Eplerenone in Metabolic Syndrome: An investigation into the effects of Eplerenone on perivascular adipose tissue and small artery tone in obesity - Eplerenone in Metabolic Syndrome

• Conditions: Obesity and Metabolic Syndrome (combination of obesity, hypertension, raised blood glucose and cholesterol abnormalities); MedDRA version: 13.1Level: PTClassification code 10052066Term: Metabolic syndromeSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 13.1Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2010-022308-34-GB
• Lead Sponsor: Central Manchester Foundation Hospitals Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-30
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• • Participants will have obesity: Waist girth > 102cm (40 inches) in men or > 94cm (37 inches) in women • In addition participants will have 3 or more components of the metabolic syndrome o Fasting plasma glucose = 6.1mmol/L o Serum triglycerides = 1.7mmolL o Serum High Density Lipoprotein (HDL) cholesterol < 1.04mmol/L o Blood pressure >130/85mmHg or treated blood pressure • Participants will be aged between 30 and 65 years of age • Patients with normal platelet count (150-400 x 109 per litre).
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Pregnant / lactating mothers • Diagnosed diabetes mellitus • Hypersensitivity to eplerenone or any of the excipients • Patients with serum potassium level > 5.5 mmol/L at initiation • Patients with moderate to severe renal insufficiency (creatinine clearance < 50 mL/min) • Patients with severe hepatic insufficiency (Child-Pugh Class C) • Patients taking a-blockers for hypertension • Patients receiving potassium-sparing diuretics or potassium-supplements • Patients taking strong inhibitors of CYP 3A4 (eg itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone) • Patients taking: Lithium, Tricyclic anti-depressants, neuroleptics, amifostine, baclofene : Co-administration of these drugs with eplerenone may potentially increase antihypertensive effects and risk of postural hypotension • Patients taking Cyclosporin or tacrolimus: Cyclosporin and tacromilus may lead to impaired renal function and increase the risk of hyperkalaemia. • Patients taking Trimethroprim: The concomitant administration of trimethroprim with eplerenone increases the risk of hyperkalaemia. • Patients taking Digoxin: Systemic exposure (AUC) to digoxin increases by 16% (90% CI: 4% - 30%) when co-administered with eplerenone. • Co-administration of St John's Wort (a strong CYP3A4 inducer) with eplerenone caused a 30 % decrease in eplerenone AUC. • Galactose intolerance or lactase deficiency (due to composition of tablet) • Systolic Blood pressure below 120mmHg

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified