Effect of Angiotensin Converting Enzyme Inhibitor, Lisinopril, on Renal Blood Flow and Its Correlation With Proteinuria Reduction in Subjects With Type 2 Diabetes and Kidney Disease

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate the effect of a blood pressure medication, Lisinopril, or similar drugs in that class, on the flow of blood to the kidneys. In this study, we will compare blood flow to the kidneys in healthy people that do not have diabetes or kidney disease with people that have diabetes and evidence of kidney disease.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Virginia
• Treatments: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors; Lisinopril

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