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Clinical Trials/NCT00285909
NCT00285909CompletedNot Applicable

Effect of Moderate Alcohol Consumption on PPAR-γ Activity and Risk Markers of Metabolic Disease: Influence of Genetic Variation in Alcohol Oxidation

TNO0 sites36 target enrollmentStarted: March 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
36
Primary Endpoint
PPAR-gamma activated gene expression

Study Overview

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.

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
40 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

  • 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

Outcomes

Primary Outcomes

PPAR-gamma activated gene expression

Secondary Outcomes

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

Investigators

Sponsor
TNO
Sponsor Class
Other

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