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

May 8, 2024 updated by: Zdeněk Šumník, University Hospital, Motol

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 15006
        • University Hospital Motol
      • Prague, Czechia, 10000
        • University hospital Kralovske Vinohrady

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gluten-free diet
Other: Gluten-free diet
No Intervention: Conventional diet

What is the study measuring?

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.
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.
Month 1 (baseline) - Month 12 (end of intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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
Time Frame: 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.
Month 1 (before intervention) - Pooled values throughout the intervention (months 3-12) - Month 15 (after intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Motol

Collaborators

Faculty Hospital Kralovske Vinohrady
Czech Academy of Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimated)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-27994A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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