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Low-carbohydrate Diet in Children with Type 1 Diabetes

NCT05078658 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-12-09

No results posted yet for this study

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;

Conditions

  • Type1diabetes

Interventions

OTHER

Low-carbohydrate diet

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.

OTHER

Recommended-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 & Collaborators

  • Czech Academy of Sciences

    collaborator OTHER

  • University Hospital, Motol

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-22
Primary Completion
2024-10-31
Completion
2025-12-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05078658 on ClinicalTrials.gov