Status:
COMPLETED
DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery
Lead Sponsor:
Medtronic - MITG
Conditions:
Type 2 Diabetes
Cardiovascular Disease
Eligibility:
All Genders
30-67 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Age 30 to 67 years at eligibility visit.
- 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 %.
- Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit.
- Willingness to accept random assignment to either treatment group.
- Expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial.
- Willingness to comply with the follow-up protocol and successful completion of the run-in (described below).
- Written informed consent.
Exclusion
- Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
- Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
- Cardiac stress test indicating that surgery or IMM would not be safe.
- Pulmonary embolus or thrombophlebitis in the past six months.
- Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.
- Significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy.
- Serum creatinine ≥ 1.5 mg/dl.
- HbA1c \> 14.0%.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00641251
Start Date
February 1 2008
End Date
December 1 2016
Last Update
November 29 2017
Active Locations (5)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55414
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Columbia University
New York, New York, United States, 10032
4
Min-Sheng General Hospital
Taipei, Taiwan