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

University of Campinas, Brazil

Status and phase

Completed

Phase 3

Phase 2

Conditions

Insulin Resistance

Obesity

Diabetes Mellitus, Type 2

Treatments

Procedure: Roux-en-Y Bypass Gastroplasty

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00566189

LIMED0004

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.