Status:
COMPLETED
Maximal Dose of Angiotensin Converting Enzyme (ACE) Inhibitor for Treatment of Diabetic Kidney Disease
Lead Sponsor:
Steno Diabetes Center Copenhagen
Conditions:
Diabetes Mellitus, Type I
Diabetic Nephropathy
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 nephr...
Detailed Description
This is a randomized, double-blind cross-over study with three treatment periods consisting of 20, 40 and 60 mg lisinopril daily in random order. The endpoints of the study will be examined after each...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00118976
Start Date
March 1 2005
End Date
September 1 2006
Last Update
November 23 2006
Active Locations (1)
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1
Steno Diabetes Center
Gentofte Municipality, Denmark, 2820