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

Type 1 Diabetes Clinical Trial

Official title:

The Effect of Gluten-free Diet on Residual Beta-cell Capacity, Immune Function and Gut Microbiome in Children With Newly Diagnosed Type 1 Diabetes (T1D)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02867436
• Other study ID #: 16-27994A
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2016
• Last updated: August 10, 2016
• Start date: March 2016
• Est. completion date: December 2019

Study information

• Verified date: August 2016
• Source: University Hospital, Motol
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ministry of Health
• Study type: Interventional

Clinical Trial 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;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 19 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Gluten-free diet

Locations

Country	Name	City	State
Czech Republic	University Hospital Královské Vinohrady	Prague
Czech Republic	University Hospital Motol	Prague

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Motol	Academy of Sciences of the Czech Republic, Institute of Microbiology, Faculty Hospital Kralovske Vinohrady

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.		Month 1-Month 44	No
Secondary	Changes in mean HbA1c at 6 and 12 months relative to baseline at month 1.		Month 1-Month 44	No
Secondary	Changes in mean insulin dose at 6 and 12 months relative to baseline at month 1.		Month 1-Month 44	No
Secondary	Changes in immunological parameters (FoxP3 Tregs, Th1 and Th17 counts) at 6 and 12 months relative to baseline at month 1.		Month 1-Month 44	No
Secondary	Differences in fecal microbiome between children on normal diet and children on gluten-free diet over the first year of diabetes duration;		Month 1-Month 44	No