ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Effects of Pioglitazone Treatment on Sympathetic Nervous System Function in the Metabolic Syndrome

This study is not yet open for participant recruitment.
Verified by Baker Heart Research Institute, October 2007

Sponsors and Collaborators: Baker Heart Research Institute
National Heart Foundation of 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

Drug Information available for:   Insulin    Pioglitazone    Pioglitazone hydrochloride    Rosiglitazone    Rosiglitazone Maleate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Mechanisms of Sympathetic Overactivity in the Metabolic Syndrome: Effects of Reversing Insulin Resistance by Drug Treatment

Further study details as provided by Baker Heart Research Institute:

Primary Outcome Measures:
  • Sympathetic nervous system activity, measured as muscle sympathetic nervous activity and whole-body noradrenaline spillover

Secondary Outcome Measures:
  • Baroreflex function, adrenoceptor expression

Estimated Enrollment:   44
Study Start Date:   January 2008
Estimated Study Completion Date:   December 2008

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.

  Eligibility
Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408850

Contacts
Contact: Nora E Straznicky, PhD, MPH     61 3 8532 1371     Nora.Straznicky@baker.edu.au    

Locations
Australia, Victoria
Baker Heart Research Institute    
      Melbourne, Victoria, Australia, 8008

Sponsors and Collaborators
Baker Heart Research Institute
National Heart Foundation of Australia

Investigators
Principal Investigator:     Nora E Straznicky, PhD, MPH     Baker Heart Research Institute    
  More Information


Publications:

Study ID Numbers:   G 06M 2610
First Received:   December 6, 2006
Last Updated:   October 30, 2007
ClinicalTrials.gov Identifier:   NCT00408850
Health Authority:   Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Baker Heart Research Institute:
sympathetic nervous system, rosiglitazone, metabolic syndrome  

Study placed in the following topic categories:
Pioglitazone
Insulin Resistance
Rosiglitazone
Insulin

Additional relevant MeSH terms:
Hypoglycemic Agents
Pathologic Processes
Disease
Syndrome
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2008




Links to all studies - primarily for crawlers