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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]

7/05

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Metabolic Syndrome X

Condition category

Condition code

Metabolic and Endocrine

Metabolic disorders

Other

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]

Whole-body sympathetic activity

Timepoint [1]

Primary outcome [2]

Muscle sympathetic activity

Timepoint [2]

Secondary outcome [1]

Insulin sensitivity

Timepoint [1]

Secondary outcome [2]

Lipid profile

Timepoint [2]

Secondary outcome [3]

Adipocytokines

Timepoint [3]

Secondary outcome [4]

Blood pressure

Timepoint [4]

Secondary outcome [5]

Baroreflex function

Timepoint [5]

Secondary outcome [6]

Forearm and calf blood flow

Timepoint [6]

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?

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

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Baker Heart Research Institute - Melbourne

Recruitment postcode(s) [1]

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

Nora E Straznicky, BPharm, PhD, MPH

Address

Baker Heart Research Institute

Country

Phone

Fax

Contact person for public queries

Name

Nora E Straznicky, BPharm, PhD, MPH

Address

Country

Phone

61 3 8532 1371

Fax

[email protected]

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00163943

Trial Review

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