Moderate Alcohol Consumption, Risk of Cardiovascular Disease and Type 2 Diabetes: Influence of Alcohol Oxidation

This study has been completed.
Sponsor:
Information provided by:
TNO
ClinicalTrials.gov Identifier:
NCT00285909
First received: January 31, 2006
Last updated: August 15, 2006
Last verified: August 2006
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
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:


Further study details as provided by TNO:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
TNO
Investigators
Principal Investigator: Henk FJ Hendriks, PhD. TNO
  More Information

No publications provided by TNO

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00285909     History of Changes
Other Study ID Numbers: P6689, Alcohol research 20
Study First Received: January 31, 2006
Last Updated: August 15, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by TNO:
Moderate alcohol consumption
Alcohol dehydrogenase 1c polymorphism
PPAR-gamma activated gene expression

Additional relevant MeSH terms:
Alcohol Drinking
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Drinking Behavior
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 28, 2014