Type1diabetes
Conditions
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;
Interventions
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.
OTHERRecommended-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.
Sponsors
Czech Academy of Sciences
University Hospital, Motol
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in continuous glucose monitoring time in target range (3.9-10.0 mmol/l) during the LCD period compared to the RCD period | Month 1 - Month 24 |
Secondary
| Measure | Time frame |
|---|---|
| Changes in mean body weight standard deviation score during the LCD period compared to the RCD period | Month 1 - Month 24 |
| Changes in the lipid spectrum during the LCD period compared to the RCD period | Month 1 - Month 24 |
| Changes in muscle strength measured by jumping mechanography during the LCD period compared to the RCD period | Month 1 - Month 24 |
| Changes in lymphocyte subgroup cell counts (flow cytometry) during the LCD period | Month 1 - Month 36 |
| Changes in mean insulin dose during the LCD period compared to the RCD period | Month 1 - Month 24 |
| Differences in faecal metabolome between the LCD and RCD periods | Month 1 - Month 36 |
| Differences in serum metabolome between the LCD and RCD periods | Month 1 - Month 36 |
| Differences in urine metabolome between the LCD and RCD periods | Month 1 - Month 36 |
| Differences in faecal microbiome between the LCD and RCD periods | Month 1 - Month 36 |
Countries
Czechia
Outcome results
None listed