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Sponsored by: |
Steno Diabetes Center |
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Information provided by: | Steno Diabetes Center |
ClinicalTrials.gov Identifier: | NCT00335413 |
To evaluate the impact of spironolactone treatment on renal autoregulation in hypertensive type 1 diabetic patients.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: Spironolactone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy |
Enrollment: | 17 |
Study Start Date: | June 2006 |
Study Completion Date: | April 2007 |
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 determined twice on the same day: first without clonidine and secondly after injection of clonidine (clonidine induces a transient reduction in blood pressure, with no influence on renal plasma flow and GFR), in order to evaluate the effect of antihypertensive treatment with spironolactone on renal autoregulation of GFR.
The study will be preceded by a wash-out period of 1 month for patients receiving antihypertensive medication. Patients will be instructed to measure blood pressure twice daily, three days a week during this period. If, during the washout period, blood pressure exceeds 170/105 mm Hg or persistent edemas develop, treatment with long-acting loop diuretics will be initiated and continued throughout the rest of the study. If blood pressure despite diuretic treatment still exceeds 170 mm Hg systolic and/or 105 mm Hg diastolic, the patient will be excluded from the study and previous/appropriate antihypertensive treatment will be restarted.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2006-001453-10, 2612-3144, KA-20060055 |
Study First Received: | June 7, 2006 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00335413 |
Health Authority: | Denmark: Ethics Committee; Denmark: Danish Medicines Agency |
Renal autoregulation Glomerular filtration rate Type 1 diabetes |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Vascular Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Spironolactone Hypertension |
Aldosterone Antagonists Immune System Diseases Natriuretic Agents Therapeutic Uses Hormone Antagonists Physiological Effects of Drugs |
Diuretics Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |