Nailfold Capillaroscopy Evaluation in Cushing Syndrome Pa... | NCT04433819

Studies
Nailfold Capillaroscopy Evaluation in Cushing Syndrome Patients

NCT04433819

Sponsor

Marmara University

Status

Unknown status

Last Update Posted

Jun 16, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Cushing Syndrome
Hypercortisolism

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2020Estimated

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Jan 15, 2021Estimated

First Submitted Date

Jun 5, 2020

First Submission Date that Met QC Criteria

Jun 12, 2020

First Posted Date

Jun 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2020

Last Update Posted Date

Jun 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dilek Gogas Yavuz, M.D.	Contact	+90 216 6254685		dilekgogas@marmara.edu.tr

Overall Officials

Name	Affiliation	Role
Dilek Gogas Yavuz, M.D.	Marmara University School of Medicine, Endocrinology and Metabolism Department	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marmara University Medical School Section of Endocrinology and Metabolism		Istanbul		34899	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003480	Cushing Syndrome
D047748	Pituitary ACTH Hypersecretion
D000182	ACTH Syndrome, Ectopic

Ancestor Terms

ID	Term
D000308	Adrenocortical Hyperfunction
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases
D006964	Hyperpituitarism

Browse Leaves

Not provided

Browse Branches

Not provided