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

Mechanisms of Sympathetic Overactivity in the Metabolic Syndrome: Effects of Reversing Insulin Resistance by Drug Treatment

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00408850
Enrollment
44
Registered
2006-12-07
Start date
2008-11-30
Completion date
2013-02-28
Last updated
2013-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

sympathetic nervous system, pioglitazone, metabolic syndrome

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.

Interventions

DRUGPioglitazone

15 mg per day for 6 weeks and 30 mg per day for further 6 weeks

DRUGsugar pill

One capsule daily for 6 weeks followed by two capsules per day for next 6 weeks

Sponsors

National Heart Foundation, Australia
CollaboratorOTHER
Baker Heart Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Sympathetic nervous system activity, measured as muscle sympathetic nervous activity and whole-body noradrenaline spillover12 weeks treatment

Secondary

MeasureTime frame
Baroreflex function, adrenoceptor expression12 weeks treatment

Countries

Australia

Contacts

Primary ContactNora E Straznicky, PhD, MPH
Nora.Straznicky@bakeridi.edu.au61 3 8532 1371

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026