The Effect of Mixed Exercise and Metabolic Stress in Relationship to Age in Healthy Men
9 de mayo de 2014 actualizado por: Johannes D. Veldhuis, Mayo Clinic
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic in Rochester
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
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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.
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Comparador de placebos: 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.
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Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Testosterone concentration after 30 minutes of exercise
Periodo de tiempo: 30 minutes after initiating exercise
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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.
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30 minutes after initiating exercise
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de febrero de 2013
Finalización primaria (Actual)
1 de abril de 2014
Finalización del estudio (Actual)
1 de abril de 2014
Fechas de registro del estudio
Enviado por primera vez
15 de febrero de 2013
Primero enviado que cumplió con los criterios de control de calidad
25 de febrero de 2013
Publicado por primera vez (Estimar)
27 de febrero de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
12 de mayo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
9 de mayo de 2014
Última verificación
1 de mayo de 2014
Más información
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .