Overview

Maximal Dose of Angiotensin Converting Enzyme (ACE) Inhibitor for Treatment of Diabetic Kidney Disease

Status:
Completed
Trial end date:
2006-09-01
Target enrollment:
0
Participant gender:
All
Summary
The primary aim is to evaluate the anti proteinuric effect of increasing doses of the ACE inhibitor, lisinopril: 20, 40 and 60 mg daily in type 1 diabetic patients with hypertension and diabetic nephropathy. The secondary aim is to evaluate the effect on blood pressure (24 hour ambulatory blood pressure) and kidney function (glomerular filtration rate (GFR)). The tertiary aim is to evaluate differences in response to treatment according to ACE/insertion/deletion (ID)-genotypes and other genetic variants in the genes of the renin angiotensin system.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Steno Diabetes Center
Steno Diabetes Center Copenhagen
Treatments:
Angiotensin-Converting Enzyme Inhibitors
Lisinopril
Criteria
Inclusion Criteria:

- Type 1 diabetes (WHO criteria)

- Diabetic nephropathy (2 out of 3 consecutive 24 hour urinary samples with albumin
excretion > 300 mg/24hour and diabetic retinopathy in the absence of signs of other
kidney or urinary tract disease) 27 or diabetic glomerulosclerosis verified by biopsy.

- Hypertension: Blood pressure > 135 mmHg systolic and/or 85 mm Hg diastolic repeatedly.

- Age from 18 to 70 years.

Exclusion Criteria:

- Age < 18 years or > 70 years.

- Pregnancy or fertile women not using adequate anticonceptive (intrauterine device,
sterilization, or oral anticonceptive)

- Malignant hypertension.

- Blood pressure > 180/105 mm Hg

- Known renal artery stenosis

- GFR < 30 ml/min/1.73 m²

- Serum potassium > 4.8 mmol/ l

- Heart failure, myocardial infarction, unstable angina or coronary bypass operation
within the previous three months.

- Abuse of drugs or alcohol.

- Not able to understand the written information.

- Known intolerance to ACE inhibitors.

- Chronic use of non steroid inflammatory drugs or aspirin (above 1 g/day)