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)

Status Recruiting

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;

Clinical Trial Description

n/a

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

• NCT number: NCT02867436
• Study type: Interventional
• Source: University Hospital, Motol
• Status: Recruiting
• Phase: N/A
• Start date: March 2016
• Completion date: December 2019