Metabolic Syndrome XNCT00716300
High Density Lipoprotein (HDL) Functionality in Metabolic Syndrome
An observational study of Metabolic Syndrome X, run by The University of Western Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2008to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 15 men with features of the metabolic syndrome 15 age-matched normolipidaemic men
Who may be able to join
- 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
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- waist circumference < 102 cm
- triglycerides < 1.0 mmol/L
- HDL-cholesterol > 1.3 mmol/L
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
University of Western Australia
Perth, Western Australia, 6000
Dick C Chan, PhD, 61-8-92240268, dick.chan@uwa.edu.au
About this study
Official title: Functional Studies of High Density Lipoprotein in the Metabolic Syndrome
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.
Read the detailed description
Background and Purpose of This Study:
The metabolic syndrome (MetS) is characterized by impaired glucose and insulin metabolism (insulin resistance), abnormal body fat distribution called central obesity (a pot belly) and high blood pressure. People with the metabolic syndrome have markedly increased risk of heart disease which is mainly attributed to the abnormal fat metabolism and its associated metabolic disorders. Therefore, understanding of the body fat disorder is important to reduce the incidence and severity of heart disease.
Fats in the blood originate from dietary sources and from production by the liver. They are then delivered into peripheral body cell for utilization or storage. A particular protein, called high-density lipoprotein (HDL) apolipoprotein (apo) A-I, is an important fat carrier responsible for transporting excess fat from cells, via the bloodstream, back to the liver. Low HDL-apoA-I concentration is related to increased risk of heart disease. Subjects with MetS have reduced level of apoA-I and we wish to test the hypothesis that it is responsible for the impaired movement of fat from the periphery to the liver. Recent evidence suggests that the functionality of HDL, including anti-oxidant, anti-inflammatory and cholesterol efflux properties, is also important in preventing the development of heart disease. However, these function tests have not yet been investigated extensively in MetS.
Consequently, we wish to examine the transport and anti-atherogenic properties of HDL in subjects with MetS and compare these with normal lean subjects. Such findings would be of significant clinical importance in the understanding of the diverse role of HDL-apoA-I in reducing or preventing the progression of heart disease.
Participation:
Patients with MetS or lean individuals will be recruited for the study via newspaper advertisements. Following informed consent and once found suitable for participation, 15 men with MetS and 15 lean men will be enrolled. We will give the participants a harmless substance called a stable (non-radioactive) isotope. The isotope will trace the speed at which apoA-I is released into the blood (production) and are removed from the bloodstream (clearance) by the liver.
Participants will be asked to fast (only water allowed) for 12 hours prior to the isotope study. The stable isotope will be administered by intravenous injection in the form of a clear fluid (total volume approximates 15 to 25ml, 1-1.5 tablespoons). A small plastic tube (a cannula) will be placed into a vein in the arm, from where a total of 160mll (10.5 tablespoons) of blood will be obtained. The isotope study lasts 10 hours, during which participants will rest quietly and be allowed water only. At the end of the study day, participants will be given a meal and will be allowed home by taxi or family transport.
These studies will allow us to measure the metabolic action of apolipoprotein A-I, thereby gaining a better understanding of the mechanisms that leads to abnormal blood fat levels in those with MetS. To complete this study, each participant is required to attend 7 visits over a 6-week period.
Benefits:
All participants will receive health education, as well as information on personal health status and a review of heart risk factors.
- Conditions
- Metabolic Syndrome X
- Keywords
- obesity, CVD, HDL kinetics, Anti-inflammatory and anti-oxidation studies, 30 subjects recruited (15 MetS and 15 lean controls)
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | obese and insulin resistant subjects | |
| 2 | lean and normolipidaemic subjects |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Investigators
- Gerald F Watts, MBBS, Principal investigator, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716300
- Sponsor's protocol ID
- DC-HDL2008
- Status last verified
- Feb 2009
- First submitted
- 14 Jul 2008
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Studies of High Density Lipoprotein in the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00716300
- Acronym / sponsor ID
- DC-HDL2008
- Conditions
- Metabolic Syndrome X
- Keywords
- obesity, CVD, HDL kinetics, Anti-inflammatory and anti-oxidation studies, 30 subjects recruited (15 MetS and 15 lean controls)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Purpose of This Study:
The metabolic syndrome (MetS) is characterized by impaired glucose and insulin metabolism (insulin resistance), abnormal body fat distribution called central obesity (a pot belly) and high blood pressure. People with the metabolic syndrome have markedly increased risk of heart disease which is mainly attributed to the abnormal fat metabolism and its associated metabolic disorders. Therefore, understanding of the body fat disorder is important to reduce the incidence and severity of heart disease.
Fats in the blood originate from dietary sources and from production by the liver. They are then delivered into peripheral body cell for utilization or storage. A particular protein, called high-density lipoprotein (HDL) apolipoprotein (apo) A-I, is an important fat carrier responsible for transporting excess fat from cells, via the bloodstream, back to the liver. Low HDL-apoA-I concentration is related to increased risk of heart disease. Subjects with MetS have reduced level of apoA-I and we wish to test the hypothesis that it is responsible for the impaired movement of fat from the periphery to the liver. Recent evidence suggests that the functionality of HDL, including anti-oxidant, anti-inflammatory and cholesterol efflux properties, is also important in preventing the development of heart disease. However, these function tests have not yet been investigated extensively in MetS.
Consequently, we wish to examine the transport and anti-atherogenic properties of HDL in subjects with MetS and compare these with normal lean subjects. Such findings would be of significant clinical importance in the understanding of the diverse role of HDL-apoA-I in reducing or preventing the progression of heart disease.
Participation:
Patients with MetS or lean individuals will be recruited for the study via newspaper advertisements. Following informed consent and once found suitable for participation, 15 men with MetS and 15 lean men will be enrolled. We will give the participants a harmless substance called a stable (non-radioactive) isotope. The isotope will trace the speed at which apoA-I is released into the blood (production) and are removed from the bloodstream (clearance) by the liver.
Participants will be asked to fast (only water allowed) for 12 hours prior to the isotope study. The stable isotope will be administered by intravenous injection in the form of a clear fluid (total volume approximates 15 to 25ml, 1-1.5 tablespoons). A small plastic tube (a cannula) will be placed into a vein in the arm, from where a total of 160mll (10.5 tablespoons) of blood will be obtained. The isotope study lasts 10 hours, during which participants will rest quietly and be allowed water only. At the end of the study day, participants will be given a meal and will be allowed home by taxi or family transport.
These studies will allow us to measure the metabolic action of apolipoprotein A-I, thereby gaining a better understanding of the mechanisms that leads to abnormal blood fat levels in those with MetS. To complete this study, each participant is required to attend 7 visits over a 6-week period.
Benefits:
All participants will receive health education, as well as information on personal health status and a review of heart risk factors.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –obese and insulin resistant subjects |
| 2 | – | –lean and normolipidaemic subjects |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 15 men with features of the metabolic syndrome 15 age-matched normolipidaemic men
Key inclusion criteria (9 listed)
- 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
- BMI < 25 kg/m2
- waist circumference < 102 cm
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald F Watts, MBBS principal investigator
The University of Western Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome X, run by The University of Western Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dick C Chan, PhD (61-8-92240268, dick.chan@uwa.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2009; AzTrials last refreshed its copy on 30 Oct 2026.