<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/NCT02977598</url>
  </required_header>
  <id_info>
    <org_study_id>44495147/1-202</org_study_id>
    <nct_id>NCT02977598</nct_id>
  </id_info>
  <brief_title>Relations Between Atherogenic Index of Plasma-Glucose Metabolism</brief_title>
  <official_title>Association Between Atherogenic Index of Plasma, Blood Pressure and Impaired Glucose Metabolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erzincan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erzincan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators aimed to find out whether there is any association between&#xD;
      the atherogenic index of plasma with the glucose metabolism.In this respect, apart from the&#xD;
      well-known diabetic risk factors, the investigators purposed to reveal new ones.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atherogenic index of plasma (AIP) is a relatively new index and a predictor of cardiovascular&#xD;
      risk. AIP has been shown to be associated with impaired glucose metabolism. This study aimed&#xD;
      to evaluate the relationship between AIP and parameters of glucose metabolism.&#xD;
&#xD;
      Methods: This observational study involved 448 healthy individuals who were at risk for&#xD;
      diabetes. They were sent to hospital for diabetes check. According to the 75 g oral glucose&#xD;
      tolerance test participants were categorized into the three groups; non-diabetic,&#xD;
      prediabetic, and diabetic based on the criteria of the American Diabetes Association (ADA).&#xD;
      The association between the diabetes group, AIP and parameters of glucose metabolism was&#xD;
      analyzed.&#xD;
&#xD;
      The accuracy of registry data compatible with medical records. Statistical analyses were&#xD;
      carried out using the Statistical Package for Social Sciences, Windows version 15.0 (SPSS,&#xD;
      Chicago, Illinois, USA). Descriptive statistics for each variable were determined. Normality&#xD;
      of the data distribution was assessed with the Kolmogorov-Smirnov test. For continuous&#xD;
      variables, non-parametric statistics (Mann-Whitney or Kruskal-Wallis), and parametric&#xD;
      statistics (t-test, ANOVA analysis) were used as appropriate. Statistically significant&#xD;
      differences between the groups were determined by the chi-square test for categorical&#xD;
      variables. Associations between the variables were explored using the Pearson correlation and&#xD;
      Spearman's rho (for data that was not normally distributed). Linear regression analysis with&#xD;
      backward elimination was also performed to define variables associated with AIP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Atherogenic index of plasma (AIP) values compared with glucose metabolism parameters like HbA1c, Fasting Plasma Glucose and 2-hour plasma glucose levels.</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">448</enrollment>
  <condition>Diabetes Mellitus Risk</condition>
  <arm_group>
    <arm_group_label>non-diabetic</arm_group_label>
    <description>According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>prediabetic</arm_group_label>
    <description>According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>diabetic</arm_group_label>
    <description>According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        448 healthy individuals who were at risk for diabetes. According to the 75 g oral glucose&#xD;
        tolerance test participants were categorized into the three groups; non-diabetic,&#xD;
        prediabetic, and diabetic based on the criteria of the American Diabetes Association.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All the participants were previously healthy, aged between 18 and 80 years, and were&#xD;
             at risk for diabetes according to new criteria provided by the American Diabetes&#xD;
             Association.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with a history of chronic medical diseases and those who reported current&#xD;
             use of any medication were excluded from the study&#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_official>
    <last_name>EMIN MURAT AKBAS, Assoc. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>ERZINCAN MENGUCEKGAZI TRAINING AND RESEARCH HOSPİTAL DEPARTMENT OF ENDOCRINOLOGY AND METABOLIC DISEASES</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erzincan Mengucekgazi Research and Training Hospital</name>
      <address>
        <city>Erzincan</city>
        <zip>00024</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erzincan Mengücekgazi Training and Research Hospital</name>
      <address>
        <city>Erzincan</city>
        <zip>00024</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 26, 2016</last_update_submitted>
  <last_update_submitted_qc>November 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erzincan University</investigator_affiliation>
    <investigator_full_name>HILAL ALPCAN</investigator_full_name>
    <investigator_title>Internal medicine, medical doctor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT02977598
org study id: 44495147/1-202
nct id: NCT02977598
lead sponsor: 
has dmc: No
In this study, the investigators aimed to find out whether there is any association between
      the atherogenic index of plasma with the glucose metabolism.In this respect, apart from the
      well-known diabetic risk factors, the investigators purposed to reveal new ones.
Atherogenic index of plasma (AIP) is a relatively new index and a predictor of cardiovascular
      risk. AIP has been shown to be associated with impaired glucose metabolism. This study aimed
      to evaluate the relationship between AIP and parameters of glucose metabolism.

      Methods: This observational study involved 448 healthy individuals who were at risk for
      diabetes. They were sent to hospital for diabetes check. According to the 75 g oral glucose
      tolerance test participants were categorized into the three groups; non-diabetic,
      prediabetic, and diabetic based on the criteria of the American Diabetes Association (ADA).
      The association between the diabetes group, AIP and parameters of glucose metabolism was
      analyzed.

      The accuracy of registry data compatible with medical records. Statistical analyses were
      carried out using the Statistical Package for Social Sciences, Windows version 15.0 (SPSS,
      Chicago, Illinois, USA). Descriptive statistics for each variable were determined. Normality
      of the data distribution was assessed with the Kolmogorov-Smirnov test. For continuous
      variables, non-parametric statistics (Mann-Whitney or Kruskal-Wallis), and parametric
      statistics (t-test, ANOVA analysis) were used as appropriate. Statistically significant
      differences between the groups were determined by the chi-square test for categorical
      variables. Associations between the variables were explored using the Pearson correlation and
      Spearman's rho (for data that was not normally distributed). Linear regression analysis with
      backward elimination was also performed to define variables associated with AIP.
measure: Atherogenic index of plasma (AIP) values compared with glucose metabolism parameters like HbA1c, Fasting Plasma Glucose and 2-hour plasma glucose levels.
time frame: 6 months
arm group label: non-diabetic
description: According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association.
arm group label: prediabetic
description: According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association.
arm group label: diabetic
description: According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association.
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: EMIN MURAT AKBAS, Assoc. Prof.
role: Principal Investigator
affiliation: ERZINCAN MENGUCEKGAZI TRAINING AND RESEARCH HOSPİTAL DEPARTMENT OF ENDOCRINOLOGY AND METABOLIC DISEASES
facility: 
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Erzincan University
investigator full name: HILAL ALPCAN
investigator title: Internal medicine, medical doctor
sharing ipd: No