Back to resultsOlfactory Function and Olfactory Bulb Volume in Acromegaly Patients
Primary Purpose
Acromegaly, Olfactory Disorder
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
OB volume
CCCRC test
Sponsored by
About this trial
This is an interventional other trial for Acromegaly focused on measuring Acromegaly, Olfaction, Olfactory disorder
Eligibility Criteria
Inclusion Criteria:
- Acromegaly diagnosis
- Healthy subjects that had no nasal problems
Exclusion Criteria:
- Previous nasal surgery
- Acute respiratory tract infection
- Nasal polyposis
- Nasal pathologies that causes nasal obstruction
Sites / Locations
- Bezmialem Vakif University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Acromegaly group
Control Group
Arm Description
CCCRC test and OB volume results
CCCRC test and OB volume results
Outcomes
Primary Outcome Measures
Olfactory bulb (OB) volume
Measurements were done individually on the right and left OB, and the mean OB volume was calculated in cubic millimeters. The mean OB volume was compared between the two groups.
CCCRC test results
Olfactory tests were scored out of 7 (0: worst, 7: best olfaction) and mean score was calculated as the total CCCRC test score.
The mean score was compared between the two groups.
Secondary Outcome Measures
Full Information
NCT ID
NCT04138537
First Posted
October 23, 2019
Last Updated
March 13, 2020
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT04138537
Brief Title
Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients
Official Title
Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective, controlled, single blinded study was planned. 20 patients with Acromegaly (Acromegaly Group) and 20 healthy subjects (Control Group) were planned to include in the study. Connecticut Chemosensory Clinical Research Center (CCCRC) test was applied to evaluate olfactory functions. Olfactory bulb(OB) volumes were measured with a 1.5 T General Electric Signa Excite MRI scanner.
Detailed Description
Acromegaly patients were assessed at the Endocrinology Department for their clinical symptoms, and the nasal examination and olfactory evaluation were done at the Department of Otorhinolaryngology. OB volume was evaluated by a single blinded radiologist. Control group patients that had similar demographical characteristics with the Acromegaly Group were recruited in the study.
The CCCRC test is composed of n-butanol odor threshold test and odor identification test. Olfactory tests were scored out of 7 (0: worst, 7: best olfaction) and mean score was calculated as the total CCCRC test score. OB measurements were done individually on the right and left olfactory bulbs and the mean OB volume was calculated in cubic millimeters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly, Olfactory Disorder
Keywords
Acromegaly, Olfaction, Olfactory disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
OB measurements were done in a single-blinded method.
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acromegaly group
Arm Type
Other
Arm Description
CCCRC test and OB volume results
Arm Title
Control Group
Arm Type
Other
Arm Description
CCCRC test and OB volume results
Intervention Type
Other
Intervention Name(s)
OB volume
Intervention Description
The mean OB volume was calculated in cubic millimeters and compared between the two groups.
Intervention Type
Other
Intervention Name(s)
CCCRC test
Intervention Description
CCCRC test was done for olfactory function assessment and compared between the two groups.
Primary Outcome Measure Information:
Title
Olfactory bulb (OB) volume
Description
Measurements were done individually on the right and left OB, and the mean OB volume was calculated in cubic millimeters. The mean OB volume was compared between the two groups.
Time Frame
18 months
Title
CCCRC test results
Description
Olfactory tests were scored out of 7 (0: worst, 7: best olfaction) and mean score was calculated as the total CCCRC test score.
The mean score was compared between the two groups.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Acromegaly diagnosis
Healthy subjects that had no nasal problems
Exclusion Criteria:
Previous nasal surgery
Acute respiratory tract infection
Nasal polyposis
Nasal pathologies that causes nasal obstruction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazan Degirmenci
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33386970
Citation
Degirmenci N, Bektas H, Senturk E, Ilhan M, Gunaldi A, Yetis EUM, Eren SB. Changes in olfactory function and olfactory bulb after treatment for acromegaly. Eur Arch Otorhinolaryngol. 2021 Jul;278(7):2357-2362. doi: 10.1007/s00405-020-06515-5. Epub 2021 Jan 2.
Results Reference
derived
Learn more about this trial
Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients
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