NCT04433819

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

June 5, 2020

Last Update Submit

June 12, 2020

Conditions

Cushing SyndromeHypercortisolism

Keywords

Cushing's syndromeCapillaroscopyCushing's diseaseAdrenal adenomaNailfold capillaryMicrovascular circulation

Outcome Measures

Primary Outcomes (3)

  • 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 (2)

  • Correlation between nailfold capillary number of tortuous loops and presence of diabetes

    6 months

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

    6 months

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Medical School Section of Endocrinology and Metabolism

Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cushing SyndromePituitary ACTH HypersecretionACTH Syndrome, Ectopic

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParaneoplastic Endocrine SyndromesParaneoplastic SyndromesNeoplasms

Study Officials

  • Dilek Gogas Yavuz, M.D.

    Marmara University School of Medicine, Endocrinology and Metabolism Department

    STUDY DIRECTOR

Central Study Contacts

Dilek Gogas Yavuz, M.D.

CONTACT

+90 216 6254685dilekgogas@marmara.edu.tr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 16, 2020

Study Start

June 15, 2020

Primary Completion

December 31, 2020

Study Completion

January 15, 2021

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)