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)

University Hospital, Motol2 sites in 1 country60 target enrollmentMarch 2016

ConditionsType 1 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: University Hospital, Motol
Enrollment: 60
Locations: 2
Primary Endpoint: Change in C-peptide Area Under the Curve Measured by Mixed-meal Tolerance Test (MMTT) Between Group on GFD and Standard Gluten-containing Diet.
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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;

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

December 2019

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Motol

Responsible Party

Principal Investigator

Zdeněk Šumník

MD, PhD

University Hospital, Motol

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

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.

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.

Secondary Outcomes

Changes in Mean HbA1c at 6 and 12 Months Relative to Baseline at Month 1.(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.(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.(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(Month 1 (before intervention) - Pooled values throughout the intervention (months 3-12) - Month 15 (after intervention))