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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-27

Study Completion Date

2023-07-31

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.

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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.

Conditions

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Diabetes Mellitus Obesity Overweight

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Duodenal Ileal interposition

Duodenal Ileal Interposition with Sleeve Gastrectomy.

Group Type EXPERIMENTAL

Duodenal Ileal Interposition with Sleeve Gastrectomy

Intervention Type PROCEDURE

Laparoscopic or open Duodenal Ileal Interposition with Sleeve Gastrectomy

Interventions

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Duodenal Ileal Interposition with Sleeve Gastrectomy

Laparoscopic or open Duodenal Ileal Interposition with Sleeve Gastrectomy

Intervention Type PROCEDURE

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).

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No