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

Phase 3

• Conditions: Metabolic Syndrome
• Interventions: Drug: sugar pill; Drug: Pioglitazone

• Registration Number: NCT00408850
• Lead Sponsor: Baker Heart Research Institute

Brief 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).

Detailed Description

The rapidly growing burden of obesity together with a population that is becoming older raises the importance of effective strategies for the primary prevention and treatment of the metabolic syndrome in order to combat the epidemic of type 2 diabetes and to reduce the increased risk of cardiovascular mortality.

Increased sympathetic nervous system activity may participate in the pathogenesis and complications of the metabolic syndrome. This Study will use a randomised controlled design to evaluate the effects of pioglitazone treatment on sympathetic activity in middle-aged subjects with the metabolic syndrome.The results will generate new information on the neuroadrenergic effects of thiazolidinediones in this clinical setting. This is relevant to the understanding of the pathophysiology of the metabolic syndrome and to its clinical management.

Study Timeline

• Study First Submitted: 2006-12-06
• Study First Submitted QC: 2006-12-06
• Study First Posted: 2006-12-07
• Study Start: 2008-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-17
• Primary Completion: 2013-02
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugar pill	sugar pill	Placebo comparator
Pioglitazone	Pioglitazone	pioglitazone 15 mg for 6 weeks followed by 30 mg for 6 weeks

Primary Outcome Measures

Name	Time	Method
Sympathetic nervous system activity, measured as muscle sympathetic nervous activity and whole-body noradrenaline spillover	12 weeks treatment

Secondary Outcome Measures

Name	Time	Method
Baroreflex function, adrenoceptor expression	12 weeks treatment

Trial Locations

Locations (1)

Baker Heart Research Institute; 🇦🇺 Melbourne, Victoria, Australia