<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/NCT04417582</url>
  </required_header>
  <id_info>
    <org_study_id>09.2019.948</org_study_id>
    <nct_id>NCT04417582</nct_id>
  </id_info>
  <brief_title>Life Style Modification Medical and Surgical Management in Patients With Obesity</brief_title>
  <official_title>Evaluation of Life Style Modification Medical and Surgical Treatment Modalities in Patients With Obesity: An Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marmara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marmara University</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>
      In this is an observational study, obese patients that administed and followed in&#xD;
      endocrinology clinic of Marmara University Medical school hospital will follow for clinical&#xD;
      and laboratory parameters prospectively for 5 years&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following available clinical and laboratory parameters will be collected for 5 years&#xD;
      Treatment modalities ( life stye modification, medication, bariatric surgery) eating habits&#xD;
      quality of life body mass index , blood pressure body fat distribution (impedance&#xD;
      measurement) laboratory parameters (serum glucose, OGTT, insülin, lipids,creatinin ,ALT&#xD;
      AST,CBC, ferritin calcium, phosphate, Parathormone,25 OH vitamin D, vitamin B12 ,uric acid,&#xD;
      albumin, FSH LH testosteron, estrogen ) muscle strength (dynomometer measurement) skin&#xD;
      glikolization autoflouresent measurement Bone mineral density mesurements (femur, spine&#xD;
      ,forarm)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>weight loss</measure>
    <time_frame>6 months interval</time_frame>
    <description>%5-10 weight loss</description>
  </primary_outcome>
  <primary_outcome>
    <measure>metabolic improvement</measure>
    <time_frame>6 months interval</time_frame>
    <description>blood glucose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>metabolic improvement</measure>
    <time_frame>6 month</time_frame>
    <description>serum lipid levels</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Obesity</condition>
  <condition>Weight Change, Body</condition>
  <condition>Obesity; Endocrine</condition>
  <condition>Obesity, Metabolically Benign</condition>
  <arm_group>
    <arm_group_label>life syte modification only</arm_group_label>
    <description>obese patients followed with life style modification</description>
  </arm_group>
  <arm_group>
    <arm_group_label>medical teatment with antiobesity drugs</arm_group_label>
    <description>patients prescribed antiobesity drugs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bariatric surgery</arm_group_label>
    <description>patients undergone bariatric surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>bariatric surgey</intervention_name>
    <description>patients undergone bariatric surgery or prescribed antiobesity drugs</description>
    <arm_group_label>life syte modification only</arm_group_label>
    <arm_group_label>medical teatment with antiobesity drugs</arm_group_label>
    <other_name>antiobesity drugs ,liraglutide or orlistat</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        obese patients refered to our tertiary center for obesity evaluation or treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Body mass index over 30 kg/m2 age between 18-65 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        active malignancy pregnancy during involvement period chronic inflamatuar diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dilek Gogas Yavuz, MD</last_name>
    <phone>+902166254685</phone>
    <email>dilekgogas@marmara.edu.tr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Marmara University Medical School Section of Endocrinology and Metabolism</name>
      <address>
        <city>Istanbul</city>
        <zip>34899</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dilek Gogas Yavuz, MD</last_name>
      <phone>+902166254685</phone>
      <email>dilekgogas@marmara.edu.tr</email>
    </contact>
    <investigator>
      <last_name>Tuğçe Apaydın, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>weight loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Metabolically Benign</mesh_term>
    <mesh_term>Body Weight Changes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liraglutide</mesh_term>
    <mesh_term>Orlistat</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>data will be shared at the second year of recruitment</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/NCT04417582
org study id: 09.2019.948
nct id: NCT04417582
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this is an observational study, obese patients that administed and followed in
      endocrinology clinic of Marmara University Medical school hospital will follow for clinical
      and laboratory parameters prospectively for 5 years
Following available clinical and laboratory parameters will be collected for 5 years
      Treatment modalities ( life stye modification, medication, bariatric surgery) eating habits
      quality of life body mass index , blood pressure body fat distribution (impedance
      measurement) laboratory parameters (serum glucose, OGTT, insülin, lipids,creatinin ,ALT
      AST,CBC, ferritin calcium, phosphate, Parathormone,25 OH vitamin D, vitamin B12 ,uric acid,
      albumin, FSH LH testosteron, estrogen ) muscle strength (dynomometer measurement) skin
      glikolization autoflouresent measurement Bone mineral density mesurements (femur, spine
      ,forarm)
observational model: Cohort
time perspective: Prospective
measure: weight loss
time frame: 6 months interval
description: %5-10 weight loss
measure: metabolic improvement
time frame: 6 months interval
description: blood glucose
measure: metabolic improvement
time frame: 6 month
description: serum lipid levels
arm group label: life syte modification only
description: obese patients followed with life style modification
arm group label: medical teatment with antiobesity drugs
description: patients prescribed antiobesity drugs
arm group label: bariatric surgery
description: patients undergone bariatric surgery
intervention type: Procedure
intervention name: bariatric surgey
description: patients undergone bariatric surgery or prescribed antiobesity drugs
arm group label: life syte modification only
arm group label: medical teatment with antiobesity drugs
other name: antiobesity drugs ,liraglutide or orlistat
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dilek Gogas Yavuz, MD
phone: +902166254685
email: dilekgogas@marmara.edu.tr
facility: 
status: Recruiting
contact: 
investigator: 
country: Turkey
responsible party type: Sponsor
mesh term: Obesity
mesh term: Obesity, Metabolically Benign
mesh term: Body Weight Changes
mesh term: Liraglutide
mesh term: Orlistat
sharing ipd: Undecided
ipd description: data will be shared at the second year of recruitment