<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/NCT04424706</url>
  </required_header>
  <id_info>
    <org_study_id>KY20200320-01</org_study_id>
    <nct_id>NCT04424706</nct_id>
  </id_info>
  <brief_title>The Effect and Mechanism of MMP-9 in Inducing Atherosclerosis</brief_title>
  <official_title>The Effect and Mechanism of MMP-9 in Inducing Atherosclerosis in Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Majianhua</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing First Hospital, Nanjing Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will assess the serum expression of MMP-9 in normal people, type 2 diabetic&#xD;
      patients and type 2 diabetic patients with atherosclerosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 30, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>total MMP-9 levels</measure>
    <time_frame>6 months</time_frame>
    <description>the different group of total MMP-9 levels</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Normal people</arm_group_label>
    <description>No diabetes and atherosclerosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>type 2 diabetes mellitus without atherosclerosis</arm_group_label>
    <description>Newly diagnosed type 2 diabetes without atherosclerosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>type 2 diabetes mellitus with atherosclerosis</arm_group_label>
    <description>Newly diagnosed type 2 diabetes with atherosclerosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>diagnosed as type 2 diabetes without atherosclerosis</intervention_name>
    <description>patients diagnosed as type 2 diabetes without atherosclerosis</description>
    <arm_group_label>type 2 diabetes mellitus without atherosclerosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>diagnosed as type 2 diabetes with atherosclerosis</intervention_name>
    <description>patients diagnosed as type 2 diabetes with atherosclerosis</description>
    <arm_group_label>type 2 diabetes mellitus with atherosclerosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>people without type 2 diabetes or atherosclerosis</intervention_name>
    <description>normal people without type 2 diabetes or atherosclerosis</description>
    <arm_group_label>Normal people</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum for testing the MMP-9 level&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Normal control group, newly diagnosis of type 2 diabetes mellitus with atherosclerosis,&#xD;
        newly diagnosis of type 2 diabetes mellitus without atherosclerosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  volunteer to participate and be able to sign informed consent prior to the trial.&#xD;
&#xD;
          -  patients with type 2 diabetes, aged 18-60 years old, meeting WHO1999 diagnostic&#xD;
             criteria, have not used any drugs.&#xD;
&#xD;
          -  The patients have completed carotid ultrasound during hospitalization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with any antidiabetic drugs.&#xD;
&#xD;
          -  impaired liver and kidney function with ALT 2.5 times higher than the upper limit of&#xD;
             normal value; Serum creatinine was 1.3 times higher than the upper limit of normal.&#xD;
&#xD;
          -  drug abuse and alcohol dependence in the past 5 years.&#xD;
&#xD;
          -  systemic hormone therapy was used in the last three months.&#xD;
&#xD;
          -  patients with infection and stress within 4 weeks.&#xD;
&#xD;
          -  any other obvious conditions or associated diseases determined by the researcher: such&#xD;
             as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors&#xD;
             and other diseases, other pancreatic diseases, history of mental diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jianhua Ma, Doctor</last_name>
    <phone>8625-52887091</phone>
    <email>majianhua196503@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nanjing First Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jianhua Ma, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing First Hospital, Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Majianhua</investigator_full_name>
    <investigator_title>Head of Department of Endocrinology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04424706
org study id: KY20200320-01
nct id: NCT04424706
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study will assess the serum expression of MMP-9 in normal people, type 2 diabetic
      patients and type 2 diabetic patients with atherosclerosis.
observational model: Case-Control
time perspective: Prospective
measure: total MMP-9 levels
time frame: 6 months
description: the different group of total MMP-9 levels
arm group label: Normal people
description: No diabetes and atherosclerosis
arm group label: type 2 diabetes mellitus without atherosclerosis
description: Newly diagnosed type 2 diabetes without atherosclerosis
arm group label: type 2 diabetes mellitus with atherosclerosis
description: Newly diagnosed type 2 diabetes with atherosclerosis
intervention type: Diagnostic Test
intervention name: diagnosed as type 2 diabetes without atherosclerosis
description: patients diagnosed as type 2 diabetes without atherosclerosis
arm group label: type 2 diabetes mellitus without atherosclerosis
intervention type: Diagnostic Test
intervention name: diagnosed as type 2 diabetes with atherosclerosis
description: patients diagnosed as type 2 diabetes with atherosclerosis
arm group label: type 2 diabetes mellitus with atherosclerosis
intervention type: Diagnostic Test
intervention name: people without type 2 diabetes or atherosclerosis
description: normal people without type 2 diabetes or atherosclerosis
arm group label: Normal people
Serum for testing the MMP-9 level
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jianhua Ma, Doctor
phone: 8625-52887091
email: majianhua196503@126.com
facility: 
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Nanjing First Hospital, Nanjing Medical University
investigator full name: Majianhua
investigator title: Head of Department of Endocrinology
mesh term: Atherosclerosis
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided