CClinicalTrials.gg
Status unknownNCT04433819Updated Jun 16, 2020

Nailfold Capillaroscopy Evaluation in Cushing Syndrome Patients

An observational study in Cushing Syndrome and Hypercortisolism, sponsored by Marmara University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by Marmara University · Observational

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cushing Syndrome
  • Hypercortisolism

Keywords

  • Cushing's syndrome
  • Capillaroscopy
  • Cushing's disease
  • Adrenal adenoma
  • Nailfold capillary
  • Microvascular circulation
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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)
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • 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

05

What researchers measure

Primary outcomes

  1. Nailfold capillary number of tortuous loops

    Nailfold capillary area changes

    Time frame: 6 months

  2. Nailfold capillary area number of meandering capillaries

    Nailfold capillary area changes

    Time frame: 6 months

  3. Nailfold capillary avascular areas

    Nailfold capillary area changes

    Time frame: 6 months

Secondary outcomes

  1. Correlation between nailfold capillary number of tortuous loops and presence of diabetes

    Independent risk factors that affected nailfold capillaroscopy images

    Time frame: 6 months

  2. Correlation between nailfold capillary number of tortuous loop with urine free cortisol levels

    Presence and severity of hypercortisolism as an independent risk factor

    Time frame: 6 months

06

Study locations

1 site
  • Marmara University Medical School Section of Endocrinology and Metabolism
    Istanbul, 34899, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04433819
Lead sponsor
Marmara University
Responsible party
Sponsor
First posted
Jun 16, 2020
Start date
Jun 15, 2020 (estimated)
Primary completion
Dec 31, 2020 (estimated)
Completion
Jan 15, 2021 (estimated)
Last update
Jun 16, 2020

Study contacts

Dilek Gogas Yavuz, M.D.
Contact
dilekgogas@marmara.edu.tr
+90 216 6254685
Dilek Gogas Yavuz, M.D.
study director · Marmara University School of Medicine, Endocrinology and Metabolism Department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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