<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/NCT02226471</url>
  </required_header>
  <id_info>
    <org_study_id>SW1000</org_study_id>
    <nct_id>NCT02226471</nct_id>
  </id_info>
  <brief_title>Serum CTRP3 and RBP4 Levels in Obesity and Hypertension</brief_title>
  <official_title>Serum CTRP3 and RBP4 Levels in Obesity and Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Third Military Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Insulin resistance is closely correlated with obesity and cardiovascular disease. Adipokines&#xD;
      may play important roles in the pathogenesis of obesity, which are a link between obesity and&#xD;
      obesity-related disorders.C1q/TNF-related protein-3 (CTRP3) and retinol-binding protein 4&#xD;
      (RBP4) are novel adipokine that modulates the action of insulin in various diseases. This&#xD;
      study addressed the relationship between CTRP3, RBP4 and IR in newly diagnosed obesity and&#xD;
      essential hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Serum CTRP3 and RBP4, anthropometric and metabolic parameters were determined in 480 newly&#xD;
      diagnosed obesity and essential hypertensive patients not taking anti-obese and&#xD;
      antihypertensive medications and 66 normal weight (NW) and normotensive subjects. All&#xD;
      subjects were divided into two groups depending on body mass index (BMI), including NW group&#xD;
      and obesity group, and then four subgroups were divided according to obesity and&#xD;
      hypertension, including NW-normal blood pressure subgroup (NW-NBP), NW-hypertension subgroup&#xD;
      (NW-HTN), obese-normal blood pressure subgroup (OB-NBP), obese-hypertension subgroup&#xD;
      (OB-HTN).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>CTRP3 and RBP4 levels were measured in obesity and hypertension</measure>
    <time_frame>1 year</time_frame>
    <description>531 subjects were required to fast overnight before the physical examination.Blood pressure was measured three times, each 2 min apart on the upper arm using a mercury sphygmomanometer in a seated, resting position after 10 minutes of rest; the mean of the three measurements was used for the statistical analysis.Weight, height and hip and waist circumference (WC), were measured. BMI was calculated as body weight in kilograms divided by the square of height (m2). WHR was calculated as the waist to hip circumference.&#xD;
Overnight fasting blood samples were collected in tubes containing liquid EDTA; the samples were centrifuged at -4°C and maintained at -80°C until assayed. FBG was assayed using the glucose oxidase method. UA, TC, TG, LDL-C and HDL-C concentrations were determined enzymatically.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">2000</enrollment>
  <condition>Obesity</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>NW-NBP group</arm_group_label>
    <description>normal weight and blood pressure subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NW-HTN group</arm_group_label>
    <description>Normal weight with hypertension subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OB-NBP group</arm_group_label>
    <description>obese-normal blood pressure subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OB-HTN group</arm_group_label>
    <description>Obese-hypertension subjects</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        We consecutively selected 2100 Chinese subjects from the general population who had&#xD;
        undergone medical check-ups at the Southwest Hospital Medical Center at the Third Military&#xD;
        Medical University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hypertension not taking antihypertensive medications&#xD;
&#xD;
          2. Obesity not taking anti-obese or lipid-lowering medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Heart failure;&#xD;
&#xD;
          2. pregnant or lactating&#xD;
&#xD;
          3. diabetes&#xD;
&#xD;
          4. thyroid disease&#xD;
&#xD;
          5. fractures&#xD;
&#xD;
          6. osteoporosis&#xD;
&#xD;
          7. tumors;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deng Wuquan, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Southwest Hospital, China</affiliation>
  </overall_official>
  <link>
    <url>http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0055744</url>
    <description>Implication of Progranulin and C1q/TNF-Related Protein-3 (CTRP3) on Inflammation and Atherosclerosis in Subjects with or without Metabolic Syndrome</description>
  </link>
  <link>
    <url>http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0099785</url>
    <description>Identification of Adipokine Clusters Related to Parameters of Fat Mass, Insulin Sensitivity and Inflammation</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 24, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>August 25, 2014</last_update_submitted>
  <last_update_submitted_qc>August 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Third Military Medical University</investigator_affiliation>
    <investigator_full_name>Deng Wu Quan</investigator_full_name>
    <investigator_title>Chongqing southwest hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <!-- 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/NCT02226471
org study id: SW1000
nct id: NCT02226471
lead sponsor: 
has dmc: Yes
Insulin resistance is closely correlated with obesity and cardiovascular disease. Adipokines
      may play important roles in the pathogenesis of obesity, which are a link between obesity and
      obesity-related disorders.C1q/TNF-related protein-3 (CTRP3) and retinol-binding protein 4
      (RBP4) are novel adipokine that modulates the action of insulin in various diseases. This
      study addressed the relationship between CTRP3, RBP4 and IR in newly diagnosed obesity and
      essential hypertension.
Serum CTRP3 and RBP4, anthropometric and metabolic parameters were determined in 480 newly
      diagnosed obesity and essential hypertensive patients not taking anti-obese and
      antihypertensive medications and 66 normal weight (NW) and normotensive subjects. All
      subjects were divided into two groups depending on body mass index (BMI), including NW group
      and obesity group, and then four subgroups were divided according to obesity and
      hypertension, including NW-normal blood pressure subgroup (NW-NBP), NW-hypertension subgroup
      (NW-HTN), obese-normal blood pressure subgroup (OB-NBP), obese-hypertension subgroup
      (OB-HTN).
observational model: Case-Crossover
time perspective: Cross-Sectional
measure: CTRP3 and RBP4 levels were measured in obesity and hypertension
time frame: 1 year
description: 531 subjects were required to fast overnight before the physical examination.Blood pressure was measured three times, each 2 min apart on the upper arm using a mercury sphygmomanometer in a seated, resting position after 10 minutes of rest; the mean of the three measurements was used for the statistical analysis.Weight, height and hip and waist circumference (WC), were measured. BMI was calculated as body weight in kilograms divided by the square of height (m2). WHR was calculated as the waist to hip circumference.
Overnight fasting blood samples were collected in tubes containing liquid EDTA; the samples were centrifuged at -4°C and maintained at -80°C until assayed. FBG was assayed using the glucose oxidase method. UA, TC, TG, LDL-C and HDL-C concentrations were determined enzymatically.
arm group label: NW-NBP group
description: normal weight and blood pressure subjects
arm group label: NW-HTN group
description: Normal weight with hypertension subjects
arm group label: OB-NBP group
description: obese-normal blood pressure subjects
arm group label: OB-HTN group
description: Obese-hypertension subjects
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Deng Wuquan, PHD
role: Study Director
affiliation: Southwest Hospital, China
url: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0055744
description: Implication of Progranulin and C1q/TNF-Related Protein-3 (CTRP3) on Inflammation and Atherosclerosis in Subjects with or without Metabolic Syndrome
url: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0099785
description: Identification of Adipokine Clusters Related to Parameters of Fat Mass, Insulin Sensitivity and Inflammation
responsible party type: Principal Investigator
investigator affiliation: Third Military Medical University
investigator full name: Deng Wu Quan
investigator title: Chongqing southwest hospital
mesh term: Hypertension
mesh term: Obesity