NCT00150163

Brief Summary

Objective:

  • To define a reference-population of healthy young men (20-29 years old).
  • To establish reference-intervals for:
  • Total, bioavailable and free serum androgens (testosterone, dihydrotestosterone, androstenedione) and serum estrogens (estradiol, estrone).
  • Total and free IGF-1.
  • To study the influence of physical activity, alcohol intake, tobacco and abuse of anabolic steroids on serum levels of androgens.
  • To identify the androgens (or estrogens) that primarily reflect the following parameters:
  • Muscle mass, muscle strength, muscle power, oxygen uptake, and hematocrit.
  • Bone mineral density and bone metabolism.
  • Total and visceral fat mass.
  • Lipid- and glucose metabolism and glucocorticoid metabolism.
  • Sexual function and quality of life.
  • To study the modifying effect of birth weight, the AR gene CAG-repeat polymorphism, and the level of IGF-1 on associations between serum androgens and the measures above: Ethics, design and schedule: The local ethic review board approved a population-based, cross-sectional study planned for the inclusion of 800 Caucasian men, 20 to 29 year old, living in the County of Funen. The only exclusion criteria were opioid drug addiction, cancer, and severe chronic disease. A basic questionnaire was mailed to 3000 men, randomly drawn from the Danish Central Personal Registry. Adequately answered questionnaires were returned from 2,199 men, who subsequently received an invitation to participate. Informed consent was obtained from 783 men. The examinations started in March 2002 and terminated in May 2003. Within subject variation was determined for all study parameters in 20 men. The men included matched the men answering the questionnaire on all questionnaire items and demographics. All analyses have been performed, except for the additional serum sex hormone assays, IGF-1 assays and AR gene analyses. A sequential rule-out from the reference population was performed on the following criteria:
  • testicular pathology: bilateral cryptorchidism, varicocele, testes volumina \< 10 ml (each), history of spermatic cord torsion.
  • severe chronic disease.
  • regular medication or abuse of anabolic steroids.
  • body mass index \< 19 kg/m2.
  • safety serum parameters: luteinizing hormone (LH) \<1.0 U/L or \>8.4 U/l, alanine-amino-transferase (ALAT) \>70 U/l and thyrotropin (TSH) \>6.0 mU/l.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 29, 2007

Status Verified

September 1, 2005

First QC Date

September 6, 2005

Last Update Submit

March 28, 2007

Conditions

Bone Diseases

Keywords

AndrogensBoneMuscleEstrogensFatLipid and glucose metabolism

Eligibility Criteria

Age20 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 20-29 years
  • Residence: County of Funen, Denmark

You may not qualify if:

  • Opioid drug addiction
  • Cancer
  • Severe chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Odense University Hospital

Odense, Funen, 5000, Denmark

Location

Related Publications (2)

  • Nielsen TL, Wraae K, Brixen K, Hermann AP, Andersen M, Hagen C. Prevalence of overweight, obesity and physical inactivity in 20- to 29-year-old, Danish men. Relation to sociodemography, physical dysfunction and low socioeconomic status: the Odense Androgen Study. Int J Obes (Lond). 2006 May;30(5):805-15. doi: 10.1038/sj.ijo.0803197.

    PMID: 16418764RESULT

  • Frost M, Abrahamsen B, Nielsen TL, Hagen C, Andersen M, Brixen K. Vitamin D status and PTH in young men: a cross-sectional study on associations with bone mineral density, body composition and glucose metabolism. Clin Endocrinol (Oxf). 2010 Nov;73(5):573-80. doi: 10.1111/j.1365-2265.2010.03847.x.

    PMID: 20718769DERIVED

MeSH Terms

Conditions

Bone DiseasesPlatelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

  • Torben L. Nielsen, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

March 1, 2002

Study Completion

December 1, 2008

Last Updated

March 29, 2007

Record last verified: 2005-09

Locations

DK(1)