Surgical Treatment in Diabetic Patients With Grade 1 Obesity

November 2, 2020 updated by: Luciana El-Kadre, Universidade Positivo

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

Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Study Overview

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ileal interposition sleeve sympathectomy
laparoscopic ileal interposition with sleeve and sympathectomy
laparoscopic ileal interposition with sleeve and sympathectomy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2016

Primary Completion (Actual)

March 1, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 21, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

October 31, 2016

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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