. Additionally, your alcohol consumption will be assessed using a questionnaire. If your score is above the recommended limits, it will be reviewed by the study team to determine if you are eligible for the study.

History of abdominal surgery including cholecystectomy and other than appendectomy, Caesarian section or tubal ligation

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

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Participant Groups

The study compares how the bile acid pathway responds to weight loss from two methods: Roux-En-Y Gastric Bypass surgery and a strict low-calorie diet alone. The goal is to see if there's a difference in this metabolic pathway depending on the weight loss strategy used.

2Treatment groups

Active Control

Group I: Roux-En-Y Gastric Bypass (RYGB)Active Control1 Intervention

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

Group II: Low-calorie DietActive Control1 Intervention

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