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Completed

NCT Number: NCT02867436

The Effect of Gluten-free Diet on New Onset 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;

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

4 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Královské Vinohrady, Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten-free diet

Other

Primary outcomes

  1. 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

  1. 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)

  2. 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)

  3. 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)

  4. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Motol

Other

Collaborators

  • Czech Academy of Sciences
  • Faculty Hospital Kralovske Vinohrady

Registry information

Official study title

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)

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Aug 16, 2016
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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