Impact of GBS on CVD in Type 2 Diabetes Mellitus
Condition: Obesity; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This research is a NIH single site study with the aims to (1) determine whether surgically
      induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. (2)
      elucidate the mechanisms by which surgically induced weight loss reduces over time the risk
      of CVD in morbidly obsess subjects with T2DM.

      Study'subjects will be enrolled from obese individuals with type 2 diabetes (T2DM). The study
      includes two groups, subjects undergoing gastric bypass surgery and a control group not
      undergoing weight loss surgery. A total of 60 subjects (30 in each group) will be recruited.

      Basal, 6 and 12 months assessments will include: insulin sensitivity determination,
      cardiovascular function by echo doppler, and DEXA scan.

      This study involves risk-level II procedures, however, the risks inherent to the gastric
      bypass surgery are not considered study-derived because subjects are enrolled from
      individuals that have already decided to have this surgery. We will determine protein
      expression profiles of inflammation-related adipokines in the subcutaneous and
      intra-abdominal adipose tissues of morbidly obese subjects with T2DM before and after
      surgically induced weight loss.
    

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 over weight 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 weigh loss. Morbidly obese patients with body mass index (BMI) over 35 kg/m2 have
      significant difficulties 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 obsess subjects with T2DM. The
      proposed study is a prospective cohort clinic 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 study will provide the foundation for a new clinic strategy aimed
      to prevent the development of CVD in obese patients with T2DM. Furthermore, it will serve as
      the baseline for future large scale longitudinal studies based on aggregate occurrence of
      severe cardiovascular events.
    

Intervention name(s): Diabetes Support and Education; gastric bypass surgery; Tissue Control Group
Intervention type(s): Other; Procedure; Other
Intervention description(s): The subjects will attend three educational/social support sessions for 1 year after enrollment. The educational sessions include informational sessions on diet/nutrition and exercise. These sessions are informational and do not teach behavioral self-regulation skills.; gastric bypass surgery to induce weight loss in obese patients with type 2 diabetes; During the abdominal surgery we would like to take 5 ml blood from the IV line and small pea-sized samples of the fat tissue just under the skin and around the stomach area. These samples will be stored so that we can compare these tissue with other patients.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obese; Type 2 Diabetes Mellitus; Gastric Bypass surgery; Risk of cardiovascular diseases