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Trial record 70 of 747 for:    Area Under Curve AND meal

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

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ClinicalTrials.gov Identifier: NCT02867436
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Sponsor:
Collaborators:
Faculty Hospital Kralovske Vinohrady
Czech Academy of Sciences
Information provided by (Responsible Party):
Zdeněk Šumník, University Hospital, Motol

Brief 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;

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: Gluten-free diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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)
Study Start Date : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Gluten-free diet
Gluten-free diet
Other: Gluten-free diet
No Intervention: Conventional diet
Conventional diet



Primary Outcome Measures :
  1. Change in C-peptide area under the curve measured by mixed-meal tolerance test (MMTT) between group on GFD and standard gluten-containing diet. [ Time Frame: Month 1-Month 44 ]

Secondary Outcome Measures :
  1. Changes in mean HbA1c at 6 and 12 months relative to baseline at month 1. [ Time Frame: Month 1-Month 44 ]
  2. Changes in mean insulin dose at 6 and 12 months relative to baseline at month 1. [ Time Frame: Month 1-Month 44 ]
  3. Changes in immunological parameters (FoxP3 Tregs, Th1 and Th17 counts) at 6 and 12 months relative to baseline at month 1. [ Time Frame: Month 1-Month 44 ]
  4. Differences in fecal microbiome between children on normal diet and children on gluten-free diet over the first year of diabetes duration; [ Time Frame: Month 1-Month 44 ]


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Ages Eligible for Study:   4 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867436


Locations
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Czech Republic
University Hospital Královské Vinohrady Recruiting
Prague, Czech Republic, 10000
Contact: Jan Vosáhlo, MD    +420267161111    vosahlo@fnkv.cz   
University Hospital Motol Recruiting
Prague, Czech Republic, 15006
Contact: Zdenek Sumnik, MD    +420702000087    zdenek.sumnik@lfmotol.cuni.cz   
Contact: Ondrej Cinek, MD    +420224432026    ondrej.cinek@lfmotol.cuni.cz   
Sponsors and Collaborators
University Hospital, Motol
Faculty Hospital Kralovske Vinohrady
Czech Academy of Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zdeněk Šumník, MD, PhD, University Hospital, Motol
ClinicalTrials.gov Identifier: NCT02867436     History of Changes
Other Study ID Numbers: 16-27994A
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases