Status:
COMPLETED
Surgical Treatment in Diabetic Patients With Grade 1 Obesity
Lead Sponsor:
Hospital Sirio-Libanes
Conditions:
Obesity
Type 2 Diabetes Mellitus
Eligibility:
All Genders
25-65 years
Phase:
NA
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 - ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01857076
Start Date
February 1 2013
Last Update
August 20 2015
Active Locations (1)
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1
Hospital Sírio Libanês Teaching and Research Center
São Paulo, São Paulo, Brazil, 01308060