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CompletedNCT00444392Updated Nov 21, 2016

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

A Phase 3 interventional study of Calorie controlled diabetic diet for the control patients in Obese Patients and Type 2 Diabetes Mellitus, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-11-21.

Sponsored by Vanderbilt University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
9
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Obese Patients
  • Type 2 Diabetes Mellitus

Keywords

  • Obese
  • type 2 Diabetes Mellitus
  • Gastric Bypass Surgery
  • Risk of CVD
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 9 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Interventions

  • BehavioralCalorie controlled diabetic diet for the control patients

    Calorie controlled diabetic diet for the control patients

06

What researchers measure

Primary outcomes

  1. Carotid artery intima-media thickness

    Time frame: 6 month, 1 year

  2. Brachial artery flow mediated dilation

    Time frame: 6 month, 1 year

Secondary outcomes

  1. Insulin Sensitivity

    Time frame: 6 month, 1 year

  2. Body Composition

    Time frame: 6 month, 1 year

  3. Lipoprotein Profiles

    Time frame: 6 months, 1 year

  4. Inflammatory Markers

    Time frame: 6 months, 1 year

07

Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00444392
Lead sponsor
Vanderbilt University
Responsible party
Sponsor
First posted
Mar 7, 2007
Start date
Mar 2007
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Nov 21, 2016

Study contacts

Alfonso Torquati, M.D.
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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