Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the impact of spironolactone treatment on renal autoregulation in hypertensive type 1 diabetic patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steno Diabetes Center; Steno Diabetes Center Copenhagen
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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