The Effect of Mixed Exercise and Metabolic Stress Upon Pituitary Secretion in Relationship to Age in Healthy Men: a Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Testosterone concentration after 30 minutes of exercise
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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.
研究组 & 干预措施
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.
干预措施: Hyperglycemia (Drug)
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.
干预措施: Blood Draws (Procedure)
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.
干预措施: Fasting procedure (Other)
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.
干预措施: Saline (Drug)
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.
干预措施: Blood Draws (Procedure)
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.
干预措施: Fasting procedure (Other)
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.
干预措施: Exercise (Other)
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.
干预措施: Blood Draws (Procedure)
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.
干预措施: Fasting procedure (Other)
结局指标
主要结局
Change in Testosterone concentration after 30 minutes of exercise
时间窗: 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.
次要结局
未报告次要终点