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OpenTrials
Completed

NCT Number: NCT02949687

Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Surgical Treatment in Diabetic Patients With Grade 1 Obesity

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Key information

Conditions

Diabetes Mellitus Body Weight Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ileal interposition with sleeve and sympathectomy

Procedure

laparoscopic ileal interposition with sleeve and sympathectomy

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Universidade Positivo

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Oct 31, 2016
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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