NCT00285909

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2006

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

August 16, 2006

Status Verified

August 1, 2006

First QC Date

January 31, 2006

Last Update Submit

August 15, 2006

Conditions

Keywords

Moderate alcohol consumptionAlcohol dehydrogenase 1c polymorphismPPAR-gamma activated gene expression

Outcome Measures

Primary Outcomes (1)

  • PPAR-gamma activated gene expression

Secondary Outcomes (2)

  • Risk factors of cardiovascular disease and type 2 diabetes

  • Postprandial changes of HPA-axis activity

Interventions

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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. doi: 10.1007/s00125-008-1031-y. Epub 2008 May 27.

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes Mellitus, Type 2

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Henk FJ Hendriks, PhD.

    TNO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 2, 2006

Study Start

March 1, 2006

Study Completion

June 1, 2006

Last Updated

August 16, 2006

Record last verified: 2006-08