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

Not Applicable
Conditions
Obesity
Overweight
Diabetes Mellitus
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.

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
Primary Outcome Measures
NameTimeMethod
Remission of type 2 Diabetes at 24 months2 years

Number of patients with glycated hemoglobin (HbA1c) of 6.0% or less, without use of diabetes medications

Secondary Outcome Measures
NameTimeMethod
Control of type 2 diabetes2 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

Hospital Federal de Bonsucesso
🇧🇷Rio de Janeiro, Brazil
Leonardo R Ferraz, MD
Contact
+55 21 996462422
lrferraz1@1hotmail.com
Thiago B Abreu, MD
Contact
+55 21 996487500
boechat1@yahoo.com.br
Miguel Madeira, PhD
Sub Investigator
Luciana El Kadre, PhD
Sub Investigator
Aureo L de Paula, PhD
Sub Investigator

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