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Vasopressin and V2 Receptor in Meniere's Disease

Primary Purpose

Meniere Disease

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

vasopressin, V2 receptor and cyclic AMP

About this trial

This is an interventional treatment trial for Meniere Disease focused on measuring 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.

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Otolaryngology, Osaka University, School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1. Meniere's disease

2. Acoustic neurinoma

Arm Description

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.

Diagnosed by CT and/or MRI

Outcomes

Primary Outcome Measures

plasma vasopressin level and V2 receptor mRNA in the endolymphatic sac in Meniere's disease vs controls

Secondary Outcome Measures

cyclic AMP activity in the endolymphatic sac in Meniere's disease vs controls

Full Information

NCT ID

NCT00599560

First Posted

January 10, 2008

Last Updated

March 28, 2016

Sponsor

Osaka University

Collaborators

Osaka City University

1. Study Identification

Unique Protocol Identification Number

NCT00599560

Brief Title

Vasopressin and V2 Receptor in Meniere's Disease

Official Title

Vasopressin and V2 Receptor in Meniere's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

April 1998 (undefined)

Primary Completion Date

September 2005 (Actual)

Study Completion Date

September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Osaka University

Collaborators

Osaka City University

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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.

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

135 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1. Meniere's disease

Arm Type

Experimental

Arm Description

Arm Title

2. Acoustic neurinoma

Arm Type

No Intervention

Arm Description

Diagnosed by CT and/or MRI

Intervention Type

Genetic

Intervention Name(s)

vasopressin, V2 receptor and cyclic AMP

Other Intervention Name(s)

plasma vasopressin, V2 receptor, cyclic AMP

Intervention Description

plasma vasopressin, V2 receptor, cyclic AMP

Primary Outcome Measure Information:

Title

plasma vasopressin level and V2 receptor mRNA in the endolymphatic sac in Meniere's disease vs controls

Time Frame

prospective

Secondary Outcome Measure Information:

Title

cyclic AMP activity in the endolymphatic sac in Meniere's disease vs controls

Time Frame

prospective

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tadashi Kitahara, M.D.,Ph.D.

Organizational Affiliation

Department of ORL, Osaka University, School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hiroshi Kiyama, Ph.D.

Organizational Affiliation

Department of Neuroanatomy, Osaka City University, School of Medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Takeshi Kubo, M.D.,Ph.D.

Organizational Affiliation

Department of ORL, Osaka University, School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Otolaryngology, Osaka University, School of Medicine

City

Suita-city

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

10392549

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.

Results Reference

result

Links:

URL

http://www.med.osaka-u.ac.jp/pub/ent/r_vertigo.html

Description

Meniere's disease group at Department of ORL, Osaka University, School of Medicine

Learn more about this trial

Vasopressin and V2 Receptor in Meniere's Disease

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