The effect of eplerenone on insulin action is being studied in patients with mild essential hypertension.
Conditions
Interventions
Trade Name: Inspra
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: EPLERENONE
CAS Number: 107724209
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Sponsors
Belfast Health and Social Care Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 20 patients aged under 70 years with mild essential hypertension will be recruited. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Presence of diabetes mellitus, significant obesity (BMI greater than 35kg/m2), a history of gout and pre-existing treatment with an agent which influences insulin action or treatment with potassium sparing diuretics will exclude participation, as will secondary hypertension, or diastolic blood pressure out with the range 80-105mmHg after 6 week placebo run-in. Pregnant women and breastfeeding mothers will be excluded, as will persons with significant hepatic or renal impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We will compare the effect of the aldosterone antagonist eplerenone on insulin action in patients with mild essential hypertension, with doxazosin acting as a control. Doxazosin has previously been shown to have a neutral effect on insulin action.;Secondary Objective: none;Primary end point(s): To assess insulin action three euglycaemic, hyperinsulinaemic clamps will be performed. The first clamp will be done after the 6 week placebo run-in. After 12 weeks of therapy a second clamp study will be done. There will be a 6 week wash-out period, a further 12 week treatment period and the third clamp study will be done at the end of the 12 weeks. | — |
Countries
United Kingdom
Outcome results
None listed