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

March 28, 2007 updated by: Odense University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Funen
      • Odense, Funen, Denmark, 5000
        • Department of Endocrinology, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 29 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Opioid drug addiction
  • Cancer
  • Severe chronic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Torben L. Nielsen, MD, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion

December 1, 2008

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

March 29, 2007

Last Update Submitted That Met QC Criteria

March 28, 2007

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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