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Surgical Treatment in Diabetic Patients With Grade 1 Obesity

NCT ID: NCT02949687

Last Updated: 2020-11-04

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-20

Study Completion Date

2020-12-01

Brief Summary

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Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Detailed Description

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There will be a randomized clinical trial, non-blind, 1-arm treatment (Duodenal Ileal Interposition with Sleeve Gastrectomy and Selective Intra-Abdominal Denervation for Type 2 Diabetes Mellitus), including 40 research subjects with type 2 diabetes mellitus and obesity class I. In order to analise the effect on weight loss and glycemic control after 2 years of follow up

Conditions

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Diabetes Mellitus Obesity

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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ileal interposition sleeve sympathectomy

laparoscopic ileal interposition with sleeve and sympathectomy

Group Type EXPERIMENTAL

ileal interposition with sleeve and sympathectomy

Intervention Type PROCEDURE

laparoscopic ileal interposition with sleeve and sympathectomy

Interventions

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ileal interposition with sleeve and sympathectomy

laparoscopic ileal interposition with sleeve and sympathectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Documented diagnosis of type 2 diabetes mellitus
* Both sexes were treated with oral antidiabetic agents and / or insulin except the current treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase 4 inhibitors
* Stable antidiabetic medication within the last 8 weeks prior to randomization (V2), if therapy includes insulin, the average daily dose should not have changed by more than 10% in the past 8 weeks
* HbA1c\> 8.0%
* Age\> 20 years and \<60 years
* Body mass index (BMI) of 30 35 kg / m²
* Agree to sign the consent form

Exclusion Criteria

* Type 1 diabetes mellitus (positive for anti-GAD), or GAD negative anti anti body with low β cell function (C-peptide after stimulation \<0.5 ng / ml)
* Current treatment with GLP-1 receptor agonist and / or dipeptidyl peptidase 4 inhibitors
* Recent vascular event (myocardial infarction, coronary angioplasty or stroke in the past 6 months)
* Malignant neoplasm
* Portal hypertension
* Inability to cooperate with segment
* Low capacity of understanding surgery
* Unrealistic expectations of the outcome
* Cognitive impairment
* Current pregnancy
* Moderate or severe mood disorder; severe anxiety; eating disorders (based on Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria)
* Chemical dependency or alcoholism (based on DSM-V criteria).
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Positivo

OTHER

Sponsor Role lead

Responsible Party

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Luciana El-Kadre

invited clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CAAE 37048114.9.0000.0093

Identifier Type: -

Identifier Source: org_study_id