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NCT04138537 Clinical Trial

Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients

Acromegaly Clinical Trial

Official title:
Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04138537
Other study ID # 20/10.11.10.2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2018
Est. completion date January 30, 2020

Study information
Verified date March 2020
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date January 30, 2020
Est. primary completion date December 10, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• OB volume
The mean OB volume was calculated in cubic millimeters and compared between the two groups.
• CCCRC test
CCCRC test was done for olfactory function assessment and compared between the two groups.

Locations
Country Name City State
Turkey Bezmialem Vakif University Istanbul Fatih

Sponsors (1)
Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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