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

NCT02867436 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-09-19

Study results available
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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;

Conditions

Interventions

OTHER

Gluten-free diet

Sponsors & Collaborators

  • Faculty Hospital Kralovske Vinohrady

    collaborator OTHER_GOV

  • Czech Academy of Sciences

    collaborator OTHER

  • University Hospital, Motol

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-12-31
Completion
2020-01-01

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02867436 on ClinicalTrials.gov