Nailfold Capillaroscopy Evaluation in Cushing Syndrome Patients

Cushing Syndrome Clinical Trial

Official title:

Skin Microcirculation Evaluation With Nailfold Capillaroscopy in Cushing's Syndrome Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04433819
• Other study ID #: 09.2019.474
• Status: Not yet recruiting
• Start date: June 15, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: June 2020
• Source: Marmara University
• Contact: Dilek Gogas Yavuz, M.D.
• Phone: +90 216 6254685
• Email: dilekgogas[@]marmara.edu.tr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This cross-sectional, single-center study will assess the microvascular function using a nailfold video-capillaroscopy in patients with endogenous Cushing syndrome.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 15, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adrenocortical Hyperfunction
• Cushing Syndrome
• Hypercortisolism
• Syndrome

Locations

Country	Name	City	State
Turkey	Marmara University Medical School Section of Endocrinology and Metabolism	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nailfold capillary number of tortuous loops	Nailfold capillary area changes	6 months
Primary	Nailfold capillary area number of meandering capillaries	Nailfold capillary area changes	6 months
Primary	Nailfold capillary avascular areas	Nailfold capillary area changes	6 months
Secondary	Correlation between nailfold capillary number of tortuous loops and presence of diabetes	Independent risk factors that affected nailfold capillaroscopy images	6 months
Secondary	Correlation between nailfold capillary number of tortuous loop with urine free cortisol levels	Presence and severity of hypercortisolism as an independent risk factor	6 months