Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Study Overview
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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

Official Title
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Duodenal Ileal Interposition With Sleeve Gastrectomy and Selective Intra-Abdominal Denervation for Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Obesity

Intervention / Treatment
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* Procedure: ileal interposition with sleeve and sympathectomy


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ileal interposition sleeve sympathectomy<br>laparoscopic ileal interposition with sleeve and sympathectomy | Procedure: ileal interposition with sleeve and sympathectomy<br>* laparoscopic ileal interposition with sleeve and sympathectomy<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ileal interposition, metabolic surgery, diabetes, intra abdominal selective denervation