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

Primary Purpose

Diabetes Mellitus, Obesity, Overweight

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Duodenal Ileal Interposition with Sleeve Gastrectomy
Sponsored by
Hospital Federal de Bonsucesso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring diabetes, metabolic surgery, ileal interposition

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital Federal de BonsucessoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duodenal Ileal interposition

Arm Description

Duodenal Ileal Interposition with Sleeve Gastrectomy.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2017
Last Updated
October 12, 2020
Sponsor
Hospital Federal de Bonsucesso
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1. Study Identification

Unique Protocol Identification Number
NCT03333642
Brief Title
Surgery Treatment of Type 2 Diabetes Mellitus Patients With Grade 1 Obesity and Overweight
Official Title
Ileal Interposition With Sleeve Gastrectomy for Type 2 Diabetes Mellitus Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 27, 2017 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Federal de Bonsucesso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Obesity, Overweight
Keywords
diabetes, metabolic surgery, ileal interposition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Duodenal Ileal interposition
Arm Type
Experimental
Arm Description
Duodenal Ileal Interposition with Sleeve Gastrectomy.
Intervention Type
Procedure
Intervention Name(s)
Duodenal Ileal Interposition with Sleeve Gastrectomy
Intervention Description
Laparoscopic or open Duodenal Ileal Interposition with Sleeve Gastrectomy
Primary Outcome Measure Information:
Title
Remission of type 2 Diabetes at 24 months
Description
Number of patients with glycated hemoglobin (HbA1c) of 6.0% or less, without use of diabetes medications
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Control of type 2 diabetes
Description
Number of patients with glycated hemoglobin (HbA1c) < 6.5%, but still in use of oral anti diabetic drugs and/or insulin
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Quality of life assessment
Description
Application of World Health Organization's Quality of Life questionnaire (WHOQOL-BREF)
Time Frame
Before and 1, 3, 6, 12, 18 and 24 months after surgery
Title
Measurement of surgical adverse events
Description
Use of Clavien-Dindo classification
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonardo R Ferraz, MD
Phone
+55 21 996462422
Email
lrferraz1@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thiago B de Abreu, MD
Phone
+55 21 996487500
Email
boechat11@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo R Ferraz, MD
Organizational Affiliation
Hospital Federal de Bonsucesso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Federal de Bonsucesso
City
Rio de Janeiro
ZIP/Postal Code
21041-020
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo R Ferraz, MD
Phone
+55 21 996462422
Email
lrferraz1@1hotmail.com
First Name & Middle Initial & Last Name & Degree
Thiago B Abreu, MD
Phone
+55 21 996487500
Email
boechat1@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Miguel Madeira, PhD
First Name & Middle Initial & Last Name & Degree
Luciana El Kadre, PhD
First Name & Middle Initial & Last Name & Degree
Aureo L de Paula, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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