TrialNet research study
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TrialNet Research Highlights
The TrialNet Study Group is a network of 18 clinical centres, internationally, dedicated to conducting studies in the early treatment, prevention and study of type 1 diabetes. Eligible participants for studies in Type 1 diabetes research may be family members of people with Type 1 diabetes or children, adolescents and adults who have been recently diagnosed with type 1 diabetes.
The Hospital for Sick Children is the major clinical Centre for TrialNet in Canada. We are privileged to have formed partnerships with diabetes centres across Canada. For information and to find a TrialNet affiliate centre near you please call 1-866-699-1899.
The following is a summary of TrialNet research studies currently being conducted at The Hospital for Sick Children.
Oral Insulin Prevention Study
TrialNet is testing oral insulin (taken by mouth, not by injection). The goal is to determine whether oral insulin may help to delay or prevent type 1 diabetes. Results from a recently completed study (called Diabetes Prevention Trial-1) suggest that oral insulin might delay or type 1 diabetes in certain individuals who have been identified as at risk.
Natural History Study
This study is the gateway for consideration for entry in the Oral Insulin Prevention Study. The study is looking at whether relatives of people with type 1 diabetes may be at increased risk for developing the disease. We are able to test for the autoantibodies (proteins that attack and destroy the cells in the body that produce insulin) in 1st and 2nd degree relatives of people with type 1 diabetes.
For those relatives who test positive for autoantibodies but are not eligible to participate in the Oral Insulin Prevention Trial or who do not want to part of the Oral Insulin Study, they can be monitored in the TrialNet Natural History Study. In this study participants will be monitored closely for diabetes. In addition, there may be other TrialNet studies that you can join in the future.
Effects of Recombinant Human Glutamic Acid Decarboxylase (rhGAD65) Formulated in Alum (GAD-alum) on the Progression of Type 1 Diabetes in New Onset Subjects
This study is currently under approval from Health Canada and enrolment is expected to start in Spring of 2009 at Hospital for Sick Kids. In this study, TrialNet researchers will use recombinant human glutamic acid decarboxylase (rhGAD65) formulated in aluminum hydroxide to try and interrupt the autoimmune attack that is present in people at the onset of type1 diabetes. If this treatment is successful, participants may continue to make some of their own insulin. The study drug will be given by injections
The initial injection will be given within the 1st 100 days of diagnosis and then an additional 2 times (1 month and 3 months after the initial injection). Follow up will be for 2 years in order to study the efficacy and safety rhGAD65 of in the early treatment of Type 1 diabetes. Participants can be ages 3-45 years of age.
Effects of CTLA-4Ig (Abatacept) on the Progression of T1D in New Onsets
This study has completed enrolment. In this study, TrialNet researchers will use a drug called Abatecept to try and interrupt the autoimmune attack that is present in people at the onset of type1 diabetes. If this treatment is successful, participants may continue to make some of their own insulin.
This drug will be given within the 1st 100 days of diagnosis and then monthly for 2 years in order to study the efficacy and safety of Abatacept in the early treatment of Type 1 diabetes. Participants can be ages 6-45 years of age.
The Mychophenolate Mofetil and Dacluzimab Study
The MMF/DZB study has completed enrolment, with a total of 126 subjects. Four of these subjects are currently enrolled at Sickkids. This protocol involved the administration of two immunosuppressive agents in people recently diagnosed with type 1 diabetes in hopes of preserving B cell mass to make diabetes easier to manage. This could help to reduce the risk of severe low blood sugar and both short-term and long-term complications.
The Rituximab Study
This study has completed enrolment. This study will try to determine whether the medication Rituximab may be used to stop or slow down the immune system’s attack on the beta cells. This study has completed enrollment and was accepting newly diagnosed people with type 1 diabetes. The goal of the study is to determine whether the medication, given intravenously, may prolong the honeymoon period.
The Genetics Consortium
The TrialNet research group at Sickkids is also involved in Type 1 Diabetes Genetics Research. We are conducting studies for families who have two children or adults who have been diagnosed with type 1 diabetes. This study involves a one-time blood test and is looking to identify genes that may help us to determine an individual’s risk for type 1 diabetes.
Trios
This is also a Type 1 diabetes genetics study to gain more information from populations who have low prevalence of Type 1 diabetes. For families with African-Canadian heritage or Mexican-Canadian heritage who are interested in being part of this research study we will need to do a blood test with the mother, father and the child or adolescent who has been diagnosed with type 1 diabetes.
For questions or concerns regarding Type 1 diabetes research at The Hospital for Sick Children please feel free to contact our team:
Dr. Diane Wherrett, PI – 416-813-8159
Brenda Ahenkorah, Project Manager – 416-813-5858
Lesley Eisel, Research Nurse – 416-813-7654 ext. 1798
Mithula Sriskandarajah, Project Coordinator – 416-813-7654 ext 2634