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

University Hospital, Motol

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Other: Gluten-free diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02867436

16-27994A

Details and patient eligibility

About

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;

Enrollment: 45 patients

Sex: All

Ages: 4 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Gluten-free diet

Experimental group

Description:

Gluten-free diet

Treatment:

Other: Gluten-free diet

Conventional diet

No Intervention group

Description:

Conventional diet