Clinical trial NCT02867436: The Effect of Gluten-free Diet on New Onset Type 1 Diabetes (T1D)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
Collaborators: name: Faculty Hospital Kralovske Vinohrady
name: Czech Academy of Sciences
First posted: 2016-08-16
Enrollment: 45
Sex: ALL
Minimum age (years): 4
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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;


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
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.
timeFrame: Month 1 (baseline) - Month 12 (end of intervention)
Secondary outcomes:
measure: Changes in Mean HbA1c at 6 and 12 Months Relative to Baseline at Month 1.
timeFrame: Month 1 (baseline) - Month 6 - Month 12 (end of intervention)
measure: Changes in Mean Insulin Dose at 6 and 12 Months Relative to Baseline at Month 1.
timeFrame: Month 1 (baseline) - Month 6 - Month 12 (end of intervention)
measure: Changes in Immunological Parameters (FoxP3 Tregs, Th1 and Th17 Counts) at 12 Months Relative to Baseline at Month 1.
timeFrame: Month 1 (baseline) - Month 12 (end of intervention)
measure: Differences in Fecal Microbiome Between Children on Normal Diet and Children on Gluten-free Diet Over the First Year of Diabetes Duration
timeFrame: Month 1 (before intervention) - Pooled values throughout the intervention (months 3-12) - Month 15 (after intervention)
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: University Hospital Královské Vinohrady
city: Prague
country: Czechia
facility: University Hospital Motol
Study officials:
References:
citation: 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.
citation: 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.