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Surgical Treatment in Diabetic Patients With Grade 1 Obesity

NCT01857076 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2015-08-20

No results posted yet for this study

Summary

There will be a randomized clinical trial, non-blind, 3-arm treatment (medical, surgical, gastric bypass and ileal transposition surgery with and sleeve), which will be conducted in a single center - S.B.S. Hospital Sirio Libanês, including 75 research subjects with type 2 diabetes mellitus and obesity class I. In order to compare the effect of weight loss on glycemic control among medical and surgical groups, and after 2 years of follow up, the results of efficacy, safety and maintenance will be compared between the three groups.

Conditions

Interventions

PROCEDURE

Gastric bypass surgery

Gastric bypass surgery performed laparoscopically

PROCEDURE

Surgical ileal transposition with sleeve

Surgical Treatment with Ileal Transposition in the duodenum and Vertical Sleeve Gastrectomy through laparoscopic surgery.

OTHER

Clinical

The study subjects allocated for clinical treatment will have these treatment divided into three phases. The first one based on glycemic control through weight loss, the second one based on anti-hyperglycemic medications and the last one based on medical monitoring for a further twelve months for the maintenance of the results.

Sponsors & Collaborators

  • Hospital Sirio-Libanes

    lead OTHER

Principal Investigators

  • Claudia Cozer, Md · Hospital Sírio-Libanês

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-05-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01857076 on ClinicalTrials.gov