hypertension/high blood pressure
Conditions
Interventions
30 obese individuals will be randomized to treatment with the selective
mineralocorticoid receptor antagonist Eplerenone, 50 mg once daily during 4
weeks. The remaining 30 obese individuals will be
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 40-65 years - Caucasian (because of ethnic differences in microvascular function, vascular stiffness, and the prevalence of cardiovascular disease and associated risk factors) - Waist circumference > 102 cm (men)/> 88 cm (women) - High-normal blood pressure (office blood pressure: 130/85 * 139/89 mm Hg) or stage I/II hypertension (office blood pressure: 140/90 mm Hg * 179/109 mm Hg; 24h ABPM: 125/80 * 169/99 mm Hg)
Exclusion criteria
Exclusion criteria: - Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death) - Diabetes mellitus/impaired fasting glucose (fasting glucose values > 6.1 mmol/L), because not only diabetes, but also intermediate hyperglycaemia has been associated with microvascular disease, which impedes the distinction between cause and consequence of disturbances in glucose metabolism in the concerning individuals - Grade 3 hypertension (office blood pressure: > 180/110 mm Hg; ABPM > 170/100 mm Hg) in order not to expose these individuals to unnecessary risks by interrupting or postponing antihypertensive treatment - Unstable or severe pulmonary disease - Unstable or severe thyroid disorders - Inflammatory diseases - Alcohol use > 2 U/day (women)/> 3 U/day (men) - Use of glucose-lowering medications, because of possible interference with microvascular function - Use of corticosteroids (have also affinity for the mineralocorticoid receptor; can decrease the antihypertensive effect of Eplerenone), medication known to inhibit or induce CYP3A4 (possible interference with metabolism of Eplerenone), lithium (possible reduction of lithium excretion when used simultaneously with Eplerenone) , and tricyclic antidepressants or antipsychotic medication (risk of orthostatic hypotension when used simultaneously with Eplerenone), and regular use (weekly or several times a week) of NSAIDs (risk of acute renal dysfunction and disturbance of electrolyte excretion when used simultaneously with Eplerenone) - Plasma potassium levels 5 mmol/L - eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are capillary recruitment during hyperinsulinemia in skeletal muscle, and insulin sensitivity. They will be related to plasma aldosterone concentration and compared before and after treatment with a mineralocorticoid receptor antagonist. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are differences in other (micro)vascular measurements (baseline capillary density, skin capillary recruitment, skin vasomotion (basal and during local heating), endothelial glycocalyx thickness, carotid distensibility, augmentation index, carotid-femoral pulse wave velocity, and reactive hyperemia index), and biomarkers representing endothelial activation and low-grade inflammation, between fasting and hyperinsulinemic states. They will also be related to plasma aldosterone concentration, and compared before and after treatment with a mineralocorticoid receptor antagonist. | — |
Countries
Netherlands
Outcome results
None listed