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

Phase 4TerminatedNCT02599701

Associação Fundo de Incentivo à Pesquisa8 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sleep

Interventions

GabapentinDRUG

A single dose Gabapentin 300mg at bedtime.

PlaceboDRUG

A single placebo dose with the same physical characteristics of the active intervention.

Eligibility

Sex: MALEMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Instituto do Sono

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: Immediately after the sleep night in that gabapentin or placebo dose were given at bedtime.

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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

Data from ClinicalTrials.gov

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