Clinical Trial

Low-carbohydrate Diet in Children with Type 1 Diabetes

Study acronym: Lowca

Active, Not Recruiting

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;

Protocol Amendment History 2 amendments

This ClinicalTrials.gov record has been amended 2 times since 2021-10-04; most recent amendment 2024-12-04.

Status change: Recruiting → Active, Not Recruiting 2024-05-08

Trial Details

NCT Number	NCT05078658
Lead Sponsor	University Hospital, Motol Collaborators: Czech Academy of Sciences
Conditions	Type1diabetes
Enrollment	35 participants
Start Date	2021-09-22
Primary Completion	2024-10-31 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2024-12-09