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 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 12:58 AM
NCT ID:
NCT02440893
Eligibility Criteria:
Inclusion Criteria:
At least 21 years of age
Any of the following:
* Chest pain syndrome, stable angina, or anginal equivalent suggesting myocardial ischemia
* Low-risk unstable angina, or
* Asymptomatic individuals with a high probability of CAD
Clinician diagnosis of pre-diabetes, per ADA guidelines, such that metformin therapy is prescribed:
* HgA1C: \>5.7% - \<6.4%,
* BMI\> 35 kg/m2
* Age\< 60 yrs
* Prior Gestational Diabetes Mellitus
* FPG: \>100mg/dl - \<126mg/dl
* OGTT: \>140mg/dl - \<200mg/dl Willingness to comply with metformin therapy, for at least seven (7) days (P.O., per physician's dosage discretion) Willingness to maintain a drug diary for duration of study, for full follow-up period (7 + 7 days) Willingness and ability to provide two (2) samples for Corus (baseline, 7 (+ 7) days post- medication start) Provide written informed consent
Exclusion Criteria:
* History of or current level of HbA1C \>6.5
* History of or current prescription of metformin or any other diabetic medication
* History of myocardial infarction (MI) or prior revascularization
* Current MI or acute coronary syndrome (ACS)
* Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
* Current systemic infectious or systemic inflammatory conditions
* Subjects currently taking steroids, immunosuppressive agents or chemotherapeutic agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02440893
Study Brief:
Protocol Section:
NCT02440893