Surgery Treatment of Type 2 Diabetes Mellitus Patients With Grade 1 Obesity and Overweight

Ileal Interposition With Sleeve Gastrectomy for Type 2 Diabetes Mellitus Treatment

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03333642

Enrollment

Registered

2017-11-07

Start date

2017-11-27

Completion date

2023-07-31

Last updated

2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Obesity, Overweight

Keywords

diabetes, metabolic surgery, ileal interposition

Brief summary

This study evaluate the Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus in grade 1 obesity and overweight patients.

Detailed description

A clinical trial, 1-arm treatment (Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus), including 50 research subjects with type 2 diabetes mellitus and obesity class I or overweight. The main objective is to analyse the effect on glycemic control after 2 years of follow-up.

Interventions

PROCEDUREDuodenal Ileal Interposition with Sleeve Gastrectomy

Laparoscopic or open Duodenal Ileal Interposition with Sleeve Gastrectomy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Documented diagnosis of type 2 diabetes mellitus; * Patients of both sexes treated with oral antidiabetic agents and / or insulins, * Stable antidiabetic medication in the last 8 weeks prior to selection, if the therapy includes insulin, the mean daily dose should not have been changed by more than 10% in the last 8 weeks; * HbA1c\> 7.0%; * Age\> 20 years and \<65 years; * Body mass index (BMI) of 25 to 35 kg / m²; * Agree to sign the consent form;

Exclusion criteria

* Diabetes mellitus type 1 (anti-glutamic acid decarboxylase(GAD) positive) or anti-GAD negative body with low β-cell function (peptide C after stimulation \<0.5 ng / ml); * Recent vascular event (myocardial infarction, coronary angioplasty or encephalic vascular accident in the last 6 months); * Malignant neoplasm; * Portal hypertension; * Difficulty to cooperate with segment; * Low ability to understand surgery; * Unrealistic expectations of results; * Cognitive deficit; * Current pregnancy; * Moderate or severe mood disorder; severe anxiety; eating disorders (based on Substance-Related Disorders DSM-V criteria); * Chemical dependence or alcoholism (based on Substance-Related Disorders DSM-V criteria).

Design outcomes

Primary

Measure	Time frame	Description
Remission of type 2 Diabetes at 24 months	2 years	Number of patients with glycated hemoglobin (HbA1c) of 6.0% or less, without use of diabetes medications

Secondary

Measure	Time frame	Description
Control of type 2 diabetes	2 years	Number of patients with glycated hemoglobin (HbA1c) \< 6.5%, but still in use of oral anti diabetic drugs and/or insulin

Other

Measure	Time frame	Description
Quality of life assessment	Before and 1, 3, 6, 12, 18 and 24 months after surgery	Application of World Health Organization's Quality of Life questionnaire (WHOQOL-BREF)
Measurement of surgical adverse events	2 years	Use of Clavien-Dindo classification

Countries

Brazil

Contacts

Primary ContactLeonardo R Ferraz, MD

lrferraz1@hotmail.com+55 21 996462422

Backup ContactThiago B de Abreu, MD

boechat11@yahoo.com.br+55 21 996487500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026