Surgery Treatment of Type 2 Diabetes Mellitus Patients With Grade 1 Obesity and Overweight

Not Applicable

• Conditions: Obesity; Overweight; Diabetes Mellitus
• Interventions: Procedure: Duodenal Ileal Interposition with Sleeve Gastrectomy

• Registration Number: NCT03333642
• Lead Sponsor: Hospital Federal de Bonsucesso

Brief Summary

This study evaluate the Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus in grade 1 obesity and overweight patients.

Detailed Description

A clinical trial, 1-arm treatment (Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus), including 50 research subjects with type 2 diabetes mellitus and obesity class I or overweight. The main objective is to analyse the effect on glycemic control after 2 years of follow-up.

Study Timeline

• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-07
• Study Start: 2017-11-27
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14
• Primary Completion: 2022-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 consent form;

Exclusion Criteria

• Diabetes mellitus type 1 (anti-glutamic acid decarboxylase(GAD) positive) or anti-GAD negative body with low β-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 Substance-Related Disorders DSM-V criteria);
• Chemical dependence or alcoholism (based on Substance-Related Disorders DSM-V criteria).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duodenal Ileal interposition	Duodenal Ileal Interposition with Sleeve Gastrectomy	Duodenal Ileal Interposition with Sleeve Gastrectomy.

Primary Outcome Measures

Name	Time	Method
Remission of type 2 Diabetes at 24 months	2 years	Number of patients with glycated hemoglobin (HbA1c) of 6.0% or less, without use of diabetes medications

Secondary Outcome Measures

Name	Time	Method
Control of type 2 diabetes	2 years	Number of patients with glycated hemoglobin (HbA1c) \< 6.5%, but still in use of oral anti diabetic drugs and/or insulin

Trial Locations

Locations (1)

Hospital Federal de Bonsucesso; 🇧🇷 Rio de Janeiro, Brazil