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

University Hospital, Motol45 enrolled

Overview

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;

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Gluten-free dietOTHER

Eligibility

Sex: ALLMin age: 4 YearsMax age: 19 Years

Medical Language ↔ Plain English

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

Locations (2)

University Hospital Královské Vinohrady

Prague, Czechia

University Hospital Motol

Prague, Czechia

Outcomes

Primary Outcomes

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.

Time frame: Month 1 (baseline) - Month 12 (end of intervention)

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

Measures are shown as pooled values at all timepoints during the intervention period compared to control group throughout the same time-period.

Time frame: Month 1 (before intervention) - Pooled values throughout the intervention (months 3-12) - Month 15 (after intervention)

Data from ClinicalTrials.gov

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