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

Obesity Clinical Trial

Official title:

Ileal Interposition With Sleeve Gastrectomy for Type 2 Diabetes Mellitus Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03333642
• Other study ID #: 67955917.2.0000.5253
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2017
• Est. completion date: July 2023

Study information

• Verified date: October 2020
• Source: Hospital Federal de Bonsucesso
• Contact: Leonardo R Ferraz, MD
• Phone: +55 21 996462422
• Email: lrferraz1[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2023
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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 ß-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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Overweight

Intervention

Procedure:
• Duodenal Ileal Interposition with Sleeve Gastrectomy
Laparoscopic or open Duodenal Ileal Interposition with Sleeve Gastrectomy

Locations

Country	Name	City	State
Brazil	Hospital Federal de Bonsucesso	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Federal de Bonsucesso

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life assessment	Application of World Health Organization's Quality of Life questionnaire (WHOQOL-BREF)	Before and 1, 3, 6, 12, 18 and 24 months after surgery
Other	Measurement of surgical adverse events	Use of Clavien-Dindo classification	2 years
Primary	Remission of type 2 Diabetes at 24 months	Number of patients with glycated hemoglobin (HbA1c) of 6.0% or less, without use of diabetes medications	2 years
Secondary	Control of type 2 diabetes	Number of patients with glycated hemoglobin (HbA1c) < 6.5%, but still in use of oral anti diabetic drugs and/or insulin	2 years