Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2018
CompletedFirst Submitted
Initial submission to the registry
October 23, 2019
CompletedFirst Posted
Study publicly available on registry
October 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2020
CompletedMarch 16, 2020
March 1, 2020
1.3 years
October 23, 2019
March 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
18 months
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.
18 months
Study Arms (2)
Acromegaly group
OTHERCCCRC test and OB volume results
Control Group
OTHERCCCRC test and OB volume results
Interventions
The mean OB volume was calculated in cubic millimeters and compared between the two groups.
CCCRC test was done for olfactory function assessment and compared between the two groups.
Eligibility Criteria
You may qualify if:
- Acromegaly diagnosis
- Healthy subjects that had no nasal problems
You may not qualify if:
- Previous nasal surgery
- Acute respiratory tract infection
- Nasal polyposis
- Nasal pathologies that causes nasal obstruction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakif University
Istanbul, Fatih, 34093, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 33386970DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nazan Degirmenci
Bezmialem Vakif University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- OB measurements were done in a single-blinded method.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2019
First Posted
October 24, 2019
Study Start
August 15, 2018
Primary Completion
December 10, 2019
Study Completion
January 30, 2020
Last Updated
March 16, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share