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

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

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).

Study Overview

• Status: Unknown
• Conditions: Obesity; Diabetes Mellitus, Type 2; Atherosclerosis
• Intervention / Treatment: Procedure: Gastric bypass; Behavioral: Medical therapy

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bariatric Surgery; Gastric bypass	Procedure: Gastric bypass; A subcardial gastric pouch with a 30±10 ml capacity will be created by sectioning the stomach with a linear stapler 3-4 cm horizontally on the lesser curve, 4 cm distal to the e-g junction, and then vertically until attainment of the angle of Hiss. After identification of the Treitz ligament, the jejunum will be transected at 100 cm from the ligament of Treitz and the two stumps will be closed. The distal stump will be anastomosed to the distal end of the gastric pouch. The preferred gastro-jejunal anastomosis is the totally hand-sewn one, but it can be performed using any other the technique the surgeon is more familiar with. Finally, the proximal stump of the transacted bowel will be joined end-to-side to the jejunum 150 cm distal to the gastro-enterostomy.
Active Comparator: Optimal Medical Therapy; planned visits, optimized hypoglycemic treatment, diet and lifestyle modification	Behavioral: Medical therapy; Assessment and treatment by a multidisciplinary team (diabetologist, dietitian, nurse);; Planned visits at baseline and at 1, 3, 6, 9, 12, and 24 months after study entry;; Oral hypoglycemic agents and insulin doses optimized on an individual basis with the aim of reaching a glycated hemoglobin level of less than 7%;; Programs for diet and lifestyle modification, including reduced overall energy and fat intake (<30% total fat, <10% saturated fat, and high fiber content) and increased physical exercise (≥30 minutes of brisk walking every day, possibly associated with moderate-intensity aerobic activity twice a week);; low-calorie diet (every day: 50% carbohydrate, 30% protein and 20% lipids).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subclinical Atherosclerosis (ecographic assessment of carotid artery intima-media thickness)	ecographic assessment of carotid artery intima-media thickness	12 months
Endothelial Function (ecographic assessment of flow-mediated dilation and nitrate mediated dilation)	ecographic assessment of flow-mediated dilation and nitrate mediated dilation	12 months
Cardiac autonomic function (heart rate variability measurements on 24-hour Holter ECG recordings)	heart rate variability measurements on 24-hour Holter ECG recordings	12 months

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: January 2, 2015
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Estimate): January 6, 2015
• Last Update Submitted That Met QC Criteria: January 5, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Atherosclerosis
• Other Study ID Numbers: 4569/14