CLIMB II Study: Gastric Bypass Limb Lengths for Morbid Obesity

This study, called CLIMB II, is looking at how different lengths of intestine used in Roux-en-Y Gastric Bypass (RYGB) surgery affect weight loss. Specifically, it compares a standard approach with fixed limb lengths to a new approach where the limb lengths are adjusted based on your total small bowel length. The goal is to see if these adjusted lengths lead to more weight loss and better improvement in conditions like diabetes and high blood pressure. You might be able to join if you are 18 to 70 years old, have morbid obesity (a BMI between 40 and 60), and agree to long-term follow-up. The study aims to enroll 262 participants to see if the adjusted limb lengths lead to better outcomes.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to one of two surgery groups. The study plans to enroll 262 participants.
What's involved
You would undergo Roux-en-Y Gastric Bypass surgery. Routine follow-up visits in the Bariatric clinic will occur every 6 months for the first two years, then yearly after that.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6, 12, 24, and 60 months after surgery to measure changes in total weight loss.

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NCT06293703

Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)

Recruiting
NAAges 18–70InterventionalTreatment
Salvador Navarrete
~262 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:Surgery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine change in TWL after aRYGB compared to sRYGB in morbidly obese patients
Measured over 6,12,24 and 60 months from surgery
Morbid Obesity
1 sites across 1 states
Ohio1
  • Salvador Navarrete, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

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Eligibility criteria

Inclusion

morbidly obese patients (defined by BMI between 40 and 60).
Patient who understands and accepts the need for a long-term follow-up.
Patient who agrees to be included in the study

Exclusion

individuals unable to understand and sign a written consent form
patients with history of previous bariatric surgery procedures
presence of a severe and evolutive life threatening pathology unrelated to obesity
previous gastric or small bowel resection
active cancer
pregnancy or desired to be pregnant during the study
mentally unbalanced patients under supervision or guardianship, patient unable to give consent
  • To determine change in TWL after aRYGB compared to sRYGB in morbidly obese patients6,12,24 and 60 months from surgery

    Measured in kilograms