Vasopressin and V2 Receptor in Meniere's Disease
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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:
|
|
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:
|
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 |
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:
- 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.
- 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| Japan | |
| Department of Otolaryngology, Osaka University, School of Medicine | |
| Suita-city, Osaka, Japan, 565-0871 | |
| 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 May 23, 2013