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 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT00808535
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 50 years
* Should be able to sign an informed consent and HIPAA Agreement
* 30 healthy, non-diabetic individuals
* 30 diabetic individuals without documented coronary artery disease
* Diagnosed diabetics less than 5 years
* HbA1c less than 8.0
Exclusion Criteria:
* Children under 18 years and adults above 50 years
* Type 1 DM
* Lactating and Pregnant females
* BMI less than 35
* Contraindication to MRI such as pacemaker, defibrillator implants, etc.
* Allergy to MR (paramagnetic) contrast
* History of Angina, MI, or documented Coronary Artery Disease
* Previous history of CHF, CABG, Angioplasty and Stenting
* History of Valvular Heart Disease and Congenital Heart Disease
* History of Peripheral Vascular Disease
* History of Cardiac Arrythmias and anti-coagulation therapy
* History of Cerebro-vascular accidents or TIA
* History of active diabetic retinopathy and nephropathy
* Uncontrolled hypertension (systolic \> 170 and diastolic \>100 mm Hg
* End Stage Renal Disease and patients on dialysis
* HbA1c of 8.0
* Creatinine greater than 1.7 mg/dl
* History of active gastrointestinal bleeding
* History of IV drug use
* Chronic or current steroid treatment
* Growth hormone treatment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00808535
Study Brief:
Protocol Section:
NCT00808535