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

Associação Fundo de Incentivo à Pesquisa

Status and phase: Terminated; Phase 4

Conditions: Sleep

Treatments: Drug: Placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT02599701

AFIP06/2015

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 8 patients

Sex: Male

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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8 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

A single dose of placebo with exactly the same characteristics of the active drug at bedtime.

Treatment:

Drug: Placebo

Gabapentin

Experimental group

Description:

A single dose of Gabapentin 300mg at bedtime.

Treatment:

Drug: Gabapentin