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

January 16, 2013 updated by: Nora E. Straznicky, Baker Heart Research Institute

Mechanisms of Sympathetic Overactivity in the Metabolic Syndrome: Effects of Reversing Insulin Resistance by Drug Treatment

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 8008
        • Recruiting
        • Baker Heart Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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:
  • 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 Names:
  • Lactose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sympathetic nervous system activity, measured as muscle sympathetic nervous activity and whole-body noradrenaline spillover
Time Frame: 12 weeks treatment
12 weeks treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Baroreflex function, adrenoceptor expression
Time Frame: 12 weeks treatment
12 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baker Heart Research Institute

Collaborators

National Heart Foundation, Australia

Investigators

  • Principal Investigator: Nora E Straznicky, PhD, MPH, Baker Heart Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ANTICIPATED)

February 1, 2013

Study Completion (ANTICIPATED)

February 1, 2013

Study Registration Dates

First Submitted

December 6, 2006

First Submitted That Met QC Criteria

December 6, 2006

First Posted (ESTIMATE)

December 7, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G 06M 2610

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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