Effectiveness of Intragastric balloon associated with diet on treatment of patients with type 2 diabetes
Not Applicable
- Conditions
- utritional and metabolic diseasesObesityDiabetes Mellitus, Type 2C18.654.726.500C18.452.394.750.149
- Registration Number
- RBR-3ypfxv
- Lead Sponsor
- Faculdade de Medicina da Univesidade de São Paulo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Volunteers males or females, age between 21 and 59 years; Overweight or obesity grade I (BMI between 27 and 34.9); Non-insulin dependent Diabetes Mellitus, glycated hemoglobin <10%, anti-GAD 65 <10 and peptide C> 1; Previous esophagogastroduodenoscopy with negative Helicobacter pylori research; Approval of psychological and nutritional profile; Clinical / drug and behavioral treatment directed to overweight patients, with no success; Signed informed consent form.
Exclusion Criteria
Contraindications to treatment with intragastric, clinical or endoscopic balloon; Impossibility of strict follow-up.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the effectiveness of the intragastric balloon in the control of diabetes type 2 verified through the measurement of weight change and the evaluation of hormonal changes and glycemic metabolism from the comparison of weight at 0,3,6 and 9 months, and the comparison of fasting and postprandial levels of glucose, insulin, PYY and GLP-1 before and after the use of intragastric balloon (0 and 6 months)<br>
- Secondary Outcome Measures
Name Time Method Control of systemic arterial hypertension and hepatic steatosis, verified by measuring blood pressure and performing pre and post-intervention abdominal ultrasonography from the suspension of medications and liver echographic improvement