DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery - NCT00641251-55414 (Clinical Trial 210605)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy210605.aspx
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| City: |
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Minneapolis |
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State:
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MN |
| Zip Code: |
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55414 |
| Conditions: |
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Type 2 Diabetes - Cardiovascular Disease |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
1. Age 35 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 ≤ 34.9 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. |
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| Study is available at: |
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University of Minnesota
Minneapolis, MN 55414
United States
Primary Contact:
Joyce Schone, RD, LD
Email: jschone1@fairview.org
Phone: 612-273-4860 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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