Type 2 Diabetes Mellitus, Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Documented diagnosis of type 2 diabetes mellitus; Patients of both sexes treated with oral antidiabetic agents and / or insulins; Stable antidiabetic medication in the last 8 weeks prior to selection, if the therapy includes insulin, the mean daily dose should not have been changed by more than 10% in the last 8 weeks; HbA1c> 7.0%; Age> 20 years and <65 years;Body mass index (BMI) of 25 to 35 kg / m²; Agree to sign the TCLE;
Exclusion criteria
Exclusion criteria: Diabetes mellitus type 1 (anti-GAD positive) or anti-GAD negative body with low ?-cell function (peptide C after stimulation <0.5 ng / ml); Recent vascular event (myocardial infarction, coronary angioplasty or encephalic vascular accident in the last 6 months); Malignant neoplasm; Portal hypertension; Difficulty to cooperate with segment; Low ability to understand surgery; Unrealistic expectations of results; Cognitive deficit; Current pregnancy; Moderate or severe mood disorder; severe anxiety; eating disorders (based on DSM-V criteria); Chemical dependence or alcoholism (based on DSM-V criteria).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the remission rate of DM2 characterized by serum glycosylated hemoglobin (A1C) less than 6.0%, without the use of anti-diabetic drugs. To evaluate the control of DM2: HbA1c lower than 6.5% but still in use of oral antidiabetic and / or insulin. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate quality of life of patients before and after GVII.;To evaluate the complications of the surgical treatment.;To evaluate the evolution of other comorbidities such as hypercholesterolemia, hypertriglyceridemia, hepatic steatosis and arterial hypertensio | — |
Countries
Brazil
Contacts
Hospital Federal de Bonsucesso