Back to results

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

Primary Purpose

Type 2 Diabetes, Cardiovascular Disease

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

intensive medical management

RYGB & IMM

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring T2 Diabetes, Type 2 diabetes CVD event rates and mortality

Eligibility Criteria

30 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept 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%.

Sites / Locations

University of Minnesota
Mayo Clinic
Columbia University
Min-Sheng General Hospital
National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

intensive medical management

Roux-en-Y gastric bypass with intensive medical management

Outcomes

Primary Outcome Measures

HbA1c < 7.0%

Systolic blood pressure < 130 mm Hg

LDL cholesterol < 100 mg/dl

Secondary Outcome Measures

Full Information

NCT ID

NCT00641251

First Posted

February 13, 2008

Last Updated

November 27, 2017

Sponsor

Medtronic - MITG

1. Study Identification

Unique Protocol Identification Number

NCT00641251

Brief Title

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

Acronym

DSS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic - MITG

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Cardiovascular Disease

Keywords

T2 Diabetes, Type 2 diabetes CVD event rates and mortality

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

intensive medical management

Arm Title

Arm Type

Active Comparator

Arm Description

Roux-en-Y gastric bypass with intensive medical management

Intervention Type

Other

Intervention Name(s)

intensive medical management

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

RYGB & IMM

Intervention Description

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

Primary Outcome Measure Information:

Title

HbA1c < 7.0%

Time Frame

12 Months

Title

Systolic blood pressure < 130 mm Hg

Time Frame

12 Months

Title

LDL cholesterol < 100 mg/dl

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

67 Years

Accepts Healthy Volunteers

Eligibility Criteria

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%.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sayeed Ikramuddin, MD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55414

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Min-Sheng General Hospital

City

Taipei

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

29340678

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.

Results Reference

derived

PubMed Identifier

27783367

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.

Results Reference

derived

PubMed Identifier

27311493

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.

Results Reference

derived

PubMed Identifier

25979364

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. Erratum In: Lancet Diabetes Endocrinol. 2015 Jul;3(7):e5.

Results Reference

derived

PubMed Identifier

23736733

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs