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
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.
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.
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 →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.
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:
Exclusion Criteria:
Calorie controlled diabetic diet for the control patients
Carotid artery intima-media thickness
Time frame: 6 month, 1 year
Brachial artery flow mediated dilation
Time frame: 6 month, 1 year
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
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt University