Low-carbohydrate Diet in Children With Type 1 Diabetes

Type1diabetes Clinical Trial

— Lowca  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078658
• Other study ID #: NU21-01-00085
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: October 2024

Study information

• Verified date: October 2021
• Source: University Hospital, Motol
• Contact: Zdenek Sumnik, Prof.
• Phone: +420702000087
• Email: zdenek.sumnik[@]lfmotol.cuni.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Czechia	University Hospital Motol	Prague

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Motol	Czech Academy of Sciences

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in mean insulin dose during the LCD period compared to the RCD period		Month 1 - Month 24
Secondary	Changes in mean body weight standard deviation score during the LCD period compared to the RCD period		Month 1 - Month 24
Secondary	Changes in the lipid spectrum during the LCD period compared to the RCD period		Month 1 - Month 24
Secondary	Changes in muscle strength measured by jumping mechanography during the LCD period compared to the RCD period		Month 1 - Month 24
Secondary	Changes in lymphocyte subgroup cell counts (flow cytometry) during the LCD period		Month 1 - Month 36
Secondary	Differences in faecal microbiome between the LCD and RCD periods		Month 1 - Month 36
Secondary	Differences in faecal metabolome between the LCD and RCD periods		Month 1 - Month 36
Secondary	Differences in serum metabolome between the LCD and RCD periods		Month 1 - Month 36
Secondary	Differences in urine metabolome between the LCD and RCD periods		Month 1 - Month 36