NCT00155961

Brief Summary

Introduction Male ageing is associated with sarcopenia, frailty, osteopenia, obesity, the metabolic syndrome and cardiovascular disease. To what extent the androgens affect these signs of ageing is still largely undetermined. A few studies have shown divergent results concerning the relation between ageing and serum levels of testosterone. It still remains to be shown whether there is a pure age-related decline in serum testosterone or whether other factors such as obesity, chronic illness or medication are responsible for the lower serum testosterone found in elderly men when compared with young men. To investigate these issues a cohort of 600 men aged 60 to 75 years is examined. Objective The aim of the study is to investigate the relation of testosterone (T) to body composition (BC) and physical performance (PP). Measures for BC are muscle mass (MM), bone mineral density (BMD) and fat mass (FM). Parameters for PP are maximum voluntary force (MVF), maximum oxygen uptake (VO2max) and muscle power (P). We hypothesize that T is positively associated with MM, BMD and all PP parameters, but negatively associated with FM. We will furthermore examine whether life style, medication, chronic disease, hormones and binding proteins exert their actions on BC and PP solely through or independently of T. The levels of s-total and free T in this cohort will be compared with the s-total and free T levels from a cohort of young men aged 20 to 30 years. Furthermore the associations found between T and BC and PP in the two cohorts will be compared to investigate whether T plays the same role in the two groups.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

February 3, 2006

Status Verified

September 1, 2005

First QC Date

September 6, 2005

Last Update Submit

February 2, 2006

Conditions

Bone DiseasesMetabolic Syndrome

Keywords

AndrogensMetabolic syndromeBone mineral densityBody compositionQuestionnaire

Eligibility Criteria

Age60 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 60-75 years

You may not qualify if:

  • Cancer
  • Severe chronic disease
  • Opioid drug addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Odense University Hospital

Odense, Funen, 5000, Denmark

Location

Related Publications (1)

  • Glintborg D, Nielsen TL, Wraae K, Hougaard D, Gudex C, Brixen K, Andersen M. The relationship between health-related quality of life, obesity and testosterone levels in older men. Age Ageing. 2014 Mar;43(2):280-4. doi: 10.1093/ageing/aft203. Epub 2013 Dec 29.

    PMID: 24375324DERIVED

MeSH Terms

Conditions

Bone DiseasesMetabolic Syndrome

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Claus Hagen, MD, DMSc

    Gentofte County Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 12, 2005

Study Start

March 1, 2002

Last Updated

February 3, 2006

Record last verified: 2005-09

Locations

DK(1)