Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Study Overview
=================
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.

Official Title
-----------------
Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Conditions
-----------------
Obesity, Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Procedure: Gastric bypass surgery
* Procedure: Surgical ileal transposition with sleeve
* Other: Clinical


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes mellitus, Grade I obesity, Inadequate glycemic control