Completed

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

What is being tested

Hyperglycemia

+ Blood Draws

+ Fasting procedure

DrugProcedureOther

Who is being recruted

From 18 to 80 Years

+27 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-ControlledPhase 1

Interventional

Study Start: February 2013

See protocol details

Summary

Principal SponsorMayo Clinic

Last updated: May 12, 2014

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01800370

Principal SponsorMayo Clinic

Last updated: May 12, 2014

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

Body-Mass Index (BMI) 18-30 kg/m2

Community dwelling, healthy men age 18 to 80

Physician acceptable screening ECG for participants 60 years and older

Willingness to provide written informed consent

23 exclusion criteria prevent from participating

BUN > 30

Gynecomastia > 2 cm, untreated

History of CHF, cardiac arrhythmias, congential QT prolongation, and medications used to treat cardiac arrhythmias

History of carcinoma (excluding localized basal cell carcinoma removed or surgically treated with no recurrence

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

Placebo

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.

Group III

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Mayo Clinic in Rochester

Rochester, United StatesOpen Mayo Clinic in Rochester in Google Maps

CompletedOne Study Center