Clinical trial NCT01857076: Surgical Treatment in Diabetic Patients With Grade 1 Obesity
Official title: Surgical Treatment in Diabetic Patients With Grade 1 Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes mellitus
Grade I obesity
Inadequate glycemic control
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 75
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Glycemic blood rates
timeFrame: In 2 years
measure: Glycemic blood rates
timeFrame: In 2 years
measure: Diabetes remission evaluated by patients glycemic rates
timeFrame: In 2 years
Secondary outcomes:
measure: Weight loss
timeFrame: In 2 years.
measure: Decrease in blood lipid
timeFrame: In 2 years
measure: Quality of life evaluation
timeFrame: In 2 years
measure: Number of Early Adverse Events
timeFrame: In 2 years
measure: Number os Nutricional Complications
timeFrame: In 2 years
measure: Number of Late Adverse Events
timeFrame: In 2 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Sírio Libanês Teaching and Research Center
Study officials:
affiliation: Hospital Sírio-Libanês
name: Claudia Cozer, Md
role: PRINCIPAL_INVESTIGATOR
References: