AcromegalyNCT04138537
Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients
A study testing OB volume and CCCRC test in people with Acromegaly and Olfactory Disorder, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acromegaly, Olfactory Disorder
- What is being tested?
- OB volume and CCCRC test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2018to 30 Jan 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Acromegaly diagnosis
- Healthy subjects that had no nasal problems
Who cannot join
- Previous nasal surgery
- Acute respiratory tract infection
- Nasal polyposis
- Nasal pathologies that causes nasal obstruction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
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.
Read the 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.
- Conditions
- Acromegaly, Olfactory Disorder
- Being tested
- OB volume, CCCRC test
- Keywords
- Acromegaly, Olfaction, Olfactory disorder
- Medical subject headings
- Acromegaly, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OB volumeOther
The mean OB volume was calculated in cubic millimeters and compared between the two groups.
CCCRC testOther
CCCRC test was done for olfactory function assessment and compared between the two groups.
| Study group | Role | What they receive |
|---|---|---|
| Acromegaly group | Other | CCCRC test and OB volume results Receives: Other: OB volume; Other: CCCRC test |
| Control Group | Other | CCCRC test and OB volume results Receives: Other: OB volume; Other: CCCRC test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start15 Aug 2018
- Primary completion10 Dec 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazan Degirmenci, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138537
- Sponsor's protocol ID
- 20/10.11.10.2017
- Status last verified
- Mar 2020
- First submitted
- 23 Oct 2019
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Degirmenci N, Bektas H, Senturk E, Ilhan M, Gunaldi A, Yetis EUM, Eren SB. Changes in olfactory function and olfactory bulb after treatment for acromegaly. Eur Arch Otorhinolaryngol. 2021 Jul;278(7):2357-2362. doi: 10.1007/s00405-020-06515-5. Epub 2021 Jan 2.
PubMed 33386970