Effects of Green Banana BIOmass Consumption in Patients With Pre-diabetes and Diabetes MELlitus (The BIOMEL Study)

Launched by FEDERAL UNIVERSITY OF SÃO PAULO · Jul 24, 2017

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ClinConnect Summary

INTRODUCTION Cardiovascular Disease and Diabetes In Brazil, chronic non-communicable diseases (NCDs) were the cause of 72% of deaths and reached 63% in the world in 2008, with large numbers of premature deaths. Cardiovascular disease (31.3%), Diabetes Mellitus (DM) (5.2%), cancer (16.3%) and respiratory disease (5.8%) are the main causes of NCDs, leading to loss of quality of life, causing economic impacts that lead to increased poverty. These factors can be reversed through broad interventions and cost-effective health promotion. (Schmidt et al, 2011;. Malta et.al., 2011).

Currently, it i...

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Eligibility criteria

• Inclusion Criteria:
• • having signed the written informed consent
• • males and females aging 18-85 years
• • glycated hemoglobin \>= 6.5% for diabetic patients
• • glycated hemoglobin between 5.7% and 6.4% for pre-diabetic patients
• • on stable dose of anti-diabetic drugs and without antecipation of dosage changes during study protocol
• Exclusion Criteria:
• • use of insulin
• • those who need change in dose or addition of medication for diabetes
• • any malignancies, except basocelular carcinoma
• • heart failure with NYHA class III or IV
• • renal failure (GFR\< 30 mL/min) or under dialysis therapy
• • AIDS
• • uncontrolled hypothyroidism (TSH \> 10 uUI/mL)
• • active liver disease
• • severe psychiatric disorders
• • any other disease that in the opinion of the investigator could interfere in the results