DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery

Type 2 Diabetes Clinical Trial

— DSS  

Official title:

Global Randomized Prospective Study of Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641251
• Other study ID #: AS07008
• Status: Completed
• Phase: N/A
• First received: February 13, 2008
• Last updated: November 27, 2017
• Start date: February 2008
• Est. completion date: December 2016

Study information

• Verified date: November 2017
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 67 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• RYGB & IMM
Roux-en-Y gastric bypass Surgery combined with intensive medical management

Locations

Country	Name	City	State
Taiwan	Min-Sheng General Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
United States	University of Minnesota	Minneapolis	Minnesota
United States	Columbia University	New York	New York
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

United States,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c < 7.0%		12 Months
Primary	Systolic blood pressure < 130 mm Hg		12 Months
Primary	LDL cholesterol < 100 mg/dl		12 Months