Acute Effects of Gabapentin in Sleep Parameters and Hormonal Release During Sleep in Older Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Sleep

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 years old or more, healthy men Exclusion Criteria: 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 Dementia Depression Rheumatic diseases Cancer Diabetes (poorly controlled, HbA1C > 7,0, requirement of insulin) Thyroid dysfunction without treatment Advanced stages in COPD, HF, liver or renal failure

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>A single dose of placebo with exactly the same characteristics of the active drug at bedtime. | Drug: Placebo<br>* A single placebo dose with the same physical characteristics of the active intervention.<br>|
| Experimental: Gabapentin<br>A single dose of Gabapentin 300mg at bedtime. | Drug: Gabapentin<br>* A single dose Gabapentin 300mg at bedtime.<br>* Other names: Neurontin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth Hormone Secretion | 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). | During only one sleep night immediately after a single gabapentin or placebo dose at bedtime. | 
| IGF-1 | It will be included in the analysis of the last sample collected for GH, testosterone and cortisol measurements at 06:00. | Immediately after the sleep night in that gabapentin or placebo dose were given at bedtime. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total testosterone | Every 20 minutes after admission to the laboratory, blood samples (2.5 mL) for free and total testosterone measurements will be collected (between 20:00 - or 2 hours before lights off - and 06:00). | During only one sleep night immediately after a single gabapentin or placebo dose at bedtime. | 
| Free testosterone | Every 20 minutes after admission to the laboratory, blood samples (2.5 mL) for free and total testosterone measurements will be collected (between 20:00 - or 2 hours before lights off - and 06:00). | During only one sleep night immediately after a single gabapentin or placebo dose at bedtime. | 
| Cortisol | Every 20 minutes after admission to the laboratory, blood samples (2.5 mL) for cortisol measurement will be collected (between 20:00 - or 2 hours before lights off - and 06:00). | During only one sleep night immediately after a single gabapentin or placebo dose at bedtime. | 
| Apnea-Hypopnea Index during sleep | Sedative drugs may increase asymptomatic airway collapsability during sleep mainly in older individuals | 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 | Full sleep night polysomnographic recording. | During only one sleep night immediately after a single gabapentin or placebo dose at bedtime. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delta Sleep, Growth Hormone, IGF-1