Actively Recruiting
Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)
Led by Salvador Navarrete · Updated on 2026-03-20
262
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized controlled trial to compare two types of Roux-en-Y gastric bypass (RYGB) surgeries for morbid obesity. The trial evaluates a surgery where biliopancreatic (BP) and roux limb lengths are adjusted to 30% and 15% of the patient's total small bowel length (aRYGB) versus the current standard approach using fixed 100 cm limb lengths (sRYGB). The study aims to understand if adjusting limb lengths improves weight loss and metabolic outcomes, such as diabetes, hyperlipidemia, and hypertension resolution, while also assessing postoperative quality of life. Participants will be randomly assigned to either the standard RYGB group with fixed limb lengths or the ratio-adjusted RYGB group with limb lengths based on individual bowel measurements taken during surgery. The trial follows patients with scheduled assessments at 6, 12, 24, and 60 months after surgery to measure weight loss, diabetes status, metabolic syndrome effects, vitamin and nutritional levels, and quality of life using validated surveys. During the study, patients will have routine follow-ups every 6 months for the first two years, then yearly thereafter, including weight and BMI measurements, blood tests for metabolic markers, and quality of life questionnaires. Researchers will track complications, adverse events, and any additional bariatric surgeries. The main measure is total weight loss at designated time points, alongside secondary outcomes like diabetes resolution and metabolic improvements, with the total study duration extending up to five years post-surgery.
CONDITIONS
Brief Title
Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Morbidly obese patients with a body mass index between 40 and 60
- Patients who understand and accept the need for long-term follow-up
- Patients who agree to be included in the study
You will not qualify if you...
- Individuals unable to understand and sign a written consent form
- Patients with a history of previous bariatric surgery procedures
- Presence of a severe and progressive life-threatening condition unrelated to obesity
- Previous gastric or small bowel resection
- Active cancer
- Pregnancy or desire to become pregnant during the study
- Mentally unbalanced patients under supervision or guardianship, or unable to give consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus immediate recovery period
Participants undergo Roux-en-Y Gastric Bypass surgery with either standard fixed limb lengths or ratio-adjusted limb lengths based on their total small bowel length.
1 surgical visit (in-person)
Duration - Up to 5 years
Participants have regular follow-up visits to monitor weight loss, diabetes resolution, metabolic syndrome status, vitamin and nutritional levels, quality of life, and any complications after surgery.
Visits at approximately 1 month, 6 months, 12 months, 24 months, and 60 months post-surgery
Trial Site Locations
Total: 1 location
1
Cleveland clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
S
Salvador Navarrete, MD
A
Andrew Strong, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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