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

Sleep Clinical Trial

Official title:

Acute Effects of Gabapentin on Polysomnography Parameters and on Hypothalamic-pituitary-adrenal, Hypothalamic-pituitary-gonadal and Somatotropic Axes During Sleep in Older Men: a Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02599701
• Other study ID #: AFIP06/2015
• Status: Terminated
• Phase: Phase 4
• First received: July 21, 2015
• Last updated: July 12, 2016
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Associação Fundo de Incentivo à Pesquisa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à Pesquisa
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep

Intervention

Drug:
• Gabapentin
A single dose Gabapentin 300mg at bedtime.
• Placebo
A single placebo dose with the same physical characteristics of the active intervention.

Locations

Country	Name	City	State
Brazil	Instituto do Sono	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Associação Fundo de Incentivo à Pesquisa

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Dattilo M, Antunes HK, Medeiros A, Mônico Neto M, Souza HS, Tufik S, de Mello MT. Sleep and muscle recovery: endocrinological and molecular basis for a new and promising hypothesis. Med Hypotheses. 2011 Aug;77(2):220-2. doi: 10.1016/j.mehy.2011.04.017. Epub 2011 May 7. — View Citation

Foldvary-Schaefer N, De Leon Sanchez I, Karafa M, Mascha E, Dinner D, Morris HH. Gabapentin increases slow-wave sleep in normal adults. Epilepsia. 2002 Dec;43(12):1493-7. — View Citation

Giannoulis MG, Martin FC, Nair KS, Umpleby AM, Sonksen P. Hormone replacement therapy and physical function in healthy older men. Time to talk hormones? Endocr Rev. 2012 Jun;33(3):314-77. doi: 10.1210/er.2012-1002. Epub 2012 Mar 20. Review. — View Citation

Giustina A, Veldhuis JD. Pathophysiology of the neuroregulation of growth hormone secretion in experimental animals and the human. Endocr Rev. 1998 Dec;19(6):717-97. Review. — View Citation

Penev P, Spiegel K, L'Hermite-Balériaux M, Schneider R, Van Cauter E. Relationship between REM sleep and testosterone secretion in older men. Ann Endocrinol (Paris). 2003 Apr;64(2):157. — View Citation

Rosenberg KP. Gabapentin for chronic insomnia. Am J Addict. 2003 May-Jun;12(3):273-4. — View Citation

Saletu M, Anderer P, Saletu-Zyhlarz GM, Parapatics S, Gruber G, Nia S, Saletu B. Comparative placebo-controlled polysomnographic and psychometric studies on the acute effects of gabapentin versus ropinirole in restless legs syndrome. J Neural Transm (Vienna). 2010 Apr;117(4):463-73. doi: 10.1007/s00702-009-0361-3. Epub 2010 Jan 5. — View Citation

Van Cauter E, Latta F, Nedeltcheva A, Spiegel K, Leproult R, Vandenbril C, Weiss R, Mockel J, Legros JJ, Copinschi G. Reciprocal interactions between the GH axis and sleep. Growth Horm IGF Res. 2004 Jun;14 Suppl A:S10-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.	No
Primary	IGF-1	It will be included in the analysis of the last sample collected for GH, testosterone and cortisol measurements at 06:00.	Immediately after the sleep night in that gabapentin or placebo dose were given at bedtime.	No
Secondary	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).	During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.	No
Secondary	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).	During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.	No
Secondary	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).	During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.	No
Secondary	Apnea-Hypopnea Index during sleep	Sedative drugs may increase asymptomatic airway collapsability during sleep mainly in older individuals	During only one sleep night immediately after a single gabapentin or placebo dose at bedtime. a single gabapentin or placebo dose at bedtime.	Yes
Secondary	Slow Wave Sleep - Stage N3	Full sleep night polysomnographic recording.	During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.	No