NCT06293703 Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)
| NCT ID | NCT06293703 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Salvador Navarrete |
| Condition | Morbid Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 262 participants |
| Start Date | 2024-01-12 |
| Primary Completion | 2030-12-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 262 participants in total. It began in 2024-01-12 with a primary completion date of 2030-12-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators propose a randomized controlled trial comparing BP and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel length versus current standard practice using fixed lengths. The findings would provide further insight into feasibility of standardizing RYGB limb lengths and optimizing resultant weight loss and metabolic effects. The investigators hypothesize RYGB with ratio-adjusted limb lengths (aRYGB) will result in higher total weight loss and resolution of metabolic syndrome comorbidities, including diabetes, hyperlipidemia, and hypertension compared to standard fixed-length RYGB (sRYGB). The study will also utilize the Short Form Rand 36-Item Health Survey (SF36) to determine differences in postoperative quality of life metrics.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Salvador Navarrete, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06293703 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Morbid Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06293703 currently recruiting?
Yes, NCT06293703 is actively recruiting participants. Contact the research team at navarrs@ccf.org for enrollment information.
Where is the NCT06293703 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06293703 clinical trial?
NCT06293703 is sponsored by Salvador Navarrete. The principal investigator is Salvador Navarrete, MD at The Cleveland Clinic. The trial plans to enroll 262 participants.
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