NCT05078658Active, not recruiting
Low-carbohydrate Diet in Children with Type 1 Diabetes
Low-carbohydrate Diet in Paediatric Type 1 Diabetes: Effects on Glycaemic Control and Islet Autoimmunity
Source: ClinicalTrials.gov · Last updated 9 Dec 2024
Brief summary (registry, in English)
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;
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 15 Sept 2021
- Start date
- 22 Sept 2021
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- University Hospital, Motol
- Diseases
- Type 1 diabetes
- NCT number
- NCT05078658
What you commit to
- Study type: Interventional
- Participants enrolled: 35
- From 22 Sept 2021 to the primary completion date, 31 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- daily average carbohydrate intake \< 130 g/day from 14 days food record prior to the intervention
Other illness
- subject has celiac disease
Lab values
- last HbA1c \< 40 or \> 70 mmol/mol
- any concomitant disease possibly affecting glucose control
- any chronic medication possibly affecting glucose control
Who the study is looking for
- 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
Age in the registry: 6 years to 20 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Motol Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.