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Completed

NCT Number: NCT01800370

The Effect of Mixed Exercise and Metabolic Stress in Relationship to Age in Healthy Men

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.

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyperglycemia

Drug

Hyperglycemia (rest controlled) will be induced by i.v. injection of 25 mL of dextrose 50% over 3 minutes with the subject supine.

Saline

Drug

Saline (rest controlled) will be induced by i.v. injection of 25 mL of saline over 3 minutes with the subject supine.

Exercise

Other

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.

Blood draws

Procedure

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.

Fasting procedure

Other

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Effect of Mixed Exercise and Metabolic Stress Upon Pituitary Secretion in Relationship to Age in Healthy Men: a Pilot Study

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 27, 2013
Registry last updated
May 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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