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Clinical Trials in Czechia / NCT05078658
Active, not recruiting Not applicable

Low-carbohydrate Diet in Children with Type 1 Diabetes

NCT05078658 · tracked via the Priya Life Science Czechia tracker
Phase
Not applicable
Started
2021-09-22
Last updated
2024-12-09

Condition(s) studied

Type1diabetes

Investigational drug(s) / intervention(s)

Low-carbohydrate dietRecommended-carbohydrate diet

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.

Study 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;

Eligibility

Sex
ALL
Min age
6 Years
Max age
20 Years
Healthy volunteers
No
Inclusion Criteria: * T1D diagnosed according to the ADA (American Diabetes Assocciation) criteria * T1D duration for at least 1 year prior to the intervention * continuous glucose monitor (CGM) worn \> 70% time in the month prior to the intervention Exclusion Criteria: * last HbA1c \< 40 or \> 70 mmol/mol * subject has celiac disease * daily average carbohydrate intake \< 130 g/day from 14 days food record prior to the intervention * any concomitant disease possibly affecting glucose control * any chronic medication possibly affecting glucose control

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospital Motol Prague Prague

More University Hospital, Motol trials in Czechia

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05078658 on ClinicalTrials.gov ↗ ← All trials in Czechia