<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/NCT03804775</url>
  </required_header>
  <id_info>
    <org_study_id>s10</org_study_id>
    <nct_id>NCT03804775</nct_id>
  </id_info>
  <brief_title>Comparative Analysis of Serum Lipid Profiles in Patients With and Without Gallstones</brief_title>
  <official_title>Comparative Analysis of Serum Lipid Profiles in Patients With and Without Gallstones: A Prospective Cross-Sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Services Hospital, Lahore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Services Hospital, Lahore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gallbladder disease is one of the most common diseases of the gastrointestinal tract. Various&#xD;
      studies have shown an association between gallstones and an alteration in the serum lipids.&#xD;
      The objective of this study will be to compare serum lipid profile of gallstone patients with&#xD;
      the controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective cross-sectional study will be conducted in the Surgical Department of the&#xD;
      Services Institute of Medical Sciences. A total of 50 patients will beincluded in the study&#xD;
      after screening through the inclusion criteria. A control group of 50 inpatients with no&#xD;
      personal or family history of gallstones will be also recruited for comparison. Results will&#xD;
      be expressed as mean with standard deviation. Students t- test will be used to compare the&#xD;
      data between the patients and the control groups (p&lt;0.05 will be considered statistically&#xD;
      significant). SPSS software, version 20 will be used for statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">August 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 30, 2018</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>serum cholesterol levels</measure>
    <time_frame>1 week</time_frame>
    <description>serum cholesterol levels of patients and case group will be compared with Students t- test was (p&lt;0.05 will be considered statistically significant)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>serum triglyceride levels</measure>
    <time_frame>1 week</time_frame>
    <description>serum triglyceride levels of gallstone patients and control group will be compared via student t-test (p&lt;0.05 was considered statistically significant)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>serum HDL levels</measure>
    <time_frame>1 week</time_frame>
    <description>serum HDL levels of patients and contoled will be compared with student t-test (p&lt;0.05 was considered statistically significant)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>serum LDL leves</measure>
    <time_frame>1 week</time_frame>
    <description>serum LDL leves of patients and control will be compared through student t-test (p&lt;0.05 was considered statistically significant)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Gallstone</condition>
  <condition>Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>case group</arm_group_label>
    <description>patients presenting with gallstone disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>inpatients with no history of gallstones</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Serum lipid profile</intervention_name>
    <description>Blood samples drawn from the patients and controls will be analyzed for serum cholesterol, serum triglycerides, serum LDLs and serum HDL levels. All the results will be recorded on a performa</description>
    <arm_group_label>case group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Case group: patients from lahore city presented with gallstone disease in Services Hospital&#xD;
        lahore&#xD;
&#xD;
        Control group: Patients admitted to Services Hospital with other diseases belonging from&#xD;
        lahore&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients with the gall stone disease&#xD;
&#xD;
          -  Age from 20 to 70 years&#xD;
&#xD;
          -  Gallstones were diagnosed through the ultrasound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with acalculous gallbladder disease on ultrasound,&#xD;
&#xD;
          -  Patients with terminal ileal resection,&#xD;
&#xD;
          -  Patients with hemolytic diseases (hereditary spherocytosis, sickle cell anemia on&#xD;
             history and CBC film),&#xD;
&#xD;
          -  Patients with liver cirrhosis (on abdominal ultrasound) and&#xD;
&#xD;
          -  Patients on antihyperlipidemic drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Mahmmood Ayyaz, mbbs, fcps</last_name>
    <role>Study Director</role>
    <affiliation>Services Hospital, Lahore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Services hospital</name>
      <address>
        <city>Lahore</city>
        <state>Punjab</state>
        <zip>54000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Services Hospital, Lahore</investigator_affiliation>
    <investigator_full_name>Dr. SamiUllah</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallstones</mesh_term>
    <mesh_term>Cholelithiasis</mesh_term>
    <mesh_term>Cholecystolithiasis</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03804775
org study id: s10
nct id: NCT03804775
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Gallbladder disease is one of the most common diseases of the gastrointestinal tract. Various
      studies have shown an association between gallstones and an alteration in the serum lipids.
      The objective of this study will be to compare serum lipid profile of gallstone patients with
      the controls.
This prospective cross-sectional study will be conducted in the Surgical Department of the
      Services Institute of Medical Sciences. A total of 50 patients will beincluded in the study
      after screening through the inclusion criteria. A control group of 50 inpatients with no
      personal or family history of gallstones will be also recruited for comparison. Results will
      be expressed as mean with standard deviation. Students t- test will be used to compare the
      data between the patients and the control groups (p<0.05 will be considered statistically
      significant). SPSS software, version 20 will be used for statistical analysis.
observational model: Case-Control
time perspective: Cross-Sectional
measure: serum cholesterol levels
time frame: 1 week
description: serum cholesterol levels of patients and case group will be compared with Students t- test was (p<0.05 will be considered statistically significant)
measure: serum triglyceride levels
time frame: 1 week
description: serum triglyceride levels of gallstone patients and control group will be compared via student t-test (p<0.05 was considered statistically significant)
measure: serum HDL levels
time frame: 1 week
description: serum HDL levels of patients and contoled will be compared with student t-test (p<0.05 was considered statistically significant)
measure: serum LDL leves
time frame: 1 week
description: serum LDL leves of patients and control will be compared through student t-test (p<0.05 was considered statistically significant)
arm group label: case group
description: patients presenting with gallstone disease
arm group label: control group
description: inpatients with no history of gallstones
intervention type: Diagnostic Test
intervention name: Serum lipid profile
description: Blood samples drawn from the patients and controls will be analyzed for serum cholesterol, serum triglycerides, serum LDLs and serum HDL levels. All the results will be recorded on a performa
arm group label: case group
arm group label: control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
last name: Mahmmood Ayyaz, mbbs, fcps
role: Study Director
affiliation: Services Hospital, Lahore
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Services Hospital, Lahore
investigator full name: Dr. SamiUllah
investigator title: Principle investigator
mesh term: Gallstones
mesh term: Cholelithiasis
mesh term: Cholecystolithiasis
mesh term: Dyslipidemias
sharing ipd: Undecided