Clinical trial NCT00599560: Vasopressin and V2 Receptor in Meniere's Disease
Official title: Vasopressin and V2 Receptor in Meniere's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniere Disease
Keywords: 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.
Lead sponsor: Osaka University
Sponsor class: OTHER
Collaborators: name: Osaka City University
First posted: 2008-01-23
Enrollment: 135
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: plasma vasopressin level and V2 receptor mRNA in the endolymphatic sac in Meniere's disease vs controls
timeFrame: prospective
Secondary outcomes:
measure: cyclic AMP activity in the endolymphatic sac in Meniere's disease vs controls
timeFrame: prospective
Other outcomes:
Locations:
city: Suita-city
country: Japan
facility: Department of Otolaryngology, Osaka University, School of Medicine
state: Osaka
Study officials:
affiliation: Department of ORL, Osaka University, School of Medicine
name: Tadashi Kitahara, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neuroanatomy, Osaka City University, School of Medicine
name: Hiroshi Kiyama, Ph.D.
role: STUDY_DIRECTOR
affiliation: Department of ORL, Osaka University, School of Medicine
name: Takeshi Kubo, M.D.,Ph.D.
role: STUDY_CHAIR
References:
citation: Kumagami H, Beitz E, Wild K, Zenner HP, Ruppersberg JP, Schultz JE. Expression pattern of adenylyl cyclase isoforms in the inner ear of the rat by RT-PCR and immunochemical localization of calcineurin in the organ of Corti. Hear Res. 1999 Jun;132(1-2):69-75. doi: 10.1016/s0378-5955(99)00035-0.