Trial Review

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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
The aim of the study is to examine the kinetic, anti-oxidant, anti-inflammatory and cellular cholesterol efflux properties of high-density lipoprotein (HDL) in subjects with the metabolic syndrome (MetS) and lean individuals.
Trial website
https://clinicaltrials.gov/study/NCT00716300
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00716300