Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06293703

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

360 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Morbidly obese patients with a BMI 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
Not Eligible

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 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

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Trial Site Locations

Total: 1 location

1

Cleveland clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

S

Salvador Navarrete, MD

CONTACT

A

Andrew Strong, MD

CONTACT

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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