Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155961
Status:
COMPLETED
Last Update Posted:
2006-02-03
First Post:
2005-09-06
Brief Title:
Odense Androgen Study in the Elderly
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Odense Androgen Study in the Elderly
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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
Methods
All blood analyses are determined in fasting condition from venous samples drawn between 8 and 9 am The influence of life style medication chronic disease hormones and binding proteins on T BC and PP are assessed by four questionnaires a physical examination and blood tests MM is determined regionally truncal lower and upper extremities and as total by Dual Energy X-ray Absorptiometry DEXA and specifically by MRI with cross sectional area of femoral and axial muscles MVF of m biceps brachii and m triceps surae is measured isometrically P is measured with the Nottingham Powerrig VO2max is determined on a Monark ergometer bike using a Jaeger Oxycon Pro BMD is determined specifically femoral and lumbar as well as total bone mass is estimated by DEXA The ratio of intraperitoneal areavolume of fat to total abdominal areavolume is determined by MRI and likewise is also abdominal subcutaneous FM Finally BMI and waist-to-hip ratio are measured
Results
Initially a questionnaire providing us with basic demographic social occupational and other information about men from Funen aged 60 to 75 was randomly mailed to 4964 men Of these questionnaires 89 were returned and 852 of the returned questionnaires had been completed Afterwards 1650 people received an invitation by mail to get an introduction to the project via telephone Of these 1650 people 508 accepted to be contacted So far 762 people have been contacted in a randomly manner and of these people 74 have agreed to participate in the project In the beginning of April 2005 550 people have been included in Odense Androgen Study in the Elderly
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
Methods
All blood analyses are determined in fasting condition from venous samples drawn between 8 and 9 am The influence of life style medication chronic disease hormones and binding proteins on T BC and PP are assessed by four questionnaires a physical examination and blood tests MM is determined regionally truncal lower and upper extremities and as total by Dual Energy X-ray Absorptiometry DEXA and specifically by MRI with cross sectional area of femoral and axial muscles MVF of m biceps brachii and m triceps surae is measured isometrically P is measured with the Nottingham Powerrig VO2max is determined on a Monark ergometer bike using a Jaeger Oxycon Pro BMD is determined specifically femoral and lumbar as well as total bone mass is estimated by DEXA The ratio of intraperitoneal areavolume of fat to total abdominal areavolume is determined by MRI and likewise is also abdominal subcutaneous FM Finally BMI and waist-to-hip ratio are measured
Results
Initially a questionnaire providing us with basic demographic social occupational and other information about men from Funen aged 60 to 75 was randomly mailed to 4964 men Of these questionnaires 89 were returned and 852 of the returned questionnaires had been completed Afterwards 1650 people received an invitation by mail to get an introduction to the project via telephone Of these 1650 people 508 accepted to be contacted So far 762 people have been contacted in a randomly manner and of these people 74 have agreed to participate in the project In the beginning of April 2005 550 people have been included in Odense Androgen Study in the Elderly
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None