<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/NCT04439851</url>
  </required_header>
  <id_info>
    <org_study_id>umraniye training hospital</org_study_id>
    <nct_id>NCT04439851</nct_id>
  </id_info>
  <brief_title>Impact of Sleeve Gastrectomy on Monocyte-to-High-Density Lipoprotein Cholesterol Ratio</brief_title>
  <official_title>The Relationship Between Monocyte-to-High-Density Lipoprotein Cholesterol Ratio, Metabolic Parameters and Excess Weight Loss in Patients Undergoing Laparoscopic Sleeve Gastrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umraniye Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umraniye Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The present study hypothesized that significant weight loss is associated with a reduction in&#xD;
      the inflammatory markers, leading to diminished cardiovascular risks in patients undergoing&#xD;
      laparoscopic sleeve gastrectomy (LGS).&#xD;
&#xD;
      We found a decrease in MHR at postoperative 6 months from baseline in patients undergoing&#xD;
      LSG. The decrease in MHR was more remarkable with increasing percentage of EWL, but no&#xD;
      relationship between the %EWL and MHR.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study aims to evaluate the relationship between MHR, metabolic parameters and the&#xD;
      percentage of excess weight loss (%EWL) in participants undergoing laparoscopic sleeve&#xD;
      gastrectomy (LSG).&#xD;
&#xD;
      This prospective cohort study will evaluate obese participants undergoing LSG. Demographic&#xD;
      data of the participants and blood glucose level, monocyte count and lipid parameters&#xD;
      baseline and at 6 months after surgery will record. The MHR baseline and at 6 months after&#xD;
      surgery and the %EWL at 6 months after surgery will calculate. The participants will be&#xD;
      divide into two groups as participants with %EWL of &lt;50 and patients with a %EWL of ≥50. The&#xD;
      parameters will compare between the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Monocyte-to-High-Density Lipoprotein Cholesterol Ratio changes</measure>
    <time_frame>6 months</time_frame>
    <description>Monocyte-to-High-Density Lipoprotein Cholesterol Ratio changes after Sleeve Gastrectomy</description>
  </primary_outcome>
  <enrollment type="Actual">125</enrollment>
  <condition>Laparoscopic Sleeve Gastrectomy</condition>
  <condition>Cardiovascular Risk Factor</condition>
  <condition>Obesity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Obese patients (BMI ≥40 or &gt;35+ and accompanying DM, HT and hyperlipidemia)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Obese patients (BMI ≥40 or &gt;35+ and accompanying DM, HT and hyperlipidemia) Underwent&#xD;
        laparoscopic sleeve gastrectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Receiving antihyperlipidemic therapy, Important complications that continue within 6 months&#xD;
        after surgery (anastomotic leaks, pulmonary embolism, deep vein thrombosis, soft tissue&#xD;
        infection) Did not attend 6-month control visit were excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Umraniye Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Sibel Ocak Serin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT04439851
org study id: umraniye training hospital
nct id: NCT04439851
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present study hypothesized that significant weight loss is associated with a reduction in
      the inflammatory markers, leading to diminished cardiovascular risks in patients undergoing
      laparoscopic sleeve gastrectomy (LGS).

      We found a decrease in MHR at postoperative 6 months from baseline in patients undergoing
      LSG. The decrease in MHR was more remarkable with increasing percentage of EWL, but no
      relationship between the %EWL and MHR.
The present study aims to evaluate the relationship between MHR, metabolic parameters and the
      percentage of excess weight loss (%EWL) in participants undergoing laparoscopic sleeve
      gastrectomy (LSG).

      This prospective cohort study will evaluate obese participants undergoing LSG. Demographic
      data of the participants and blood glucose level, monocyte count and lipid parameters
      baseline and at 6 months after surgery will record. The MHR baseline and at 6 months after
      surgery and the %EWL at 6 months after surgery will calculate. The participants will be
      divide into two groups as participants with %EWL of <50 and patients with a %EWL of ≥50. The
      parameters will compare between the two groups.
observational model: Cohort
time perspective: Prospective
measure: Monocyte-to-High-Density Lipoprotein Cholesterol Ratio changes
time frame: 6 months
description: Monocyte-to-High-Density Lipoprotein Cholesterol Ratio changes after Sleeve Gastrectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Umraniye Education and Research Hospital
investigator full name: Sibel Ocak Serin
investigator title: Principal Investigator