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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00641251
First received: February 13, 2008
Last updated: March 21, 2014
Last verified: March 2014

February 13, 2008
March 21, 2014
February 2008
January 2014   (final data collection date for primary outcome measure)
  • HbA1c < 7.0% [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Systolic blood pressure < 130 mm Hg [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • LDL cholesterol < 100 mg/dl [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00641251 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery
Global Randomized Prospective Study of Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Cardiovascular Disease
  • 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.
  • Other: RYGB & IMM
    Roux-en-Y gastric bypass Surgery combined with intensive medical management
  • Active Comparator: 1
    intensive medical management
    Intervention: Other: intensive medical management
  • Active Comparator: 2
    Roux-en-Y gastric bypass with intensive medical management
    Intervention: Other: RYGB & IMM
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
March 2017
January 2014   (final data collection date for primary outcome measure)

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%.
Both
30 Years to 67 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Taiwan
 
NCT00641251
AS07008
Yes
Covidien
Covidien
Not Provided
Principal Investigator: Sayeed Ikramuddin, MD University of Minnesota - Clinical and Translational Science Institute
Covidien
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP