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Active, Not Recruiting

NCT Number: NCT05078658

Low-carbohydrate Diet in Children with Type 1 Diabetes

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;

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type1diabetes

Age range

6 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Motol

Prague, CZ-15600, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in continuous glucose monitoring time in target range (3.9-10.0 mmol/l) during the LCD period compared to the RCD period

    Time frame: Month 1 - Month 24

Secondary outcomes

  1. Changes in mean insulin dose during the LCD period compared to the RCD period

    Time frame: Month 1 - Month 24

  2. Changes in mean body weight standard deviation score during the LCD period compared to the RCD period

    Time frame: Month 1 - Month 24

  3. Changes in the lipid spectrum during the LCD period compared to the RCD period

    Time frame: Month 1 - Month 24

  4. Changes in muscle strength measured by jumping mechanography during the LCD period compared to the RCD period

    Time frame: Month 1 - Month 24

  5. Changes in lymphocyte subgroup cell counts (flow cytometry) during the LCD period

    Time frame: Month 1 - Month 36

  6. Differences in faecal microbiome between the LCD and RCD periods

    Time frame: Month 1 - Month 36

  7. Differences in faecal metabolome between the LCD and RCD periods

    Time frame: Month 1 - Month 36

  8. Differences in serum metabolome between the LCD and RCD periods

    Time frame: Month 1 - Month 36

  9. Differences in urine metabolome between the LCD and RCD periods

    Time frame: Month 1 - Month 36

Sponsors and collaborators

Lead sponsor

University Hospital, Motol

Other

Collaborators

  • Czech Academy of Sciences

Registry information

Official study title

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

Acronym: Lowca

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Oct 14, 2021
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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