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Sponsored by: |
Bayside Health |
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Information provided by: | Bayside Health |
ClinicalTrials.gov Identifier: | NCT00163943 |
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:
Condition | Intervention |
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Metabolic Syndrome X |
Behavioral: Dietary weight loss +/- aerobic exercise |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment |
Official Title: | Neural Mechanisms Predisposing to Cardiovascular Risk in Individuals With the Metabolic Syndrome: Benefits of Dietary Weight Loss, Weight Loss Maintenance and Aerobic Exercise |
Estimated Enrollment: | 66 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | December 2007 |
Ages Eligible for Study: | 45 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Sixty six (33 male and 33 postmenopausal female) weight-stable (body mass index 26 to 39 kg/m2), sedentary, non-smoking subjects, aged 45 to 65 years will be recruited on the basis of having > 3 indices of the MetS as defined by Adult Treatment Panel (ATP) III criteria:
Exclusion Criteria:
Exclusion criteria will comprise:
Contact: Nora E Straznicky, BPharm, PhD, MPH | 61 3 8532 1371 | Nora.Straznicky@baker.edu.au |
Contact: Elisabeth A Lambert, Bsc, MSc, PhD | 61 8532 1345 | Elisabeth.Lambert@baker.edu.au |
Australia, Victoria | |
Baker Heart Research Institute | Recruiting |
Melbourne, Victoria, Australia, 8008 | |
Contact: Nora E Straznicky, BPharm, PhD, MPH 61 3 8532 1371 Nora.Straznicky@baker.edu.au | |
Principal Investigator: Nora E Straznicky, BPharm, PhD, MPH |
Principal Investigator: | Nora E Straznicky, BPharm, PhD, MPH | Baker Heart Research Institute |
Study ID Numbers: | 7/05 |
Study First Received: | September 12, 2005 |
Last Updated: | July 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00163943 History of Changes |
Health Authority: | Australia: National Health and Medical Research Council |
Metabolic syndrome Sympathetic nervous system activity Insulin sensitivity weight loss aerobic exercise |
Body Weight Hyperinsulinism Metabolic Diseases Metabolic Syndrome X Weight Loss |
Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder Insulin Abdominal Obesity Metabolic Syndrome |
Hyperinsulinism Metabolic Diseases Pathologic Processes Disease |
Metabolic Syndrome X Syndrome Insulin Resistance Glucose Metabolism Disorders |