PROBLEMS RELATED TO RECRUITMENT OF PARTICIPANTS FOR THE TRIGR
PROJECT
Aleksandra Górska
Department of Paediatric and Adolescent Endocrinology, University Children’s Hospital, Kraków, Poland
Introduction: The main objective of the TRIGR project (Trial to Reduce IDDM in the Genetically at Risk) is to answer the following question: can the risk of developing type 1 diabetes mellitus (T1D) in children with increased genetic predisposition to this disease be decreased by weaning to a highly hydrolysed formula? The potential candidates for TRIGR are: pregnant women affected by T1D, men with T1D who are to become fathers or families with an affected child who are going to have another child. Therefore process of identifying and recruiting participants for TRIGR is challenging. It includes three subsequent steps: recruitment, registration and randomisation. This complex procedure requires excellent cooperation between at least three different specialities:t obstetrics, adult endocrinology and paediatric endocrinology. In our centre we work together in such a team.
Results: We started recruiting families in May 2003. Our aim was to recruit 35 each year. So far we have recruited 41 families. 11 families (26%) have refused to take part in the study. 30 participants have been registered and randomised.
22 of them (73%) were not eligible according to their genotype, and do not continue in the study; 8 (27%) had positive genetic results and are actively taking part in the study. Among those: 1 has all three family members affected, 1 has two diabetic parents, 1 has an affected sibling and 5 an affected mother.
The longest follow-up period so far is 12 months.
Conclusions: Our results indicate that: good cooperation between doctors is crucial for successful recruitment; the majority of families invited to the TRIGR have agreed to participate; recruitment rate among affected by T1D mothers and children is good; we still lack a good strategy to attract men with T1D; in our centre only 27% of infants had the genetic predisposition to T1D, while the expected frequency was about 45%; in both families were more than one member was affected by T1D, genetic predisposition was confirmed.
Key words: TRIGR, diabetes mellitus type 1, prevention, genetic predisposition.
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