Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients

Official Title

Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients

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 Type

Interventional

Primary Outcome

Olfactory bulb (OB) volume

Condition

Acromegaly

Intervention

OB volume

Study Arms / Comparison Groups

 Acromegaly group
Description:  CCCRC test and OB volume results

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

40

Start Date

August 15, 2018

Completion Date

January 30, 2020

Primary Completion Date

December 10, 2019

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Nazan Degirmenci, ,

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations

NCT ID

NCT04138537

Organization ID

20/10.11.10.2017

Responsible Party

Sponsor

Study Sponsor

Bezmialem Vakif University

Study Sponsor

Nazan Degirmenci, Principal Investigator, Bezmialem Vakif University

Verification Date

March 2020