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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Baker Heart Research Institute
Sponsor:
Collaborator:
National Heart Foundation, Australia
Information provided by (Responsible Party):
Nora E. Straznicky, Baker Heart Research Institute
ClinicalTrials.gov Identifier:
NCT00408850
First received: December 6, 2006
Last updated: January 16, 2013
Last verified: January 2013
  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: Pioglitazone
Drug: sugar pill
Phase 3

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

Resource links provided by NLM:


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 [ Time Frame: 12 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Baroreflex function, adrenoceptor expression [ Time Frame: 12 weeks treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
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)
Arms Assigned Interventions
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 Name: Actos
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 Name: Lactose

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Locations
Australia, Victoria
Baker Heart Research Institute Recruiting
Melbourne, Victoria, Australia, 8008
Principal Investigator: Nora E Straznicky, PhD MPH         
Sponsors and Collaborators
Baker Heart Research Institute
National Heart Foundation, Australia
Investigators
Principal Investigator: Nora E Straznicky, PhD, MPH Baker Heart Research Institute
  More Information

Publications:
Responsible Party: Nora E. Straznicky, Dr, Baker Heart Research Institute
ClinicalTrials.gov Identifier: NCT00408850     History of Changes
Other Study ID Numbers: G 06M 2610
Study First Received: December 6, 2006
Last Updated: January 16, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014