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

Not Applicable

• Conditions: Type 1 Diabetes

• Registration Number: NCT02867436
• Lead Sponsor: University Hospital, Motol

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;

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-07
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-10
• Last Update Submitted: 2016-08-10
• Study First Posted: 2016-08-16
• Last Update Posted: 2016-08-16
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 (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 Outcome Measures

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

Trial Locations

Locations (2)

University Hospital Královské Vinohrady; 🇨🇿 Prague, Czechia

University Hospital Motol; 🇨🇿 Prague, Czechia