Low-carbohydrate Diet in Children with Type 1 Diabetes

N/AActive Not RecruitingNCT05078658

University Hospital, Motol35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type1diabetes

Interventions

Low-carbohydrate dietOTHER

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 dietOTHER

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Motol

Prague, Prague, Czechia

Outcomes

Primary Outcomes

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

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

Time frame: Month 1 - Month 24

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

Time frame: Month 1 - Month 24

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

Time frame: Month 1 - Month 24

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

Time frame: Month 1 - Month 24

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