Stomach Reduction with Interposition of the Small Intestine for the Treatment of Type 2 Diabetes Mellitus

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes Mellitus, Obesity; C18.452.394.750.149; C18.654.726.500; E10-E14; E66.0

• Registration Number: RBR-736xwr
• Lead Sponsor: Hospital Federal de Bonsucesso

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-27
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Documented diagnosis of type 2 diabetes mellitus; Patients of both sexes treated with oral antidiabetic agents and / or insulins; Stable antidiabetic medication in the last 8 weeks prior to selection, if the therapy includes insulin, the mean daily dose should not have been changed by more than 10% in the last 8 weeks; HbA1c> 7.0%; Age> 20 years and <65 years;Body mass index (BMI) of 25 to 35 kg / m²; Agree to sign the TCLE;

Exclusion Criteria

Diabetes mellitus type 1 (anti-GAD positive) or anti-GAD negative body with low ?-cell function (peptide C after stimulation <0.5 ng / ml); Recent vascular event (myocardial infarction, coronary angioplasty or encephalic vascular accident in the last 6 months); Malignant neoplasm; Portal hypertension; Difficulty to cooperate with segment; Low ability to understand surgery; Unrealistic expectations of results; Cognitive deficit; Current pregnancy; Moderate or severe mood disorder; severe anxiety; eating disorders (based on DSM-V criteria); Chemical dependence or alcoholism (based on DSM-V criteria).

Study & Design

• Study Type: Intervention
• Study Design: Not specified