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

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Associação Fundo de Incentivo à Pesquisa
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

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