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Roux-en-Y-Gastric Bypass for Type 2 Diabetes

N/A
Waitlist Available
Led By Francesco Rubino, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 2 and year 5
Awards & highlights

Study Summary

The study is aimed to compare: Laparoscopic Roux-en-Y-Gastric Bypass (RYGB) + optimal medical therapy versus Intensive lifestyle modification and optimal medical therapy in the treatment of type 2 diabetes in overweight-to-moderately obese patients (BMI: 28-34kg/m2; the lower BMI cut-off will be 26kg/m2 in patients of Asian descent). This is a single center, prospective randomized study. The study at the Weill College Medical College Diabetes Surgery Center. This study is intended to be a pilot investigation whose results can inform clinicians and researchers for future larger or multi-site trials of diabetes surgery. This study will also be used for the definition of a "core" protocol for independent randomized clinical trials to be carried out at various centers participating in a multinational consortium.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 2 and year 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and year 2 and year 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary end-point will be the control of hyperglycemia (HbA1c <6.5% + FG<126mg/dl).
Secondary outcome measures
Short (2 yrs) and long term (5 yrs.) achievement of 'adequate" glycemic control, mean change in HbA1c from baseline.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Roux-en-Y-Gastric BypassExperimental Treatment1 Intervention
A laparoscopic gastric bypass will be performed in the treatment of type 2 diabetes in Overweight-to-Moderately Obese Patients
Group II: Lifestyle modificationActive Control1 Intervention
Intensive nutritional/exercise counseling for weight loss by lifestyle modification in addition to optimum medical treatment.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,279 Total Patients Enrolled
Medtronic - MITGIndustry Sponsor
252 Previous Clinical Trials
300,636 Total Patients Enrolled
Francesco Rubino, MDPrincipal InvestigatorWeill Medical College of Cornell University

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
Roux-en-Y-Gastric Bypass vs. Lifestyle Modification and Medical Therapy in the Treatment of Type 2 Diabetes
2010. "Roux-en-Y-Gastric Bypass vs. Lifestyle Modification and Medical Therapy in the Treatment of Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01231308.
All > Gestational Diabetes > Gastric Bypass
~3 spots leftby Apr 2025
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