Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT00477204
Eligibility Criteria:
Inclusion Criteria:
* 12-18 years of age with Type 1 Diabetes and seen at the Barbara Davis Center for Childhood Diabetes
* Positive diabetes auto-antibodies or provider diagnosed Type 1 Diabetes
* LDL \> 130 mg/dl.
Exclusion Criteria:
* Familial hypercholesterolemia, Triglycerides (TG) \> 400mg/dl
* Type 1 Diabetes of less than three-month duration
* HbA1c\>9.5%
* Abnormal thyroid function
* Abnormal Creatine Kinase (CK) values (defined as \> 10 times the upper limit of normal)
* Abnormal liver function tests (ALT/AST) (defined as \>3 times the upper limit of normal)
* Pregnancy, and patients on oral contraceptives
* All resources are in English. Spanish speakers will not be available for the follow-up calls.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT00477204
Study Brief:
Protocol Section:
NCT00477204