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