Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285909
Status:
COMPLETED
Last Update Posted:
2006-08-16
First Post:
2006-01-31
Brief Title:
Moderate Alcohol Consumption Risk of Cardiovascular Disease and Type 2 Diabetes Influence of Alcohol Oxidation
Sponsor:
TNO
Organization:
TNO
Study Overview
Official Title:
Effect of Moderate Alcohol Consumption on PPAR-γ Activity and Risk Markers of Metabolic Disease Influence of Genetic Variation in Alcohol Oxidation
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 alcoholday
Reference substance White grape juice
Study treatments Treatment A 250 ml white wine daily ca 25 g alcoholday 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
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 alcoholday
Reference substance White grape juice
Study treatments Treatment A 250 ml white wine daily ca 25 g alcoholday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Alcohol research 20 | None | None | None |