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Sympathetic Activity in Individuals With the Metabolic Syndrome: Benefits of Lifestyle Interventions

NCT00163943 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2007-08-01

No results posted yet for this study

Summary

An abdominal distribution of fat is associated with the greatest heart disease risk, because commonly, several risk factors of metabolic origin (high blood pressure, unfavourable cholesterol profile, elevated blood sugar, impaired insulin action) cluster in these individuals. When this occurs the condition is called the 'metabolic syndrome' (MetS). The cause of the MetS is yet to be fully elucidated. Increased activity of the nervous system resulting in enhanced release of the stress hormone 'norepinephrine', may be one mechanism by which adverse cardiovascular and metabolic sequelae of the MetS might be mediated. Dietary weight loss, and exercise are first-line treatments for the MetS and provide an opportunity to prevent or delay the development of type 2 diabetes and heart disease in this high risk group. However, there is a paucity of data regarding the effects of these lifestyle factors on the nervous system. Furthermore, it is also unknown whether active weight loss ('negative energy balance') or a stable lower weight (weight loss maintenance) is more important in modifying MetS components and nervous system activity. The aims of the proposed project are:

1. To determine whether dietary weight loss in combination with aerobic exercise is more beneficial than dietary weight loss alone in reducing nervous system activity and improving metabolic and cardiovascular parameters in middle-aged men and women with abdominal obesity and the MetS.
2. To determine whether weight loss maintenance four months after active weight loss is associated with a preservation of clinical benefits.
3. To study biological determinants of successful weight loss and weight loss maintenance.

Conditions

  • Metabolic Syndrome X

Interventions

BEHAVIORAL

Dietary weight loss +/- aerobic exercise

Sponsors & Collaborators

  • Bayside Health

    lead OTHER_GOV

Principal Investigators

  • Nora E Straznicky, BPharm, PhD, MPH · Baker Heart Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Completion
2007-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00163943 on ClinicalTrials.gov