Sympathetic Activity in Individuals With the Metabolic Syndrome: Benefits of Lifestyle Interventions
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|ClinicalTrials.gov Identifier: NCT00163943|
Recruitment Status : Unknown
Verified September 2005 by Bayside Health.
Recruitment status was: Recruiting
First Posted : September 14, 2005
Last Update Posted : August 1, 2007
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:
- 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.
- To determine whether weight loss maintenance four months after active weight loss is associated with a preservation of clinical benefits.
- To study biological determinants of successful weight loss and weight loss maintenance.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome X||Behavioral: Dietary weight loss +/- aerobic exercise||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2005|
|Estimated Study Completion Date :||December 2007|
- Whole-body sympathetic activity
- Muscle sympathetic activity
- Insulin sensitivity
- Lipid profile
- Blood pressure
- Baroreflex function
- Forearm and calf blood flow
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163943
|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|
|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|