<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/NCT02227043</url>
  </required_header>
  <id_info>
    <org_study_id>SOWOT</org_study_id>
    <nct_id>NCT02227043</nct_id>
  </id_info>
  <brief_title>Study Of Weight Development Over Time</brief_title>
  <acronym>SOWOT</acronym>
  <official_title>Study Of Adipose Tissue Function and Weight Development Over Time</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Stockholm</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will study the influence of fat cell size/number and adipose function on&#xD;
      weight development over very long time periods (years). By comparing fat biopsies obtained at&#xD;
      baseline and after &gt;7 years, the investigators will determine the association between adipose&#xD;
      morphology/function and changes in weight or development of cardiometabolic complications&#xD;
      (e.g. insulin resistance, type 2 diabetes, dyslipidemia and hypertension).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will ask all subjects that have previously been examined at the&#xD;
      investigators laboratory (from 1992 and forward) in studies of adipose tissue function if&#xD;
      they are interested to participate in a new study. The minimal follow up time is 7 years.&#xD;
&#xD;
      Saved blood samples and samples from old fat biopsies will be analyzed together with samples&#xD;
      from new examinations.&#xD;
&#xD;
      The investigators plan to examine the subjects in the same way as performed at the baseline&#xD;
      examinations. This includes estimation of total body fat using bioimpedance, venous blood&#xD;
      samples for determination of insulin, glucose and lipids, subcutaneous fat biopsies with&#xD;
      determination of fat cell size/number, lipolysis/lipogenesis as well as analysis of adipokine&#xD;
      secretion.&#xD;
&#xD;
      In selected patients, baseline examinations included DEXA-measurement (dual energy x-ray&#xD;
      absorptiometry) for determination of body fat distribution as well as hyperinsulinemic&#xD;
      euglycemic clamp. In these cases, the same type of examinations will be repeated at their&#xD;
      follow up visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 1, 2017</completion_date>
  <primary_completion_date type="Actual">March 1, 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>Weight development over time and correlation to adipose morphology</measure>
    <time_frame>from 2014 up to 2024, up to 10 years</time_frame>
    <description>Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years (84 months). Weight will be assessed with a regular scale and adipose morphology will be determined by measurement of fat cell size and adjustment for body weight.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight development and correlation to lipolysis</measure>
    <time_frame>2014 to 2024, up to 10 years</time_frame>
    <description>Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years. Weight will be assessed with a regular scale. Fat cells will be isolated and assessment of lipolysis will be made with previously published standardized protocols.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight development and correlation to lipogenesis</measure>
    <time_frame>2014 to 2024, up to 10 years</time_frame>
    <description>Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years. Weight will be assessed with a regular scale and lipogenesis will be measured according to previously published standardized protocol after isolated fat cells have been stimulated with insulin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adipose tissue morphology development and insulin sensitivity</measure>
    <time_frame>2014 to 2024, up to 10 years</time_frame>
    <description>Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years. Adipose morphology will be determined by measurement of fat cell size and adjustment for body weight. Insulin sensitivity will be assessed by measurement of glucose and insulin and in some cases also hyperinsulinemic euglycemic clamp.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adipose morphology and changes in fat mass</measure>
    <time_frame>2014 to 2024, up to 10 years</time_frame>
    <description>Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years. Adipose morphology will be determined by measurement of fat cell size and adjustment for body weight. Fat mass will be assessed by impedance measurement and in some cases DEXA according to previously published protocols.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adipose morphology and development of fat mass</measure>
    <time_frame>2014 to 2024, up to 10 years</time_frame>
    <description>Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years. Fat mass will be assessed by impedance measurement and in some cases DEXA according to previously published protocols.</description>
  </secondary_outcome>
  <enrollment type="Actual">105</enrollment>
  <condition>Obesity</condition>
  <condition>Insulin Resistance</condition>
  <condition>Weight Reduction</condition>
  <condition>Weight Gain</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood, serum, plasma, adipose tissue, adipocytes&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Observational study All subjects that have been previously investigated at our lab at least&#xD;
        7 years ago&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participated in previous examination at our lab at least 7 years ago.&#xD;
&#xD;
          -  No blood samples or adipose samples saved from last examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Decline to participate after invitation.&#xD;
&#xD;
          -  Serious illness or mental disorder.&#xD;
&#xD;
          -  Warfarin or other new oral anticoagulant that increase risk of bleeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mikael Ryden, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Arner, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel P Andersson, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lipid laboratory Karolinska University Hospital Huddinge</name>
      <address>
        <city>Stockholm</city>
        <zip>141 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>March 1, 2017</last_update_submitted>
  <last_update_submitted_qc>March 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Mikael Ryden</investigator_full_name>
    <investigator_title>MD, PhD, Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Gain</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- 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/NCT02227043
org study id: SOWOT
nct id: NCT02227043
lead sponsor: 
collaborator: 
has dmc: No
The investigators will study the influence of fat cell size/number and adipose function on
      weight development over very long time periods (years). By comparing fat biopsies obtained at
      baseline and after >7 years, the investigators will determine the association between adipose
      morphology/function and changes in weight or development of cardiometabolic complications
      (e.g. insulin resistance, type 2 diabetes, dyslipidemia and hypertension).
The investigators will ask all subjects that have previously been examined at the
      investigators laboratory (from 1992 and forward) in studies of adipose tissue function if
      they are interested to participate in a new study. The minimal follow up time is 7 years.

      Saved blood samples and samples from old fat biopsies will be analyzed together with samples
      from new examinations.

      The investigators plan to examine the subjects in the same way as performed at the baseline
      examinations. This includes estimation of total body fat using bioimpedance, venous blood
      samples for determination of insulin, glucose and lipids, subcutaneous fat biopsies with
      determination of fat cell size/number, lipolysis/lipogenesis as well as analysis of adipokine
      secretion.

      In selected patients, baseline examinations included DEXA-measurement (dual energy x-ray
      absorptiometry) for determination of body fat distribution as well as hyperinsulinemic
      euglycemic clamp. In these cases, the same type of examinations will be repeated at their
      follow up visits.
observational model: Cohort
time perspective: Prospective
measure: Weight development over time and correlation to adipose morphology
time frame: from 2014 up to 2024, up to 10 years
description: Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years (84 months). Weight will be assessed with a regular scale and adipose morphology will be determined by measurement of fat cell size and adjustment for body weight.
measure: Weight development and correlation to lipolysis
time frame: 2014 to 2024, up to 10 years
description: Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years. Weight will be assessed with a regular scale. Fat cells will be isolated and assessment of lipolysis will be made with previously published standardized protocols.
measure: Weight development and correlation to lipogenesis
time frame: 2014 to 2024, up to 10 years
description: Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years. Weight will be assessed with a regular scale and lipogenesis will be measured according to previously published standardized protocol after isolated fat cells have been stimulated with insulin.
measure: adipose tissue morphology development and insulin sensitivity
time frame: 2014 to 2024, up to 10 years
description: Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years. Adipose morphology will be determined by measurement of fat cell size and adjustment for body weight. Insulin sensitivity will be assessed by measurement of glucose and insulin and in some cases also hyperinsulinemic euglycemic clamp.
measure: adipose morphology and changes in fat mass
time frame: 2014 to 2024, up to 10 years
description: Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years. Adipose morphology will be determined by measurement of fat cell size and adjustment for body weight. Fat mass will be assessed by impedance measurement and in some cases DEXA according to previously published protocols.
measure: adipose morphology and development of fat mass
time frame: 2014 to 2024, up to 10 years
description: Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years. Fat mass will be assessed by impedance measurement and in some cases DEXA according to previously published protocols.
Whole blood, serum, plasma, adipose tissue, adipocytes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 24 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mikael Ryden, MD, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
last name: Peter Arner, MD, PhD
role: Study Director
affiliation: Karolinska Institutet
last name: Daniel P Andersson, MD
role: Study Chair
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Mikael Ryden
investigator title: MD, PhD, Professor
mesh term: Insulin Resistance
mesh term: Body Weight
mesh term: Weight Gain
mesh term: Weight Loss