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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00163943




Registration number
NCT00163943
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
1/08/2007

Titles & IDs
Public title
Sympathetic Activity in Individuals With the Metabolic Syndrome: Benefits of Lifestyle Interventions
Scientific title
Neural Mechanisms Predisposing to Cardiovascular Risk in Individuals With the Metabolic Syndrome: Benefits of Dietary Weight Loss, Weight Loss Maintenance and Aerobic Exercise
Secondary ID [1] 0 0
7/05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome X 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Whole-body sympathetic activity
Timepoint [1] 0 0
Primary outcome [2] 0 0
Muscle sympathetic activity
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Insulin sensitivity
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Lipid profile
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Adipocytokines
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Blood pressure
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Baroreflex function
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Forearm and calf blood flow
Timepoint [6] 0 0

Eligibility
Key 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:

* waist circumference > 102 cm for men and > 88 cm for women;
* fasting plasma glucose level > 6.1 mmol/L, but nondiabetic (< 7.1 mmol/L);
* fasting plasma triglyceride level > 1.69 mmol/L;
* plasma high-density lipoprotein (HDL) level < 1.04 mmol/L (males) and < 1.29 mmol/L (females);
* supine resting blood pressure > 130/85 mmHg and < 165/105 mmHg, at least 4 weeks off blood pressure lowering medications.
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will comprise:

* A history of diabetes, secondary hypertension, sleep apnoea, cardiovascular, cerebrovascular, renal, liver, or thyroid disease
* Inability to cease medications which may affect measured parameters
* Inability or contraindication to exercise

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2007
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker Heart Research Institute - Melbourne
Recruitment postcode(s) [1] 0 0
8008 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT00163943
Trial related presentations / publications
Khan AA, Mundra PA, Straznicky NE, Nestel PJ, Wong G, Tan R, Huynh K, Ng TW, Mellett NA, Weir JM, Barlow CK, Alshehry ZH, Lambert GW, Kingwell BA, Meikle PJ. Weight Loss and Exercise Alter the High-Density Lipoprotein Lipidome and Improve High-Density Lipoprotein Functionality in Metabolic Syndrome. Arterioscler Thromb Vasc Biol. 2018 Feb;38(2):438-447. doi: 10.1161/ATVBAHA.117.310212. Epub 2017 Dec 28.
Nestel PJ, Straznicky N, Mellett NA, Wong G, De Souza DP, Tull DL, Barlow CK, Grima MT, Meikle PJ. Specific plasma lipid classes and phospholipid fatty acids indicative of dairy food consumption associate with insulin sensitivity. Am J Clin Nutr. 2014 Jan;99(1):46-53. doi: 10.3945/ajcn.113.071712. Epub 2013 Oct 23.
Public notes

Contacts
Principal investigator
Name 0 0
Nora E Straznicky, BPharm, PhD, MPH
Address 0 0
Baker Heart Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nora E Straznicky, BPharm, PhD, MPH
Address 0 0
Country 0 0
Phone 0 0
61 3 8532 1371
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00163943