N/A N=45 Supportive Care

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

Type 1 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT02867436 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Change in C-peptide Area Under the Curve Measured by Mixed-meal Tolerance Test (MMTT) Between Group on GFD and Standard Gluten-containing Diet. — 1539; 1173 pmol*min/l — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Gluten-free diet (Other)
Age: Pediatric, Adult · 4+ yrs
Sex: All
Sponsor: University Hospital, Motol
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in C-peptide Area Under the Curve Measured by Mixed-meal Tolerance Test (MMTT) Between Group on GFD and Standard Gluten-containing Diet.	1539; 1173	<0.05 sig
SECONDARY Changes in Mean HbA1c at 6 and 12 Months Relative to Baseline at Month 1.	44.8; 47.2; 44; 52.2	<0.05 sig
SECONDARY Changes in Mean Insulin Dose at 6 and 12 Months Relative to Baseline at Month 1.	0.41; 0.62; 0.50; 0.75	<0.05 sig
SECONDARY Changes in Immunological Parameters (FoxP3 Tregs, Th1 and Th17 Counts) at 12 Months Relative to Baseline at Month 1.	8; 12.5; 1.02; 0.46	<0.05 sig
SECONDARY Differences in Fecal Microbiome Between Children on Normal Diet and Children on Gluten-free Diet Over the First Year of Diabetes Duration	3.3; 8; 3.2; 1.2; 1.01; 0.21	<0.05 sig

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;

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02867436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.