Moderate Alcohol Consumption, Risk of Cardiovascular Disease and Type 2 Diabetes: Influence of Alcohol Oxidation - Full Text View

Sponsor:	TNO Quality of Life
Information provided by:	TNO Quality of Life
ClinicalTrials.gov Identifier:	NCT00285909

Purpose

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.

Condition	Intervention
Cardiovascular Disease Type 2 Diabetes	Behavioral: Alcohol: 25 gday (white wine)

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Crossover Assignment, Safety/Efficacy 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

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Alcohol Diabetes Metabolic Disorders

Drug Information available for: Ethanol

U.S. FDA Resources

Further study details as provided by TNO Quality of Life:

Primary Outcome Measures:

PPAR-gamma activated gene expression

Secondary Outcome Measures:

Risk factors of cardiovascular disease and type 2 diabetes
Postprandial changes of HPA-axis activity

Estimated Enrollment:	36
Study Start Date:	March 2006
Estimated Study Completion Date:	June 2006

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)

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285909

Sponsors and Collaborators

TNO Quality of Life

Investigators

Principal Investigator:

Henk FJ Hendriks, PhD.

TNO Quality of Life

More Information

No publications provided by TNO Quality of Life

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Joosten 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. Epub 2008 May 27.

Study ID Numbers:	P6689, Alcohol research 20
Study First Received:	January 31, 2006
Last Updated:	August 15, 2006
ClinicalTrials.gov Identifier:	NCT00285909 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by TNO Quality of Life:

Moderate alcohol consumption
Alcohol dehydrogenase 1c polymorphism
PPAR-gamma activated gene expression

Additional relevant MeSH terms:

Anti-Infective Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus
Drinking Behavior
Central Nervous System Depressants
Endocrine System Diseases
Alcohol Drinking

Pharmacologic Actions
Anti-Infective Agents, Local
Therapeutic Uses
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Central Nervous System Agents
Ethanol

ClinicalTrials.gov processed this record on February 08, 2010