- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01800370
The Effect of Mixed Exercise and Metabolic Stress in Relationship to Age in Healthy Men
The Effect of Mixed Exercise and Metabolic Stress Upon Pituitary Secretion in Relationship to Age in Healthy Men: a Pilot Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic in Rochester
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
Hyperglycemia (rest controlled) will be induced by i.v.
injection of 25 mL of dextrose 50% over 3 minutes with the subject supine.
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.
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.
|
Placebo komparator: 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.
|
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.
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.
Saline (rest controlled) will be induced by i.v.
injection of 25 mL of saline over 3 minutes with the subject supine.
|
Eksperimentel: 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. |
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.
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.
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Testosterone concentration after 30 minutes of exercise
Tidsramme: 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.
|
30 minutes after initiating exercise
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 12-007753
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