Type 1 diabetes Mellitus
Conditions
Interventions
The study is a 26 weeks clinical trial. During the first 15 days, participants will receive approximately 130g of daily carbohydrates, followed by a phase of 7 days, with th consumption of 90g of dail
SP6.051.227
Sponsors
Amanda Aparecida Felizardo
Universidade Federal de Minas Gerais
Eligibility
Age
21 Years to 50 Years
Inclusion criteria
Inclusion criteria: Have a diagnosis of type 1 diabetes Mellitus; present from 21 to 50 years of age of both sexes; have glycated hemoglobin (Hb1Ac) >7.0%; agree to follow all parameters considered in the protocol for the treatment of type 1 diabetes with a low-carbohydrate diet; belong to any region of the country; have creatinine clearance < 60; use a glucometer or sensor (Libre, Flash Glucose Monitoring) for minimum of 7 measurements per day; perform a fundus examination for the diagnosis of diabetic retinopathy; have mild retinopathy treated (to be evaluated by the ophthalmologist and endocrinologist); be willing to consume, during the first 15 days of the protocol, the amount of 130g of daily carbohydrates; sign the authorization to participate in the research through the Informed Consent Form (TCLE); agree to perform all laboratory tests before starting the survey, three months after the start of the 50g daily carbohydrate phase, and at the end of the sixth month of the survey.
Exclusion criteria
Exclusion criteria: Have moderate to advanced diabetic retinopathy (to be evaluated by the ophthalmologist and endocrinologist); present reports or suspicion of gastroparesis; have an eating disorder, such as binge eating; be an athlete; use an insulin pump; have a pregnancy diagnosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in glycated hemoglobin assessed by blood test, before intervetion, after three months of starting intervention and at the end of treatment, that is, after six months of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycemic variability - will be evaluated by measuring daily blood glucose, using a glucometer and a glucose sensor Frequency of hypoglycemia - will be evaluated by measuring daily blood glucose, using a glucometer and a glucose sensor Total daily insulin - assessed by the total daily insulin dose used by the participant, according to the prescription and medical advice and the multidisciplinary team | — |
Countries
Brazil
Contacts
Public ContactGiselle Foureaux
Outcome results
None listed