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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients
- ClinicalTrials.gov ID
- NCT04138537
- Acronym / sponsor ID
- 20/10.11.10.2017
- Conditions
- Acromegaly, Olfactory Disorder
- Keywords
- Acromegaly, Olfaction, Olfactory disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acromegaly group | Other | Other: OB volume, Other: CCCRC testCCCRC test and OB volume results |
| Control Group | Other | Other: OB volume, Other: CCCRC testCCCRC test and OB volume results |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acromegaly diagnosis
- Healthy subjects that had no nasal problems
Key exclusion criteria (4 listed)
- Previous nasal surgery
- Acute respiratory tract infection
- Nasal polyposis
- Nasal pathologies that causes nasal obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OB volumeThe mean OB volume was calculated in cubic millimeters and compared between the two groups. | Other | Acromegaly group, Control Group |
| CCCRC testCCCRC test was done for olfactory function assessment and compared between the two groups. | Other | Acromegaly group, Control Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Derived from this study: PubMed 33386970Degirmenci 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazan Degirmenci principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olfactory bulb (OB) volume (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04138537, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.