Low-carbohydrate Diet in Children with Type 1 Diabetes (Lowca)

University Hospital, Motol

Status: Active, not recruiting

Conditions: Type1diabetes

Treatments: Other: Low-carbohydrate diet; Other: Recommended-carbohydrate diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05078658

NU21-01-00085

Details and patient eligibility

About

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;

Enrollment: 35 patients

Sex: All

Ages: 6 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Low-carbohydrate diet

Experimental group

Description:

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.

Treatment:

Other: Low-carbohydrate diet

Recommended carbohydrate diet

Active Comparator group

Description:

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.

Treatment:

Other: Recommended-carbohydrate diet