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Effects of Gluten Free Diet on Type 1 Diabetes Mellitus in Children

NCT02605564 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-11-02

No results posted yet for this study

Summary

The central hypothesis of this proposal is that a gluten-free diet introduced shortly after diagnosis can reverse or arrest islet destruction in children and adolescents with type 1 diabetes mellitus (T1DM). The specific aims are to determine the effects of a gluten-free diet on 1) endogenous insulin production and 2) the corresponding gut flora of children with new-onset type 1 diabetes. This is a randomized placebo controlled clinical trial testing the effect of altering the gut microbiome via a gluten-free diet on endogenous insulin production as a measure of the pace and severity of islet destruction at the time of diagnosis of type 1 diabetes. The project entails eliminating gluten from the diet of the intervention group and comparing bacterial gut flora and endogenous insulin response with those in a control group up to one year following the diagnosis of type 1 diabetes. The proposal introduces a new potential etiology for type 1 diabetes in humans: the Bacterial Hypothesis. The short term goal is to identify specific islet-preserving microbiome changes induced by eliminating gluten from the diet of patients recently diagnosed with type 1 diabetes. The long term goal is to develop these changes into effective and safe strategies that can allow patients with type 1 diabetes to achieve permanent insulin-independence.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

OTHER

Placebo

Placebo No intervention, standard T1DM diet

OTHER

Gluten Free Diet

Gluten Free Diet

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Eba Hathout, MD · Loma Linda University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-19
Primary Completion
2022-08-02
Completion
2022-08-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02605564 on ClinicalTrials.gov