Diabetes Mellitus, Type 1
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial with a total of 56 participants. Experimental group: 28 individuals diagnosed with Type 1 Diabetes Mellitus (DM1) will receive cap
G07.203.300.456
Sponsors
Universidade Federal do Rio Grande do Norte
Universidade Federal do Rio Grande do Norte
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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).;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. | — |
Countries
Brazil
Contacts
Public ContactSilvana Zucolotto Langassner
Universidade Federal do Rio Grande do Norte
Outcome results
None listed