The Effect of Mixed Exercise and Metabolic Stress in Relationship to Age in Healthy Men
May 9, 2014 updated by: Johannes D. Veldhuis, Mayo Clinic
The Effect of Mixed Exercise and Metabolic Stress Upon Pituitary Secretion in Relationship to Age in Healthy Men: a Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hyperglycemia
Hyperglycemia (rest controlled) will be induced by i.v.
injection of 25 mL of dextrose 50% over 3 minutes with the subject supine.
Includes blood draws and fasting requirements.
|
Hyperglycemia (rest controlled) will be induced by i.v.
injection of 25 mL of dextrose 50% over 3 minutes with the subject supine.
Blood will be sampled every 10 min from 0700 to 1300 h.
Each intervention will begin at 0800 h after 1 h of baseline sampling, and be completed by 0900 h.
Intervention is followed by 4 additional h of sampling to capture recovery (total sampling 6 h).
Ten-min samples are for Te, LH, ACTH, cortisol, and GH.
Glucose will be checked every 30 min.
At 07000 h an archival serum sample will be obtained for safety-monitoring purposes.
Beginning at 1900 h on the evening prior to each study visit, subjects will remain fasting except for water, diet soda, and other non-caloric and non-caffeinated fluids, until 1300 h the next day.
|
|
Placebo Comparator: Saline
Saline (rest controlled) will be induced by i.v.
injection of 25 mL of saline over 3 minutes with the subject supine.
Includes blood draws and fasting requirements.
|
Blood will be sampled every 10 min from 0700 to 1300 h.
Each intervention will begin at 0800 h after 1 h of baseline sampling, and be completed by 0900 h.
Intervention is followed by 4 additional h of sampling to capture recovery (total sampling 6 h).
Ten-min samples are for Te, LH, ACTH, cortisol, and GH.
Glucose will be checked every 30 min.
At 07000 h an archival serum sample will be obtained for safety-monitoring purposes.
Beginning at 1900 h on the evening prior to each study visit, subjects will remain fasting except for water, diet soda, and other non-caloric and non-caffeinated fluids, until 1300 h the next day.
Saline (rest controlled) will be induced by i.v.
injection of 25 mL of saline over 3 minutes with the subject supine.
|
|
Experimental: Exercise
Monitored exercise of 7-minute biking, 2-minute arm weights and a blood draw at the 10-minute time point will be repeated 3 times,which takes 30 minutes. Bilateral arm curls begin at 20 pounds and decrease by 5 pounds as needed to sustain 2 minutes of exercise at a rate of 1 complete curl every 2 seconds. Includes blood draws and fasting requirements. |
Blood will be sampled every 10 min from 0700 to 1300 h.
Each intervention will begin at 0800 h after 1 h of baseline sampling, and be completed by 0900 h.
Intervention is followed by 4 additional h of sampling to capture recovery (total sampling 6 h).
Ten-min samples are for Te, LH, ACTH, cortisol, and GH.
Glucose will be checked every 30 min.
At 07000 h an archival serum sample will be obtained for safety-monitoring purposes.
Beginning at 1900 h on the evening prior to each study visit, subjects will remain fasting except for water, diet soda, and other non-caloric and non-caffeinated fluids, until 1300 h the next day.
Monitored exercise of 7-minute biking, 2-minute arm weights and a blood draw at the 10-minute time point will be repeated 3 times,which takes 30 minutes. Bilateral arm curls begin at 20 pounds and decrease by 5 pounds as needed to sustain 2 minutes of exercise at a rate of 1 complete curl every 2 seconds. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Testosterone concentration after 30 minutes of exercise
Time Frame: 30 minutes after initiating exercise
|
During the exercise visit subjects will perform an exercise test on a bike and lift weights with both arms for a total of 30 minutes.
|
30 minutes after initiating exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
February 15, 2013
First Submitted That Met QC Criteria
February 25, 2013
First Posted (Estimate)
February 27, 2013
Study Record Updates
Last Update Posted (Estimate)
May 12, 2014
Last Update Submitted That Met QC Criteria
May 9, 2014
Last Verified
May 1, 2014
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.