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

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

Detailed Description
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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.

Official Title
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Ileal Interposition With Sleeve Gastrectomy for Type 2 Diabetes Mellitus Treatment

Conditions
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Diabetes Mellitus, Obesity, Overweight

Intervention / Treatment
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* Procedure: Duodenal Ileal Interposition with Sleeve Gastrectomy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duodenal Ileal interposition<br>Duodenal Ileal Interposition with Sleeve Gastrectomy. | Procedure: Duodenal Ileal Interposition with Sleeve Gastrectomy<br>* Laparoscopic or open Duodenal Ileal Interposition with Sleeve Gastrectomy<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, metabolic surgery, ileal interposition