Hormonal Mechanisms of Sleep Restriction
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Insulin Sensitivity
研究概览
简要总结
The purpose of this study is to study the effects of sleep restriction on the production of two hormones, cortisol and testosterone. The investigators aim to show that changing these hormones leads to insulin resistance, which is an important cause of type 2 diabetes mellitus. The investigators may also study the effect of sleep restriction on your food intake and cravings, mood, inflammation, metabolism (including bone), and other hormones. Inflammation is your body's response to stress and injury. Bone metabolism is a process of how your body regenerates (renews) new bone cells and removes old bone cells. Hormones are natural substances (materials) that are produced in the body and that influences (effects) the way the body grows or develops.
详细描述
Screening Visits
-
To see if you are able to take part in this study, you will first have an outpatient visit at the CTRC (Clinical and Translational Research Center). This visit will take about 90 minutes.
-
The following tests/procedures will be done at this visit:
-
We will ask you about your medical history and past health
-
We will give you a physical examination (including digital rectal examination of the prostate gland if you are over the age of 40)
-
We will ask you to answer sleep, mood and general health screening questionnaires.
-
We will ask you to complete a questionnaire to help us understand how testosterone and other hormones control sexual function and drive.
-
We will draw about 1 tablespoon of blood from a needle placed in a vein in your arm for routine safety tests and to check to see if you have any hormonal problems.
-
We will give you an ECG (recording of heartbeat). For this test we will attach 12-lead sensors to your chest.
-
We will collect urine sample from you for a drug screening test.
-
A dietitian will review meal plans for the inpatient stay (Study Visit 1 and 3 only).
If the first screening visit shows that you are able to continue to take part in this study, you will continue the screening part of the study at home. The following will be done at home: We will ask you to undergo an at-home actigraphy and keep a daily sleep diary for two weeks to document your sleeping habits. For the actigraphy you will be asked to wear a small wrist-watch like device. This device will monitor and record your motion, and will also test your sleep and wake periods. It may be worn for up to 2 weeks, 24 hours per day (except while taking a shower).
If the results of the at-home actigraphy show that you are still able to take part in this study, you will continue the final part of the screening procedure which is an inpatient visit to conduct a sleep study. The following tests/procedures will be done for this final screening visit: We will ask you to come into the sleep laboratory to sleep overnight (sleep study). A technician will attach the leads (wires) to your body and you will need to keep these leads on during the night. The attached wires will be connected to a machine to measure chest and abdominal (stomach area) movements, airflow at your mouth and lips, blood oxygen level, muscle tone, eye movements, heart rate and electrical activity of the brain. In the morning, the technician will remove the attached wires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 22-45 years
- •Willingness to provide written informed consent
- •Stable weight over preceding 6 weeks
- •Body Mass index (BMI) 20-28 kg/m2
排除标准
- •Unable or unwilling to provide IRB-approved informed consent
- •Clinical disorders and/or illnesses
- •Current medical or drug treatment, as assessed by questionnaire
- •History of brain injury or of learning disability
- •Vision or hearing impairment unless corrected back to normal
- •Anemia (Hct <38%)
- •History of psychiatric illness
- •Clinically significant abnormalities in blood and urine, and free of traces of drugs Other endocrine abnormalities including hypothyroidism or adrenal failure; primary gonadal disease as indicated by serum LH or FSH concentration >10 or >15 IU/L, respectively, hyperprolactinemia indicated by prolactin >25ug/L
- •Type 2 Diabetes (HgbA1C)
- •Current smoker
- •Recent or concurrent drug or alcohol abuse
- •Blood donation in previous eight weeks
- •Travel across time zones within one month of entering the study
- •Sleep or circadian disorder
- •Shift work within three months of entering the study
- •Irregular bedtimes (not between 6 and 10 hours in duration)
- •Unoperated obstructive uropathy, recurrent prostatitis, indeterminate prostatic nodularity, Hx or Suspicion of cancer of the prostate gland or PSA >4ng/ml
- •Previous adverse reaction to sleep deprivation or any of the drugs to be administered
- •Concurrent participation in another research study
研究组 & 干预措施
Placebo and Drug Group 2
Placebo pills and gel is used in place. Placebo for Ketoconazole is taken 4 times a day Placebo for Hydrocortisone is taken 3 times a day Placebo for testosterone gel is applied once a day.
干预措施: Ketoconazole (Drug)
Placebo and Drug Group 2
Placebo pills and gel is used in place. Placebo for Ketoconazole is taken 4 times a day Placebo for Hydrocortisone is taken 3 times a day Placebo for testosterone gel is applied once a day.
干预措施: Hydrocortisone (Drug)
Placebo and Drug Group 2
Placebo pills and gel is used in place. Placebo for Ketoconazole is taken 4 times a day Placebo for Hydrocortisone is taken 3 times a day Placebo for testosterone gel is applied once a day.
干预措施: Testosterone (Drug)
Placebo and Drug Group 2
Placebo pills and gel is used in place. Placebo for Ketoconazole is taken 4 times a day Placebo for Hydrocortisone is taken 3 times a day Placebo for testosterone gel is applied once a day.
干预措施: Placebo for ketoconazole (Drug)
Placebo and Drug Group 2
Placebo pills and gel is used in place. Placebo for Ketoconazole is taken 4 times a day Placebo for Hydrocortisone is taken 3 times a day Placebo for testosterone gel is applied once a day.
干预措施: Placebo for hydrocortisone (Drug)
Placebo and Drug Group 2
Placebo pills and gel is used in place. Placebo for Ketoconazole is taken 4 times a day Placebo for Hydrocortisone is taken 3 times a day Placebo for testosterone gel is applied once a day.
干预措施: Placebo for testosterone (Drug)
Drug and Placebo Group 1
Ketoconazole is taken 4 times a day Hydrocortisone is taken 3 times a day Testosterone gel is applied once a day
干预措施: Ketoconazole (Drug)
Drug and Placebo Group 1
Ketoconazole is taken 4 times a day Hydrocortisone is taken 3 times a day Testosterone gel is applied once a day
干预措施: Hydrocortisone (Drug)
Drug and Placebo Group 1
Ketoconazole is taken 4 times a day Hydrocortisone is taken 3 times a day Testosterone gel is applied once a day
干预措施: Testosterone (Drug)
Drug and Placebo Group 1
Ketoconazole is taken 4 times a day Hydrocortisone is taken 3 times a day Testosterone gel is applied once a day
干预措施: Placebo for ketoconazole (Drug)
Drug and Placebo Group 1
Ketoconazole is taken 4 times a day Hydrocortisone is taken 3 times a day Testosterone gel is applied once a day
干预措施: Placebo for hydrocortisone (Drug)
Drug and Placebo Group 1
Ketoconazole is taken 4 times a day Hydrocortisone is taken 3 times a day Testosterone gel is applied once a day
干预措施: Placebo for testosterone (Drug)
结局指标
主要结局
Insulin Sensitivity
时间窗: 3 years
Insulin sensitivity determined by minimal model of a frequently sampled oral glucose tolerance test (OGTT).This method is extensively validated, and previously utilized by us.
次要结局
- Karolinska Sleepiness Scale(3 years)
- Urinary Catecholamines(3 years)
- Free Fatty Acid Concentrations(3 years)
- Computerized cognitive testing(3 years)
- Food cravings,(3 years)
- Food intake(3 years)
- Disposition index(3 years)
- C-peptide glucose dose-response(3 years)
- Inflammatory marker panel(3 years)
- Lapses on Psychomotor Vigilance Task(3 years)
- Heart Rate Variability(3 years)
- Assessment of mood states.(3 years)
- Bone turnover panel(3 years)
- Hunger measurement(3 years)
研究者
Peter y. Liu
Principal Investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center