Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Not Applicable

Withdrawn

• Conditions: Diabetes Mellitus; Obesity
• Interventions: Procedure: ileal interposition with sleeve and sympathectomy

• Registration Number: NCT02949687
• Lead Sponsor: Universidade Positivo

Brief Summary

Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Detailed Description

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

Study Timeline

• Study Start: 2016-09-20
• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-31
• Primary Completion: 2019-03-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ileal interposition sleeve sympathectomy	ileal interposition with sleeve and sympathectomy	laparoscopic ileal interposition with sleeve and sympathectomy

Primary Outcome Measures

Name	Time	Method
glycated hemoglobin(HbA1c) level of 6.0% or less, without the use of diabetes medications	2 YEARS	Success Rate of Biochemical Resolution of Diabetes at 24 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications