Effect of BAriatric Surgery Versus Optimal Medical Therapy on Cardiovascular Health and Atherosclerosis in Obese, Type II Diabetic Patients (BASTA)

Catholic University of the Sacred Heart

Status: Unknown

Conditions: Obesity; Diabetes Mellitus, Type 2; Atherosclerosis

Treatments: Behavioral: Medical therapy; Procedure: Gastric bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT02331420

4569/14

Details and patient eligibility

About

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).

Enrollment: 58 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Bariatric Surgery

Experimental group

Description:

Gastric bypass

Treatment:

Procedure: Gastric bypass

Optimal Medical Therapy

Active Comparator group

Description:

planned visits, optimized hypoglycemic treatment, diet and lifestyle modification

Treatment:

Behavioral: Medical therapy