Type1diabetesLowcaNCT05078658
Low-carbohydrate Diet in Children with Type 1 Diabetes
A study testing Low-carbohydrate diet and Recommended-carbohydrate diet in people with Type1diabetes, run by University Hospital, Motol at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Low-carbohydrate diet and Recommended-carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCzechia
- Study dates
- 22 Sep 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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;
- Conditions
- Type1diabetes
- Being tested
- Low-carbohydrate diet, Recommended-carbohydrate diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Recommended-carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in continuous glucose monitoring time in target range (3.9-10.0 mmol/l) during the LCD period compared to the RCD period
Measured: Month 1 - Month 24
Secondary outcomes (9)
Changes in mean insulin dose during the LCD period compared to the RCD period
Measured: Month 1 - Month 24
Changes in mean body weight standard deviation score during the LCD period compared to the RCD period
Measured: Month 1 - Month 24
Changes in the lipid spectrum during the LCD period compared to the RCD period
Measured: Month 1 - Month 24
Changes in muscle strength measured by jumping mechanography during the LCD period compared to the RCD period
Measured: Month 1 - Month 24
Changes in lymphocyte subgroup cell counts (flow cytometry) during the LCD period
Measured: Month 1 - Month 36
Differences in faecal microbiome between the LCD and RCD periods
Measured: Month 1 - Month 36
Differences in faecal metabolome between the LCD and RCD periods
Measured: Month 1 - Month 36
Differences in serum metabolome between the LCD and RCD periods
Measured: Month 1 - Month 36
Differences in urine metabolome between the LCD and RCD periods
Measured: Month 1 - Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start22 Sep 2021
- Primary completion31 Oct 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Collaborators
- Czech Academy of Sciences
- Responsible party
- Principal investigator, Zdeněk Šumník, University Hospital, Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078658
- Sponsor's protocol ID
- NU21-01-00085
- Acronym
- Lowca
- Status last verified
- Dec 2024
- First submitted
- 15 Sep 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-carbohydrate Diet in Paediatric Type 1 Diabetes: Effects on Glycaemic Control and Islet Autoimmunity
- ClinicalTrials.gov ID
- NCT05078658
- Acronym / sponsor ID
- Lowca / NU21-01-00085
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Collaborators
- Czech Academy of Sciences
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-carbohydrate diet | Experimental | Other: Low-carbohydrate dietThe 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. |
| Recommended carbohydrate diet | Active comparator | Other: Recommended-carbohydrate dietThe 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. |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-carbohydrate dietThe 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. | Other | Low-carbohydrate diet |
| Recommended-carbohydrate dietThe 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. | Other | Recommended carbohydrate diet |
Primary outcome
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
9 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
Time frame: Month 1 - Month 36
Differences in faecal microbiome between the LCD and RCD periods
Time frame: Month 1 - Month 36
Differences in faecal metabolome between the LCD and RCD periods
Time frame: Month 1 - Month 36
Differences in serum metabolome between the LCD and RCD periods
Time frame: Month 1 - Month 36
Differences in urine metabolome between the LCD and RCD periods
Time frame: Month 1 - Month 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-carbohydrate diet and Recommended-carbohydrate diet in people with Type1diabetes, run by University Hospital, Motol at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.