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

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Mayo Clinic

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Saline
Procedure: Blood Draws
Drug: Hyperglycemia
Other: Fasting procedure
Other: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT01800370
12-007753

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Male

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

40 participants in 3 patient groups, including a placebo group

Hyperglycemia
Experimental group
Description:
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.
Treatment:
Other: Fasting procedure
Drug: Hyperglycemia
Procedure: Blood Draws
Saline
Placebo Comparator group
Description:
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.
Treatment:
Other: Fasting procedure
Procedure: Blood Draws
Drug: Saline
Exercise
Experimental group
Description:
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.
Treatment:
Other: Exercise
Other: Fasting procedure
Procedure: Blood Draws

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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