Type 2 DiabetesNCT00558935
The Effect of Alcohol on ABCA1 Expression and Lipid Metabolism
A study testing Red Wine in people with Type 2 Diabetes and Heart Disease, run by Bayside Health at 1 site in Australia.
Trial summary
The purpose of this study is to investigate the effects of red wine on ABCA1 levels Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Heart Disease
- What is being tested?
- Red Wine
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2007to Dec 2008
- Phase
- Interventional
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants
- Aged 18-65 years
- Free of overt coronary disease
- BMI < 35
- Fasting plasma glucose <6.1 mmol
- Unmedicated
- No major illness
Who cannot join
- Unable to give informed consent
- Smokers
- Participants with alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effects of red wine on ABCA1 levels
- Conditions
- Type 2 Diabetes, Heart Disease
- Being tested
- Red Wine
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red WineDietary supplement
20g alcohol daily/red wine for 4 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
measurements of dyslipidemia
Measured: 2 years
Secondary outcomes (1)
lipid functionality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2008
- Study completionDec 2008
Why it stopped: It was found that 20g of alcohol daily had no effect on ABCA1 expression or HDL levels.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Investigators
- Bronwyn A Kingwell, PhD, Principal investigator, Baker Heart Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558935
- Sponsor's protocol ID
- 24/06
- Status last verified
- May 2011
- First submitted
- 14 Nov 2007
- Last updated
- 10 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alcohol on ABCA1 Expression and Lipid Metabolism
- ClinicalTrials.gov ID
- NCT00558935
- Acronym / sponsor ID
- 24/06
- Conditions
- Type 2 Diabetes, Heart Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was found that 20g of alcohol daily had no effect on ABCA1 expression or HDL levels.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bayside HealthOther government
- Study start
- Oct 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Nov 2007 (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 purpose of this study is to investigate the effects of red wine on ABCA1 levels
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy participants
- Aged 18-65 years
- Free of overt coronary disease
- BMI < 35
- Fasting plasma glucose <6.1 mmol
Key exclusion criteria (3 listed)
- Unable to give informed consent
- Smokers
- Participants with alcoholism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Wine20g alcohol daily/red wine for 4 weeks | Dietary supplement | – |
Primary outcome
measurements of dyslipidemia
Time frame: 2 years
1 secondary outcome
lipid functionality
Time frame: 2 years
Results and safety
The study was stopped early (reason given: It was found that 20g of alcohol daily had no effect on ABCA1 expression or HDL levels.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
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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.
Bronwyn A Kingwell, PhD principal investigator
Baker Heart Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Wine in people with Type 2 Diabetes and Heart Disease, run by Bayside Health 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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 10 May 2011. 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?
The study was stopped early (reason given: It was found that 20g of alcohol daily had no effect on ABCA1 expression or HDL levels.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurements of dyslipidemia (time frame: 2 years). It is what the study was designed to measure, not a finding.
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 10 May 2011.