Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients

• Sponsor: Bezmialem Vakif University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04138537
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.5
• Patients Per Site Per Month: 2.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acromegaly; Olfactory Disorder	Other: OB volume; Other: CCCRC test	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: OB measurements were done in a single-blinded method.
• Primary Purpose: Other
• Official Title: Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients
• Actual Study Start Date: Aug 15, 2018
• Actual Primary Completion Date: Dec 10, 2019
• Actual Study Completion Date: Jan 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Acromegaly group CCCRC test and OB volume results	Other: OB volume; The mean OB volume was calculated in cubic millimeters and compared between the two groups.; Other: CCCRC test; CCCRC test was done for olfactory function assessment and compared between the two groups.
Other: Control Group CCCRC test and OB volume results	Other: OB volume; The mean OB volume was calculated in cubic millimeters and compared between the two groups.; Other: CCCRC test; CCCRC test was done for olfactory function assessment and compared between the two groups.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bezmialem Vakif University	Istanbul	Fatih	Turkey	34093

Sponsors and Collaborators

• Bezmialem Vakif University

Investigators

• Principal Investigator: Nazan Degirmenci, Bezmialem Vakif University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bezmialem Vakif University
• ClinicalTrials.gov Identifier: NCT04138537
• Other Study ID Numbers: 20/10.11.10.2017
• First Posted: Oct 24, 2019
• Last Update Posted: Mar 16, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bezmialem Vakif University: Acromegaly; Olfaction; Olfactory disorder
• Additional relevant MeSH terms: Acromegaly

Study Results

No Results Posted as of Mar 16, 2020