Hormonal Mechanisms of Sleep Restriction - Axis Study

Peter y. Liu1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2017年5月8日最近更新: 2025年9月11日

适应症

干预措施

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Peter y. Liu
入组人数: 80
试验地点: 1
主要终点: Average Blood Cortisol Concentration

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.

详细描述

Sleep restriction increases evening cortisol and decreases testosterone. These are the main catabolic and anabolic hormones in men, respectively. This catabolic-anabolic imbalance likely leads to metabolic and reproductive ill-health. The hypothalamic-pituitary-end organ (adrenal or testis) mechanisms that must underpin these changes are unknown. This study will administer drugs to clamp the function of each of these nodes to determine the regulatory changes that have occurred with sleep restriction. Even though the study is randomized order in design, the main comparison is before and after sleep restriction under each of these clamp conditions. Participants are admitted to the chronobiology laboratory where they are given 1 night of 10 hours sleep opportunity, followed by 4 nights of 4 hours sleep opportunity. Up to 80 participants (assuming twenty different participant for each of the 4 clamp conditions) can be enrolled. However, participants will be allowed an opportunity to be randomized to all 4 conditions so that as few as 20 participants may be required. Urn randomization will be used to ensure that 20 different participants are involved in each of the 4 conditions.

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: Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

3 of the 4 conditions are masked by use of identical injections and pills. However one condition (adrenal testis) is not masked. Hence the study is partially masked.

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 (Internal Review Board)-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 (luteinizing hormone) or FSH (follicle stimulating hormone) 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 (prostate-specific antigen) >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

Control Condition

Experimental

8 am - Saline Solution for Injection 10 am - Placebo oral capsule

1 pm - Saline Solution for Injection 4 pm - Placebo oral capsule & start hourly blood sampling 7 pm - Gonadorelin (GnRH) and Corticorelin (CRH) injections 9 pm - Saline Solution for Injection & last blood sample

干预措施: Gonadorelin (Drug)

Control Condition

Experimental

8 am - Saline Solution for Injection 10 am - Placebo oral capsule

干预措施: Corticorelin (Drug)

Control Condition

Experimental

8 am - Saline Solution for Injection 10 am - Placebo oral capsule

干预措施: Placebo oral capsule (Drug)

Control Condition

Experimental

8 am - Saline Solution for Injection 10 am - Placebo oral capsule

干预措施: Saline Solution (Drug)

Control Condition

Experimental

8 am - Saline Solution for Injection 10 am - Placebo oral capsule

干预措施: Saline Solution for Injection (Drug)