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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2; Insulin Resistance; Obesity
• Interventions: Procedure: Roux-en-Y Bypass Gastroplasty

• Registration Number: NCT00566189
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-11-30
• Study First Submitted QC: 2007-11-30
• Study First Posted: 2007-12-03
• Primary Completion: 2011-08
• Study Completion: 2012-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-07
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Roux-en-Y Bypass Gastroplasty	Roux-en-Y bypass gastroplasty

Primary Outcome Measures

Name	Time	Method
Improvement or reversal of type 2 diabetes mellitus	7 days, 14 days, 21 days, 1 month, 2 months, 3 months, six months and one year.

Secondary Outcome Measures

Name	Time	Method
Changes in body weight and fat distribution after intervention	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	6 months and 1 year
Improvement of insulin sensitivity as measured by insulin tolerance test	1 month, 3 months, 6 months and 1 year
Changes in seric free fatty acids, lipoproteins, adiponectin and other adipokines	one month, 2 months, 3 months, 6 months and 1 year
Regression of carotid intima-media thickness	1 month, 3 months, 6 months and 1 year
Retardation of progression of disturbances of peripheral nerves as detected by electroneuromyography	1 year and 2 years
Retardation of progression of diabetic retinal complications as detected by fundoscopy and retinography	1 year and 2 years
Retardation of progression or regression of albuminuria as detected by microalbuminuria assay in 24-h urine collection	6 months, 1 year and 2 years

Trial Locations

Locations (1)

LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP); 🇧🇷 Campinas, SP, Brazil