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

This study is currently recruiting participants.
Verified November 2017 by Leonardo Rocha Ferraz, Hospital Federal de Bonsucesso
Sponsor:
ClinicalTrials.gov Identifier:
NCT03333642
First Posted: November 7, 2017
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Leonardo Rocha Ferraz, Hospital Federal de Bonsucesso
  Purpose
This study evaluate the Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus in grade 1 obesity and overweight patients.

Condition Intervention
Diabetes Mellitus Obesity Overweight Procedure: Duodenal Ileal Interposition with Sleeve Gastrectomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ileal Interposition With Sleeve Gastrectomy for Type 2 Diabetes Mellitus Treatment

Resource links provided by NLM:


Further study details as provided by Leonardo Rocha Ferraz, Hospital Federal de Bonsucesso:

Primary Outcome Measures:
  • Remission of type 2 Diabetes at 24 months [ Time Frame: 2 years ]
    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 [ Time Frame: 2 years ]
    Number of patients with glycated hemoglobin (HbA1c) < 6.5%, but still in use of oral anti diabetic drugs and/or insulin


Other Outcome Measures:
  • Quality of life assessment [ Time Frame: Before and 1, 3, 6, 12, 18 and 24 months after surgery ]
    Application of World Health Organization's Quality of Life questionnaire (WHOQOL-BREF)

  • Measurement of surgical adverse events [ Time Frame: 2 years ]
    Use of Clavien-Dindo classification


Estimated Enrollment: 50
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333642


Contacts
Contact: Leonardo R Ferraz, MD +55 21 996462422 lrferraz1@hotmail.com
Contact: Thiago B de Abreu, MD +55 21 996487500 boechat11@yahoo.com.br

Locations
Brazil
Hospital Federal de Bonsucesso Recruiting
Rio de Janeiro, Brazil, 21041-020
Contact: Leonardo R Ferraz, MD    +55 21 996462422    lrferraz1@1hotmail.com   
Contact: Thiago B Abreu, MD    +55 21 996487500    boechat1@yahoo.com.br   
Sub-Investigator: Miguel Madeira, PhD         
Sub-Investigator: Luciana El Kadre, PhD         
Sub-Investigator: Aureo L de Paula, PhD         
Sponsors and Collaborators
Hospital Federal de Bonsucesso
Investigators
Principal Investigator: Leonardo R Ferraz, MD Hospital Federal de Bonsucesso
  More Information

Responsible Party: Leonardo Rocha Ferraz, Surgeon MD, Hospital Federal de Bonsucesso
ClinicalTrials.gov Identifier: NCT03333642     History of Changes
Other Study ID Numbers: 67955917.2.0000.5253
First Submitted: October 23, 2017
First Posted: November 7, 2017
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Leonardo Rocha Ferraz, Hospital Federal de Bonsucesso:
diabetes
metabolic surgery
ileal interposition

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms