Surgical Treatment in Diabetic Patients With Grade 1 Obesity

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Clinical; Procedure: Gastric bypass surgery; Procedure: Surgical ileal transposition with sleeve

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01308060
    • Hospital Sírio Libanês Teaching and Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clinical; Subject submitted to clinical obesity treatment	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.
Active Comparator: Gastric bypass surgery; Subjects submitted to Gastric Bypass Surgery	Procedure: Gastric bypass surgery; Gastric bypass surgery performed laparoscopically
Active Comparator: Surgical ileal transposition with sleeve; Subjects submitted to surgical ileal transposition with sleeve	Procedure: Surgical ileal transposition with sleeve; Surgical Treatment with Ileal Transposition in the duodenum and Vertical Sleeve Gastrectomy through laparoscopic surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic blood rates	Comparison of efficacy and safety in glycemic control between the medical and surgical treatment.	In 2 years
Glycemic blood rates	Comparison of efficacy and safety in glycemic control between the two surgical modalities.	In 2 years
Diabetes remission evaluated by patients glycemic rates	Comparison of diabetes remission between the two surgical modalities.	In 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Sirio-Libanes
• Investigators: Principal Investigator: Claudia Cozer, Md, Hospital Sírio-Libanês

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: May 7, 2013
• First Submitted That Met QC Criteria: May 17, 2013
• First Posted (Estimate): May 20, 2013

Study Record Updates

• Last Update Posted (Estimate): August 20, 2015
• Last Update Submitted That Met QC Criteria: August 18, 2015
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Type 2 Diabetes mellitus; Grade I obesity; Inadequate glycemic control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity
• Other Study ID Numbers: HSL 2012-01 (Other Identifier: CEPesq Register Number); 00747112.3.0000.5461 (Registry Identifier: CAAE)