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| Name | Class |
|---|---|
| Czech Academy of Sciences | OTHER |
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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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-carbohydrate diet | Experimental | 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. |
|
| Recommended carbohydrate diet | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-carbohydrate diet | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Motol | Prague | Prague | CZ-15600 | Czechia |
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| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Recommended-carbohydrate diet | Other | 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. |
|
| 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 |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |