DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 30 - 67 |
| Updated: | 12/1/2017 |
| Start Date: | February 2008 |
| End Date: | December 2016 |
Global Randomized Prospective Study of Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery
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 39.9 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.
a randomized clinical trial involving type 2 diabetics with BMI from 30.0 to 39.9 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.
Inclusion Criteria:
1. Age 30 to 67 years at eligibility visit.
2. Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a
doctor for at least the six months prior to enrollment, and HbA1c ≥ 8.0 %.
3. Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit.
4. Willingness to accept random assignment to either treatment group.
5. Expect to live or work within approximately one hour's traveling time from the study
clinic for the duration of the two-year trial.
6. Willingness to comply with the follow-up protocol and successful completion of the
run-in (described below).
7. Written informed consent.
Exclusion Criteria:
1. Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery
angioplasty or bypass, stroke) in the past six months.
2. Current evidence of congestive heart failure, angina pectoris, or symptomatic
peripheral vascular disease.
3. Cardiac stress test indicating that surgery or IMM would not be safe.
4. Pulmonary embolus or thrombophlebitis in the past six months.
5. Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented
to be disease-free for five years.
6. Significant anemia (hemoglobin 1.0 g or more below normal range) or history of
coagulopathy.
7. Serum creatinine ≥ 1.5 mg/dl.
8. HbA1c > 14.0%.
We found this trial at
4
sites
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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