Biometabolic Outcomes After Weight Loss Surgery: An Individualized Approach

Launched by UNIVERSITY OF MISSOURI-COLUMBIA · Apr 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether the length of the bypassed intestine in gastric bypass surgery affects how much weight people lose and how their body’s metabolism improves, including effects on gut hormones, gut bacteria, and certain blood markers called microRNAs. It uses a randomized design with five groups: three different lengths of the bypass (50 cm, 100 cm, and 150 cm), plus two control groups (a sleeve gastrectomy and a best non-surgical medical weight-loss program). The study will compare weight loss and health improvements (like diabetes and cholesterol) and will also look for possible complications related to malabsorption. It is being conducted at the University of Missouri-Columbia and is currently enrolling by invitation, with results not yet available.

If you’re eligible, you’d be an adult between 18 and 80 with a body mass index (BMI) of 40–60, and you’d need to meet your insurance criteria for weight-loss surgery. Eligible participants could be randomized to one of the three bypass lengths, or to sleeve gastrectomy, or to medical therapy. Those in the surgical groups would have a standard laparoscopic procedure, and all participants would provide blood samples before surgery and again at about 6 and 12 months, plus stool samples at the same times. Researchers will track weight, diabetes status, and lipid levels, and will monitor for any surgery-related complications. Data from the study will be shared in a de-identified way with other researchers to help understand the biology behind weight loss after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age greater than 18
• • 2. Body mass index of 40-60 kg/m2
• • 3. Meet insurance criteria, as set forth by the patient's insurance policy, to qualify for coverage for weight loss surgery
• • 4. Planned laparoscopic Roux-en-Y gastric bypass
• • 5. Willingness to have blood collected before and after surgical procedure at defined points and collect and mail stool sample before operation and at defined post-operative time points.
• Exclusion Criteria:
• • 1. Age less than 18
• • 2. Patient fails to fulfill insurance mandated criteria
• • 3. Unwilling to be randomized to variable length to gastric bypass or unwilling to have blood collected or personally collect and mail in stool sample
• • 4. Unwilling to follow-up at required postoperative visits