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

Primary Purpose

Type 1 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Gluten-free diet
Sponsored by
University Hospital, Motol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes

Eligibility Criteria

4 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Královské VinohradyRecruiting
  • University Hospital MotolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Gluten-free diet

Conventional diet

Arm Description

Gluten-free diet

Conventional diet

Outcomes

Primary Outcome Measures

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 Outcome Measures

Changes in mean HbA1c at 6 and 12 months relative to baseline at month 1.
Changes in mean insulin dose at 6 and 12 months relative to baseline at month 1.
Changes in immunological parameters (FoxP3 Tregs, Th1 and Th17 counts) at 6 and 12 months relative to baseline at month 1.
Differences in fecal microbiome between children on normal diet and children on gluten-free diet over the first year of diabetes duration;

Full Information

First Posted
March 7, 2016
Last Updated
August 10, 2016
Sponsor
University Hospital, Motol
Collaborators
Faculty Hospital Kralovske Vinohrady, Czech Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02867436
Brief Title
The Effect of Gluten-free Diet on New Onset Type 1 Diabetes (T1D)
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Motol
Collaborators
Faculty Hospital Kralovske Vinohrady, Czech Academy of Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gluten-free diet
Arm Type
Experimental
Arm Description
Gluten-free diet
Arm Title
Conventional diet
Arm Type
No Intervention
Arm Description
Conventional diet
Intervention Type
Other
Intervention Name(s)
Gluten-free diet
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Changes in mean HbA1c at 6 and 12 months relative to baseline at month 1.
Time Frame
Month 1-Month 44
Title
Changes in mean insulin dose at 6 and 12 months relative to baseline at month 1.
Time Frame
Month 1-Month 44
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital Královské Vinohrady
City
Prague
ZIP/Postal Code
10000
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Vosáhlo, MD
Phone
+420267161111
Email
vosahlo@fnkv.cz
Facility Name
University Hospital Motol
City
Prague
ZIP/Postal Code
15006
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zdenek Sumnik, MD
Phone
+420702000087
Email
zdenek.sumnik@lfmotol.cuni.cz
First Name & Middle Initial & Last Name & Degree
Ondrej Cinek, MD
Phone
+420224432026
Email
ondrej.cinek@lfmotol.cuni.cz

12. IPD Sharing Statement

Citations:
PubMed Identifier
36194251
Citation
Neuman V, Pruhova S, Kulich M, Kolouskova S, Vosahlo J, Romanova M, Petruzelkova L, Havlik J, Mascellani A, Henke S, Sumnik Z, Cinek O. Changes in the gut bacteriome upon gluten-free diet intervention do not mediate beta cell preservation. Diabetologia. 2023 Jan;66(1):241-246. doi: 10.1007/s00125-022-05805-3. Epub 2022 Oct 4.
Results Reference
derived
PubMed Identifier
31025045
Citation
Neuman V, Cinek O, Funda DP, Hudcovic T, Golias J, Kramna L, Petruzelkova L, Pruhova S, Sumnik Z. Human gut microbiota transferred to germ-free NOD mice modulate the progression towards type 1 diabetes regardless of the pace of beta cell function loss in the donor. Diabetologia. 2019 Jul;62(7):1291-1296. doi: 10.1007/s00125-019-4869-2. Epub 2019 Apr 25.
Results Reference
derived

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

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