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

Study Overview
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Brief Summary
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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;

Official Title
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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)

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: Gluten-free diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gluten-free diet<br>Gluten-free diet | Other: Gluten-free diet<br> <br> |
| No Intervention: Conventional diet<br>Conventional diet | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in C-peptide area under the curve measured by mixed-meal tolerance test (MMTT) between group on GFD and standard gluten-containing diet. |  | Month 1-Month 44 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mean HbA1c at 6 and 12 months relative to baseline at month 1. |  | Month 1-Month 44 | 
| Changes in mean insulin dose at 6 and 12 months relative to baseline at month 1. |  | Month 1-Month 44 | 
| Changes in immunological parameters (FoxP3 Tregs, Th1 and Th17 counts) at 6 and 12 months relative to baseline at month 1. |  | Month 1-Month 44 | 
| Differences in fecal microbiome between children on normal diet and children on gluten-free diet over the first year of diabetes duration; |  | Month 1-Month 44 |