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

NCT02599701 | Terminated Phase 4

• 1 other identifier: AFIP06/2015
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 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.

Conditions

Sleep

Keywords

Delta Sleep; Growth Hormone; IGF-1

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Secondary Outcomes (5)

• Total testosterone

  During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.

• Free testosterone

  During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.

• Cortisol

  During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.

• 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.

• Slow Wave Sleep - Stage N3

  During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Gabapentin

EXPERIMENTAL

A single dose of Gabapentin 300mg at bedtime.

Drug: Gabapentin

Interventions

Gabapentin DRUG

A single dose Gabapentin 300mg at bedtime.

Also known as: Neurontin

Gabapentin

Placebo DRUG

A single placebo dose with the same physical characteristics of the active intervention.

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or more,
• healthy men

You may not qualify if:

• 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

Sponsors & Collaborators

• Associação Fundo de Incentivo à Pesquisa: lead

Study Sites (1)

Instituto do Sono

São Paulo, São Paulo, 04024-002, Brazil

Location

Related Publications (8)

• 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.

  PMID: 22433122 BACKGROUND

• 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. doi: 10.1210/edrv.19.6.0353.

  PMID: 9861545 BACKGROUND

• Dattilo M, Antunes HK, Medeiros A, Monico 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.

  PMID: 21550729 BACKGROUND

• Penev P, Spiegel K, L'Hermite-Baleriaux M, Schneider R, Van Cauter E. Relationship between REM sleep and testosterone secretion in older men. Ann Endocrinol (Paris). 2003 Apr;64(2):157. No abstract available.

  PMID: 12773954 BACKGROUND

• 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. doi: 10.1016/j.ghir.2004.03.006.

  PMID: 15135771 BACKGROUND

• 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.

  PMID: 20049491 BACKGROUND

• 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. doi: 10.1046/j.1528-1157.2002.21002.x.

  PMID: 12460250 BACKGROUND

• Rosenberg KP. Gabapentin for chronic insomnia. Am J Addict. 2003 May-Jun;12(3):273-4. No abstract available.

  PMID: 12851024 BACKGROUND

MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sergio Tufik, PhD

  AFIP - Associação Fundo de Incentivo a Pesquisa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: November 9, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

BR (1)