New Frontiers on Bariatric Surgical Procedures: Classical Bypass for Type-2 Diabetic Patients With Obesity Grade I

University of Campinas, Brazil36 enrolled

Overview

Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well. This study is proposed to describe the effects of Roux-en-Y gastric bypass in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.

Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases; most of the remainder achieve better glycemic control, even if they regain weight. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well. Actually, many clinical researchers worldwide would consider a lower limit BMI of 30kg/m2, i.e., any grade of obesity. This study is proposed to describe the effects of Roux-en-Y gastric bypass (Fobi-Capella technique, adapted to create a larger gastric pouch, about 80ml)in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Roux-en-Y Bypass GastroplastyPROCEDURE

Under open laparotomy, a stomach section separates a 80-ml proximal gastric pouch. A jejunum section below Treitz's Angle creates an excluded gastrobiliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the continuity between the gastric pouch and the jejunum and a silastic ring reduces the pouch outlet.The anastomosis of the excluded limb is done 100cm below the silastic ring.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Obesity grade I (BMI 30-34,9) * Weight variance less than 5% in the last 3 months. * Previous diagnosis of diabetes type 2. * Insulin requirement, alone or along with oral agents * Capacity to understand the procedures of the study. * To agree voluntarily to participate of the study, signing an informed consent. Exclusion Criteria: * Positive Anti-GAD antibodies * Laboratorial signal of probable failure of insulin production, i. e., seric peptide C lesser than 1 ng/mL. * History of hepatic disease like cirrhosis or chronic active hepatitis. * Kidney dysfunction (creatinine \> 1,4 mg/dl in women and \> 1,5 mg/dl in men). * Hepatic dysfunction: aspartate aminotransferase or alanine aminotransferase 3x above upper normal limit. * Recent history of neoplasia (\< 5 years). * Use of oral or injectable corticosteroids for more than consecutive 14 days in the last three months.

Outcomes

Primary Outcomes

Improvement or reversal of type 2 diabetes mellitus

Time frame: 7 days, 14 days, 21 days, 1 month, 2 months, 3 months, six months and one year.

Secondary Outcomes

Changes in body weight and fat distribution after intervention

Time frame: 1 month, 2 months, 3 months, 6 months and 1 year

Changes in the secretion pattern of incretins, insulin and glucagon after intervention, as measured by standardized mixed meal tolerance test

Time frame: 6 months and 1 year

Improvement of insulin sensitivity as measured by insulin tolerance test

Time frame: 1 month, 3 months, 6 months and 1 year

Changes in seric free fatty acids, lipoproteins, adiponectin and other adipokines

Time frame: one month, 2 months, 3 months, 6 months and 1 year

Regression of carotid intima-media thickness

Time frame: 1 month, 3 months, 6 months and 1 year

Retardation of progression of disturbances of peripheral nerves as detected by electroneuromyography

Time frame: 1 year and 2 years

Retardation of progression of diabetic retinal complications as detected by fundoscopy and retinography