<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/NCT01684280</url>
  </required_header>
  <id_info>
    <org_study_id>CRC-06-09-10</org_study_id>
    <nct_id>NCT01684280</nct_id>
  </id_info>
  <brief_title>Obesity-related Genes in Taiwanese Undergoing Weight Loss</brief_title>
  <official_title>Searching for the Most Influential Obesity-related Diabetic Genes and Exploring the Expression Profiles of Those Genes in Taiwanese Undergoing Weight Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sung Ling Yeh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Science Council, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taipei Medical University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate:&#xD;
&#xD;
        1. Associations between miRNA and insulin signaling-related gene expressions in abdominal&#xD;
           adipose tissues in obese subjects.&#xD;
&#xD;
        2. Differences in miRNAs expressed by intrabdominal omental adipose tissues between&#xD;
           genders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Compared the differences in microRNA expressions of abdominal adipose tissue in morbid obese&#xD;
      male and female subjects to elucidate the possible regulatory role of microRNA in insulin&#xD;
      signaling-related gene expression levels and its association with biochemical markers. We&#xD;
      hope to find a miRNA that can be used to predict the syndrome associated with obesity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">September 2010</completion_date>
  <primary_completion_date type="Actual">September 2010</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MicroRNA expression in abdominal omental adipose tissues</measure>
    <time_frame>up to 28 weeks</time_frame>
    <description>MicroRNA-125a-3p expression in abdominal omental adipose tissues is associated with insulin signaling-related gene expression levels in morbid obesity</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>gender</arm_group_label>
    <description>Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were obtained from men and women who underwent bariatric surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>gender</intervention_name>
    <description>Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were obtained from men and women who underwent bariatric surgery.</description>
    <arm_group_label>gender</arm_group_label>
    <other_name>BMI were all over 40 kg/ m2</other_name>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were&#xD;
      obtained from men and women who underwent laparoscopic bariatric surgery.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were&#xD;
        obtained from men (n = 9) and women (n =10) who underwent bariatric surgery. Their BMI were&#xD;
        all over 40 kg/ m2, and ages between 19-63 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Morbid obesity,BMIs&gt; 40 kg/m2&#xD;
&#xD;
          -  Subjects who underwent bariatric surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Obese subjects with complicated metabolic disorders&#xD;
&#xD;
          -  Thyroid disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>63 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wang Weu</last_name>
    <role>Study Director</role>
    <affiliation>Comprehensive Weight Management Center Taipei Medical University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei Medical University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>110</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>http://irb.xms.tmu.edu.tw/xms/index.php</url>
    <description>Taipei Medical University-Joint Institutional Review Board</description>
  </link>
  <reference>
    <citation>Brennecke J, Stark A, Russell RB, Cohen SM. Principles of microRNA-target recognition. PLoS Biol. 2005 Mar;3(3):e85. doi: 10.1371/journal.pbio.0030085.</citation>
    <PMID>15723116</PMID>
  </reference>
  <reference>
    <citation>Bartel DP. MicroRNAs: genomics, biogenesis, mechanism, and function. Cell. 2004 Jan 23;116(2):281-97. doi: 10.1016/s0092-8674(04)00045-5.</citation>
    <PMID>14744438</PMID>
  </reference>
  <reference>
    <citation>Hilton C, Neville MJ, Karpe F. MicroRNAs in adipose tissue: their role in adipogenesis and obesity. Int J Obes (Lond). 2013 Mar;37(3):325-32. doi: 10.1038/ijo.2012.59. Epub 2012 Apr 24.</citation>
    <PMID>22531086</PMID>
  </reference>
  <reference>
    <citation>Krotkiewski M, Bjorntorp P, Sjostrom L, Smith U. Impact of obesity on metabolism in men and women. Importance of regional adipose tissue distribution. J Clin Invest. 1983 Sep;72(3):1150-62. doi: 10.1172/JCI111040.</citation>
    <PMID>6350364</PMID>
  </reference>
  <results_reference>
    <citation>Jiang L, Huang Q, Zhang S, Zhang Q, Chang J, Qiu X, Wang E. Hsa-miR-125a-3p and hsa-miR-125a-5p are downregulated in non-small cell lung cancer and have inverse effects on invasion and migration of lung cancer cells. BMC Cancer. 2010 Jun 22;10:318. doi: 10.1186/1471-2407-10-318.</citation>
    <PMID>20569443</PMID>
  </results_reference>
  <results_reference>
    <citation>Herrera BM, Lockstone HE, Taylor JM, Wills QF, Kaisaki PJ, Barrett A, Camps C, Fernandez C, Ragoussis J, Gauguier D, McCarthy MI, Lindgren CM. MicroRNA-125a is over-expressed in insulin target tissues in a spontaneous rat model of Type 2 Diabetes. BMC Med Genomics. 2009 Aug 18;2:54. doi: 10.1186/1755-8794-2-54.</citation>
    <PMID>19689793</PMID>
  </results_reference>
  <results_reference>
    <citation>John B, Enright AJ, Aravin A, Tuschl T, Sander C, Marks DS. Human MicroRNA targets. PLoS Biol. 2004 Nov;2(11):e363. doi: 10.1371/journal.pbio.0020363. Epub 2004 Oct 5. Erratum In: PLoS Biol. 2005 Jul;3(7):e264.</citation>
    <PMID>15502875</PMID>
  </results_reference>
  <results_reference>
    <citation>Kanehisa M, Goto S. KEGG: kyoto encyclopedia of genes and genomes. Nucleic Acids Res. 2000 Jan 1;28(1):27-30. doi: 10.1093/nar/28.1.27.</citation>
    <PMID>10592173</PMID>
  </results_reference>
  <results_reference>
    <citation>Gustafson B. Adipose tissue, inflammation and atherosclerosis. J Atheroscler Thromb. 2010 Apr 30;17(4):332-41. doi: 10.5551/jat.3939. Epub 2010 Feb 3.</citation>
    <PMID>20124732</PMID>
  </results_reference>
  <results_reference>
    <citation>O'Connell J, Lynch L, Cawood TJ, Kwasnik A, Nolan N, Geoghegan J, McCormick A, O'Farrelly C, O'Shea D. The relationship of omental and subcutaneous adipocyte size to metabolic disease in severe obesity. PLoS One. 2010 Apr 1;5(4):e9997. doi: 10.1371/journal.pone.0009997.</citation>
    <PMID>20376319</PMID>
  </results_reference>
  <results_reference>
    <citation>Wellen KE, Hotamisligil GS. Inflammation, stress, and diabetes. J Clin Invest. 2005 May;115(5):1111-9. doi: 10.1172/JCI25102.</citation>
    <PMID>15864338</PMID>
  </results_reference>
  <results_reference>
    <citation>Niswender KD, Morrison CD, Clegg DJ, Olson R, Baskin DG, Myers MG Jr, Seeley RJ, Schwartz MW. Insulin activation of phosphatidylinositol 3-kinase in the hypothalamic arcuate nucleus: a key mediator of insulin-induced anorexia. Diabetes. 2003 Feb;52(2):227-31. doi: 10.2337/diabetes.52.2.227.</citation>
    <PMID>12540590</PMID>
  </results_reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>September 11, 2012</last_update_submitted>
  <last_update_submitted_qc>September 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 13, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University Hospital</investigator_affiliation>
    <investigator_full_name>Sung Ling Yeh</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>abdominal adipose tissue; microRNA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
    <mesh_term>Weight Loss</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/NCT01684280
org study id: CRC-06-09-10
nct id: NCT01684280
lead sponsor: 
collaborator: 
has dmc: Yes
To investigate:

        1. Associations between miRNA and insulin signaling-related gene expressions in abdominal
           adipose tissues in obese subjects.

        2. Differences in miRNAs expressed by intrabdominal omental adipose tissues between
           genders.
Compared the differences in microRNA expressions of abdominal adipose tissue in morbid obese
      male and female subjects to elucidate the possible regulatory role of microRNA in insulin
      signaling-related gene expression levels and its association with biochemical markers. We
      hope to find a miRNA that can be used to predict the syndrome associated with obesity.
observational model: Case-Control
time perspective: Cross-Sectional
measure: MicroRNA expression in abdominal omental adipose tissues
time frame: up to 28 weeks
description: MicroRNA-125a-3p expression in abdominal omental adipose tissues is associated with insulin signaling-related gene expression levels in morbid obesity
arm group label: gender
description: Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were obtained from men and women who underwent bariatric surgery.
intervention type: Genetic
intervention name: gender
description: Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were obtained from men and women who underwent bariatric surgery.
arm group label: gender
other name: BMI were all over 40 kg/ m2
Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were
      obtained from men and women who underwent laparoscopic bariatric surgery.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 63 Years
healthy volunteers: No
last name: Wang Weu
role: Study Director
affiliation: Comprehensive Weight Management Center Taipei Medical University Hospital
facility: 
country: Taiwan
url: http://irb.xms.tmu.edu.tw/xms/index.php
description: Taipei Medical University-Joint Institutional Review Board
citation: Brennecke J, Stark A, Russell RB, Cohen SM. Principles of microRNA-target recognition. PLoS Biol. 2005 Mar;3(3):e85. doi: 10.1371/journal.pbio.0030085.
PMID: 15723116
citation: Bartel DP. MicroRNAs: genomics, biogenesis, mechanism, and function. Cell. 2004 Jan 23;116(2):281-97. doi: 10.1016/s0092-8674(04)00045-5.
PMID: 14744438
citation: Hilton C, Neville MJ, Karpe F. MicroRNAs in adipose tissue: their role in adipogenesis and obesity. Int J Obes (Lond). 2013 Mar;37(3):325-32. doi: 10.1038/ijo.2012.59. Epub 2012 Apr 24.
PMID: 22531086
citation: Krotkiewski M, Bjorntorp P, Sjostrom L, Smith U. Impact of obesity on metabolism in men and women. Importance of regional adipose tissue distribution. J Clin Invest. 1983 Sep;72(3):1150-62. doi: 10.1172/JCI111040.
PMID: 6350364
citation: Jiang L, Huang Q, Zhang S, Zhang Q, Chang J, Qiu X, Wang E. Hsa-miR-125a-3p and hsa-miR-125a-5p are downregulated in non-small cell lung cancer and have inverse effects on invasion and migration of lung cancer cells. BMC Cancer. 2010 Jun 22;10:318. doi: 10.1186/1471-2407-10-318.
PMID: 20569443
citation: Herrera BM, Lockstone HE, Taylor JM, Wills QF, Kaisaki PJ, Barrett A, Camps C, Fernandez C, Ragoussis J, Gauguier D, McCarthy MI, Lindgren CM. MicroRNA-125a is over-expressed in insulin target tissues in a spontaneous rat model of Type 2 Diabetes. BMC Med Genomics. 2009 Aug 18;2:54. doi: 10.1186/1755-8794-2-54.
PMID: 19689793
citation: John B, Enright AJ, Aravin A, Tuschl T, Sander C, Marks DS. Human MicroRNA targets. PLoS Biol. 2004 Nov;2(11):e363. doi: 10.1371/journal.pbio.0020363. Epub 2004 Oct 5. Erratum In: PLoS Biol. 2005 Jul;3(7):e264.
PMID: 15502875
citation: Kanehisa M, Goto S. KEGG: kyoto encyclopedia of genes and genomes. Nucleic Acids Res. 2000 Jan 1;28(1):27-30. doi: 10.1093/nar/28.1.27.
PMID: 10592173
citation: Gustafson B. Adipose tissue, inflammation and atherosclerosis. J Atheroscler Thromb. 2010 Apr 30;17(4):332-41. doi: 10.5551/jat.3939. Epub 2010 Feb 3.
PMID: 20124732
citation: O'Connell J, Lynch L, Cawood TJ, Kwasnik A, Nolan N, Geoghegan J, McCormick A, O'Farrelly C, O'Shea D. The relationship of omental and subcutaneous adipocyte size to metabolic disease in severe obesity. PLoS One. 2010 Apr 1;5(4):e9997. doi: 10.1371/journal.pone.0009997.
PMID: 20376319
citation: Wellen KE, Hotamisligil GS. Inflammation, stress, and diabetes. J Clin Invest. 2005 May;115(5):1111-9. doi: 10.1172/JCI25102.
PMID: 15864338
citation: Niswender KD, Morrison CD, Clegg DJ, Olson R, Baskin DG, Myers MG Jr, Seeley RJ, Schwartz MW. Insulin activation of phosphatidylinositol 3-kinase in the hypothalamic arcuate nucleus: a key mediator of insulin-induced anorexia. Diabetes. 2003 Feb;52(2):227-31. doi: 10.2337/diabetes.52.2.227.
PMID: 12540590
responsible party type: Sponsor-Investigator
investigator affiliation: Taipei Medical University Hospital
investigator full name: Sung Ling Yeh
investigator title: professor
mesh term: Obesity
mesh term: Obesity, Morbid
mesh term: Weight Loss