Status:
NOT_YET_RECRUITING
Meal Frequency and Glycemic Control in Individuals With Type 1 Diabetes
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
Type 1 Diabetes (T1D)
Nutrition Therapy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ran...
Detailed Description
This is a single center, randomized, open-label, non-inferiority and crossover clinical trial. Subjects with type 1 diabetes (T1D) and will be recruited through advertisement on the web page of Hospit...
Eligibility Criteria
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
- 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) in the last 12 weeks prior to screening.
- Treatment with thyroid hormone that has not been maintained at a stable dose in the last 12 weeks prior to screening.
- 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.
- Women who are pregnant, intending to become pregnant during the study period, or who are breastfeeding.
- 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.
- Night workers who work after 10 pm.
Key Trial Info
Start Date :
April 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 29 2027
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06934707
Start Date
April 20 2025
End Date
December 29 2027
Last Update
April 18 2025
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil