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Nailfold Capillaroscopy Evaluation in Cushing Syndrome Patients

M

Marmara University

Status

Unknown

Conditions

Cushing Syndrome
Hypercortisolism

Study type

Observational

Funder types

Other

Identifiers

NCT04433819
09.2019.474

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

200 participants in 2 patient groups

Cushing syndrome
Description:
Male and female patients diagnosed as Cushing syndrome caused by ACTH-producing pituitary adenoma or cortisol producing adrenal adenoma
Controls
Description:
Healthy controls matched for age, gender, and body mass index

Trial contacts and locations

1

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Central trial contact

Dilek Gogas Yavuz, M.D.

Data sourced from clinicaltrials.gov

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