Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000298617
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
5/09/2005
Date last updated
4/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Left ventricular diastolic function in lean and overweight subjects.
Scientific title
Left ventricular diastolic function in lean and overweight subjects.
Secondary ID [1] 287787 0
Nil known
Universal Trial Number (UTN)
Trial acronym
LOVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-diabetic subjects with a spectrum of body mass ranging from lean (body mass index<25kg/m2) to overweight (BMI 25kg/m2 or greater) 386 0
Condition category
Condition code
Diet and Nutrition 457 457 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A cross-sectional observational study of left ventricular diastolic function in non-diabetic subjects over a range of body mass. No treatment intervention.
Intervention code [1] 288 0
Early detection / Screening
Comparator / control treatment
Non-interventional/observational - cross-sectional comparisons across a range of body mass
Control group
Uncontrolled

Outcomes
Primary outcome [1] 518 0
Diastolic function as assessed by transthoracic cardiac ultrasound, employing a variety of echo-Doppler techniques. Echocardiography done at 1 timepoint.
Timepoint [1] 518 0
Cross-sectional
Secondary outcome [1] 1111 0
Individual echo-Doppler parameters (including pulsed wave Doppler transmitral flow and tissue Doppler imaging).
Timepoint [1] 1111 0
Secondary outcomes measured only at one time point.
Secondary outcome [2] 1112 0
Non-invasive measures of arterial stiffness using pulse analysis techniques: central augmentation index and pulse wave velocity (Sphygmocor system, AtCor Medical); large (C1) and small (C2) artery compliance (PulseWave CR-2000 system, HDI).
Timepoint [2] 1112 0
Secondary outcomes measured only at one time point.

Eligibility
Key inclusion criteria
Subjects without diabetes (excluded by oral glucose tolerance test); lean subjects (BMI<25kg/m2) with waist circumference <94cm for men and <88cm for women; overweight subjects (BMI 25kg/m2 or greater) with waist circumference 94cm or greater for men and 88cm or greater for women.
Minimum age
40 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Atrial fibrillation; abnormal thyroid function; history of cardiovascular disease (myocardial or cerebral ischaemia); other major systemic illness. Lean subjects: impaired glucose tolerance, blood pressure>140/80mmHg, fasting total cholesterol 6.0mmol/L or greater; fasting triglycerides 2.2mmol/L or greater; treatment for hypertension or dyslipidaemia. Overweight subjects: blood pressure 150/90mmHg or greater; fasting total cholesterol>7.0mmol/L; fasting triglycerides>4.0mmol/L.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/08/2005
Actual
21/10/2004
Date of last participant enrolment
Anticipated
Actual
25/01/2006
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 507 0
University
Name [1] 507 0
School of Medicine and Pharmacology, University of Western Australia (Royal Perth Hospital and Fremantle Hospital Units)
Country [1] 507 0
Australia
Funding source category [2] 508 0
Other
Name [2] 508 0
Keogh Institute for Medical Research
Country [2] 508 0
Australia
Funding source category [3] 509 0
Commercial sector/Industry
Name [3] 509 0
Echo Services
Country [3] 509 0
Australia
Primary sponsor type
Individual
Name
Professor Gerald F Watts
Address
University of Western Australia School of Medicine and Pharmacology (Royal Perth Hospital Unit)
Level 4, Medical Research Foundation Building
Rear 50 Murray Street
PERTH, Western Australia, AUSTRALIA 6000
Country
Australia
Secondary sponsor category [1] 415 0
Individual
Name [1] 415 0
Professor Timothy ME Davis
Address [1] 415 0
University of Western Australia School of Medicine and Pharmacology (Fremantle Hospital Unit)
7th Floor, T Block, Fremantle Hospital
Alma Street
FREMANTLE, Western Australia, AUSTRALIA 6160
Country [1] 415 0
Australia
Secondary sponsor category [2] 416 0
Individual
Name [2] 416 0
Dr Philip J Currie
Address [2] 416 0
Echo Services
Suite 13, Hollywood Specialist Centre
95 Monash Avenue
NEDLANDS, Western Australia, AUSTRALIA 6009
Country [2] 416 0
Australia
Secondary sponsor category [3] 417 0
Individual
Name [3] 417 0
Dr Bronwyn GA Stuckey
Address [3] 417 0
Keogh Institute for Medical Research
1st Floor, C Block
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS, Western Australia, AUSTRALIA 6009
Country [3] 417 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1486 0
Royal Perth Hospital
Ethics committee address [1] 1486 0
Ethics committee country [1] 1486 0
Australia
Date submitted for ethics approval [1] 1486 0
Approval date [1] 1486 0
26/08/2004
Ethics approval number [1] 1486 0
Ethics committee name [2] 1487 0
Fremantle Hospital
Ethics committee address [2] 1487 0
Ethics committee country [2] 1487 0
Australia
Date submitted for ethics approval [2] 1487 0
Approval date [2] 1487 0
Ethics approval number [2] 1487 0
Ethics committee name [3] 1488 0
Keogh Institute for Medical Research
Ethics committee address [3] 1488 0
Ethics committee country [3] 1488 0
Australia
Date submitted for ethics approval [3] 1488 0
Approval date [3] 1488 0
Ethics approval number [3] 1488 0

Summary
Brief summary
This cross-sectional (snapshot) study aims to measure the relaxation function of the heart (using ultrasound) in a group of people who do not have diabetes, who are of varying weight and body size (ranging from lean to overweight).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35936 0
Prof Gerald F Watts
Address 35936 0
University of Western Australia School of Medicine and Pharmacology
Level 4, Medical Research Foundation Building
Rear 50 Murray Street
PERTH, Western Australia, AUSTRALIA 6000
Country 35936 0
Australia
Phone 35936 0
+61892240248
Fax 35936 0
Email 35936 0
[email protected]
Contact person for public queries
Name 9477 0
Prof Gerald F Watts
Address 9477 0
GPO Box X2213
Perth WA 6847
Country 9477 0
Australia
Phone 9477 0
+61892240248
Fax 9477 0
+61892240246
Email 9477 0
[email protected]
Contact person for scientific queries
Name 405 0
Prof Gerald F Watts
Address 405 0
GPO Box X2213
Perth WA 6847
Country 405 0
Australia
Phone 405 0
+61 8 92240248
Fax 405 0
+61 8 92240246
Email 405 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.