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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-01-01

Brief Summary

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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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Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Gluten-free diet

Group Type EXPERIMENTAL

Gluten-free diet

Intervention Type OTHER

Conventional diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gluten-free diet

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No