NCT03333642

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

November 27, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

4.6 years

First QC Date

October 23, 2017

Last Update Submit

October 12, 2020

Conditions

Diabetes MellitusObesityOverweight

Keywords

diabetesmetabolic surgeryileal interposition

Outcome Measures

Primary Outcomes (1)

  • Remission of type 2 Diabetes at 24 months

    Number of patients with glycated hemoglobin (HbA1c) of 6.0% or less, without use of diabetes medications

    2 years

Secondary Outcomes (1)

  • Control of type 2 diabetes

    2 years

Other Outcomes (2)

  • Quality of life assessment

    Before and 1, 3, 6, 12, 18 and 24 months after surgery

  • Measurement of surgical adverse events

    2 years

Study Arms (1)

Duodenal Ileal interposition

EXPERIMENTAL

Duodenal Ileal Interposition with Sleeve Gastrectomy.

Procedure: Duodenal Ileal Interposition with Sleeve Gastrectomy

Interventions

Duodenal Ileal Interposition with Sleeve GastrectomyPROCEDURE

Laparoscopic or open Duodenal Ileal Interposition with Sleeve Gastrectomy

Duodenal Ileal interposition

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Federal de Bonsucesso

Rio de Janeiro, 21041-020, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusObesityOverweight

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leonardo R Ferraz, MD

    Hospital Federal de Bonsucesso

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonardo R Ferraz, MD

CONTACT

+55 21 996462422lrferraz1@hotmail.com

Thiago B de Abreu, MD

CONTACT

+55 21 996487500boechat11@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgeon MD

Study Record Dates

First Submitted

October 23, 2017

First Posted

November 7, 2017

Study Start

November 27, 2017

Primary Completion

July 1, 2022

Study Completion

July 1, 2023

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

BR(1)