search
Back to results

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
Sponsored by
Osaka University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
January 10, 2008
Last Updated
March 28, 2016
Sponsor
Osaka University
Collaborators
Osaka City University
search

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
No

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
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.
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
No
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

We'll reach out to this number within 24 hrs