Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients

Not Applicable

Completed

• Conditions: Acromegaly; Olfactory Disorder
• Interventions: Other: OB volume; Other: CCCRC test

• Registration Number: NCT04138537
• Lead Sponsor: Bezmialem Vakif University

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.

Study Timeline

• Study Start: 2018-08-15
• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-24
• Primary Completion: 2019-12-10
• Study Completion: 2020-01-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-13
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	CCCRC test	CCCRC test and OB volume results
Control Group	OB volume	CCCRC test and OB volume results
Acromegaly group	CCCRC test	CCCRC test and OB volume results
Acromegaly group	OB volume	CCCRC test and OB volume results

Primary Outcome Measures

Name	Time	Method
Olfactory bulb (OB) volume	18 months	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	18 months	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.

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Fatih, Turkey