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

Ileal Interposition With Sleeve Gastrectomy for Type 2 Diabetes Mellitus Treatment

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

Study Overview

• Status: Recruiting
• Conditions: Obesity; Diabetes Mellitus; Overweight
• Intervention / Treatment: Procedure: Duodenal Ileal Interposition with Sleeve Gastrectomy

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leonardo R Ferraz, MD; Phone Number: +55 21 996462422; Email: lrferraz1@hotmail.com
• Study Contact Backup: Name: Thiago B de Abreu, MD; Phone Number: +55 21 996487500; Email: boechat11@yahoo.com.br

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21041-020
    • Recruiting
    • Hospital Federal de Bonsucesso
    • Contact: Leonardo R Ferraz, MD; Phone Number: +55 21 996462422; Email: lrferraz1@1hotmail.com
    • Contact: Thiago B Abreu, MD; Phone Number: +55 21 996487500; Email: boechat1@yahoo.com.br
    • Sub-Investigator: Luciana El Kadre, PhD
    • Sub-Investigator: Aureo L de Paula, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Duodenal Ileal interposition; Duodenal Ileal Interposition with Sleeve Gastrectomy.	Procedure: Duodenal Ileal Interposition with Sleeve Gastrectomy; Laparoscopic or open Duodenal Ileal Interposition with Sleeve Gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Measurement of surgical adverse events	Use of Clavien-Dindo classification	2 years

Collaborators and Investigators

• Sponsor: Hospital Federal de Bonsucesso
• Investigators: Principal Investigator: Leonardo R Ferraz, MD, Hospital Federal de Bonsucesso

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 27, 2017
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (ACTUAL): November 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: diabetes; metabolic surgery; ileal interposition
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity; Overweight
• Other Study ID Numbers: 67955917.2.0000.5253

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No