Meal Frequency and Glycemic Control in Individuals With Type 1 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHospital de Clinicas de Porto Alegre
About this trial
The goal of this clinical trial is to examine the effect of 3 versus 6 daily meals of isocaloric diets on glycemic control and variability in individuals with type 1 diabetes. Participants will be randomized in a crossover clinical trial and will receive two different types of isocaloric diet interventions, in 3 meals/day (calorie distribution: 30% at breakfast, 40% at lunch and 30% at dinner) or 6 meals/day (calorie distribution: 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 25% at dinner and 5% at evening snack), for three weeks, with a 4-week washout period between diets.
Eligibility criteria
Qualifiers
• Adults (18 to 60 years old) with a medical diagnosis of type 1 diabetes mellitus
Individuals who perform carbohydrate counting
Individuals diagnosed > 12 months ago
Perform daily glycemic control using a blood glucose monitor or use of a glucose sensor
Disqualifiers
Individuals with glycated hemoglobin ≥ 11%
Individuals who are using NPH insulin
Retinopathy with vision deficit that limits the activities proposed in the disciplines.
Individuals with gastrointestinal disease such as celiac disease, Crohn's disease and Irritable Bowel Syndrome (IBS)
Trial design
Treatments tested in this trial
- Three meals a day
- Six meals a day
Treatment groups
27 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov