<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/NCT03229044</url>
  </required_header>
  <id_info>
    <org_study_id>9461701203</org_study_id>
    <nct_id>NCT03229044</nct_id>
  </id_info>
  <brief_title>Tetranectin as a Novel Obesity-associated Adipokine for Regulating Lipid Accumulation</brief_title>
  <official_title>Tetranectin as a Novel Obesity-associated Adipokine for Regulating Lipid Accumulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      Adipose tissue is strongly correlated to obesity and diabetes which are two major problems in&#xD;
      the worldwide. Adipose tissue is involved in modulating glucose and energy metabolism locally&#xD;
      and systemically by secreting factors, called adipocytokines. Tetranectin (TN), a novel&#xD;
      adipocytokine, is secreted by adipose tissues. TN may regulate the glucose/energy homeostasis&#xD;
      to affect lipid accumulation.The role of TN in adipocytes with or without TN on regulation of&#xD;
      adipose tissue growth and lipid metabolism is valuable to be studied.&#xD;
&#xD;
      Materials and methods: Secreted proteins from human adipocyte culture medium were deciphered&#xD;
      using 2-D polyacrylamide gel electrophoresis and determined by LC/MS with MALDI-TOF analysis&#xD;
      of proteins. Adipose tissues were obtained from the breast of 15 women undergoing mastectomy.&#xD;
      Serum samples from 200 normal healthy people and 54 breast cancer patients were assigned to&#xD;
      either a lean or obese group according to the body mass index. The TN protein concentration&#xD;
      was measured in the culture medium of stromal-vascular fraction (SVF)-derived adipocytes from&#xD;
      healthy humans, breast cancer patients, pigs and also from 3T3-L1 cells. Associations between&#xD;
      plasma TN and other biomarkers were assessed with Pearson's correlations and multivariable&#xD;
      linear regression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adipose tissues were obtained from the breast of breast cancer patients with 0 to 1&#xD;
      progression stage. All participants gave permission and the study was approved by the Ethics&#xD;
      Committee of National Taiwan University Hospital as no. 9461701203.&#xD;
&#xD;
      From 2012 to 2013 in National Taiwan University Hospital, a cross-sectional sampling of 21 to&#xD;
      78 -year old people included women and men who were living in Taiwan. Blood samples were&#xD;
      collected after an overnight fasting. Serum was separated by centrifugation and stored at -80&#xD;
      ℃ until analysis. Plasma triglyceride (TG), high density lipoprotein (HDL), low density&#xD;
      lipoprotein (LDL), cholesterol, glucose and insulin were measured. Fasting serum samples were&#xD;
      obtained from 193 randomly selected persons having health check-ups. To investigate the&#xD;
      relationship among TN and breast cancer, fasting serum samples also obtained from 54 randomly&#xD;
      selected breast cancer patients who were 25 to 59 years old with elected surgery for breast&#xD;
      cancer stage 0 and 1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2005</start_date>
  <completion_date type="Actual">December 5, 2008</completion_date>
  <primary_completion_date type="Actual">December 5, 2008</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tetranectin expression measure</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Detect Tetranectin expression in adipose tissue by qPCR or Western blotting</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">289</enrollment>
  <condition>Obesity</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>BMI 18-21</arm_group_label>
    <description>Tetranectin mRNA and protein level were measure in the adipose tissues which were belonging to body mass index is 18-21 kg/m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMI 33-39</arm_group_label>
    <description>Tetranectin mRNA and protein level were measure in the adipose tissues which were belonging to body mass index is 33-39 kg/m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMI 25-30</arm_group_label>
    <description>Tetranectin mRNA and protein level were measure in the adipose tissues which were belonging to body mass index is 25-30 kg/m2</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Tetranectin</intervention_name>
    <description>Adipose tissues were obtained from the breast of breast cancer patients with 0 to 1 progression stage. The subjects were 33-51 y of age (mean = 43.6, SD = 6.2) with a BMI of 16-33 kg/m2 (mean = 21.5, SD = 4.5). Blood samples were collected after an overnight fasting. Serum was separated by centrifugation and stored at -80 ℃ until analysis. Plasma Tetranectin,triglyceride (TG), high density lipoprotein (HDL), low density lipoprotein (LDL), cholesterol, glucose and insulin were measured. And the tetranectin mRNA and protein level was measure in adipose tissue</description>
    <arm_group_label>BMI 18-21</arm_group_label>
    <arm_group_label>BMI 25-30</arm_group_label>
    <arm_group_label>BMI 33-39</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Adipose tissues from breast were preserve in -80 refrigerator&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adipose tissues were obtained from the breast of breast cancer patients with 0 to 1&#xD;
        progression stage.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must be above age 20 years old.&#xD;
&#xD;
          2. Subjects must sign the written informed consent form.&#xD;
&#xD;
          3. Must have residual fat after surgery.&#xD;
&#xD;
          4. Clinical diagnosis of liposuction and tumor resection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Terminal cancer.&#xD;
&#xD;
          2. Subjects have no fat tissue after surgery.&#xD;
&#xD;
          3. Pregnant subjects.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shih-Torng Ding, Ph D</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University</affiliation>
  </overall_official>
  <reference>
    <citation>Jaquinod M, Holtet TL, Etzerodt M, Clemmensen I, Thogersen HC, Roepstorff P. Mass spectrometric characterisation of post-translational modification and genetic variation in human tetranectin. Biol Chem. 1999 Nov;380(11):1307-14. doi: 10.1515/BC.1999.166.</citation>
    <PMID>10614823</PMID>
  </reference>
  <reference>
    <citation>Iba K, Durkin ME, Johnsen L, Hunziker E, Damgaard-Pedersen K, Zhang H, Engvall E, Albrechtsen R, Wewer UM. Mice with a targeted deletion of the tetranectin gene exhibit a spinal deformity. Mol Cell Biol. 2001 Nov;21(22):7817-25. doi: 10.1128/MCB.21.22.7817-7825.2001.</citation>
    <PMID>11604516</PMID>
  </reference>
  <verification_date>December 2005</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>July 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adipokine, tetranectin, lipid metabolism, body mass index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Serum samples and adipose tissue from breast cancer patients were assigned to either a lean or obese group according to the body mass index. The TN protein concentration was measured in the serum samples and culture medium of stromal-vascular fraction (SVF)-derived adipocytes from breast cancer patients,</ipd_description>
  </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/NCT03229044
org study id: 9461701203
nct id: NCT03229044
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Adipose tissue is strongly correlated to obesity and diabetes which are two major problems in
      the worldwide. Adipose tissue is involved in modulating glucose and energy metabolism locally
      and systemically by secreting factors, called adipocytokines. Tetranectin (TN), a novel
      adipocytokine, is secreted by adipose tissues. TN may regulate the glucose/energy homeostasis
      to affect lipid accumulation.The role of TN in adipocytes with or without TN on regulation of
      adipose tissue growth and lipid metabolism is valuable to be studied.

      Materials and methods: Secreted proteins from human adipocyte culture medium were deciphered
      using 2-D polyacrylamide gel electrophoresis and determined by LC/MS with MALDI-TOF analysis
      of proteins. Adipose tissues were obtained from the breast of 15 women undergoing mastectomy.
      Serum samples from 200 normal healthy people and 54 breast cancer patients were assigned to
      either a lean or obese group according to the body mass index. The TN protein concentration
      was measured in the culture medium of stromal-vascular fraction (SVF)-derived adipocytes from
      healthy humans, breast cancer patients, pigs and also from 3T3-L1 cells. Associations between
      plasma TN and other biomarkers were assessed with Pearson's correlations and multivariable
      linear regression.
Adipose tissues were obtained from the breast of breast cancer patients with 0 to 1
      progression stage. All participants gave permission and the study was approved by the Ethics
      Committee of National Taiwan University Hospital as no. 9461701203.

      From 2012 to 2013 in National Taiwan University Hospital, a cross-sectional sampling of 21 to
      78 -year old people included women and men who were living in Taiwan. Blood samples were
      collected after an overnight fasting. Serum was separated by centrifugation and stored at -80
      ℃ until analysis. Plasma triglyceride (TG), high density lipoprotein (HDL), low density
      lipoprotein (LDL), cholesterol, glucose and insulin were measured. Fasting serum samples were
      obtained from 193 randomly selected persons having health check-ups. To investigate the
      relationship among TN and breast cancer, fasting serum samples also obtained from 54 randomly
      selected breast cancer patients who were 25 to 59 years old with elected surgery for breast
      cancer stage 0 and 1.
observational model: Case-Only
time perspective: Retrospective
measure: Tetranectin expression measure
time frame: through study completion, an average of 2 years
description: Detect Tetranectin expression in adipose tissue by qPCR or Western blotting
arm group label: BMI 18-21
description: Tetranectin mRNA and protein level were measure in the adipose tissues which were belonging to body mass index is 18-21 kg/m2
arm group label: BMI 33-39
description: Tetranectin mRNA and protein level were measure in the adipose tissues which were belonging to body mass index is 33-39 kg/m2
arm group label: BMI 25-30
description: Tetranectin mRNA and protein level were measure in the adipose tissues which were belonging to body mass index is 25-30 kg/m2
intervention type: Genetic
intervention name: Tetranectin
description: Adipose tissues were obtained from the breast of breast cancer patients with 0 to 1 progression stage. The subjects were 33-51 y of age (mean = 43.6, SD = 6.2) with a BMI of 16-33 kg/m2 (mean = 21.5, SD = 4.5). Blood samples were collected after an overnight fasting. Serum was separated by centrifugation and stored at -80 ℃ until analysis. Plasma Tetranectin,triglyceride (TG), high density lipoprotein (HDL), low density lipoprotein (LDL), cholesterol, glucose and insulin were measured. And the tetranectin mRNA and protein level was measure in adipose tissue
arm group label: BMI 18-21
arm group label: BMI 25-30
arm group label: BMI 33-39
Adipose tissues from breast were preserve in -80 refrigerator
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shih-Torng Ding, Ph D
role: Principal Investigator
affiliation: National Taiwan University
citation: Jaquinod M, Holtet TL, Etzerodt M, Clemmensen I, Thogersen HC, Roepstorff P. Mass spectrometric characterisation of post-translational modification and genetic variation in human tetranectin. Biol Chem. 1999 Nov;380(11):1307-14. doi: 10.1515/BC.1999.166.
PMID: 10614823
citation: Iba K, Durkin ME, Johnsen L, Hunziker E, Damgaard-Pedersen K, Zhang H, Engvall E, Albrechtsen R, Wewer UM. Mice with a targeted deletion of the tetranectin gene exhibit a spinal deformity. Mol Cell Biol. 2001 Nov;21(22):7817-25. doi: 10.1128/MCB.21.22.7817-7825.2001.
PMID: 11604516
responsible party type: Sponsor
mesh term: Obesity
mesh term: Metabolic Syndrome
sharing ipd: Undecided
ipd description: Serum samples and adipose tissue from breast cancer patients were assigned to either a lean or obese group according to the body mass index. The TN protein concentration was measured in the serum samples and culture medium of stromal-vascular fraction (SVF)-derived adipocytes from breast cancer patients,