Effects of Pioglitazone Treatment on Sympathetic Nervous System Function in Metabolic Syndrome Obesity
Recruitment status was: Recruiting
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Mechanisms of Sympathetic Overactivity in the Metabolic Syndrome: Effects of Reversing Insulin Resistance by Drug Treatment|
- Sympathetic nervous system activity, measured as muscle sympathetic nervous activity and whole-body noradrenaline spillover [ Time Frame: 12 weeks treatment ] [ Designated as safety issue: No ]
- Baroreflex function, adrenoceptor expression [ Time Frame: 12 weeks treatment ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Pioglitazone
pioglitazone 15 mg for 6 weeks followed by 30 mg for 6 weeks
15 mg per day for 6 weeks and 30 mg per day for further 6 weeks
Other Name: Actos
Placebo Comparator: sugar pill
Drug: sugar pill
One capsule daily for 6 weeks followed by two capsules per day for next 6 weeks
Other Name: Lactose
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408850
|Baker Heart Research Institute|
|Melbourne, Victoria, Australia, 8008|
|Principal Investigator:||Nora E Straznicky, PhD, MPH||Baker Heart Research Institute|