Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02949687
• Other study ID #: CAAE 37048114.9.0000.0093
• Status: Withdrawn
• Phase: N/A
• Start date: September 20, 2016
• Est. completion date: December 1, 2020

Study information

• Verified date: November 2020
• Source: Universidade Positivo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Surgical Treatment in Diabetic Patients With Grade 1 Obesity

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2020
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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 ß 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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity

Intervention

Procedure:
• ileal interposition with sleeve and sympathectomy
laparoscopic ileal interposition with sleeve and sympathectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Positivo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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