NCT02331420

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Obesity
• Diabetes Mellitus, Type 2
• Atherosclerosis

Interventions

Type	Name	Description
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.
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).

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-01-01
• Completion: 2017-07-01
• First posted: 2015-01-06
• Last updated: 2015-01-06