Acute Effects of Gabapentin in Sleep Parameters and Hormonal Release During Sleep in Older Men
NCT ID: NCT02599701
Last Updated: 2016-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
8 participants
INTERVENTIONAL
2015-09-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Placebo
A single dose of placebo with exactly the same characteristics of the active drug at bedtime.
Placebo
A single placebo dose with the same physical characteristics of the active intervention.
Gabapentin
A single dose of Gabapentin 300mg at bedtime.
Gabapentin
A single dose Gabapentin 300mg at bedtime.
Interventions
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Gabapentin
A single dose Gabapentin 300mg at bedtime.
Placebo
A single placebo dose with the same physical characteristics of the active intervention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* healthy men
Exclusion Criteria
* 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
60 Years
MALE
Yes
Sponsors
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Associação Fundo de Incentivo à Pesquisa
OTHER
Responsible Party
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Dalva Poyares
Professor
Principal Investigators
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Sergio Tufik, PhD
Role: STUDY_CHAIR
AFIP - Associação Fundo de Incentivo a Pesquisa
Locations
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Instituto do Sono
São Paulo, São Paulo, Brazil
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Rosenberg KP. Gabapentin for chronic insomnia. Am J Addict. 2003 May-Jun;12(3):273-4. No abstract available.
Other Identifiers
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AFIP06/2015
Identifier Type: -
Identifier Source: org_study_id
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