Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Behaviour - Dietary weight loss +/- aerobic exercise

Behaviour: Dietary weight loss +/- aerobic exercise
Intervention code [1] 0 0
Behaviour
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
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
Other
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/ct2/show/NCT00163943
Trial related presentations / publications
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/ct2/show/NCT00163943