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Vasopressin and V2 Receptor in Meniere's Disease

This study has been completed.
Sponsor:
Collaborator:
Osaka City University
Information provided by:
Osaka University
ClinicalTrials.gov Identifier:
NCT00599560
First received: January 10, 2008
Last updated: January 22, 2008
Last verified: January 2008
  Purpose

Summary: Some of sicknesses are well known to be provoked by inadequate adaptation to physical and/or psychogenic stress in their daily life. Meniere's disease is also a common inner ear disease accompanied with vertigo, hearing loss and tinnitus especially in civilized people under stressed life style. Its oto-pathology was firstly revealed in 1938 to be inner ear endolymphatic hydrops through the temporal bone study. To elucidate the neuroscientific relationship between "stress" and "inner ear", we examined plasma vasopressin (the anti-diuretic "stress" hormone) and its receptor, V2R in the endolymphatic sac (the "inner ear" endo-organ for endolymph absorption) in Meniere's patients.


Condition Intervention
Meniere Disease
Genetic: vasopressin, V2 receptor and cyclic AMP

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vasopressin and V2 Receptor in Meniere's Disease

Resource links provided by NLM:


Further study details as provided by Osaka University:

Primary Outcome Measures:
  • plasma vasopressin level and V2 receptor mRNA in the endolymphatic sac in Meniere's disease vs controls [ Time Frame: prospective ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • cyclic AMP activity in the endolymphatic sac in Meniere's disease vs controls [ Time Frame: prospective ] [ Designated as safety issue: Yes ]

Enrollment: 135
Study Start Date: April 1998
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1. Meniere's disease
Patients were eligible for enrollment if they had received a clinical diagnosis of Meniere's disease according to the 1995 AAO-HNS criteria (Committee, 1995). These criteria can be briefly described as follows: 1) Repeated attacks of vertigo: A definitive spell is spontaneous vertigo lasting at least 20 minutes. A mixed type of spontaneous nystagmus is observed during attacks. 2) Fluctuating cochlear symptoms: The hearing test usually reveals a marked fluctuation of the threshold in the low and middle tone range.
Genetic: vasopressin, V2 receptor and cyclic AMP
plasma vasopressin, V2 receptor, cyclic AMP
Other Names:
  • plasma vasopressin
  • V2 receptor
  • cyclic AMP
No Intervention: 2. Acoustic neurinoma
Diagnosed by CT and/or MRI
Genetic: vasopressin, V2 receptor and cyclic AMP
plasma vasopressin, V2 receptor, cyclic AMP
Other Names:
  • plasma vasopressin
  • V2 receptor
  • cyclic AMP

Detailed Description:

Methods: Between 1998 and 2006, we enrolled and assigned 105 intractable Meniere's patients to examine plasma vasopressin during remission of vertigo attacks (controls: 30 patients with chronic otitis media). Using the real-time PCR method, we examined V2R mRNA expression in the endolymphatic sac in 12 patients (controls: 6 patients with acoustic neurinoma). By means of cell culture and cyclic AMP assay, we also examined cyclic AMP activity in the endolymphatic sac in 3 patients (controls: 3 patients with acoustic neurinoma).

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients were eligible for enrollment if they had received a clinical diagnosis of Meniere's disease according to the 1995 AAO-HNS criteria (Committee, 1995). These criteria can be briefly described as follows:

    1. Repeated attacks of vertigo: A definitive spell is spontaneous vertigo lasting at least 20 minutes. A mixed type of spontaneous nystagmus is observed during attacks.
    2. Fluctuating cochlear symptoms: The hearing test usually reveals a marked fluctuation of the threshold in the low and middle tone range.

Exclusion Criteria:

  • Any other neuro-otologic diseases.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599560

Locations
Japan
Department of Otolaryngology, Osaka University, School of Medicine
Suita-city, Osaka, Japan, 565-0871
Sponsors and Collaborators
Osaka University
Osaka City University
Investigators
Principal Investigator: Tadashi Kitahara, M.D.,Ph.D. Department of ORL, Osaka University, School of Medicine
Study Director: Hiroshi Kiyama, Ph.D. Department of Neuroanatomy, Osaka City University, School of Medicine
Study Chair: Takeshi Kubo, M.D.,Ph.D. Department of ORL, Osaka University, School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Meniere's disease association at Osaka University, Tadashi Kitahara, M.D.,Ph.D.
ClinicalTrials.gov Identifier: NCT00599560     History of Changes
Other Study ID Numbers: tk19661218, Osaka Univ. School of Medicine
Study First Received: January 10, 2008
Last Updated: January 22, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Osaka University:
Meniere's disease
stress
vasopressin
endolymphatic sac
V2 receptor
cyclic AMP
Plasma vasopressin level and V2R mRNA expression level in the endolymphatic sac both were significantly higher in patients with Meniere's disease.
In Meniere's disease, there were significant negative co-relationships between vasopressin and V2R.
The cyclic AMP activity was basically up-regulated in the endolymphatic sac in Meniere's disease..
The cyclic AMP sensitivity for vasopressin was significantly elevated in the endolymphatic sac in Meniere's disease.

Additional relevant MeSH terms:
Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014