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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-02-28

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pioglitazone

pioglitazone 15 mg for 6 weeks followed by 30 mg for 6 weeks

Group Type ACTIVE_COMPARATOR

Pioglitazone

Intervention Type DRUG

15 mg per day for 6 weeks and 30 mg per day for further 6 weeks

sugar pill

Placebo comparator

Group Type PLACEBO_COMPARATOR

sugar pill

Intervention Type DRUG

One capsule daily for 6 weeks followed by two capsules per day for next 6 weeks

Interventions

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Pioglitazone

15 mg per day for 6 weeks and 30 mg per day for further 6 weeks

Intervention Type DRUG

sugar pill

One capsule daily for 6 weeks followed by two capsules per day for next 6 weeks

Intervention Type DRUG

Other Intervention Names

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Actos Lactose

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No