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Impact of Gastric Bypass Surgery on Risk of CVD in Type 2 Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00444392
First received: March 5, 2007
Last updated: February 7, 2008
Last verified: February 2008
History of Changes
  Purpose

Central hypothesis is: Gastric bypass surgery reduces the risk of CVD in morbidly obese subjects (defined as BMI ≥35 kg/m2) with T2DM.

To determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. I hypothesize that patients with T2DM who undergo gastric bypass surgery will significantly reduce mean levels of risk factors for CVD compared with diabetic individuals with the same BMI who maintain their weight.


Condition Intervention Phase
Obese Patients
Type 2 Diabetes Mellitus
 Behavioral: Calorie controlled diabetic diet for the control patients
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Gastric Bypass Surgery on Risk of CVD in Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Carotid artery intima-media thickness [ Time Frame: 6 month, 1 year ] [ Designated as safety issue: No ]
  • Brachial artery flow mediated dilation [ Time Frame: 6 month, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: 6 month, 1 year ] [ Designated as safety issue: No ]
  • Body Composition [ Time Frame: 6 month, 1 year ] [ Designated as safety issue: No ]
  • Lipoprotein Profiles [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]
  • Inflammatory Markers [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2007
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Calorie controlled diabetic diet for the control patients
    Calorie controlled diabetic diet for the control patients
Detailed Description:

Patients with type 2 diabetes mellitus (T2DM) are more likely to die from cardiovascular diseases (CVD) than people without diabetes. Furthermore, patients with diabetes have not benefited from the advances in the management of CVD and/or its risk factors that have resulted in a decrease in mortality for CVD patients without diabetes. Short-term studies have demonstrated that weight loss in overweight or obese subjects with T2DM is associated with decreased insulin resistance, substantial improvements in glycemic and lipoprotein profile, and reduction in blood pressure. However, long-term data substantiating that these improvements can be maintained are limited. Obesity, and susceptibility to weight gain, is a chronic condition. Continuous care is required to avoid weight regain especially after intensive weight loss. Morbidly obese patients with body mass index (BMI) over 35 kg/m2 have significant difficulty maintaining weight loss adequate to resolve obesity-related medical conditions by changes in lifestyle or pharmacologic strategies. Currently, surgical treatment of morbid obesity, termed bariatric surgery, appears to be the only modality that results in significant and sustained weight loss along with reversal of diabetes and improvements in cholesterol biosynthesis, and lipoprotein metabolism in morbidly obese patients. Given these observations, we question if patients with T2DM who undergo gastric bypass surgery will significantly reduce levels of abnormalities in vascular structure and function that are central to the development of atherosclerosis. In Specific Aim 1, we will determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. In Specific Aim 2, we will elucidate the mechanisms by which surgically induced weight loss reduces over time the risk of CVD in morbidly obese subjects with T2DM. The proposed study is a prospective cohort clinical trial aimed to evaluate changes over time in cardiovascular structure and function of morbidly obese subjects with T2DM undergoing gastric bypass surgery compared to a matched control group who do not undergo gastric bypass surgery. The results of the proposed studies will provide the foundation for a new clinical strategy aimed to prevent the development of CVD in obese patients with T2DM. Furthermore, they will serve as the baseline for future large scale longitudinal studies based on aggregate occurrence of severe cardiovascular events.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of T2DM diabetes mellitus with HbA1c ≤ 10.0%

    Any one of the following will be considered to be sufficient evidence that diabetes is present:

    • Current regular use of insulin
    • Current regular use of oral hypoglycemic medication.
    • Documented diabetes by current ADA criteria (98).
  2. Body mass index ≥ 35 kg/m2 in accord with the 1991 NIH obesity surgery consensus conference criteria and stable weight for the previous 3 months (99).
  3. Age between 18-60 years old. Individuals older than 60 years of age are excluded due to their increased risk of mortality and peri-operative morbidity.
  4. Ability and willingness to provide informed consent.
  5. No expectation that subject will be moving out of the area of the clinical center during the next 24 months.

Exclusion Criteria:

  1. Presence of CVD defined as: CAD, electrocardiographic criteria for past myocardial infarction(s), ischemic stroke, peripheral artery bypass surgery, percutaneous transluminal angioplasty, or amputation because of atherosclerotic disease.
  2. Significant non-diabetic co-morbidity affecting life expectancy (e.g., malignancy).
  3. Significant other co-morbidities (e.g. psychiatric disorder) that results in ineligibility for gastric bypass surgery.
  4. Pregnancy or planning pregnancy.
  5. Severe dyslipidemia (triglycerides >600 mg/dl or cholesterol >350 mg/dl).
  6. Uncontrolled hypertension.
  7. Smoking.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444392

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Alfonso Torquati, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Alfonso Torquati MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00444392     History of Changes
Other Study ID Numbers: 061003, 1K23DK075907-01
Study First Received: March 5, 2007
Last Updated: February 7, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Obese
type 2 Diabetes Mellitus
Gastric Bypass Surgery
Risk of CVD

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

ClinicalTrials.gov processed this record on May 23, 2013