Type 1 DiabetesNCT02867436

The Effect of Gluten-free Diet on New Onset Type 1 Diabetes (T1D)

A study testing Gluten-free diet in people with Type 1 Diabetes, run by University Hospital, Motol at 2 sites in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 4 to 19 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Gluten-free diet
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 2 sitesCzechia
Study dates: Mar 2016to 1 Jan 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 4 to 19 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Type 1 Diabetes (T1D) diagnosed according to the American Diabetes Association criteria

Who cannot join

negativity of the three diabetes-related autoantibodies at T1D onset;
negativity of celiac-disease high risk Human Leucocyte Antigen DQB1 (HLA-DQB1) and Human Leucocyte Antigen DQA1 (HLA-DQA1) genotype HLA-DQB1*03:02-DQA1*03 nor DQB1*02-DQA1*05 molecules;
celiac disease or positive transglutaminase antibody test;
body mass index over two standard deviations of the age and height standard;
any concomitant disease potentially influencing immune response or gluten sensitivity

Trial locations and contacts

2 sites in 1 country.

Czechia2 sites

University Hospital Královské Vinohrady
Prague, 10000
University Hospital Motol
Prague, 15006

Other trials in Czechia

About this study

Official title: The Effect of Gluten-free Diet on Residual Beta-cell Capacity, Immune Function and Gut Microbiome in Children With Newly Diagnosed Type 1 Diabetes (T1D)

The primary aim of this pilot study is to test whether gluten-free diet (GFD) instituted in children shortly after onset of Type 1 Diabetes (T1D) can decelerate the decline in beta cell function as compared to age matched controls. Primary objective of the trial is the change in C-peptide area under the curve measured by mixed-meal tolerance test (MMTT) between group on GFD and standard gluten-containing diet.

Secondary objectives are:

Changes in immune parameters between gluten-free diet group and control group;
Differences in fecal microbiome between children on normal diet and children on GFD;

Conditions: Type 1 Diabetes
Being tested: Gluten-free diet
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gluten-free dietOther

Study groups in NCT02867436
Study group	Role	What they receive
Gluten-free diet	Experimental	Gluten-free diet Receives: Other: Gluten-free diet
Conventional diet	No intervention	Conventional diet

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in C-peptide Area Under the Curve Measured by Mixed-meal Tolerance Test (MMTT) Between Group on GFD and Standard Gluten-containing Diet.
Area under the curve of C-peptide in MMT test at 0, 30, 60, 90 and 120 minutes.
Measured: Month 1 (baseline) - Month 12 (end of intervention)

Secondary outcomes (4)

Changes in Mean HbA1c at 6 and 12 Months Relative to Baseline at Month 1.
Measured: Month 1 (baseline) - Month 6 - Month 12 (end of intervention)
Changes in Mean Insulin Dose at 6 and 12 Months Relative to Baseline at Month 1.
Measured: Month 1 (baseline) - Month 6 - Month 12 (end of intervention)
Changes in Immunological Parameters (FoxP3 Tregs, Th1 and Th17 Counts) at 12 Months Relative to Baseline at Month 1.
Measured: Month 1 (baseline) - Month 12 (end of intervention)
Differences in Fecal Microbiome Between Children on Normal Diet and Children on Gluten-free Diet Over the First Year of Diabetes Duration
Measures are shown as pooled values at all timepoints during the intervention period compared to control group throughout the same time-period.
Measured: Month 1 (before intervention) - Pooled values throughout the intervention (months 3-12) - Month 15 (after intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 20161 Jan 2020

First posted16 Aug 2016 (estimated)
Study startMar 2016
Primary completionDec 2019
Study completion1 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies 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: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02867436
Sponsor's protocol ID: 16-27994A
Status last verified: May 2024
First submitted: 7 Mar 2016
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Neuman V, Pruhova S, Kulich M, Kolouskova S, Vosahlo J, Romanova M, Petruzelkova L, Havlik J, Mascellani A, Henke S, Sumnik Z, Cinek O. Changes in the gut bacteriome upon gluten-free diet intervention do not mediate beta cell preservation. Diabetologia. 2023 Jan;66(1):241-246. doi: 10.1007/s00125-022-05805-3. Epub 2022 Oct 4.
PubMed 36194251
Neuman V, Cinek O, Funda DP, Hudcovic T, Golias J, Kramna L, Petruzelkova L, Pruhova S, Sumnik Z. Human gut microbiota transferred to germ-free NOD mice modulate the progression towards type 1 diabetes regardless of the pace of beta cell function loss in the donor. Diabetologia. 2019 Jul;62(7):1291-1296. doi: 10.1007/s00125-019-4869-2. Epub 2019 Apr 25.
PubMed 31025045

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Gluten-free Diet on Residual Beta-cell Capacity, Immune Function and Gut Microbiome in Children With Newly Diagnosed Type 1 Diabetes (T1D)
ClinicalTrials.gov ID: NCT02867436
Acronym / sponsor ID: 16-27994A
Conditions: Type 1 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: University Hospital, MotolUniversity, hospital or other
Collaborators: Faculty Hospital Kralovske Vinohrady, Czech Academy of Sciences
Study start: Mar 2016
Primary completion: Dec 2019 (actual)
Study completion: 1 Jan 2020 (actual)
First posted: 16 Aug 2016 (estimated)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Secondary objectives are:

Changes in immune parameters between gluten-free diet group and control group;
Differences in fecal microbiome between children on normal diet and children on GFD;

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Gluten-free diet	Experimental	Other: Gluten-free dietGluten-free diet
Conventional diet	No intervention	–Conventional diet

Who may qualify

Ages: 4 to 19 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Type 1 Diabetes (T1D) diagnosed according to the American Diabetes Association criteria

Key exclusion criteria (5 listed)

negativity of the three diabetes-related autoantibodies at T1D onset;
negativity of celiac-disease high risk Human Leucocyte Antigen DQB1 (HLA-DQB1) and Human Leucocyte Antigen DQA1 (HLA-DQA1) genotype HLA-DQB1*03:02-DQA1*03 nor DQB1*02-DQA1*05 molecules;
celiac disease or positive transglutaminase antibody test;
body mass index over two standard deviations of the age and height standard;
any concomitant disease potentially influencing immune response or gluten sensitivity

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
Gluten-free diet	Other	Gluten-free diet

Primary outcome

Change in C-peptide Area Under the Curve Measured by Mixed-meal Tolerance Test (MMTT) Between Group on GFD and Standard Gluten-containing Diet.
Time frame: Month 1 (baseline) - Month 12 (end of intervention)
Area under the curve of C-peptide in MMT test at 0, 30, 60, 90 and 120 minutes.

4 secondary outcomes

Changes in Mean HbA1c at 6 and 12 Months Relative to Baseline at Month 1.
Time frame: Month 1 (baseline) - Month 6 - Month 12 (end of intervention)
Changes in Mean Insulin Dose at 6 and 12 Months Relative to Baseline at Month 1.
Time frame: Month 1 (baseline) - Month 6 - Month 12 (end of intervention)
Changes in Immunological Parameters (FoxP3 Tregs, Th1 and Th17 Counts) at 12 Months Relative to Baseline at Month 1.
Time frame: Month 1 (baseline) - Month 12 (end of intervention)
Differences in Fecal Microbiome Between Children on Normal Diet and Children on Gluten-free Diet Over the First Year of Diabetes Duration
Time frame: Month 1 (before intervention) - Pooled values throughout the intervention (months 3-12) - Month 15 (after intervention)

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gluten-free Diet	26	20
Conventional Diet	19	19

Primary outcome: Change in C-peptide Area Under the Curve Measured by Mixed-meal Tolerance Test (MMTT) Between Group on GFD and Standard Gluten-containing Diet.

Time frame: Month 1 (baseline) - Month 12 (end of intervention). Mean (Standard Deviation). Unit: pmol*min/l

Measure	Gluten-free Diet n = 20	Conventional Diet n = 19
Value	1539 (1255)	1173 (1006)

Gluten-free Diet vs Conventional Diet: Mean Difference (Final Values): 205 (95% CI -223 to 633), p <0.05, Regression, Linear

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 15 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gluten-free Diet	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Conventional Diet	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Limitations and caveats (from the sponsor): The main limitation is the lack of randomization. Second, the study did not achieve the sample size needed for sufficient power according to the pre-study power analysis. Furthermore, the duration of the study might have been too short for the assessment of the long-term effect of the GFD on the course of T1D.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36194251Neuman V, Pruhova S, Kulich M, Kolouskova S, Vosahlo J, Romanova M, Petruzelkova L, Havlik J, Mascellani A, Henke S, Sumnik Z, Cinek O. Changes in the gut bacteriome upon gluten-free diet intervention do not mediate beta cell preservation. Diabetologia. 2023 Jan;66(1):241-246. doi: 10.1007/s00125-022-05805-3. Epub 2022 Oct 4.
Derived from this study: PubMed 31025045Neuman V, Cinek O, Funda DP, Hudcovic T, Golias J, Kramna L, Petruzelkova L, Pruhova S, Sumnik Z. Human gut microbiota transferred to germ-free NOD mice modulate the progression towards type 1 diabetes regardless of the pace of beta cell function loss in the donor. Diabetologia. 2019 Jul;62(7):1291-1296. doi: 10.1007/s00125-019-4869-2. Epub 2019 Apr 25.

Related trials for Type 1 Diabetes

Not yet recruitingPhase 3
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Obesity, Overweight
RecruitingPhase 1
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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.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Gluten-free diet in people with Type 1 Diabetes, run by University Hospital, Motol at 2 sites 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 1 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 C-peptide Area Under the Curve Measured by Mixed-meal Tolerance Test (MMTT) Between Group on GFD and Standard Gluten-containing Diet. (time frame: Month 1 (baseline) - Month 12 (end of intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02867436, which also lists 2 linked publications.

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 19 Sep 2024.