| Full title | PREVEFIN project - Prevention
of type 1 diabetes in the general population |
Summary
| The
aim of this study is to try to see whether a change in diet can reduce the development
of autoimmunity to beta cells in these individuals and ultimately prevent the
development of type 1 diabetes.
The study consists of following individuals
without family history for type 1 diabetes but who have tested positive at birth
for genetic susceptibility to the disease through evaluation of the HLA genetic
marker.
Neonates once identified are enrolled in the prospective trial in
which an hydrolisate of cow's milk protein (trials have suggested that the proteins
present in cow's milk can increase a person's risk of developing diabetes) is
offered or a diet enriched in Vitamin D, a vitamin which has been shown to be
protective for type 1 diabetes. These children, as well as those in the TRIGR
study, will be followed-up for up to 10 years to see if a reduction in the incidence
of type 1 diabetes can be observed due to this immunomodulatory therapy.
During
the first two years of the study, the presence of islet cell antibodies in the
pancreas will be used as a surrogate end-marker to demonstrate an effect. |
Time
frame
| |
| Co-financed
by | Italian Ministry of Education, University and Research |
| Project
leader for Campus Bio-Medico | Prof. Paolo Pozzilli, Dr.ssa Manon
Merola |
| Main partners | University
of Genova - Istituto Gaslini - Coordinating centre - University of Ancona - Dept.
of Pediatrics, University of Perugia - Faculty of Medicine, University of Rome
"La Sapienza" - Dept. of Pediatrics. |
| Campus
Bio-Medico role | Participating centre |
| Reference
web site | www.unicampus.it |
| Notes | This
is one of the first studies in the world which look at intervention at birth in
individuals who do not come from a history of diabetes but who are genetically
susceptible to type 1 diabetes as identified from amongst the general population. |
