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

Conditions

Type 2 Diabetes, Cardiovascular Disease

Keywords

T2 Diabetes, Type 2 diabetes CVD event rates and mortality

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.

Sayeed Ikramuddin, Judith Körner, Wei‐Jei Lee, Avis J. Thomas, John E. Connett et al. (17 authors)

JAMA2018-01-16284 citations

10.1001/jama.2017.20813

National Differences in Remission of Type 2 Diabetes Mellitus After Roux-en-Y Gastric Bypass Surgery-Subgroup Analysis of 2-Year Results of the Diabetes Surgery Study Comparing Taiwanese with Americans with Mild Obesity (BMI 30-35 kg/m<sup>2</sup>).

Chong K, Ikramuddin S, Lee WJ, Billington CJ, Bantle JP, Wang Q, Thomas AJ, Connett JE, Leslie DB, Inabnet WB, Jeffery RW, Sarr MG, Jensen MD, Vella A, Ahmed L, Belani K, Schone JL, Olofson AE, Bainbridge HA, Laqua PS, Korner J, Chuang LM.

2017-05-0115 citations

10.1007/s11695-016-2433-4

Roux-en-Y gastric bypass for diabetes (the Diabetes Surgery Study): 2-year outcomes of a 5-year, randomised, controlled trial.

Ikramuddin S, Billington CJ, Lee WJ, Bantle JP, Thomas AJ, Connett JE, Leslie DB, Inabnet WB, Jeffery RW, Chong K, Chuang LM, Sarr MG, Jensen MD, Vella A, Ahmed L, Belani K, Schone JL, Olofson AE, Bainbridge HA, Laqua PS, Wang Q, Korner J.

2015-05-12139 citations

10.1016/s2213-8587(15)00089-3

Roux-en-Y Gastric Bypass vs Intensive Medical Management for the Control of Type 2 Diabetes, Hypertension, and Hyperlipidemia

Sayeed Ikramuddin, Judith Körner, Wei‐Jei Lee, John E. Connett, William B. Inabnet et al. (19 authors)

JAMA2013-06-05729 citations

10.1001/jama.2013.5835

Interventions

OTHERintensive 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.

OTHERRYGB & IMM

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 67 Years

Healthy volunteers

No

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%.

Design outcomes

Primary

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

Countries

Taiwan, United States

Outcome results

None listed