Clinical trial NCT01800370: The Effect of Mixed Exercise and Metabolic Stress in Relationship to Age in Healthy Men
Official title: The Effect of Mixed Exercise and Metabolic Stress Upon Pituitary Secretion in Relationship to Age in Healthy Men: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Male
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Aging in men reduces the amount of luteinizing hormone (LH) and testosterone (Te) secreted in each burst. Stress-associated mechanisms introduced by acute illness and chronic disease decrease LH and Te secretion further. A major unresolved issue is whether the aging process heightens the negative effects of a stressor (whether physical or metabolic) upon LH and Te secretion. This study will assess LH and Te secretion in response to a physical stressor (maximal exercise) and a common metabolic stressor (hyperglycemia) as a function of age in healthy men ages 18-80 yr.


Eligibility criteria: Inclusion Criteria:

* Community dwelling, healthy men age 18 to 80
* Body-Mass Index (BMI) 18-30 kg/m2
* Willingness to provide written informed consent
* Physician acceptable screening ECG for participants 60 years and older

Exclusion Criteria:

* recent use of psychotropic or neuroactive drugs (within five biological half-live)
* obesity (outside weight range above)
* acute weight change (loss or gain of \>2 kg in 6 weeks
* Laboratory test results not deemed physician acceptable
* triglycerides \> 300
* BUN \>30
* creatinine \> 1.5 mg/dL
* liver functions tests twice upper limit of normal
* electrolyte abnormality
* anemia; hemoglobin \< 12.0 gm/dL
* drug or alcohol abuse
* psychosis, depression, mania or severe anxiety
* acute or chronic organ-system disease
* endocrinopathy, other than primary thyroidal failure receiving replacement
* untreated osteoporosis
* nightshift work or recent transmeridian travel (exceeding 3 time zones within 7 days of admission)
* PSA \> 4.0 ng/mL, History or suspicion of prostatic disease (elevated PSA,indeterminate nodule or mass, obstructive uropathy)
* History of carcinoma (excluding localized basal cell carcinoma removed or surgically treated with no recurrence
* History of thrombotic arterial disease (stroke, TIA, MI, angina) or deep vein thrombophlebitis
* History of CHF, cardiac arrhythmias, congential QT prolongation, and medications used to treat cardiac arrhythmias
* Gynecomastia \> 2 cm, untreated
* Untreated gallbladder disease
* History of smoking greater than one ppd.

Primary outcomes:
measure: Change in Testosterone concentration after 30 minutes of exercise
timeFrame: 30 minutes after initiating exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Johannes Veldhuis, MD
role: PRINCIPAL_INVESTIGATOR
References: