Completed

Weight Loss Impact on Glycemic Control in Type 2 Diabetic Patients with Class I Obesity

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Study Aim

This study aims to compare the effectiveness and safety of medical and surgical treatments in controlling glycemic blood rates, as well as evaluating diabetes remission in type 2 diabetic patients with class I obesity.

What is being tested

Gastric bypass surgery

+ Surgical ileal transposition with sleeve

+ Clinical

ProcedureOther
Who is being recruted

Body Weight+10

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

From 25 to 65 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorHospital Sirio-Libanes
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

Official TitleSurgical Treatment in Diabetic Patients With Grade 1 Obesity
NCT01857076
Principal SponsorHospital Sirio-Libanes
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

75 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 25 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweight

Criteria

5 inclusion criteria required to participate
Man or woman with Type 2 diabetes mellitus (DM) aged between 25 and 65 years, with time since diagnosis of diabetes less than 10 years.
Grade I obesity (BMI between 30-35)
Inadequate glycemic control with HbA1c between 7.0 to 9.5% at baseline, in the presence of drug treatment for diabetes in the last year.
Reserve pancreatic C-peptide> 1.0 at baseline.
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20 exclusion criteria prevent from participating
History ketoacidosis, diabetes mellitus type 1, diabetes followed by pancreatitis.
Repetition of measurements (ie, 2 or more within 1 week) fasting plasma glucose(FPG) > 240 mg / dL during the pre-treatment.
History of Severe Proliferative Diabetic Retinopathy.
Autonomic neuropathy.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Subjects submitted to Gastric Bypass Surgery

Group II

Active Comparator
Subjects submitted to surgical ileal transposition with sleeve

Group III

Active Comparator
Subject submitted to clinical obesity treatment

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hospital Sírio Libanês Teaching and Research Center

São Paulo, BrazilOpen Hospital Sírio Libanês Teaching and Research Center in Google Maps
CompletedOne Study Center