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Can Gluten-free Diet Prevent the Destruction of Beta-cells During Remission?

NCT02284815 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-11-06

No results posted yet for this study

Summary

Type 1 diabetes (T1D) emerge when the auto-immune destruction exceeds the beta cell's regenerative capacity. The patients' beta-cell capacity increases shortly after onset when glucotoxicity decreases after the start of insulin therapy. Children have fewer beta cells and therefore shorter remission; but the expansion potential is larger the younger the child is. The problem with the majority of intervention studies is the many and serious side effects, or a quite marginal effect on the residual beta-cell function. However, in animals that had received gluten-free diet, the T1D incidence fell from 61% to only 6%. Gluten-free diet increases the number of regulatory T cells in Peyer's patches, affect the composition of intestinal microflora and modify the balance between pro and anti-inflammatory cytokines in T cells. Therefore, the aim of our study is to prolong the remission phase by introducing a gluten-free diet intervention to children at T1D onset.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DIETARY_SUPPLEMENT

Glutenfree diet

Newly diagnosed children could choose glutenfree diet

Sponsors & Collaborators

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Jannet Svensson, Phd · Copenhagen University Hospital at Herlev

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-06-30
Completion
2015-08-31

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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 NCT02284815 on ClinicalTrials.gov