Status:
UNKNOWN
Effects of Green Banana BIOmass Consumption in Patients With Pre-diabetes and Diabetes MELlitus (The BIOMEL Study)
Lead Sponsor:
Federal University of São Paulo
Conditions:
Diabetes Mellitus
Pre-diabetes
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Costa ES, Izar MC, Fonseca FAH, França C, Tria H. The benefits of green banana biomass consumption in patients with diabetes mellitus. Federal University of São Paulo, São Paulo, 2015. According to t...
Detailed Description
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 prematu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2018
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT03230123
Start Date
May 1 2016
End Date
June 1 2018
Last Update
July 26 2017
Active Locations (1)
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1
Federal University of Sao Paulo
São Paulo, São Paulo, Brazil, 04039030