Low-carbohydrate Diet in Children With Type 1 Diabetes

Study Overview
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Brief Summary
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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
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Low-carbohydrate Diet in Paediatric Type 1 Diabetes: Effects on Glycaemic Control and Islet Autoimmunity

Conditions
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Type1diabetes

Intervention / Treatment
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* Other: Low-carbohydrate diet
* Other: Recommended-carbohydrate diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-carbohydrate diet<br>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 but the amount of carbohydrates would be limited to provide only 15% (+/- 5%) of the recommended energy a day. | Other: Low-carbohydrate diet<br>* 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.<br>|
| Active Comparator: Recommended carbohydrate diet<br>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 50% (+/- 5%) of the recommended energy from carbohydrates. | Other: Recommended-carbohydrate diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mean insulin dose during the LCD period compared to the RCD period |  | Month 1 - Month 24 | 
| 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 | 
| Differences in faecal microbiome between the LCD and RCD periods |  | Month 1 - Month 36 | 
| 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 |