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

Not Applicable

Completed

• Conditions: Cardiovascular Disease; Type 2 Diabetes
• Interventions: Other: RYGB & IMM; Other: intensive medical management

• Registration Number: NCT00641251
• Lead Sponsor: Medtronic - MITG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-03-17
• Study First Posted: 2008-03-24
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	RYGB & IMM	Roux-en-Y gastric bypass with intensive medical management
1	intensive medical management	intensive medical management

Primary Outcome Measures

Name	Time	Method
HbA1c < 7.0%	12 Months
LDL cholesterol < 100 mg/dl	12 Months
Systolic blood pressure < 130 mm Hg	12 Months

Trial Locations

Locations (5)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Columbia University; 🇺🇸 New York, New York, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Min-Sheng General Hospital; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan