NCT02867436

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University Hospital, Motol · Academic / Other
• Sex: All
• Age: 4 Years – 19 Years
• Healthy volunteers: Not accepted

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;

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
OTHER	Gluten-free diet

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-12-01
• Completion: 2020-01-01
• First posted: 2016-08-16
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

2 sites across 1 country: Czechia