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

NCT01800370 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-05-12

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Hyperglycemia

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

DRUG

Saline

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

OTHER

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.

PROCEDURE

Blood Draws

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.

OTHER

Fasting procedure

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.

Sponsors & Collaborators

Principal Investigators

  • Johannes Veldhuis, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01800370 on ClinicalTrials.gov