Effects of Pioglitazone Treatment on Sympathetic Nervous System Function in Metabolic Syndrome Obesity

• Status: Unknown status
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

An abdominal distribution of fat is associated with the greatest heart disease risk, because commonly, several risk factors of metabolic origin cluster in these individuals. When this occurs the condition is called the 'metabolic syndrome'.

Increased activity of the sympathetic nervous system resulting in enhanced release of the stress hormone 'noradrenaline', may be one mechanism by which adverse cardiovascular and metabolic sequela of the metabolic syndrome might be mediated. Impaired insulin action may be one factor contributing to increased noradrenaline release.

The aim of this Study is to determine whether treatment with a drug called pioglitazone which is known to improve insulin action, results in reduced sympathetic nervous system activity and stress hormone release when compared to treatment with a dummy drug (placebo).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baker Heart Research Institute
• Collaborator: National Heart Foundation, Australia
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• Males and females aged 45-65 years,

• non-smokers,

• HOMA index > 2.5 and

• who meet ATP III criteria for the metabolic syndrome

Exclusion Criteria:

• History of diabetes,

• previous MI, stroke, heart failure, impaired hepatic or renal function.

• Inability to cease medications which may affect study parameters.