Diabetes Mellitus, Obesity
Conditions
Keywords
ileal interposition, metabolic surgery, diabetes, intra abdominal selective denervation
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
Interventions
PROCEDUREileal interposition with sleeve and sympathectomy
laparoscopic ileal interposition with sleeve and sympathectomy
Sponsors
Universidade Positivo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed