Clinical trial NCT00641251: DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery
Official title: Global Randomized Prospective Study of Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Cardiovascular Disease
Keywords: T2 Diabetes
Type 2 diabetes CVD event rates and mortality
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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%.

Primary outcomes:
measure: HbA1c < 7.0%
timeFrame: 12 Months
measure: Systolic blood pressure < 130 mm Hg
timeFrame: 12 Months
measure: LDL cholesterol < 100 mg/dl
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Columbia University
state: New York
city: Taipei
country: Taiwan
facility: Min-Sheng General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: University of Minnesota
name: Sayeed Ikramuddin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ikramuddin S, Korner J, Lee WJ, Thomas AJ, Connett JE, Bantle JP, Leslie DB, Wang Q, Inabnet WB 3rd, Jeffery RW, Chong K, Chuang LM, Jensen MD, Vella A, Ahmed L, Belani K, Billington CJ. Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study. JAMA. 2018 Jan 16;319(3):266-278. doi: 10.1001/jama.2017.20813.
citation: Chong K, Ikramuddin S, Lee WJ, Billington CJ, Bantle JP, Wang Q, Thomas AJ, Connett JE, Leslie DB, Inabnet WB 3rd, Jeffery RW, Sarr MG, Jensen MD, Vella A, Ahmed L, Belani K, Schone JL, Olofson AE, Bainbridge HA, Laqua PS, Korner J, Chuang LM. 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/m2). Obes Surg. 2017 May;27(5):1189-1195. doi: 10.1007/s11695-016-2433-4.
citation: Ikramuddin S, Korner J, Lee WJ, Bantle JP, Thomas AJ, Connett JE, Leslie DB, Inabnet WB 3rd, Wang Q, Jeffery RW, Chong K, Chuang LM, Jensen MD, Vella A, Ahmed L, Belani K, Olofson AE, Bainbridge HA, Billington CJ. Durability of Addition of Roux-en-Y Gastric Bypass to Lifestyle Intervention and Medical Management in Achieving Primary Treatment Goals for Uncontrolled Type 2 Diabetes in Mild to Moderate Obesity: A Randomized Control Trial. Diabetes Care. 2016 Sep;39(9):1510-8. doi: 10.2337/dc15-2481. Epub 2016 Jun 16.
citation: Ikramuddin S, Billington CJ, Lee WJ, Bantle JP, Thomas AJ, Connett JE, Leslie DB, Inabnet WB 3rd, 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. Roux-en-Y gastric bypass for diabetes (the Diabetes Surgery Study): 2-year outcomes of a 5-year, randomised, controlled trial. Lancet Diabetes Endocrinol. 2015 Jun;3(6):413-422. doi: 10.1016/S2213-8587(15)00089-3. Epub 2015 May 12.
citation: Ikramuddin S, Korner J, Lee WJ, Connett JE, Inabnet WB, Billington CJ, Thomas AJ, Leslie DB, Chong K, Jeffery RW, Ahmed L, Vella A, Chuang LM, Bessler M, Sarr MG, Swain JM, Laqua P, Jensen MD, Bantle JP. Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery Study randomized clinical trial. JAMA. 2013 Jun 5;309(21):2240-9. doi: 10.1001/jama.2013.5835.