Sleep
Conditions
Keywords
Delta Sleep, Growth Hormone, IGF-1
Brief summary
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
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.
Interventions
DRUGGabapentin
A single dose Gabapentin 300mg at bedtime.
DRUGPlacebo
A single placebo dose with the same physical characteristics of the active intervention.
Sponsors
Associação Fundo de Incentivo à Pesquisa
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth Hormone Secretion | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cortisol | 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 cortisol measurement will be collected (between 20:00 - or 2 hours before lights off - and 06:00). |
| Total testosterone | 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 free and total testosterone measurements will be collected (between 20:00 - or 2 hours before lights off - and 06:00). |
| Slow Wave Sleep - Stage N3 | During only one sleep night immediately after a single gabapentin or placebo dose at bedtime. | Full sleep night polysomnographic recording. |
| 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. | Sedative drugs may increase asymptomatic airway collapsability during sleep mainly in older individuals |
| Free testosterone | 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 free and total testosterone measurements will be collected (between 20:00 - or 2 hours before lights off - and 06:00). |
Countries
Brazil
Outcome results
None listed