Diet Intervention in Newly Diagnosed Children With Type 1 Diabetes. How to Prolong Remission Using a Non-medical Approach?
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Herlev Hospital
- Enrollment
- 20
- Primary Endpoint
- Insulin Adjusted HbA1c change from baseline to 12 months follow-up
Study Overview
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.
Detailed Description
Introduction Type 1 diabetes (T1D) is characterised by a progressive loss and destruction of beta cells. The optimal timing of intervention is during remission when the beta cells regenerative power is still present, because we are treating only already diseased children, and there are enough beta cells to improve outcome if the cells survive.
Thus, the overall aim of this study is to prolong the remission phase by introducing glutenfree diet intervention to children with T1D and in addition, investigate the role of physical activity/fitness.
Hypothesis:
- Gluten-free diet leads to a shift in balance between the destruction and the regenerative capacity as well as increases insulin sensitivity.
- The diet have an impact on the gut microbiome composition and projected function, metabolic, immune and inflammatory biomarkers.
This is the first study with a non-pharmacological intervention in children combining both factors with a potential effect on the immune system as well as on insulin sensitivity and the first to include dietary factors, measures of physical fitness and measures of inflammation.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 18 Years (Child, Adult)
- Sex
- 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
Arms & Interventions
Glutenfree diet
Self-chosen glutenfree diet
Intervention: Glutenfree diet (Dietary Supplement)
Normal diet
Those not following the glutenfree diet
Outcomes
Primary Outcomes
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
C-peptide change from baseline to 12 months follow-up
Time Frame: 12 months
Stimulated C-peptide
Secondary Outcomes
- Microbiota (feces samples) change from baseline to 6 months follow-up(6 months)
- Immune system (Th1 and Th2 cytokines) change from baseline to 12 months follow-up(12 months)
Investigators
Flemming Pociot
Professor
Herlev Hospital