Nailfold Capillaroscopy Evaluation in Cushing Syndrome Patients

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.

Study Overview

• Status: Unknown
• Conditions: Cushing Syndrome; Hypercortisolism

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Dilek Gogas Yavuz, M.D.; Phone Number: +90 216 6254685; Email: dilekgogas@marmara.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey, 34899
    • Marmara University Medical School Section of Endocrinology and Metabolism

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosed as endogenous Cushing syndrome, and age and sex matched controls

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nailfold capillary number of tortuous loops	Nailfold capillary area changes	6 months
Nailfold capillary area number of meandering capillaries	Nailfold capillary area changes	6 months
Nailfold capillary avascular areas	Nailfold capillary area changes	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between nailfold capillary number of tortuous loops and presence of diabetes	Independent risk factors that affected nailfold capillaroscopy images	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	6 months

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Director: Dilek Gogas Yavuz, M.D., Marmara University School of Medicine, Endocrinology and Metabolism Department

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 15, 2020
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): January 15, 2021

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (ACTUAL): June 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 12, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Cushing's syndrome; Cushing's disease; Adrenal adenoma; Capillaroscopy; Nailfold capillary; Microvascular circulation
• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Disease; Adrenal Gland Diseases; Syndrome; Cushing Syndrome; Adrenocortical Hyperfunction
• Other Study ID Numbers: 09.2019.474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No