Nailfold Capillaroscopy Evaluation in Cushing Syndrome Patients

• Conditions: Hypercortisolism; Cushing Syndrome

• Registration Number: NCT04433819
• Lead Sponsor: Marmara University

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.

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-12
• Last Update Submitted: 2020-06-12
• Study Start: 2020-06-15
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nailfold capillary avascular areas	6 months	Nailfold capillary area changes
Nailfold capillary number of tortuous loops	6 months	Nailfold capillary area changes
Nailfold capillary area number of meandering capillaries	6 months	Nailfold capillary area changes

Secondary Outcome Measures

Name	Time	Method
Correlation between nailfold capillary number of tortuous loops and presence of diabetes	6 months	Independent risk factors that affected nailfold capillaroscopy images
Correlation between nailfold capillary number of tortuous loop with urine free cortisol levels	6 months	Presence and severity of hypercortisolism as an independent risk factor

Trial Locations

Locations (1)

Marmara University Medical School Section of Endocrinology and Metabolism; 🇹🇷 Istanbul, Turkey