Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00150163
Study type Observational
Source Odense University Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date March 2002
Completion date December 2008

See also
  Status Clinical Trial Phase
Completed NCT03672513 - Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause N/A
Completed NCT00070681 - Outcomes of Sleep Disorders in Older Men Phase 3
Recruiting NCT03905174 - Massive Implants the Next Generation N/A
Completed NCT03050203 - Custom Pack in Spine Surgery N/A
Completed NCT00000466 - Postmenopausal Estrogen/Progestin Interventions (PEPI) Phase 3
Recruiting NCT03904914 - Thumb Ossification Composite Index (TOCI) to Predict Skeletal Maturity and Curve Progression in AIS
Completed NCT04608708 - 3D Analysis of Cemento-Osseous Lesions
Completed NCT02252679 - Study of the Diagnostic Value of Stable Calcium Isotope Profiling in Bone and Calcium Disorders
Completed NCT03633032 - Radiation-free Bone Imaging UTE MRI in Healthy and Diseased Patients N/A
Recruiting NCT03431727 - Acromegaly - Before and After Treatment
Completed NCT03072186 - Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base Surgery N/A
Completed NCT03438123 - Data Collection Study for the Spectrum Dynamics Multi-purpose CZT SPECT Camera N/A
Recruiting NCT06116071 - Biomarkers Related to Bone in Pediatric Gaucher Disease
Not yet recruiting NCT05840003 - Image Quality: Ultra-Low Dose Scanner Versus Standard Dose Conventional Scanner for Thoraco-abdominopelvic Scans N/A
Withdrawn NCT04955652 - Evaluation of Alerts in Promoting Bone Densitometry Scans N/A
Recruiting NCT00270608 - How Does Early Age Life Style Affect Bone Strength and General Health Parameters at Middle Age? N/A
Completed NCT00155961 - Odense Androgen Study in the Elderly Phase 1
Terminated NCT03802656 - Vertebral Body Tethering Treatment for Idiopathic Scoliosis N/A
Not yet recruiting NCT05802121 - Akkermansia Muciniphilia and Metabolic Side Effects of ADT Early Phase 1
Recruiting NCT02809781 - A Pilot Study of MSCs Iufusion and Etanercept to Treat Ankylosing Spondylitis Phase 2/Phase 3