Impact of Gastric Bypass Surgery on Risk of CVD in Type 2 Diabetes Mellitus
Condition: Obese Patients; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): Calorie controlled diabetic diet for the control patients
Intervention type(s): Behavioral
Intervention description(s): Calorie controlled diabetic diet for the control patients
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obese; type 2 Diabetes Mellitus; Gastric Bypass Surgery; Risk of CVD