HealthyPhase 1NCT01800370
The Effect of Mixed Exercise and Metabolic Stress in Relationship to Age in Healthy Men
A Phase 1 study testing Hyperglycemia, Saline and Exercise in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hyperglycemia, Saline and Exercise
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Effect of Mixed Exercise and Metabolic Stress Upon Pituitary Secretion in Relationship to Age in Healthy Men: a Pilot Study
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
- Being tested
- Hyperglycemia, Saline, Exercise, Blood Draws, Fasting procedure
- Keywords
- Healthy, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperglycemiaDrug
Hyperglycemia (rest controlled) will be induced by i.v. injection of 25 mL of dextrose 50% over 3 minutes with the subject supine.
SalineDrug
Saline (rest controlled) will be induced by i.v. injection of 25 mL of saline over 3 minutes with the subject supine.
ExerciseOther
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.
Blood DrawsProcedure or surgery
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.
Fasting procedureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Exercise; Procedure: Blood Draws; Other: Fasting procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes after initiating exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes D. Veldhuis, Mayo Clinic
- Investigators
- Johannes Veldhuis, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800370
- Sponsor's protocol ID
- 12-007753
- Status last verified
- May 2014
- First submitted
- 15 Feb 2013
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mixed Exercise and Metabolic Stress Upon Pituitary Secretion in Relationship to Age in Healthy Men: a Pilot Study
- ClinicalTrials.gov ID
- NCT01800370
- Acronym / sponsor ID
- 12-007753
- Conditions
- Healthy
- Keywords
- Healthy, Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyperglycemia | Experimental | Drug: Hyperglycemia, Procedure: Blood Draws, Other: Fasting procedureHyperglycemia (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 | Placebo comparator | Drug: Saline, Procedure: Blood Draws, Other: Fasting procedureSaline (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 | Experimental | Other: Exercise, Procedure: Blood Draws, Other: Fasting procedureMonitored 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyperglycemiaHyperglycemia (rest controlled) will be induced by i.v. injection of 25 mL of dextrose 50% over 3 minutes with the subject supine. | Drug | Hyperglycemia |
| SalineSaline (rest controlled) will be induced by i.v. injection of 25 mL of saline over 3 minutes with the subject supine. | Drug | Saline |
| ExerciseMonitored 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. | Other | Exercise |
| Blood DrawsBlood 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. | Procedure or surgery | Exercise, Hyperglycemia, Saline |
| Fasting procedureBeginning 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. | Other | Exercise, Hyperglycemia, Saline |
Primary outcome
Change in Testosterone concentration after 30 minutes of exercise
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Veldhuis, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyperglycemia, Saline and Exercise in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Testosterone concentration after 30 minutes of exercise (time frame: 30 minutes after initiating exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2014.