Status:
COMPLETED
Trial of Intranasal Insulin in Children and Young Adults at Risk of Type 1 Diabetes
Lead Sponsor:
Melbourne Health
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
4-30 years
Phase:
PHASE2
Brief Summary
In people with type 1 diabetes the beta cells of the pancreas no longer make insulin because the body's immune system has attacked and destroyed the beta cells. It is thought that exposure of the muco...
Detailed Description
Autoimmune diseases are the outcome of dysregulated immune responses to self-antigens. Type 1 diabetes (T1D), previously known as insulin-dependent or juvenile diabetes, is an autoimmune disease in wh...
Eligibility Criteria
Inclusion
- First-degree or second-degree relative of a person with Type 1 diabetes (T1D) diagnosed before age 40.
- Age 4-30 years if first-degree relative; age 4-20 years if second-degree relative.
- Confirmed serum antibodies to two or more islet antigens.
- Normal oral glucose tolerance test (OGTT).
- First phase insulin response (FPIR) at or above threshold - Primary Stratum - greater than or equal to 10th percentile for siblings, offspring and second-degree relatives of person with T1D (greater than or equal to 100uU/ml if aged 8 or more years OR greater than or equal to 60 uU/ml if aged less than 8) and greater than or equal to the 1st percentile for parents of someone with T1D (greater than ore equal to 60uU/ml). Secondary Stratum: Greater than or equal 1st percentile, less than 10th percentile for siblings, offspring and second-degree relatives of someone with T1D (greater than or equal to 50uU/ml less than 100 uU/ml if aged greater than or equal to 8 years or greater than or equal to 20 uU/ml less than 60uU/ml if aged less than 8 years)
- Provision of written consent. -
Exclusion
- History of treatment with insulin or oral hypoglycemic agents
- Known diabetes by ADA/WHO criteria
- Pregnant or lactating or of child-bearing potential not using an adequate method of contraception
- Concomitant disease or treatment which may interfere with assessment or cause immunosuppression, as judged by the investigators.
- Uncorrected vitamin D deficiency
- Known alcohol or drug abuse, psychiatric or other condition that could be associated with poor compliance.
- Known liver disease, or persisting elevation of plasma Aspartate transaminase (AST) or Alanine transaminase (ALT) levels.
- Impaired renal function
- Any defect or pathology of nasal passage which would preclude application of the intranasal spray.
- \-
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2019
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00336674
Start Date
December 1 2006
End Date
November 13 2019
Last Update
October 8 2020
Active Locations (6)
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1
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
2
Mater Children's Hospital
Brisbane, Queensland, Australia, 4101
3
Womens and Childrens Hospital
North Adelaide, South Australia, Australia, 5006
4
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050