Effectiveness, safety and tolerability of Passion Fruit Peel in the control of type 1 Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Type 1C18.452
- Registration Number
- RBR-3qfbw73
- Lead Sponsor
- niversidade Federal do Rio Grande do Norte
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Both sexes aged between 18 and 60 years; type 1 diabetes mellitus diagnosis at least two years ago; absence of C-peptide; glycated hemoglobin between 7% and 10%; patients without significant changes in insulin dose (<10% of the number of daily units) in the last eight weeks; agreeing to participate in the trial by signing the informed consent form
Illiterate; pregnant or breastfeeding; inability to follow research protocol; hypothyroidism; hyperthyroidism; Alzheimer's; Parkinson's; Schizophrenia; renal insufficiency; anemia; obesity (BMI> 30 kg /m2); hemoglobinopathy; acute liver disease; chronic liver disease; unit of alcohol per week: > 21 men and > 10 women; consumption of 1 or more cigarettes per day; phytotherapy; non-steroidal anti-inflammatory drugs, opiates and corticosteroids; juices or other foods based on passion fruit (P. edulis); food supplements containing passion fruit (P. edulis) in the composition
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Expect to find a 10% decrease in the time that blood glucose remains outside the therapeutic range, as measured by Free Style continuously, over a 2-week period between trial visits.
- Secondary Outcome Measures
Name Time Method It is expected to observe a 10% decrease in the proportion of patients with hypoglycemia, measured through self-report one day before and after the intervention (90 days).;A 5-point decrease in the HFS (Hypoglycemia Fear Survey) scale, measured by questionnaire, is expected to be seen over a 2-week period between trial visits.;It is expected to observe a decrease of 0.5% in the average of glycated hemoglobin, measured through laboratory tests performed one day before and after the intervention (90 days).;It is expected to observe a 10% increase in the proportion of patients with glycated hemoglobin < 7% and without occurrence of hypoglycemia, measured through laboratory tests performed one day before and after the intervention (90 days).;It is expected to see a decrease of 6 IU in the average dose of insulin administered, as measured by prescription evaluation one day pre and post intervention (90 days).