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:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT00488033
Eligibility Criteria:
Inclusion Criteria:
1. Age: Males ≥ 50 years; Females ≥55 years with: History of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin A1C \> 6.5%), either type 1 or type 2, documented for at least 3 years and on medication for at least one year.
2. Age: Males ≥ 40 years; Females ≥45 years with: History of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin A1C \> 6.5%), either type 1 or type 2, documented for at least 5 years and on medication for at least one year.
3. The patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board.
Exclusion Criteria:
1. Known coronary artery disease (stenosis \>70%, history of myocardial infarction, or angina)
2. Symptomatic cerebral vascular disease (history of TIA, CVA, or cerebrovascular \[carotid or cerebral arteries\] revascularization)
3. Symptomatic peripheral vascular disease (history of claudication, amputation, or peripheral \[including renal arteries\] arterial revascularization)
4. Treatment with any other investigational drug within the previous 30 days
5. Any therapy or condition that would pose a risk to the patient or make it difficult to comply with study requirements.
6. Pregnant and/or lactating women, and women of child bearing potential not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
7. Any life threatening condition/significant co-morbidity such that primary screening is inappropriate.
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00488033
Study Brief:
Protocol Section:
NCT00488033