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

NCT01800370 | Completed Phase 1

• 1 other identifier: 12-007753
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; Male

Outcome Measures

Primary Outcomes (1)

• Change in Testosterone concentration after 30 minutes of 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

Study Arms (3)

Hyperglycemia

EXPERIMENTAL

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.

Drug: Hyperglycemia; Procedure: Blood Draws; Other: Fasting procedure

Saline

PLACEBO COMPARATOR

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.

Drug: Saline; Procedure: Blood Draws; Other: Fasting procedure

Exercise

EXPERIMENTAL

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.

Other: Exercise; Procedure: Blood Draws; Other: Fasting procedure

Interventions

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.

Hyperglycemia

Saline DRUG

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

Saline

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.

Exercise

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.

Exercise; Hyperglycemia; Saline

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.

Exercise; Hyperglycemia; Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Sodium Chloride; Exercise; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Johannes Veldhuis, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: February 27, 2013
• Study Start: February 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 12, 2014

Record last verified: 2014-05

Locations

US (1)