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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT01101269
Eligibility Criteria:
Inclusion For subjects with diabetic nephropathy,
1. Adults (ages 40 - 75 years)
2. Diagnosis of type 2 diabetes for more than 5 years
3. Evidence of diabetic nephropathy as evidenced by
a. More than 150 mg of proteinuria per day in a 24-hour urine collection, or a spot morning urine protein to creatinine of greater than 0.15, or a spot morning urine albumin to creatinine ratio greater than 100 confirmed on two separate occasions within 12 months
4. Treatment with a blocker of the renin -angiotensin-aldosterone system (either ACE inhibitor or ARB)
For healthy controls,
1. Adults (ages 40 - 75 years)
2. Good general health
Exclusion For subjects with diabetic nephropathy,
1. Type 1 diabetes
2. Glomerular filtration rate less than 40 ml/min/1.73 m2 by MDRD formula
3. Hemoglobin A1C greater than 10%
4. Blood pressure greater than 150/90 mm Hg or less than 100/55 mm Hg
5. History of kidney transplantation
6. Oxygen saturation is less than 80%
7. History of unstable cardiopulmonary conditions, known intracardiac shunts, or pulmonary hypertension
8. History of active cancer within the last 3 years
For healthy controls,
1. History or clinical evidence of any chronic disease
2. Chronic and regular use of any medications except for oral contraceptives and vitamins
3. Clinically significant abnormal screening laboratory values
4. Pregnancy or lactation for women
5. Blood pressure at screening visit less than 110/60
6. History of unstable cardiopulmonary conditions, known intracardiac shunts, or pulmonary hypertension
7. History of active cancer within the last 3 years
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT01101269
Study Brief:
Protocol Section:
NCT01101269