Specialised Dietary Intervention in Human Type 1 Diabetes
Future Research Leaders Program 2018 Pilot Study: Specialised dietary intervention in human type 1 diabetes
The first group of participants of the JDRF/Macquarie Group Foundation Future Research Leaders Program are successfully collaborating on a world first safety trial in type 1 diabetes (T1D) testing a novel dietary supplement.
There is increasing evidence that the gut microbiota may play a role in the development of autoimmune diseases including type 1 diabetes. In 2017, one of the group’s Principal Investigators published findings in Nature Immunology that the supplement prevented 90% of T1D cases in mice. This effect was achieved through altering the gut microbiota, which in turn reduced systemic inflammation and prevented the autoimmune beta-cell destruction seen in T1D.
The supplement is a modified starch that releases large amount of the short chain fatty acids (SCFAs) acetate and butyrate during fermentation in the colon. SCFAs have been proven to favourably modulate the immune system.
In order to translate the recent findings into humans, the group have received funding from the T1DCRN and the Macquarie Group Foundation to determine whether the supplement is safe and well-tolerated in adults with T1D and, second, to determine whether this supplement affects numerous biomarkers of T1D, including glucose control, changes in the gut bacteria, inflammatory markers and evidence of changes in gut homeostasis. This is a pilot study in 25 adults with pre-existing T1D consuming the dietary fibre supplement twice daily for 6 weeks, with a follow-up at 12 weeks. Recruitment is expected to start in September 2018 and will take place at the Charles Perkins Centre at the University of Sydney NSW.
A dietary intervention should be a widely acceptable and natural means of preserving beta-cell function, not only in individuals at diagnosis but also in those at high risk of developing T1D in the future. This could see a new treatment or way to prevent T1D in future generations.
If the primary outcome of safety is met, then this study will inform the group on how best to implement the next stage – a larger randomized, double blinded, placebo controlled multi-centre Phase I/II study with the aim of establishing safety in people with newly diagnosed disease as well as determining efficacy for preserving beta-cell function over a two-year follow up period. The results of this study are expected in late 2019.
The study group are:
- Dr Eliana Marino – Monash University
- Dr Kirstine Bell – Charles Perkins Centre, University of Sydney
- A/Prof Sonia Saad – Kolling Institute, University of Sydney
- Dr Emma Hamilton-Williams – University of Queensland Diamantina Institute
- Dr Esteban Gurzov – Universite libre de Bruxelles
- Dr Phillip Bedggood – University of Melbourne
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