Low-carbohydrate Diet in Children With Type 1 Diabetes

  • STATUS
    Recruiting
  • End date
    Oct 21, 2024
  • participants needed
    30
  • sponsor
    University Hospital, Motol
Updated on 21 October 2021

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;

Details
Condition Type1diabetes
Treatment Low-carbohydrate diet, Recommended-carbohydrate diet
Clinical Study IdentifierNCT05078658
SponsorUniversity Hospital, Motol
Last Modified on21 October 2021

Eligibility

Yes No Not Sure

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
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