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Sponsored by: |
Covidien |
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Information provided by: | Covidien |
ClinicalTrials.gov Identifier: | NCT00641251 |
The present study is the first stage of a research program whose ultimate goal is to conduct a randomized clinical trial involving type 2 diabetics with BMI from 30.0 to 34.9 kg/m2. This program will determine the relative effectiveness of RYGB combined with intensive medical management (IMM), versus IMM alone, in reducing CVD event rates and mortality in patients with poorly controlled diabetes. IMM will include rigorous lifestyle modification for weight loss and stepped pharmacologic treatment for diabetes and other CVD risk factors. The proposed study is a randomized trial which will provide an assessment of the efficacy of treatment, in reducing CVD risk factors and also assessing the feasibility, cost, and safety of a larger trial.
Condition | Intervention | Phase |
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Type 2 Diabetes Cardiovascular Disease |
Other: intensive medical management Other: RYGB & IMM |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Global Randomized Prospective Study of Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery |
Estimated Enrollment: | 120 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
intensive medical management
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Other: intensive medical management
IMM will include rigorous lifestyle modification for weight loss and stepped pharmacologic treatment consistent with standard of care for diabetes and other CVD risk factors.
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2: Active Comparator
Roux-en-Y gastric bypass with intensive medical management
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Other: RYGB & IMM
Roux-en-Y gastric bypass Surgery combined with intensive medical management
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Ages Eligible for Study: | 35 Years to 67 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55414 | |
Contact: Joyce Schone, RD, LD 612-273-4860 jschone1@fairview.org | |
Principal Investigator: Sayeed Ikramuddin, MD | |
United States, New York | |
Columbia University | Recruiting |
New York City, New York, United States, 10032 | |
Contact: Heather Bainbridge, RD 212-305-0486 dssresearch@columbia.edu | |
Principal Investigator: William B Inabnet, MD | |
Principal Investigator: Judith Korner, MD, PhD | |
Taiwan | |
National Taiwan University Hospital | Not yet recruiting |
Taipei, Taiwan | |
Contact: Linda Huang linda590203@gmail.com | |
Principal Investigator: Lee-Ming Chuang, MD, PhD | |
Min-Sheng General Hospital | Not yet recruiting |
Taipei, Taiwan | |
Contact: Yi-Ting Chung ya858880@yahoo.com.tw | |
Principal Investigator: Wei-Jei Lee, MD |
Responsible Party: | Covidien Surgical Devices ( Ross D. Segan, MD, FACS- Global Medical Director ) |
Study ID Numbers: | AS07008 |
Study First Received: | February 13, 2008 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00641251 History of Changes |
Health Authority: | United States: Institutional Review Board |
T2 Diabetes Type 2 diabetes CVD event rates and mortality |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Cardiovascular Diseases Glucose Metabolism Disorders |