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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00444392
First Posted: March 7, 2007
Last Update Posted: November 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vanderbilt University
  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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Carotid artery intima-media thickness [ Time Frame: 6 month, 1 year ]
  • Brachial artery flow mediated dilation [ Time Frame: 6 month, 1 year ]

Secondary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: 6 month, 1 year ]
  • Body Composition [ Time Frame: 6 month, 1 year ]
  • Lipoprotein Profiles [ Time Frame: 6 months, 1 year ]
  • Inflammatory Markers [ Time Frame: 6 months, 1 year ]

Enrollment: 9
Study Start Date: March 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (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

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Medical Center
  More Information

Responsible Party: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00444392     History of Changes
Other Study ID Numbers: 061003
1K23DK075907-01 ( U.S. NIH Grant/Contract )
First Submitted: March 5, 2007
First Posted: March 7, 2007
Last Update Posted: November 21, 2016
Last Verified: November 2016

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