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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT00770367
Eligibility Criteria:
Inclusion Criteria:
* Adults age 40--75 years-of-age, non-pregnant
* Informed consent
* History of type 2 Diabetes Mellitus
* Stable weight for the last 3 months (no change greater than +5% of body weight)
* ADMA \> 0.50 µM/L (mean of non-diabetic reference group) (Devangelio 2007)
* On stable medical therapy for at least 3 months
* A working telephone
Exclusion Criteria:
* Any history of known coronary heart disease, including a history of congestive heart failure, myocardial infarction, coronary re-vascularization, or stroke
* Pregnancy
* Chronic kidney disease, serum creatinine \>2.0mg/dl, chronic liver disease, or uncontrolled hypertension (\>160/100).
* Current participation in a formal weight loss program or planning to start such a program during the next 3 months
* Collagen vascular disease, infection, or other inflammatory condition
* Electrocardiogram (EKG) evidence of ischemia or infarction
* Macular edema (swelling of the back of the eye), recent excessive weight gain (over 5% of weight in 30 days), elevated liver function tests \> 2.5 X the upper limit, or history of osteoporosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00770367
Study Brief:
Protocol Section:
NCT00770367