Meal Frequency and Glycemic Control in Individuals With Type 1 Diabetes (NCT06934707) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Meal Frequency and Glycemic Control in Individuals With Type 1 Diabetes
Brazil27 participantsStarted 2025-04-20
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • 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
* Have the ability to understand and be able to adhere to the proposed interventions.
* Complete a detailed 3-day food record for one week prior to the intervention and record episodes of hypoglycemia (\<70 mg/dL) and hyperglycemia (\>180 mg/dL)
* Able and willing to provide written informed consent and comply with the requirements of the study protocol.
Exclusion Criteria:
* 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)
* History of bariatric surgery
* That you are following a carbohydrate, protein and/or fat restriction diet
* Individuals with BMI ≥ 40kg/m2
* Chronic kidney disease with estimated glomerular filtration \<30mL/min per 1.73 m2.
* Liver failure or chronic viral hepatitis
* Active or progressive neurodegenerative disease
* Use of medications that affect glucose metabolism (corticosteroids and immunosuppressants) or cause weight loss. ● Treatment with weight-reducing agents (e.g., orlistat, sibutramine, topiramate, liraglutide)…