Low-carbohydrate Diet in Children with Type 1 Diabetes

NCT05078658 | Active Not Recruiting

• 1 other identifier: NU21-01-00085
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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;

Conditions

Type1diabetes

Outcome Measures

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

  Month 1 - Month 24

Secondary Outcomes (9)

• 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

Study Arms (2)

Low-carbohydrate diet

EXPERIMENTAL

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

Recommended carbohydrate diet

ACTIVE COMPARATOR

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

Interventions

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.

Low-carbohydrate diet

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.

Recommended carbohydrate diet

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Motol: lead
• Czech Academy of Sciences: collaborator

Study Sites (1)

University Hospital Motol

Prague, Prague, CZ-15600, Czechia

Location

MeSH Terms

Interventions

Diet, Carbohydrate-Restricted

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 14, 2021
• Study Start: September 22, 2021
• Primary Completion: October 31, 2024
• Study Completion: December 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)