Clinical trial NCT04433819: Nailfold Capillaroscopy Evaluation in Cushing Syndrome Patients
Official title: Skin Microcirculation Evaluation With Nailfold Capillaroscopy in Cushing's Syndrome Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cushing Syndrome
Hypercortisolism
Keywords: Cushing's syndrome
Capillaroscopy
Cushing's disease
Adrenal adenoma
Nailfold capillary
Microvascular circulation
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosed as endogenous Cushing syndrome, and age and sex matched controls

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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)

Primary outcomes:
measure: Nailfold capillary number of tortuous loops
timeFrame: 6 months
measure: Nailfold capillary area number of meandering capillaries
timeFrame: 6 months
measure: Nailfold capillary avascular areas
timeFrame: 6 months
Secondary outcomes:
measure: Correlation between nailfold capillary number of tortuous loops and presence of diabetes
timeFrame: 6 months
measure: Correlation between nailfold capillary number of tortuous loop with urine free cortisol levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Medical School Section of Endocrinology and Metabolism
Study officials:
affiliation: Marmara University School of Medicine, Endocrinology and Metabolism Department
name: Dilek Gogas Yavuz, M.D.
role: STUDY_DIRECTOR
References: