Effects of Pioglitazone Treatment on Sympathetic Nervous System Function in Metabolic Syndrome Obesity
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Pioglitazone pioglitazone 15 mg for 6 weeks followed by 30 mg for 6 weeks |
Drug: Pioglitazone
15 mg per day for 6 weeks and 30 mg per day for further 6 weeks
Other Names:
|
| Placebo Comparator: sugar pill Placebo comparator |
Drug: sugar pill
One capsule daily for 6 weeks followed by two capsules per day for next 6 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Sympathetic nervous system activity, measured as muscle sympathetic nervous activity and whole-body noradrenaline spillover [12 weeks treatment]
Secondary Outcome Measures
- Baroreflex function, adrenoceptor expression [12 weeks treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males and females aged 45-65 years,
-
non-smokers,
-
HOMA index > 2.5 and
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who meet ATP III criteria for the metabolic syndrome
Exclusion Criteria:
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History of diabetes,
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previous MI, stroke, heart failure, impaired hepatic or renal function.
-
Inability to cease medications which may affect study parameters.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baker Heart Research Institute | Melbourne | Victoria | Australia | 8008 |
Sponsors and Collaborators
- Baker Heart Research Institute
- National Heart Foundation, Australia
Investigators
- Principal Investigator: Nora E Straznicky, PhD, MPH, Baker Heart Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- Esler M, Straznicky N, Eikelis N, Masuo K, Lambert G, Lambert E. Mechanisms of sympathetic activation in obesity-related hypertension. Hypertension. 2006 Nov;48(5):787-96. Epub 2006 Sep 25. Review.
- Straznicky NE, Lambert EA, Lambert GW, Masuo K, Esler MD, Nestel PJ. Effects of dietary weight loss on sympathetic activity and cardiac risk factors associated with the metabolic syndrome. J Clin Endocrinol Metab. 2005 Nov;90(11):5998-6005. Epub 2005 Aug 9.
- G 06M 2610