Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy
Summary
To evaluate the impact of spironolactone treatment on renal autoregulation in hypertensive type 1 diabetic patients.
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 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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Hypertension
Intervention
Spironolactone
Status
Completed
Source
Steno Diabetes Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00335413
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Hypertension, Pregnancy-induced
A condition in pregnant women with elevated systolic (>140 mm Hg) and diastolic (>90 mm Hg) blood pressure on at least two occasions 6 h apart. HYPERTENSION complicates 8-10% of all pregnancies, generally after 20 weeks of gestation. Gestational hypertension can be divided into several broad categories according to the complexity and associated symptoms, such as EDEMA; PROTEINURIA; SEIZURES; abnormalities in BLOOD COAGULATION and liver functions.
Hypertension, Renovascular
Hypertension due to RENAL ARTERY OBSTRUCTION or compression.
Spironolactone
A potassium sparing diuretic that acts by antagonism of aldosterone in the distal renal tubules. It is used mainly in the treatment of refractory edema in patients with congestive heart failure, nephrotic syndrome, or hepatic cirrhosis. Its effects on the endocrine system are utilized in the treatments of hirsutism and acne but they can lead to adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p827)
Intracranial Hypertension
Increased pressure within the cranial vault. This may result from several conditions, including HYDROCEPHALUS; BRAIN EDEMA; intracranial masses; severe systemic HYPERTENSION; PSEUDOTUMOR CEREBRI; and other disorders.
Hypertension, Malignant
A condition of markedly elevated BLOOD PRESSURE with DIASTOLIC PRESSURE usually greater than 120 mm Hg. Malignant hypertension is characterized by widespread vascular damage, PAPILLEDEMA, retinopathy, HYPERTENSIVE ENCEPHALOPATHY, and renal dysfunction.
Clinical Trials
Addition of Spironolactone in Patients With Resistant Arterial Hypertension
The purpose of this study is to evaluate the efficacy of spironolactone on lowering blood pressure when added to therapy in patients with resistant arterial hypertension.
The purpose of this study is to determine whether a larger dose of the aldosterone antagonist spironolactone combined with an ACE inhibitor (captopril) and a beta-blocker (carvedilol) is e...
The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension
The purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics.
Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease
The Renin-Angiotensin-Aldosterone-system is important in the development of cardiovascular organ damage caused by arterial hypertension. This study aims at evaluating the importance of ald...
Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease
The hypothesis of this trial is to assess the effect of spironolactone on heart size and mass
PubMed Articles
Spironolactone for hypertension.
BACKGROUND: Spironolactone is an aldosterone antagonist, considered fourth line therapy for hypertension in patients already treated with multiple medications. OBJECTIVES: Primary: to determine the ef...
Mineralocorticoid receptor antagonists: their use and differentiation in Japan.
In the presence of salt, aldosterone causes hypertension and organ damage via the mineralocorticoid receptor (MR) through various mechanisms. MR antagonists are considered to be potassium-sparing diur...
Resistant hypertension has evolved as an important global health care problem. Primary aldosteronism is one of several potentially reversible causes of resistant hypertension. Primary aldosteronism ca...
The beneficial effects of spironolactone in chronic heart failure (HF) have been demonstrated in patients with New York Heart Association (NYHA) class III to IV HF. This study examined the effect of s...
Aldosterone modulates cell proliferation and apoptosis in the neonatal rat heart.
In the present study, we investigated whether and how the mineralocorticoid receptor antagonist spironolactone affects cardiac growth and development through apoptosis and cell proliferation in the ne...
