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

Sponsor

Medtronic - MITG (Industry)

Overall Status

Completed

CT.gov ID

NCT00641251

Collaborator

(none)

120

Enrollment

Locations

Arms

106

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Cardiovascular Disease	Other: intensive medical management Other: RYGB & IMM	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 intensive medical management	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.
Active Comparator: 2 Roux-en-Y gastric bypass with intensive medical management	Other: RYGB & IMM Roux-en-Y gastric bypass Surgery combined with intensive medical management

Arm

Intervention/Treatment

Active Comparator: 1

intensive medical management

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.

Active Comparator: 2

Roux-en-Y gastric bypass with intensive medical management

Other: RYGB & IMM

Roux-en-Y gastric bypass Surgery combined with intensive medical management

Outcome Measures

Primary Outcome Measures

HbA1c < 7.0% [12 Months]
Systolic blood pressure < 130 mm Hg [12 Months]
LDL cholesterol < 100 mg/dl [12 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 67 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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%.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	National Taiwan University Hospital	Taipei		Taiwan