Status:
COMPLETED
The Effect of Mixed Exercise and Metabolic Stress in Relationship to Age in Healthy Men
Lead Sponsor:
Mayo Clinic
Conditions:
Healthy
Eligibility:
MALE
18-80 years
Phase:
PHASE1
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 T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01800370
Start Date
February 1 2013
End Date
April 1 2014
Last Update
May 12 2014
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905