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| Sponsor: | Baker Heart Research Institute |
|---|---|
| Collaborator: |
National Heart Foundation, Australia |
| Information provided by: | Baker Heart Research Institute |
| ClinicalTrials.gov Identifier: | NCT00408850 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Metabolic Syndrome |
Drug: Rosiglitazone |
Phase III |
| Study Type: | Interventional |
| 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 |
| Estimated Enrollment: | 44 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2008 |
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.
Eligibility| Ages Eligible for Study: | 45 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nora E Straznicky, PhD, MPH | 61 3 8532 1371 | Nora.Straznicky@baker.edu.au |
| Australia, Victoria | |
| Baker Heart Research Institute | Not yet recruiting |
| Melbourne, Victoria, Australia, 8008 | |
| Principal Investigator: Nora E Straznicky, PhD MPH | |
| Principal Investigator: | Nora E Straznicky, PhD, MPH | Baker Heart Research Institute |
More Information
| ClinicalTrials.gov Identifier: | NCT00408850 History of Changes |
| Other Study ID Numbers: | G 06M 2610 |
| Study First Received: | December 6, 2006 |
| Last Updated: | October 30, 2007 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
sympathetic nervous system, rosiglitazone, metabolic syndrome |
|
Metabolic Syndrome X Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
