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Can Gluten-free Diet Prevent the Destruction of Beta-cells During Remission?

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Flemming Pociot, Herlev Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284815
First Posted: November 6, 2014
Last Update Posted: November 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Flemming Pociot, Herlev Hospital
  Purpose
Type 1 diabetes (T1D) emerge when the auto-immune destruction exceeds the beta cell's regenerative capacity. The patients' beta-cell capacity increases shortly after onset when glucotoxicity decreases after the start of insulin therapy. Children have fewer beta cells and therefore shorter remission; but the expansion potential is larger the younger the child is. The problem with the majority of intervention studies is the many and serious side effects, or a quite marginal effect on the residual beta-cell function. However, in animals that had received gluten-free diet, the T1D incidence fell from 61% to only 6%. Gluten-free diet increases the number of regulatory T cells in Peyer's patches, affect the composition of intestinal microflora and modify the balance between pro and anti-inflammatory cytokines in T cells. Therefore, the aim of our study is to prolong the remission phase by introducing a gluten-free diet intervention to children at T1D onset.

Condition Intervention Phase
Diabetes Mellitus, Type 1 Dietary Supplement: Glutenfree diet Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diet Intervention in Newly Diagnosed Children With Type 1 Diabetes. How to Prolong Remission Using a Non-medical Approach?

Resource links provided by NLM:


Further study details as provided by Flemming Pociot, Herlev Hospital:

Primary Outcome Measures:
  • C-peptide change from baseline to 12 months follow-up [ Time Frame: 12 months ]
    Stimulated C-peptide

  • Insulin Adjusted HbA1c change from baseline to 12 months follow-up [ Time Frame: 12 months ]
    4*insulin + HbA1c (%)

  • Insulin per kg from baseline to 12 months follow-up [ Time Frame: 12 months ]
    total insulin dose per day


Secondary Outcome Measures:
  • Microbiota (feces samples) change from baseline to 6 months follow-up [ Time Frame: 6 months ]
    feces samples

  • Immune system (Th1 and Th2 cytokines) change from baseline to 12 months follow-up [ Time Frame: 12 months ]
    Th1 and Th2 cytokines


Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glutenfree diet
Self-chosen glutenfree diet
Dietary Supplement: Glutenfree diet
Newly diagnosed children could choose glutenfree diet
Placebo Comparator: Normal diet
Those not following the glutenfree diet

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed with type 1 diabetes (duration < 3 month)

Exclusion Criteria:

  • Diabetes duration > 3 months,
  • not type 1 diabetes
  Contacts and Locations
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): NCT02284815


Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Jannet Svensson, Phd Copenhagen University Hospital at Herlev
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Flemming Pociot, Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02284815     History of Changes
Other Study ID Numbers: DIRECT-2011-119
First Submitted: October 28, 2014
First Posted: November 6, 2014
Last Update Posted: November 6, 2014
Last Verified: November 2014

Keywords provided by Flemming Pociot, Herlev Hospital:
Gluten
T1D
Remission

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases