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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 4 Years - 19 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02867436
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Motol
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Czech Republic
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Type 1 Diabetes
Arms & Interventions

Arms

Experimental: Gluten-free diet

Gluten-free diet

No Intervention: Conventional diet

Conventional diet

Interventions

Other: - Gluten-free diet

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University Hospital Královské Vinohrady, Prague, Czech Republic

Status

Recruiting

Address

University Hospital Královské Vinohrady

Prague, , 10000

Site Contact

Jan Vosáhlo, MD

vosahlo@fnkv.cz

+420267161111

University Hospital Motol, Prague, Czech Republic

Status

Recruiting

Address

University Hospital Motol

Prague, , 15006

Site Contact

Zdenek Sumnik, MD

zdenek.sumnik@lfmotol.cuni.cz

+420702000087

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