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Low-carbohydrate Diet in Children with Type 1 Diabetes
Sponsor: University Hospital, Motol
Summary
The primary aim of this pilot study is to test whether low-carbohydrate diet (LCD) instituted in children/adolescents with type 1 diabetes (T1D) can improve their disease control. The primary objective of the trial is the change in continuous glucose monitoring time in target range 3.9-10.0 mmol/l (TIR) in a 5-week period on LCD as opposed to a 5-week period on recommended carbohydrate diet (RCD). Secondary objectives are: Changes in immune parameters during the LCD period; Differences in fecal microbiome during the LCD period; Differences in fecal, serum and urine metabolome during the LCD period;
Official title: Low-carbohydrate Diet in Paediatric Type 1 Diabetes: Effects on Glycaemic Control and Islet Autoimmunity
Key Details
Gender
All
Age Range
6 Years - 20 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2021-09-22
Completion Date
2025-12
Last Updated
2024-12-09
Healthy Volunteers
No
Conditions
Interventions
Low-carbohydrate diet
The diet will contain age- and gender-specific recommended amount of calories but the amount of carbohydrates would be limited to provide only 15% (+/- 5%) of the recommended energy a day.
Recommended-carbohydrate diet
The subjects will be delivered five pre-made ready meals per day throughout the period (5 weeks). These will contain age- and gender-specific recommended amount of calories with the amount of carbohydrates equal to 45% (+/- 5%) of the recommended energy a day.
Locations (1)
University Hospital Motol
Prague, Prague, Czechia