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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Cardiovascular Disease
Other: intensive medical management
Other: RYGB & IMM
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Global Randomized Prospective Study of Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • 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 ]

Enrollment: 120
Study Start Date: February 2008
Estimated Study Completion Date: March 2017
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
intensive medical management
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.
Active Comparator: 2
Roux-en-Y gastric bypass with intensive medical management
Other: RYGB & IMM
Roux-en-Y gastric bypass Surgery combined with intensive medical management

  Eligibility

Ages Eligible for Study:   30 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641251

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Columbia University
New York City, New York, United States, 10032
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Min-Sheng General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Sayeed Ikramuddin, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided by Covidien

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT00641251     History of Changes
Other Study ID Numbers: AS07008
Study First Received: February 13, 2008
Last Updated: March 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
T2 Diabetes
Type 2 diabetes CVD event rates and mortality

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 01, 2014