Status:
COMPLETED
Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy
Lead Sponsor:
Steno Diabetes Center Copenhagen
Conditions:
Hypertension
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
To evaluate the impact of spironolactone treatment on renal autoregulation in hypertensive type 1 diabetic patients.
Detailed Description
Double-masked, randomized, crossover trial. In random order, patients will be treated with spironolactone 25 mg o.d. and matched placebo for 28 days. On the last day of treatment, GFR will be determi...
Eligibility Criteria
Inclusion
- Type 1 diabetes
- Age between 18 and 70 years
- Blood pressure ≥ 135 mm Hg systolic and/or ≥ 85 mm Hg diastolic or ongoing antihypertensive treatment
- Informed consent
Exclusion
- Diabetic nephropathy
- Other known kidney or renal tract disease
- Malignant hypertension
- Blood pressure \> 170/105 at baseline or during AHT wash-out period
- Plasma potassium \> 4.7 mmol/l
- Elevated plasma creatinine (\>88 µmol/l for women and \>100 µmol/l for men)
- Symptoms of Ischemic heart disease within 3 months prior to study start
- Previous cerebrovascular event (apoplexy, TCI)
- Abuse of medicine or alcohol
- Pregnancy or breastfeeding
- Woman of child-bearing age who are not using adequate contraception
- ASA treatment \> 1g/day or regular use of NSAIDs
- Known allergy to or side-effects of spironolactone
- Inability to understand patient information
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00335413
Start Date
June 1 2006
End Date
April 1 2007
Last Update
June 5 2008
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