Clinical trial NCT05078658: Low-carbohydrate Diet in Children with Type 1 Diabetes
Official title: Low-carbohydrate Diet in Paediatric Type 1 Diabetes: Effects on Glycaemic Control and Islet Autoimmunity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type1diabetes
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
Collaborators: name: Czech Academy of Sciences
First posted: 2021-10-14
Enrollment: 35
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Change in continuous glucose monitoring time in target range (3.9-10.0 mmol/l) during the LCD period compared to the RCD period
timeFrame: Month 1 - Month 24
Secondary outcomes:
measure: Changes in mean insulin dose during the LCD period compared to the RCD period
timeFrame: Month 1 - Month 24
measure: Changes in mean body weight standard deviation score during the LCD period compared to the RCD period
timeFrame: Month 1 - Month 24
measure: Changes in the lipid spectrum during the LCD period compared to the RCD period
timeFrame: Month 1 - Month 24
measure: Changes in muscle strength measured by jumping mechanography during the LCD period compared to the RCD period
timeFrame: Month 1 - Month 24
measure: Changes in lymphocyte subgroup cell counts (flow cytometry) during the LCD period
timeFrame: Month 1 - Month 36
measure: Differences in faecal microbiome between the LCD and RCD periods
timeFrame: Month 1 - Month 36
measure: Differences in faecal metabolome between the LCD and RCD periods
timeFrame: Month 1 - Month 36
measure: Differences in serum metabolome between the LCD and RCD periods
timeFrame: Month 1 - Month 36
measure: Differences in urine metabolome between the LCD and RCD periods
timeFrame: Month 1 - Month 36
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: University Hospital Motol
Study officials:
References: