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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Odense University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00150163
First received: September 6, 2005
Last updated: March 28, 2007
Last verified: September 2005
  Purpose

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
Bone Diseases

Study Type: Observational
Study Design: Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Odense Androgen Study – A Population-Based Study of Androgens, Body Composition, and Muscle Function in 20-29 Year-Old Danish Men

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Estimated Enrollment: 800
Study Start Date: March 2002
Estimated Study Completion Date: December 2008
  Eligibility

Ages Eligible for Study:   20 Years to 29 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00150163     History of Changes
Other Study ID Numbers: 015
Study First Received: September 6, 2005
Last Updated: March 28, 2007
Health Authority: Denmark: National Board of Health

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014