Nailfold Capillaroscopy Evaluation in Cushing Syndrome Patients

NCT ID: NCT04433819

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2021-01-15

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.

Conditions

Cushing Syndrome; Hypercortisolism

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Cushing syndrome

Male and female patients diagnosed as Cushing syndrome caused by ACTH-producing pituitary adenoma or cortisol producing adrenal adenoma

No interventions assigned to this group

Controls

Healthy controls matched for age, gender, and body mass index

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dilek Gogas Yavuz, M.D.

Role: STUDY_DIRECTOR

Marmara University School of Medicine, Endocrinology and Metabolism Department

Locations

Marmara University Medical School Section of Endocrinology and Metabolism

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Dilek Gogas Yavuz, M.D.

Role: CONTACT

dilekgogas@marmara.edu.tr

+90 216 6254685

Facility Contacts

Dilek Gogas Yavuz, MD

Role: primary

dilekgogas@marmara.edu.tr

+902166254685

Other Identifiers

09.2019.474

Identifier Type: -

Identifier Source: org_study_id