EUCTR2017-003088-36-DE
Active, not recruiting
Phase 1
GPPAD-POInT (Global Platform of Autoimmune Diabetes – Primary Oral Insulin Trial)Oral Insulin Therapy for Prevention of Autoimmune Diabetes - GPPAD-POInT (Global Platform of Autoimmune Diabetes – Primary Oral Insulin Trial)
Technische Universität München, Represented by the school of medicine0 sites1,040 target enrollmentNovember 13, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- risk for type 1 diabetes
- Sponsor
- Technische Universität München, Represented by the school of medicine
- Enrollment
- 1040
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Infant between the ages of 4 months and 7 months at the time of randomization.
- •2\. A high genetic risk (\>10%) to develop beta\-cell autoantibodies by age 6 years:
- •A) For infants without a first degree family history of type 1 diabetes, high genetic risk is defined as a DR3/DR4\-DQ8 or DR4\-DQ8/DR4\-DQ8 genotype, and a genetic risk score that is \>14\.4\.
- •B) For infants with a first degree family history of type 1 diabetes, high genetic risk is defined as having HLA DR4 and DQ8, and none of the following protective alleles: DRB1\*1501, DQB1\*0503\.
- •3\. Solid foods introduced into diet of infant
- •4\. Written informed consent signed by the custodial parent(s).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1040
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. Concomitant disease or treatment that may interfere with the assessments, as judged by the investigators.
- •2\. Any condition that could be associated with poor compliance.
- •3\. Any medical condition or medical condition coexisting, which, in the opinion of the investigator, may jeopardize the participant’s safe participation in the study.
- •4\. Diagnosis of diabetes at the time of recruitment.
- •5\. Participation in another clinical trial.
Outcomes
Primary Outcomes
Not specified
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Not Applicable
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