Prospective Randomized Controlled Trial on the Effect of BAriatric Surgery Versus Optimal Medical Therapy on Cardiovascular Health and Progression of Atherosclerosis in Obese, Type II Diabetic Patients

Catholic University of the Sacred Heart0 sites58 target enrollmentFebruary 2015

ConditionsObesity Diabetes Mellitus, Type 2 Atherosclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Catholic University of the Sacred Heart
Enrollment: 58
Primary Endpoint: Subclinical Atherosclerosis (ecographic assessment of carotid artery intima-media thickness)
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

To assess the impact of weight loss due to bariatric surgery, as compared to the effect of optimal medical therapy alone on endothelial function, subclinical atherosclerosis, cardiovascular autonomic function in obese patient affected by type 2 diabetes.The study consists in a 2-arm randomized trial, in which patients will be randomly assigned to bariatric surgery or optimal medical therapy. Each patient will be studied at baseline (T0) and 12 months thereafter (T1).

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

July 2017

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Catholic University of the Sacred Heart

Responsible Party

Principal Investigator

Geltrude Mingrone

Associate Professor

Catholic University of the Sacred Heart

Eligibility Criteria

Inclusion Criteria

•type 2 diabetes: the American Diabetes Association (ADA) recommends the following criteria for diagnosis of diabetes: HbA1c ≥6.5% OR fasting plasma glucose‡ ≥126 mg/dL (7.0 mmol/L) OR 2-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; 75-g glucose load should be used OR random plasma glucose concentration ≥200 mg/dL (11.1 mmol/L) in persons with symptoms of hyperglycemia or hyperglycemic crisis;
•indication to bariatric surgery: BMI ≥35 kg/m2 and one or more obesity related co-morbidities, including Type 2 Diabetes Mellitus.

Exclusion Criteria

•overt cardiovascular disease (as assessed by clinical evaluation, physical examination, 12-lead ECG, 2D-echocardiogram);
•smoking habit;
•associated medical conditions, as chronic kidney disease (defined as creatinine clearance \<60 mL/min/L.73m2), liver cirrhosis, malignancies, chronic congestive heart failure, acute or chronic inflammatory disease;
•specific contraindication to bariatric surgery;
•pregnancy;
•medical conditions requiring acute hospitalization;
•psychological conditions which may hamper patient's cooperation;
•geographic inaccessibility.