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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Saline; Drug: Hyperglycemia; Other: Exercise; Procedure: Blood Draws; Other: Fasting procedure

• Registration Number: NCT01800370
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-15
• Study First Submitted QC: 2013-02-25
• Study First Posted: 2013-02-27
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hyperglycemia	Blood Draws	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	Fasting procedure	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.
Saline	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.
Hyperglycemia	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.
Saline	Blood Draws	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.
Saline	Fasting procedure	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.
Exercise	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.
Exercise	Blood Draws	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.
Exercise	Fasting procedure	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.

Primary Outcome Measures

Name	Time	Method
Change in Testosterone concentration after 30 minutes of exercise	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States