<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/NCT02999841</url>
  </required_header>
  <id_info>
    <org_study_id>2119000273</org_study_id>
    <nct_id>NCT02999841</nct_id>
  </id_info>
  <brief_title>Effect of Acarbose and Vildagliptin on Visceral Fat Distribution in Newly Diagnosed Type 2 Diabetes Patients</brief_title>
  <acronym>VISA-T2DM</acronym>
  <official_title>Effect of Acarbose and Vildagliptin on Visceral Fat Distribution in Overweight and Obesity Patients With Newly Diagnosed Type 2 Diabetes Mellitus: A Randomized Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Focusing on newly diagnosed type 2 diabetes participants with overweight and obesity (24kg/m2&#xD;
      ≤ body mass index ≤ 30kg/m2).&#xD;
&#xD;
      50 participants per arm (acarbose &amp; lifestyle combination / vildagliptin &amp; lifestyle&#xD;
      combination), using abdominal computed tomography scans and other methods to evaluate the&#xD;
      effects of acarbose and vildagliptin on visceral fat distribution in overweight and obesity&#xD;
      patients with newly diagnosed type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2016</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of the visceral fat area in square centimeter assessed by abdominal CT scans from baseline to 24 weeks.</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of body weight in kilograms measured by investigators from baseline to 24 weeks.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of waist circumstance in centimeters measured by investigators from baseline to 24 weeks.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of body mass index in kg/m^2 measured by investigators from baseline to 24 weeks.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the subcutaneous fat area in square centimeters assessed by abdominal CT scans from baseline to 24 weeks.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of hemoglobin A1c in percents from baseline to 24 weeks.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of hemoglobin fasting plasma glucose in millimols per liter from baseline to 24 weeks.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of hemoglobin 2-hour-post-prandial plasma glucose in millimols per liter from baseline to 24 weeks.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of triglyceride in millimols per liter from baseline to 24 weeks.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of total cholesterol in millimols per liter from baseline to 24 weeks.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of low-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of high-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of insulin in international units per liter from baseline to 24 weeks.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of brain natriuretic peptide in nanograms per milliliter from baseline to 24 weeks.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acarbose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vildagliptin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acarbose</intervention_name>
    <description>1-2 week: 50mg tid; 3-24 week: 100mg tid.</description>
    <arm_group_label>Group A</arm_group_label>
    <other_name>Glucobay (Acarbose Tablets)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vildagliptin</intervention_name>
    <description>1-24 week: 50mg bid</description>
    <arm_group_label>Group B</arm_group_label>
    <other_name>Galvus (Vidagliptin Tablets)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients was diagnosed within the past 12 months with type 2 diabetes patients&#xD;
             (WHO, 1999 criteria ).&#xD;
&#xD;
          -  Not received oral anti-diabetic drugs or has been on short-term(1month) treatment that&#xD;
             had been discontinued 3 months before enrollment.&#xD;
&#xD;
          -  30 ≤ Age ≤ 70 years old, male or female.&#xD;
&#xD;
          -  HbA1c between 7% and 9% (7.0% ≤ HbA1c ≤9.0%).&#xD;
&#xD;
          -  24 ≤ BMI ≤ 30 kg/m2.&#xD;
&#xD;
          -  Written Informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject with type 1 diabetes or gestational diabetes mellitus and other specific types&#xD;
             DM.&#xD;
&#xD;
          -  Those who can not tolerate AGI or who is suffering GI disease.&#xD;
&#xD;
          -  Subject with repeated severe hypoglycemia and/or unawareness of hypoglycemia.&#xD;
&#xD;
          -  Known or suspected allergy to trial product(s) or related products.&#xD;
&#xD;
          -  Females of child bearing potential who are pregnant, breast-feeding or have the&#xD;
             intention of becoming pregnant or not using adequate contraceptive methods throughout&#xD;
             the trial&#xD;
&#xD;
          -  Impaired liver function, defined as ALT≥2 or AST≥ 2 times upper referenced limit times&#xD;
             upper normal limit.&#xD;
&#xD;
          -  Any other clinically significant condition or major systemic diseases, including&#xD;
             serious coronary heart disease, cardiovascular disease, cancer, TB, acute infection.&#xD;
&#xD;
          -  Endocrine diseases (hypo thyroidism, hyperthyroidism,Cushing's syndrome).&#xD;
&#xD;
          -  Uncontrolled hypertension(SBP≥180mmHg and/or DBP≥100mmHg).&#xD;
&#xD;
          -  Diabetic ketoacidosis; or hyperosmolar non-ketotic coma.&#xD;
&#xD;
          -  Concomitant treatment which influences blood glucose and bodyweight.&#xD;
&#xD;
          -  Impaired renal function(Cr≥ 1.5 mg/dl in male or Cr≥1.4 mg/dl in female).&#xD;
&#xD;
          -  Mental disorders; drug or other substance misuse.&#xD;
&#xD;
          -  Participation in any drug clinical trials during the past 3 months before enrolment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linong Ji, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Linong Ji, MD</last_name>
    <phone>+86 10 8832 4108</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Pinggu Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>101200</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yufeng Li, MD</last_name>
      <phone>+86 139 1108 0328</phone>
    </contact>
    <investigator>
      <last_name>Yufeng Li, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Ibrahim MM. Subcutaneous and visceral adipose tissue: structural and functional differences. Obes Rev. 2010 Jan;11(1):11-8. doi: 10.1111/j.1467-789X.2009.00623.x. Epub 2009 Jul 28.</citation>
    <PMID>19656312</PMID>
  </results_reference>
  <results_reference>
    <citation>Schernthaner GH, Schernthaner G. Insulin resistance and inflammation in the early phase of type 2 diabetes: potential for therapeutic intervention. Scand J Clin Lab Invest Suppl. 2005;240:30-40. doi: 10.1080/00365510500236119.</citation>
    <PMID>16112958</PMID>
  </results_reference>
  <results_reference>
    <citation>Monami M, Iacomelli I, Marchionni N, Mannucci E. Dipeptydil peptidase-4 inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis. 2010 May;20(4):224-35. doi: 10.1016/j.numecd.2009.03.015. Epub 2009 Jun 9.</citation>
    <PMID>19515542</PMID>
  </results_reference>
  <results_reference>
    <citation>Kodama N, Tahara N, Tahara A, Honda A, Nitta Y, Mizoguchi M, Kaida H, Ishibashi M, Abe T, Ikeda H, Narula J, Fukumoto Y, Yamagishi S, Imaizumi T. Effects of pioglitazone on visceral fat metabolic activity in impaired glucose tolerance or type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 Nov;98(11):4438-45. doi: 10.1210/jc.2013-2920. Epub 2013 Sep 12.</citation>
    <PMID>24030946</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>March 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 18, 2016</last_update_submitted>
  <last_update_submitted_qc>December 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Linong Ji</investigator_full_name>
    <investigator_title>Director of Department of Endocrinology and Metabolism, Peking University People's Hospital.</investigator_title>
  </responsible_party>
  <keyword>Visceral fat</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vildagliptin</mesh_term>
    <mesh_term>Acarbose</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Do not share data.</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/NCT02999841
org study id: 2119000273
nct id: NCT02999841
lead sponsor: 
has dmc: No
Focusing on newly diagnosed type 2 diabetes participants with overweight and obesity (24kg/m2
      ≤ body mass index ≤ 30kg/m2).

      50 participants per arm (acarbose & lifestyle combination / vildagliptin & lifestyle
      combination), using abdominal computed tomography scans and other methods to evaluate the
      effects of acarbose and vildagliptin on visceral fat distribution in overweight and obesity
      patients with newly diagnosed type 2 diabetes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of the visceral fat area in square centimeter assessed by abdominal CT scans from baseline to 24 weeks.
time frame: 24 weeks
measure: Change of body weight in kilograms measured by investigators from baseline to 24 weeks.
time frame: 24 weeks
measure: Change of waist circumstance in centimeters measured by investigators from baseline to 24 weeks.
time frame: 24 weeks
measure: Change of body mass index in kg/m^2 measured by investigators from baseline to 24 weeks.
time frame: 24 weeks
measure: Change of the subcutaneous fat area in square centimeters assessed by abdominal CT scans from baseline to 24 weeks.
time frame: 24 weeks
measure: Change of hemoglobin A1c in percents from baseline to 24 weeks.
time frame: 24 weeks
measure: Change of hemoglobin fasting plasma glucose in millimols per liter from baseline to 24 weeks.
time frame: 24 weeks
measure: Change of hemoglobin 2-hour-post-prandial plasma glucose in millimols per liter from baseline to 24 weeks.
time frame: 24 weeks
measure: Change of triglyceride in millimols per liter from baseline to 24 weeks.
time frame: 24 weeks
measure: Change of total cholesterol in millimols per liter from baseline to 24 weeks.
time frame: 24 weeks
measure: Change of low-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks.
time frame: 24 weeks
measure: Change of high-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks.
time frame: 24 weeks
measure: Change of insulin in international units per liter from baseline to 24 weeks.
time frame: 24 weeks
measure: Change of brain natriuretic peptide in nanograms per milliliter from baseline to 24 weeks.
time frame: 24 weeks
arm group label: Group A
arm group type: Experimental
description: Acarbose
arm group label: Group B
arm group type: Active Comparator
description: Vildagliptin
intervention type: Drug
intervention name: Acarbose
description: 1-2 week: 50mg tid; 3-24 week: 100mg tid.
arm group label: Group A
other name: Glucobay (Acarbose Tablets)
intervention type: Drug
intervention name: Vildagliptin
description: 1-24 week: 50mg bid
arm group label: Group B
other name: Galvus (Vidagliptin Tablets)
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Linong Ji, MD
role: Principal Investigator
affiliation: Peking University People's Hospital
last name: Linong Ji, MD
phone: +86 10 8832 4108
facility: 
status: Recruiting
contact: 
investigator: 
country: China
citation: Ibrahim MM. Subcutaneous and visceral adipose tissue: structural and functional differences. Obes Rev. 2010 Jan;11(1):11-8. doi: 10.1111/j.1467-789X.2009.00623.x. Epub 2009 Jul 28.
PMID: 19656312
citation: Schernthaner GH, Schernthaner G. Insulin resistance and inflammation in the early phase of type 2 diabetes: potential for therapeutic intervention. Scand J Clin Lab Invest Suppl. 2005;240:30-40. doi: 10.1080/00365510500236119.
PMID: 16112958
citation: Monami M, Iacomelli I, Marchionni N, Mannucci E. Dipeptydil peptidase-4 inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis. 2010 May;20(4):224-35. doi: 10.1016/j.numecd.2009.03.015. Epub 2009 Jun 9.
PMID: 19515542
citation: Kodama N, Tahara N, Tahara A, Honda A, Nitta Y, Mizoguchi M, Kaida H, Ishibashi M, Abe T, Ikeda H, Narula J, Fukumoto Y, Yamagishi S, Imaizumi T. Effects of pioglitazone on visceral fat metabolic activity in impaired glucose tolerance or type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 Nov;98(11):4438-45. doi: 10.1210/jc.2013-2920. Epub 2013 Sep 12.
PMID: 24030946
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Linong Ji
investigator title: Director of Department of Endocrinology and Metabolism, Peking University People's Hospital.
mesh term: Diabetes Mellitus
mesh term: Obesity
mesh term: Diabetes Mellitus, Type 2
mesh term: Vildagliptin
mesh term: Acarbose
sharing ipd: No
ipd description: Do not share data.