Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Obesity
• Interventions: Other: Clinical; Procedure: Surgical ileal transposition with sleeve; Procedure: Gastric bypass surgery

• Registration Number: NCT01857076
• Lead Sponsor: Hospital Sirio-Libanes

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-05
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-20
• Primary Completion: 2015-05
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• 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.
• Overweight stable defined as BMI> 30 in the last two years.

Exclusion Criteria

• 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.
• Loss or gain significant weight within the last 12 weeks (range, 5% body weight)
• Renal insufficiency
• History of renal disease treated with immunosuppressive therapy, history of dialysis or kidney transplantation.
• Presence of other renal diseases (eg nephrotic syndrome, glomerulonephritis)
• Acute myocardial infarction, unstable angina (NYHA class III-IV), revascularization or stroke within the previous 3 months of the initial visit.
• Uncontrolled hypertension defined as diastolic blood pressure> 100mm/Hg and diastolic blood pressure> 160mm/Hg at the initial visit.
• History of Hepatitis B or Hepatitis C.
• Criteria for Hepatic insufficiency defined as Child B and C liver disease clinically active and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) above 3 times the upper limit of normal.
• History of prior bariatric surgery.
• Inflammatory Bowel Disease.
• History neoplasm within the last 5 years (except for squamous cell carcinoma and basal skin and cervical carcinoma in situ)
• Clinically important hematologic disorder (symptomatic anemia, bone marrow proliferative disorders, thrombocytopenia, ..)
• History antibody positive human immunodeficiency virus (HIV)
• Surgery with general anesthesia within 12 weeks prior to the initial visit or incomplete recovery from prior surgery.
• History of drug or alcohol abuse within 3 years before the initial visit.
• Pregnancy or breastfeeding or planning pregnancy in the next two years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinical	Clinical	Subject submitted to clinical obesity treatment
Surgical ileal transposition with sleeve	Surgical ileal transposition with sleeve	Subjects submitted to surgical ileal transposition with sleeve
Gastric bypass surgery	Gastric bypass surgery	Subjects submitted to Gastric Bypass Surgery

Primary Outcome Measures

Name	Time	Method
Glycemic blood rates	In 2 years	Comparison of efficacy and safety in glycemic control between the two surgical modalities.
Diabetes remission evaluated by patients glycemic rates	In 2 years	Comparison of diabetes remission between the two surgical modalities.

Secondary Outcome Measures

Name	Time	Method
Quality of life evaluation	In 2 years	Comparison of quality of life between the medical and surgical treatment through specific interviews
Number of Late Adverse Events	In 2 years	Comparison of late complications between the two surgical modalities.
Weight loss	In 2 years.	Comparison of efficacy in the control of overweight in the medical and surgical treatment.
Decrease in blood lipid	In 2 years	Comparison of the effectiveness in controlling lipid between the medical and surgical treatment.
Number of Early Adverse Events	In 2 years	Comparison of early complications between the two surgical modalities.
Number os Nutricional Complications	In 2 years	Comparison of nutritional complications between the two surgical modalities.

Trial Locations

Locations (1)

Hospital Sírio Libanês Teaching and Research Center; 🇧🇷 São Paulo, Brazil