Metabolic Syndrome Clinical Trial
Official title:
Odense Androgen Study in the Elderly
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.
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 a.m. 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
area/volume of fat to total abdominal area/volume 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 4,964 men. Of
these questionnaires, 89% were returned and 85.2% of the returned questionnaires had been
completed. Afterwards 1,650 people received an invitation by mail to get an introduction to
the project via telephone. Of these 1,650 people 50.8% 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.
;
Allocation: Random Sample, Primary Purpose: Screening, Time Perspective: Cross-Sectional
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