Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Universidade Positivo

Status: Withdrawn

Conditions: Diabetes Mellitus; Obesity

Treatments: Procedure: ileal interposition with sleeve and sympathectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02949687

CAAE 37048114.9.0000.0093

Details and patient eligibility

About

Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Full 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

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

ileal interposition sleeve sympathectomy

Experimental group

Description:

laparoscopic ileal interposition with sleeve and sympathectomy

Treatment:

Procedure: ileal interposition with sleeve and sympathectomy