Roux-en-Y-Gastric Bypass vs. Lifestyle Modification and Medical Therapy in the Treatment of Type 2 Diabetes
Public ClinicalTrials.gov record NCT01231308. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Roux-en-Y-Gastric Bypass (RYGB) Versus Lifestyle Modification Plus Medical Therapy in the Treatment of Type 2 Diabetes in Overweight-to-Moderately Obese Patients: A Randomized Clinical Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01231308
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Interventions
- Roux-en-Y-Gastric Bypass Procedure
- Intensive lifestyle modification and Optimal medical Therapy Behavioral
Procedure · Behavioral
Eligibility (public fields only)
- Age range
- 21 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2010
- Primary completion
- Sep 30, 2013
- Completion
- Sep 30, 2014
- Last update posted
- Dec 23, 2012
2010 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10065 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01231308, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 23, 2012 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01231308 live on ClinicalTrials.gov.