Obesity, Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes mellitus, Grade I obesity, Inadequate glycemic control
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.
Interventions
PROCEDUREGastric bypass surgery
Gastric bypass surgery performed laparoscopically
PROCEDURESurgical ileal transposition with sleeve
Surgical Treatment with Ileal Transposition in the duodenum and Vertical Sleeve Gastrectomy through laparoscopic surgery.
OTHERClinical
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
Hospital Sirio-Libanes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic blood rates | In 2 years | Comparison of efficacy and safety in glycemic control between the medical and surgical treatment. |
| Diabetes remission evaluated by patients glycemic rates | In 2 years | Comparison of diabetes remission between the two surgical modalities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life evaluation | In 2 years | Comparison of quality of life between the medical and surgical treatment through specific interviews |
| Number of Early Adverse Events | In 2 years | Comparison of early 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. |
| Number of Late Adverse Events | In 2 years | Comparison of late complications between the two surgical modalities. |
| Number os Nutricional Complications | In 2 years | Comparison of nutritional complications between the two surgical modalities. |
| Decrease in blood lipid | In 2 years | Comparison of the effectiveness in controlling lipid between the medical and surgical treatment. |
Countries
Brazil
Outcome results
None listed