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

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. Identifier: NCT02284815
Recruitment Status : Unknown
Verified November 2014 by Flemming Pociot, Herlev Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 6, 2014
Last Update Posted : November 6, 2014
Information provided by (Responsible Party):
Flemming Pociot, Herlev Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Dietary Supplement: Glutenfree diet Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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?
Study Start Date : March 2012
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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

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

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

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

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

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

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes duration > 3 months,
  • not type 1 diabetes

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 identifier (NCT number): NCT02284815

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

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

Keywords provided by Flemming Pociot, Herlev Hospital:

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