Cardiovascular DiseaseNCT00285909
Moderate Alcohol Consumption, Risk of Cardiovascular Disease and Type 2 Diabetes: Influence of Alcohol Oxidation
A study testing Alcohol: 25 gday (white wine) in people with Cardiovascular Disease and Type 2 Diabetes, run by TNO.
Trial summary
Moderate alcohol consumption is associated with a decreased risk of cardiovascular disease and type 2 diabetes. The association of alcohol consumption with cardiovascular disease is mediated by a functional polymorphism of alcohol dehydrogenase 1c, but the effect of this polymorphism on alcohol metabolism is only… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Type 2 Diabetes
- What is being tested?
- Alcohol: 25 gday (white wine)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Jun 2006
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy women aged 40 to 65 years
- Absence of menstrual period for at least 2 years
- Homozygotes for the ADH1C*1 or ADH1C*2 allele of ADH1C I349V polymorphism
- Alcohol consumption ≥ 5 and ≤ 21 units/week
Who cannot join
- Smoking
- Family history of alcoholism
- History of medical or surgical events that may significantly affect the study outcome, particularly metabolic or endocrine disorders and gastrointestinal disorders
- Recent blood donation
About this study
Official title: Effect of Moderate Alcohol Consumption on PPAR-γ Activity and Risk Markers of Metabolic Disease: Influence of Genetic Variation in Alcohol Oxidation
Moderate alcohol consumption is associated with a decreased risk of cardiovascular disease and type 2 diabetes. The association of alcohol consumption with cardiovascular disease is mediated by a functional polymorphism of alcohol dehydrogenase 1c, but the effect of this polymorphism on alcohol metabolism is only investigated in vitro.
The risk reduction of moderate alcohol consumption for cardiovascular disease is explained largely by an increase of HDL cholesterol, but an increase of adiponectin concentrations after moderate alcohol consumption may also be involved. It seems likely that adiponectin is a mediator for the association of moderate alcohol consumption with type 2 diabetes. The mechanism by which moderate alcohol consumption increases adiponectin concentrations is unknown, but ppar-gamma activation may be involved.
effects of this polymorphism on mediators of this relation are not known. This study therefore investigates the effect of moderate alcohol consumption and the influence of alcohol dehydrogenase 1c polymorphism on ppar-gamma activated gene expression and risk factors of cardiovascular disease and type 2 diabetes.
Read the detailed description
Objectives :
To investigate the effect of moderate alcohol consumption and influence of genetic variation of ethanol oxidation on:
- PPAR-γ activated gene expression
- Markers of coronary heart disease or type 2 diabetes
- Postprandial changes of HPA-axis activity among 36 postmenopausal women with ADH1C genotype associated with slow or fast alcohol metabolism.
Design : Randomized, controlled, not blinded crossover trial with 1 week wash-out preceding each treatment period
Participants
- Description : Apparently healthy postmenopausal women
- Number : 36
Study substances
- Test substance : White wine (ca. 25 g alcohol/day)
- Reference substance : White grape juice
Study treatments Treatment A: 250 ml white wine daily (ca. 25 g alcohol/day) Treatment B: 250 ml white grape juice daily
Study period
- Duration : two periods of 6 weeks preceded by 1 week wash-out period
Test parameters:
- Adiponectin mRNA expression
- Expression of PPAR-gamma activated genes: CD36, lipoprotein lipase, AP2
- Markers of cardiovascular disease (blood lipid profile, Lp-PLA2 activity, hs-CRP, fibrinogen)
- Markers of type 2 diabetes (adiponectin, adiponectin oligomers, insulin sensitivity)
- Parameters of alcohol oxidation (postprandial: blood alcohol and acetate, acetaldehyde)
- HPA-axis activity (postprandial \& fasting: cortisol, ACTH, testosterone)
- Conditions
- Cardiovascular Disease, Type 2 Diabetes
- Being tested
- Alcohol: 25 gday (white wine)
- Keywords
- Moderate alcohol consumption, Alcohol dehydrogenase 1c polymorphism, PPAR-gamma activated gene expression
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol: 25 gday (white wine)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
PPAR-gamma activated gene expression
Secondary outcomes (2)
Risk factors of cardiovascular disease and type 2 diabetes
Postprandial changes of HPA-axis activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startMar 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Investigators
- Henk FJ Hendriks, PhD., Principal investigator, TNO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285909
- Sponsor's protocol ID
- P6689
- Other IDs
- Alcohol research 20
- Status last verified
- Aug 2006
- First submitted
- 31 Jan 2006
- Last updated
- 16 Aug 2006
- Results posted
- No
Publications
Joosten MM, Schrieks IC, Hendriks HF. Effect of moderate alcohol consumption on fetuin-A levels in men and women: post-hoc analyses of three open-label randomized crossover trials. Diabetol Metab Syndr. 2014 Feb 18;6(1):24. doi: 10.1186/1758-5996-6-24.
PubMed 24548643Joosten MM, Beulens JW, Kersten S, Hendriks HF. Moderate alcohol consumption increases insulin sensitivity and ADIPOQ expression in postmenopausal women: a randomised, crossover trial. Diabetologia. 2008 Aug;51(8):1375-81. doi: 10.1007/s00125-008-1031-y. Epub 2008 May 27.
PubMed 18504547
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Moderate Alcohol Consumption on PPAR-γ Activity and Risk Markers of Metabolic Disease: Influence of Genetic Variation in Alcohol Oxidation
- ClinicalTrials.gov ID
- NCT00285909
- Acronym / sponsor ID
- P6689
- Conditions
- Cardiovascular Disease, Type 2 Diabetes
- Keywords
- Moderate alcohol consumption, Alcohol dehydrogenase 1c polymorphism, PPAR-gamma activated gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- TNOUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Jun 2006
- First posted
- 2 Feb 2006 (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.
Moderate alcohol consumption is associated with a decreased risk of cardiovascular disease and type 2 diabetes. The association of alcohol consumption with cardiovascular disease is mediated by a functional polymorphism of alcohol dehydrogenase 1c, but the effect of this polymorphism on alcohol metabolism is only investigated in vitro.
The risk reduction of moderate alcohol consumption for cardiovascular disease is explained largely by an increase of HDL cholesterol, but an increase of adiponectin concentrations after moderate alcohol consumption may also be involved. It seems likely that adiponectin is a mediator for the association of moderate alcohol consumption with type 2 diabetes. The mechanism by which moderate alcohol consumption increases adiponectin concentrations is unknown, but ppar-gamma activation may be involved.
effects of this polymorphism on mediators of this relation are not known. This study therefore investigates the effect of moderate alcohol consumption and the influence of alcohol dehydrogenase 1c polymorphism on ppar-gamma activated gene expression and risk factors of cardiovascular disease and type 2 diabetes.
Detailed description
Objectives :
To investigate the effect of moderate alcohol consumption and influence of genetic variation of ethanol oxidation on:
- PPAR-γ activated gene expression
- Markers of coronary heart disease or type 2 diabetes
- Postprandial changes of HPA-axis activity among 36 postmenopausal women with ADH1C genotype associated with slow or fast alcohol metabolism.
Design : Randomized, controlled, not blinded crossover trial with 1 week wash-out preceding each treatment period
Participants
- Description : Apparently healthy postmenopausal women
- Number : 36
Study substances
- Test substance : White wine (ca. 25 g alcohol/day)
- Reference substance : White grape juice
Study treatments Treatment A: 250 ml white wine daily (ca. 25 g alcohol/day) Treatment B: 250 ml white grape juice daily
Study period
- Duration : two periods of 6 weeks preceded by 1 week wash-out period
Test parameters:
- Adiponectin mRNA expression
- Expression of PPAR-gamma activated genes: CD36, lipoprotein lipase, AP2
- Markers of cardiovascular disease (blood lipid profile, Lp-PLA2 activity, hs-CRP, fibrinogen)
- Markers of type 2 diabetes (adiponectin, adiponectin oligomers, insulin sensitivity)
- Parameters of alcohol oxidation (postprandial: blood alcohol and acetate, acetaldehyde)
- HPA-axis activity (postprandial \& fasting: cortisol, ACTH, testosterone)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy women aged 40 to 65 years
- Absence of menstrual period for at least 2 years
- Homozygotes for the ADH1C*1 or ADH1C*2 allele of ADH1C I349V polymorphism
- Alcohol consumption ≥ 5 and ≤ 21 units/week
Key exclusion criteria (4 listed)
- Smoking
- Family history of alcoholism
- History of medical or surgical events that may significantly affect the study outcome, particularly metabolic or endocrine disorders and gastrointestinal disorders
- Recent blood donation
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 |
|---|---|---|
| Alcohol: 25 gday (white wine) | Behavioural | – |
Primary outcome
PPAR-gamma activated gene expression
2 secondary outcomes
Risk factors of cardiovascular disease and type 2 diabetes
Postprandial changes of HPA-axis activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2006.
- Derived from this study: PubMed 24548643Joosten MM, Schrieks IC, Hendriks HF. Effect of moderate alcohol consumption on fetuin-A levels in men and women: post-hoc analyses of three open-label randomized crossover trials. Diabetol Metab Syndr. 2014 Feb 18;6(1):24. doi: 10.1186/1758-5996-6-24.
- Derived from this study: PubMed 18504547Joosten MM, Beulens JW, Kersten S, Hendriks HF. Moderate alcohol consumption increases insulin sensitivity and ADIPOQ expression in postmenopausal women: a randomised, crossover trial. Diabetologia. 2008 Aug;51(8):1375-81. doi: 10.1007/s00125-008-1031-y. Epub 2008 May 27.
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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.
Henk FJ Hendriks, PhD. principal investigator
TNO
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol: 25 gday (white wine) in people with Cardiovascular Disease and Type 2 Diabetes, run by TNO.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 16 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PPAR-gamma activated gene expression. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00285909, which also lists 2 linked publications.
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 16 Aug 2006.