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

Bone Diseases Clinical Trial

Official title:

Odense Androgen Study – A Population-Based Study of Androgens, Body Composition, and Muscle Function in 20-29 Year-Old Danish Men

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00150163
• Other study ID #: 015
• Status: Active, not recruiting
• Phase: N/A
• First received: September 6, 2005
• Last updated: March 28, 2007
• Start date: March 2002
• Est. completion date: December 2008

Study information

• Verified date: September 2005
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 29 Years

Eligibility

Inclusion Criteria:

• Age: 20-29 years

• Residence: County of Funen, Denmark

Exclusion Criteria:

• Opioid drug addiction

• Cancer

• Severe chronic disease

Study Design

Allocation: Random Sample, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Bone Diseases

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Odense University Hospital	Odense	Funen

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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 Androge — View Citation