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Odense Androgen Study: Study of Androgens, Body Composition, and Muscle Function in Danish Men

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ClinicalTrials.gov Identifier: NCT00150163
Recruitment Status : Unknown
Verified September 2005 by Odense University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 8, 2005
Last Update Posted : March 29, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:

Objective:

  • To define a reference-population of healthy young men (20-29 years old).
  • To establish reference-intervals for:

    1. Total, bioavailable and free serum androgens (testosterone, dihydrotestosterone, androstenedione) and serum estrogens (estradiol, estrone).
    2. 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:

    1. Muscle mass, muscle strength, muscle power, oxygen uptake, and hematocrit.
    2. Bone mineral density and bone metabolism.
    3. Total and visceral fat mass.
    4. Lipid- and glucose metabolism and glucocorticoid metabolism.
    5. 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:

  1. testicular pathology: bilateral cryptorchidism, varicocele, testes volumina < 10 ml (each), history of spermatic cord torsion.
  2. severe chronic disease.
  3. regular medication or abuse of anabolic steroids.
  4. body mass index < 19 kg/m2.
  5. 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.

Condition or disease
Bone Diseases

Study Design

Study Type : Observational
Estimated Enrollment : 800 participants
Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Odense Androgen Study – A Population-Based Study of Androgens, Body Composition, and Muscle Function in 20-29 Year-Old Danish Men
Study Start Date : March 2002
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Diseases
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Opioid drug addiction
  • Cancer
  • Severe chronic disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150163


Locations
Denmark
Department of Endocrinology, Odense University Hospital
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Torben L. Nielsen, MD Odense University Hospital
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00150163     History of Changes
Other Study ID Numbers: 015
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: March 29, 2007
Last Verified: September 2005

Keywords provided by Odense University Hospital:
Androgens
Bone
Muscle
Estrogens
Fat
Lipid and glucose metabolism

Additional relevant MeSH terms:
Bone Diseases
Musculoskeletal Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs