Acute Effects of Gabapentin on Polysomnography Parameters and on Hypothalamic-pituitary-adrenal, Hypothalamic-pituitary-gonadal and Somatotropic Axes During Sleep in Older Men: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Growth Hormone Secretion
研究概览
简要总结
The primary objective of this study is to evaluate the effects of gabapentin in sleep polysomnography parameters and in nocturnal secretion of endogenous hypothalamic-pituitary-adrenal (HPA), hypothalamic-pituitary-gonadal (HPG) and somatotropic axes hormones and basal IGF-1 in older men.
详细描述
The influence of sleep variables on muscle protein anabolism is little studied, but data on the effects of slow-wave sleep and the syndrome of obstructive sleep apnea on the hypothalamic-pituitary axis indicate that interventions in the sleep structure and disorders impact on the age-related muscle loss. Thus, we propose to assess the acute effects of a drug potentially capable of increasing slow wave sleep, and consequently growth hormone release during sleep, on the physiological release of growth hormone, testosterone and IGF-1 during the night in older healthy men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •60 years old or more,
- •healthy men
排除标准
- •Basal Apnea-Hypopnea index (aHI)>=15
- •Restless Legs Syndrome Symptons
- •BMI less than 18.5 kg/m2 or greater than 30 kg/m2
- •Less than 30 min. of regular physical activity (at least walking inside home, etc.)
- •Plasma albumin below 3.5 mg/dL
- •Psychoactive drugs use
- •Drugs with muscle anabolic potential
- •Current treatment for obesity or weight gain
- •Enteral or parenteral feeding
- •Inability to walk without assistance,
- •Loss of independence in any activity of daily living
- •Nocturia above 2 episodes
- •Smoking more than 2 cigarettes per day
- •Alcoholism (more than 2 doses a day)
- •Prior epilepsy diagnosis
- •Clinically evident atherosclerotic disease
- •Depression
- •Rheumatic diseases
- •Diabetes (poorly controlled, HbA1C > 7,0, requirement of insulin)
- •Thyroid dysfunction without treatment
- •Advanced stages in COPD, HF, liver or renal failure
研究组 & 干预措施
Placebo
A single dose of placebo with exactly the same characteristics of the active drug at bedtime.
干预措施: Placebo (Drug)
Gabapentin
A single dose of Gabapentin 300mg at bedtime.
干预措施: Gabapentin (Drug)
结局指标
主要结局
Growth Hormone Secretion
时间窗: During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.
Every 20 minutes after admission to the laboratory, blood samples (2.5 mL) for GH measurement will be collected (between 20:00 - or 2 hours before lights off - and 06:00).
IGF-1
时间窗: Immediately after the sleep night in that gabapentin or placebo dose were given at bedtime.
It will be included in the analysis of the last sample collected for GH, testosterone and cortisol measurements at 06:00.
次要结局
- Total testosterone(During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.)
- Apnea-Hypopnea Index during sleep(During only one sleep night immediately after a single gabapentin or placebo dose at bedtime. a single gabapentin or placebo dose at bedtime.)
- Slow Wave Sleep - Stage N3(During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.)
- Free testosterone(During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.)
- Cortisol(During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.)
研究者
Dalva Poyares
Professor
Associação Fundo de Incentivo à Pesquisa