Cushing SyndromeNCT04433819
Nailfold Capillaroscopy Evaluation in Cushing Syndrome Patients
An observational study of Cushing Syndrome and Hypercortisolism, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional, single-center study will assess the microvascular function using a nailfold video-capillaroscopy in patients with endogenous Cushing syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cushing Syndrome, Hypercortisolism
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 15 Jan 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with diagnosed as endogenous Cushing syndrome, and age and sex matched controls
Who may be able to join
- Male and female patients diagnosed as Cushing syndrome (CS) caused by ACTH-producing pituitary adenoma or cortisol producing adrenal adenoma
- Age between 18 and 70 years
Who cannot join
- Chronic glucocorticoid use
- CS caused by ectopic ACTH producing tumors
- CS caused by adrenocortical carcinoma
- Pseudo CS
- Patients with Raynaud phenomenon
- Patients with collagen tissue disease
Show all 9Show fewer
- Patients who use drugs that affect the metabolism of fibrinolysis (such as oral contraceptives)
- Employees at work at risk of microtrauma (such as gardeners, farmers)
- Skin diseases with nail fold involvement (such as dermatitis, psoriasis)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Medical School Section of Endocrinology and Metabolism
Istanbul, 34899
Dilek Gogas Yavuz, MD, +902166254685, dilekgogas@marmara.edu.tr
Tuğçe Apaydın, MD
About this study
Official title: Skin Microcirculation Evaluation With Nailfold Capillaroscopy in Cushing's Syndrome Patients
This cross-sectional, single-center study will assess the microvascular function using a nailfold video-capillaroscopy in patients with endogenous Cushing syndrome.
Read the detailed description
Endogenous Cushing's syndrome (CS) is associated with increased macrovascular diseases and impaired endothelial function. There is no clear data about the effects of hypercortisolism on microcirculation.
The primary aim of this study is to evaluate the peripheric microvascular area in patients with Cushing's syndrome. The association of microvascular changes with present comorbidities (diabetes, hypertension, etc.) and disease activation will be evaluated.
Method:
Cushing syndrome patients admitted to our clinic will be included in this study for the next six months after given informed consent.
The following clinical laboratory parameters will be evaluated as cross-sectionally.
Previous medical history, available laboratory parameters (fasting plasma glucose, HbA1c, total cholesterol, triglyceride, HDL, LDL, creatine, AST, ALT, complete blood count, ACTH, dexamethasone suppression tests (1 mg- 2mg), urine free cortisol, FSH, LH, total testosterone, estradiol, IGF-1, TSH, free T3, free T4, prolactin), radiologic images (Cranial MRI and Adrenal MRI) will be recorded from medical charts.
Nailfold microcirculation will be evaluated with video-capillaroscopy: it is a non-invasive atraumatic assessment of the morphology and some functional aspects of cutaneous capillaries.
- Conditions
- Cushing Syndrome, Hypercortisolism
- Keywords
- Cushing's syndrome, Capillaroscopy, Cushing's disease, Adrenal adenoma, Nailfold capillary, Microvascular circulation
- Medical subject headings
- Cushing Syndrome, Pituitary ACTH Hypersecretion, ACTH Syndrome, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cushing syndrome | Male and female patients diagnosed as Cushing syndrome caused by ACTH-producing pituitary adenoma or cortisol producing adrenal adenoma | |
| Controls | Healthy controls matched for age, gender, and body mass index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nailfold capillary number of tortuous loops
Nailfold capillary area changes
Measured: 6 months
Nailfold capillary area number of meandering capillaries
Nailfold capillary area changes
Measured: 6 months
Nailfold capillary avascular areas
Nailfold capillary area changes
Measured: 6 months
Secondary outcomes (2)
Correlation between nailfold capillary number of tortuous loops and presence of diabetes
Independent risk factors that affected nailfold capillaroscopy images
Measured: 6 months
Correlation between nailfold capillary number of tortuous loop with urine free cortisol levels
Presence and severity of hypercortisolism as an independent risk factor
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start15 Jun 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion15 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dilek Gogas Yavuz, M.D., Study director, Marmara University School of Medicine, Endocrinology and Metabolism Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433819
- Sponsor's protocol ID
- 09.2019.474
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Microcirculation Evaluation With Nailfold Capillaroscopy in Cushing's Syndrome Patients
- ClinicalTrials.gov ID
- NCT04433819
- Acronym / sponsor ID
- 09.2019.474
- Conditions
- Cushing Syndrome, Hypercortisolism
- Keywords
- Cushing's syndrome, Capillaroscopy, Cushing's disease, Adrenal adenoma, Nailfold capillary, Microvascular circulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 15 Jan 2021 (estimated)
- First posted
- 16 Jun 2020 (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.
This cross-sectional, single-center study will assess the microvascular function using a nailfold video-capillaroscopy in patients with endogenous Cushing syndrome.
Detailed description
Endogenous Cushing's syndrome (CS) is associated with increased macrovascular diseases and impaired endothelial function. There is no clear data about the effects of hypercortisolism on microcirculation.
The primary aim of this study is to evaluate the peripheric microvascular area in patients with Cushing's syndrome. The association of microvascular changes with present comorbidities (diabetes, hypertension, etc.) and disease activation will be evaluated.
Method:
Cushing syndrome patients admitted to our clinic will be included in this study for the next six months after given informed consent.
The following clinical laboratory parameters will be evaluated as cross-sectionally.
Previous medical history, available laboratory parameters (fasting plasma glucose, HbA1c, total cholesterol, triglyceride, HDL, LDL, creatine, AST, ALT, complete blood count, ACTH, dexamethasone suppression tests (1 mg- 2mg), urine free cortisol, FSH, LH, total testosterone, estradiol, IGF-1, TSH, free T3, free T4, prolactin), radiologic images (Cranial MRI and Adrenal MRI) will be recorded from medical charts.
Nailfold microcirculation will be evaluated with video-capillaroscopy: it is a non-invasive atraumatic assessment of the morphology and some functional aspects of cutaneous capillaries.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cushing syndrome | – | –Male and female patients diagnosed as Cushing syndrome caused by ACTH-producing pituitary adenoma or cortisol producing adrenal adenoma |
| Controls | – | –Healthy controls matched for age, gender, and body mass index |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed as endogenous Cushing syndrome, and age and sex matched controls
Key inclusion criteria (2 listed)
- Male and female patients diagnosed as Cushing syndrome (CS) caused by ACTH-producing pituitary adenoma or cortisol producing adrenal adenoma
- Age between 18 and 70 years
Key exclusion criteria (9 listed)
- Chronic glucocorticoid use
- CS caused by ectopic ACTH producing tumors
- CS caused by adrenocortical carcinoma
- Pseudo CS
- Patients with Raynaud phenomenon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nailfold capillary number of tortuous loops
Time frame: 6 months
Nailfold capillary area changes
Nailfold capillary area number of meandering capillaries
Time frame: 6 months
Nailfold capillary area changes
Nailfold capillary avascular areas
Time frame: 6 months
Nailfold capillary area changes
2 secondary outcomes
Correlation between nailfold capillary number of tortuous loops and presence of diabetes
Time frame: 6 months
Correlation between nailfold capillary number of tortuous loop with urine free cortisol levels
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- 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.
Dilek Gogas Yavuz, M.D. study director
Marmara University School of Medicine, Endocrinology and Metabolism Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cushing Syndrome and Hypercortisolism, run by Marmara 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 9 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: status not confirmed, as of the sponsor's last update on 16 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilek Gogas Yavuz, M.D. (+90 216 6254685, dilekgogas@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nailfold capillary number of tortuous loops (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2020; AzTrials last refreshed its copy on 31 Oct 2026.