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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00716300




Registration number
NCT00716300
Ethics application status
Date submitted
14/07/2008
Date registered
16/07/2008
Date last updated
18/02/2009

Titles & IDs
Public title
High Density Lipoprotein (HDL) Functionality in Metabolic Syndrome
Scientific title
Functional Studies of High Density Lipoprotein in the Metabolic Syndrome
Secondary ID [1] 0 0
DC-HDL2008
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
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1 - obese and insulin resistant subjects

2 - lean and normolipidaemic subjects
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
MetS :the presence of at least three of the following:

* waist circumference > 102 cm, triglycerides > 1.7 mmol/L, HDL cholesterol < 1.05 mmol/L
* blood pressure = 130/ = 85 mmHg
* fasting glucose > 6.1 mmol/L

Lean control:

* BMI < 25 kg/m2
* waist circumference < 102 cm
* triglycerides < 1.0 mmol/L
* HDL-cholesterol > 1.3 mmol/L
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* subjects with plasma LDL-cholesterol > 5 mmo/L
* diabetes mellitus (defined by oral glucose tolerance test)
* genetic hyperlipidaemia (e.g. FH)
* consumption of > 30 g alcohol/day
* apolipoprotein E2/E2 genotype
* macroproteinuria
* creatinaemia ( > 120 umol/L)
* hypothyroidism
* hepatic dysfunction (AST or ALT > 2x ULN)
* major systemic illness and use of steroids or other agents that may influence lipid metabolism
* cardiovascular event within the past 6 months
* subjects on hypocaloric diets
* anaemia; any significant illness that in the opinion of reviewing physician would bear on the study (e.g. heart murmur or psychiatric conditions)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2009
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
University of Western Australia - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Western Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gerald F Watts, MBBS
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dick C Chan, PhD
Address 0 0
Country 0 0
Phone 0 0
61-8-92240268
Fax 0 0
Email 0 0
dick.chan@uwa.edu.au
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/NCT00716300