Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients

March 13, 2020 updated by: Bezmialem Vakif University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Olfactory bulb (OB) volume
Time Frame: 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.
18 months
CCCRC test results
Time Frame: 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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Principal Investigator: Nazan Degirmenci, Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2018

Primary Completion (Actual)

December 10, 2019

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (Actual)

October 24, 2019

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20/10.11.10.2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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