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

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

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;

Study Overview

• Status: Active, not recruiting
• Conditions: Type1diabetes
• Intervention / Treatment: Other: Low-carbohydrate diet; Other: Recommended-carbohydrate diet

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, CZ-15600
    • University Hospital Motol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Changes in mean insulin dose during the LCD period compared to the RCD period	Month 1 - Month 24
Changes in mean body weight standard deviation score 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
Changes in muscle strength measured by jumping mechanography during the LCD period compared to the RCD period	Month 1 - Month 24
Changes in lymphocyte subgroup cell counts (flow cytometry) during the LCD period	Month 1 - Month 36
Differences in faecal microbiome between the LCD and RCD periods	Month 1 - Month 36
Differences in faecal metabolome 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

Collaborators and Investigators

• Sponsor: University Hospital, Motol
• Collaborators: Czech Academy of Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2021
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: NU21-01-00085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No