Low-carbohydrate Diet in Children with Type 1 Diabetes

Not Applicable

Active, not recruiting

• Conditions: Type1diabetes
• Interventions: Other: Low-carbohydrate diet; Other: Recommended-carbohydrate diet

• Registration Number: NCT05078658
• Lead Sponsor: University Hospital, Motol

Brief 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;

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-15
• Study Start: 2021-09-22
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-14
• Primary Completion: 2024-10-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low-carbohydrate diet	Low-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 but the amount of carbohydrates would be limited to provide only 15% (+/- 5%) of the recommended energy a day.
Recommended carbohydrate diet	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 50% (+/- 5%) of the recommended energy from carbohydrates.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes in mean body weight standard deviation score 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 the lipid spectrum during the LCD period compared to the RCD period	Month 1 - Month 24
Differences in faecal microbiome 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
Changes in mean insulin dose during the LCD period compared to the RCD period	Month 1 - Month 24
Differences in faecal metabolome between the LCD and RCD periods	Month 1 - Month 36
Changes in lymphocyte subgroup cell counts (flow cytometry) during the LCD period	Month 1 - Month 36

Trial Locations

Locations (1)

University Hospital Motol; 🇨🇿 Prague, Czechia