Insulin action and hypertension: effects of hyperaldosteronism and its treatment.

Conditions: The effect of eplerenone on insulin action is being studied in patients with mild essential hypertension.

Registration Number: EUCTR2007-004689-42-GB

Lead Sponsor: Belfast Health and Social Care Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>

Secondary Outcome Measures