Clinical trial NCT00150163: Odense Androgen Study: Study of Androgens, Body Composition, and Muscle Function in Danish Men
Official title: Odense Androgen Study - A Population-Based Study of Androgens, Body Composition, and Muscle Function in 20-29 Year-Old Danish Men
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Diseases
Keywords: Androgens
Bone
Muscle
Estrogens
Fat
Lipid and glucose metabolism
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2005-09-08
Enrollment: 800
Sex: MALE
Minimum age (years): 20
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Opioid drug addiction
* Cancer
* Severe chronic disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Endocrinology, Odense University Hospital
state: Funen
Study officials:
affiliation: Odense University Hospital
name: Torben L. Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.