<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04433819</url>
  </required_header>
  <id_info>
    <org_study_id>09.2019.474</org_study_id>
    <nct_id>NCT04433819</nct_id>
  </id_info>
  <brief_title>Nailfold Capillaroscopy Evaluation in Cushing Syndrome Patients</brief_title>
  <official_title>Skin Microcirculation Evaluation With Nailfold Capillaroscopy in Cushing's Syndrome Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marmara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marmara University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This cross-sectional, single-center study will assess the microvascular function using a&#xD;
      nailfold video-capillaroscopy in patients with endogenous Cushing syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endogenous Cushing's syndrome (CS) is associated with increased macrovascular diseases and&#xD;
      impaired endothelial function. There is no clear data about the effects of hypercortisolism&#xD;
      on microcirculation.&#xD;
&#xD;
      The primary aim of this study is to evaluate the peripheric microvascular area in patients&#xD;
      with Cushing's syndrome. The association of microvascular changes with present comorbidities&#xD;
      (diabetes, hypertension, etc.) and disease activation will be evaluated.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      Cushing syndrome patients admitted to our clinic will be included in this study for the next&#xD;
      six months after given informed consent.&#xD;
&#xD;
      The following clinical laboratory parameters will be evaluated as cross-sectionally.&#xD;
&#xD;
      Previous medical history, available laboratory parameters (fasting plasma glucose, HbA1c,&#xD;
      total cholesterol, triglyceride, HDL, LDL, creatine, AST, ALT, complete blood count, ACTH,&#xD;
      dexamethasone suppression tests (1 mg- 2mg), urine free cortisol, FSH, LH, total&#xD;
      testosterone, estradiol, IGF-1, TSH, free T3, free T4, prolactin), radiologic images (Cranial&#xD;
      MRI and Adrenal MRI) will be recorded from medical charts.&#xD;
&#xD;
      Nailfold microcirculation will be evaluated with video-capillaroscopy: it is a non-invasive&#xD;
      atraumatic assessment of the morphology and some functional aspects of cutaneous capillaries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 15, 2020</start_date>
  <completion_date type="Anticipated">January 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Nailfold capillary number of tortuous loops</measure>
    <time_frame>6 months</time_frame>
    <description>Nailfold capillary area changes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nailfold capillary area number of meandering capillaries</measure>
    <time_frame>6 months</time_frame>
    <description>Nailfold capillary area changes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nailfold capillary avascular areas</measure>
    <time_frame>6 months</time_frame>
    <description>Nailfold capillary area changes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between nailfold capillary number of tortuous loops and presence of diabetes</measure>
    <time_frame>6 months</time_frame>
    <description>Independent risk factors that affected nailfold capillaroscopy images</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between nailfold capillary number of tortuous loop with urine free cortisol levels</measure>
    <time_frame>6 months</time_frame>
    <description>Presence and severity of hypercortisolism as an independent risk factor</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cushing Syndrome</condition>
  <condition>Hypercortisolism</condition>
  <arm_group>
    <arm_group_label>Cushing syndrome</arm_group_label>
    <description>Male and female patients diagnosed as Cushing syndrome caused by ACTH-producing pituitary adenoma or cortisol producing adrenal adenoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Healthy controls matched for age, gender, and body mass index</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diagnosed as endogenous Cushing syndrome, and age and sex matched controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients diagnosed as Cushing syndrome (CS) caused by ACTH-producing&#xD;
             pituitary adenoma or cortisol producing adrenal adenoma&#xD;
&#xD;
          -  Age between 18 and 70 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic glucocorticoid use&#xD;
&#xD;
          -  CS caused by ectopic ACTH producing tumors&#xD;
&#xD;
          -  CS caused by adrenocortical carcinoma&#xD;
&#xD;
          -  Pseudo CS&#xD;
&#xD;
          -  Patients with Raynaud phenomenon&#xD;
&#xD;
          -  Patients with collagen tissue disease&#xD;
&#xD;
          -  Patients who use drugs that affect the metabolism of fibrinolysis (such as oral&#xD;
             contraceptives)&#xD;
&#xD;
          -  Employees at work at risk of microtrauma (such as gardeners, farmers)&#xD;
&#xD;
          -  Skin diseases with nail fold involvement (such as dermatitis, psoriasis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dilek Gogas Yavuz, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Marmara University School of Medicine, Endocrinology and Metabolism Department</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dilek Gogas Yavuz, M.D.</last_name>
    <phone>+90 216 6254685</phone>
    <email>dilekgogas@marmara.edu.tr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Marmara University Medical School Section of Endocrinology and Metabolism</name>
      <address>
        <city>Istanbul</city>
        <zip>34899</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <contact>
      <last_name>Dilek Gogas Yavuz, MD</last_name>
      <phone>+902166254685</phone>
      <email>dilekgogas@marmara.edu.tr</email>
    </contact>
    <investigator>
      <last_name>Tuğçe Apaydın, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cushing's syndrome</keyword>
  <keyword>Capillaroscopy</keyword>
  <keyword>Cushing's disease</keyword>
  <keyword>Adrenal adenoma</keyword>
  <keyword>Nailfold capillary</keyword>
  <keyword>Microvascular circulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cushing Syndrome</mesh_term>
    <mesh_term>Adrenocortical Hyperfunction</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04433819
org study id: 09.2019.474
nct id: NCT04433819
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This cross-sectional, single-center study will assess the microvascular function using a
      nailfold video-capillaroscopy in patients with endogenous Cushing syndrome.
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Nailfold capillary number of tortuous loops
time frame: 6 months
description: Nailfold capillary area changes
measure: Nailfold capillary area number of meandering capillaries
time frame: 6 months
description: Nailfold capillary area changes
measure: Nailfold capillary avascular areas
time frame: 6 months
description: Nailfold capillary area changes
measure: Correlation between nailfold capillary number of tortuous loops and presence of diabetes
time frame: 6 months
description: Independent risk factors that affected nailfold capillaroscopy images
measure: Correlation between nailfold capillary number of tortuous loop with urine free cortisol levels
time frame: 6 months
description: Presence and severity of hypercortisolism as an independent risk factor
arm group label: Cushing syndrome
description: Male and female patients diagnosed as Cushing syndrome caused by ACTH-producing pituitary adenoma or cortisol producing adrenal adenoma
arm group label: Controls
description: Healthy controls matched for age, gender, and body mass index
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dilek Gogas Yavuz, M.D.
role: Study Director
affiliation: Marmara University School of Medicine, Endocrinology and Metabolism Department
last name: Dilek Gogas Yavuz, M.D.
phone: +90 216 6254685
email: dilekgogas@marmara.edu.tr
facility: 
contact: 
investigator: 
country: Turkey
responsible party type: Sponsor
mesh term: Cushing Syndrome
mesh term: Adrenocortical Hyperfunction
mesh term: Syndrome
sharing ipd: No