Comparing 3 and 6 daily meals for blood sugar in type 1 diabetes

Trial details

Who runs it

Hospital de Clinicas de Porto Alegre

Trial code

NCT06934707

Record updated

18 April 2025

Original description

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.Read full original descriptionShow less

Meal Frequency, Glycemic Control and Variability in Individuals With Type 1 Diabetes: a Randomized Crossover Clinical 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.

Inclusion: • 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: Treatment with thyroid hormone that has not been maintained at a stable dose in the last 12 weeks prior to screening; Individuals with gastrointestinal disease such as celiac disease, Crohn's disease and Irritable Bowel Syndrome (IBS); History of bariatric surgery; Chronic kidney disease with estimated glomerular filtration <30mL/min per 1.73 m2; Liver failure or chronic viral hepatitis; Active or progressive neurodegenerative disease; History of active substance abuse (including alcohol) in the last year; Serious psychiatric illness: Mood disorders, anxiety disorders, severe psychotic disorders, and personality disorders that are revealed or identified in the clinical evaluation, listed or reported in the medical record, and that have no clinical findings; Predisposition to or diagnosis of eating disorders; Hyperglycemia characterized by acute symptoms: polyuria, polydipsia, and/or weight loss in the last 3 months. ● Metabolic and acute complications of diabetes such as ketoacidosis or hyperosmolar coma; Individuals with glycated hemoglobin ≥ 11%; 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) in the last 12 weeks prior to screening; Individuals who are using NPH insulin; Retinopathy with vision deficit that limits the activities proposed in the disciplines; That you are following a carbohydrate, protein and/or fat restriction diet; Individuals with BMI ≥ 40kg/m2; Women who are pregnant, intending to become pregnant during the study period, or who are breastfeeding; Night workers who work after 10 pm.

ClinicalTrials.gov NCT06934707