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

Hospital Federal de Bonsucesso

Status: Unknown

Conditions: Overweight; Diabetes Mellitus; Obesity

Treatments: Procedure: Duodenal Ileal Interposition with Sleeve Gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03333642

67955917.2.0000.5253

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Duodenal Ileal interposition

Experimental group

Description:

Duodenal Ileal Interposition with Sleeve Gastrectomy.

Treatment:

Procedure: Duodenal Ileal Interposition with Sleeve Gastrectomy