xml: <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/NCT05989035</url>
    </required_header>
    <id_info>
      <org_study_id>1389184</org_study_id>
      <nct_id>NCT05989035</nct_id>
    </id_info>
    <brief_title>Effects of MetAP2 Inhibition on Bioenergetics and Aging-associated Characteristics in Adipose Tissue in Healthy Participants</brief_title>
    <acronym>BIO-AGE</acronym>
    <official_title>Effects of MetAP2 Inhibition on Bioenergetics and Aging-associated Characteristics in Adipose Tissue (BIO-AGE) in Healthy Participants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AdventHealth Translational Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AdventHealth Translational Research Institute</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>
        This study is being done to collect Adipose tissue from young and older individuals and&#xD;
        gather data on the effect of methionine aminopeptidase protein (MetAP2) inhibition on that&#xD;
        Adipose tissue in the laboratory.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 31, 2020</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Actual">March 25, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This is a prospective single-site study, consisting of two groups of participants. Group 1 will be younger participants between the ages of 18 and 30 years old. Group will be older participants that are 65 years and older. Each participant will have an abdominal subcutaneous adipose tissue (AT) biopsies. Two aliquots from each biopsy will be incubated for conditioned media with and without MetAP2 inhibition</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The effect of MetAP2 inhibition on senescence markers in adipose tissue explants</measure>
      <time_frame>4 weeks</time_frame>
      <description>CXCL14 concentration (pg/ml/mg) in conditioned media</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The effect of MetAP2 inhibition on adipose tissue quality in adipose tissue explants</measure>
      <time_frame>4 weeks</time_frame>
      <description>Adiponectin and resistin concentration (ng/ml/mg) in conditioned media</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The effect of MetAP2 inhibition on adipose tissue quality in adipose tissue explants</measure>
      <time_frame>4 weeks</time_frame>
      <description>Leptin concentration (pg/ml/mg) in conditioned media</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">31</enrollment>
    <condition>Aging</condition>
    <arm_group>
      <arm_group_label>Younger without MetAP2 inhibition</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants between 18 and 30 years old without MetAP2 inhibition in conditioned media</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Older without MetAP2 inhibition</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants 65 years old and without MetAP2 inhibition in conditioned media</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Younger with MetAP2 inhibition</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants between 18 and 30 years old with MetAP2 inhibition in conditioned media</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Older with MetAP2 inhibition</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants 65 years old with MetAP2 inhibition in conditioned media</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Abdominal subcutaneous adipose tissue biopsy</intervention_name>
      <description>Fatty tissue biopsy- Participant will be placed in a supine position with arms placed at side while abdominal skin is marked with a skin marker and cleansed with chlorhexidine. Afterwards, the abdominal fatty tissue biopsy will be performed.&#xD;
  Collect fatty tissue from young and older individuals and gather data on the effect of methionine aminopeptidase protein (MetAP2) inhibition on that fatty tissue in the laboratory.</description>
      <arm_group_label>Older with MetAP2 inhibition</arm_group_label>
      <arm_group_label>Older without MetAP2 inhibition</arm_group_label>
      <arm_group_label>Younger with MetAP2 inhibition</arm_group_label>
      <arm_group_label>Younger without MetAP2 inhibition</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Group 1 cohort are male or female participants between 18 and 30 years old&#xD;
  &#xD;
            2. Group 2 cohort are male or female participants ≥ 65 years old&#xD;
  &#xD;
            3. Body mass index (BMI) ≤ 40 kg/m2&#xD;
  &#xD;
            4. Weight stable (±5 kg) for the last 3 months prior to the Screening visit&#xD;
  &#xD;
            5. Sedentary (&lt;20 min of activity, 3x/week).&#xD;
  &#xD;
            6. Able to speak and understand written and spoken English&#xD;
  &#xD;
            7. Willing and able to comply with scheduled visits, laboratory tests, and other study&#xD;
               procedures&#xD;
  &#xD;
            8. Participant has voluntarily signed and dated an informed consent form, approved by an&#xD;
               Institutional Review Board/Independent Ethics Committee, and provided Health Insurance&#xD;
               Portability and Accountability Act authorization (HIPAA) or other privacy&#xD;
               authorization prior to any participation in study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Diagnosis of type 1 diabetes mellitus&#xD;
  &#xD;
            2. Diagnosis of type 2 diabetes mellitus (HbA1C ≥ 6.5)&#xD;
  &#xD;
            3. Insulin use and use of any other medications for diabetes.&#xD;
  &#xD;
            4. Use of metformin for polycystic ovarian disease&#xD;
  &#xD;
            5. Untreated or poorly controlled hypertension (SBP &gt; 160, DBP &gt; 100)&#xD;
  &#xD;
            6. Participants are actively pursuing weight loss and/or lifestyle changes&#xD;
  &#xD;
            7. Participants have a sensitivity or allergy to lidocaine&#xD;
  &#xD;
            8. Drug or alcohol abuse (&gt; 3 drinks per day) within the last 5 years&#xD;
  &#xD;
            9. Any unstable medical condition (i.e., coronary heart disease, stroke, chronic renal&#xD;
               failure [serum creatinine should not exceed 1.5-fold the upper laboratory norm and&#xD;
               estimated eGFR should not be lower than 60 mL/min/1.73 m2 at screening], chronic&#xD;
               hepatic disease, severe pulmonary disease, bleeding disorders, autoimmune disease,&#xD;
               active rheumatoid arthritis or other inflammatory rheumatic disorder, or&#xD;
               gastrointestinal disease requiring medication)&#xD;
  &#xD;
           10. Participants currently taking anti-inflammatory medications within 2 days prior to&#xD;
               biopsy or antiplatelet medications within 7 days prior to biopsy, that cannot be&#xD;
               safely stopped for study procedures&#xD;
  &#xD;
           11. Participants who have a TSH &gt;10 µIU/ml or less than 0.4 µIU/ml&#xD;
  &#xD;
           12. Triglycerides &gt;500&#xD;
  &#xD;
           13. Pregnant or nursing females or females less than 9 months postpartum.&#xD;
  &#xD;
           14. For females only, any new onset (&lt; 3 months on a stable regime) use of oral&#xD;
               contraceptives (with the exception of hormone replacement therapy)&#xD;
  &#xD;
           15. Tobacco or nicotine containing product use within the past 3 months&#xD;
  &#xD;
           16. Major surgery within 4 weeks prior to the Screening Visit&#xD;
  &#xD;
           17. Anemia (hemoglobin &lt;11 g/dl in men, &lt;10 g/dl in women) at Screening&#xD;
  &#xD;
           18. Participation in studies involving investigational drug(s) within 30 days prior to the&#xD;
               Screening Visit&#xD;
  &#xD;
           19. Known history of Human Immunodeficiency Virus (HIV), chronic, contagious, infectious&#xD;
               disease, such as active tuberculosis, Hepatitis B or C.&#xD;
  &#xD;
           20. Any malignancy not considered cured, except basal cell carcinoma and squamous cell&#xD;
               carcinoma of the skin (a participant is considered cured if there has been no evidence&#xD;
               of cancer recurrence in the previous 5 years)&#xD;
  &#xD;
           21. Presence of any condition that, in the opinion of the Investigator, compromises&#xD;
               participant safety or data integrity or the participant's ability to complete study&#xD;
               visits&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lauren Sparks, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Study Principal Investigator</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>AdventHealth Translational Research Institute</name>
        <address>
          <city>Orlando</city>
          <state>Florida</state>
          <zip>32803</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.adventhealthresearchinstitute.com/research/translational-research</url>
      <description>Website for AdventHealth Translational Research Institute</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>adipose tissue</keyword>
    <keyword>adipocyte</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>February 4, 2021</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT05989035/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989035
  org study id: 1389184
  nct id: NCT05989035
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is being done to collect Adipose tissue from young and older individuals and
        gather data on the effect of methionine aminopeptidase protein (MetAP2) inhibition on that
        Adipose tissue in the laboratory.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a prospective single-site study, consisting of two groups of participants. Group 1 will be younger participants between the ages of 18 and 30 years old. Group will be older participants that are 65 years and older. Each participant will have an abdominal subcutaneous adipose tissue (AT) biopsies. Two aliquots from each biopsy will be incubated for conditioned media with and without MetAP2 inhibition
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: The effect of MetAP2 inhibition on senescence markers in adipose tissue explants
  time frame: 4 weeks
  description: CXCL14 concentration (pg/ml/mg) in conditioned media
  measure: The effect of MetAP2 inhibition on adipose tissue quality in adipose tissue explants
  time frame: 4 weeks
  description: Adiponectin and resistin concentration (ng/ml/mg) in conditioned media
  measure: The effect of MetAP2 inhibition on adipose tissue quality in adipose tissue explants
  time frame: 4 weeks
  description: Leptin concentration (pg/ml/mg) in conditioned media
  arm group label: Younger without MetAP2 inhibition
  arm group type: Active Comparator
  description: Participants between 18 and 30 years old without MetAP2 inhibition in conditioned media
  arm group label: Older without MetAP2 inhibition
  arm group type: Active Comparator
  description: Participants 65 years old and without MetAP2 inhibition in conditioned media
  arm group label: Younger with MetAP2 inhibition
  arm group type: Experimental
  description: Participants between 18 and 30 years old with MetAP2 inhibition in conditioned media
  arm group label: Older with MetAP2 inhibition
  arm group type: Experimental
  description: Participants 65 years old with MetAP2 inhibition in conditioned media
  intervention type: Procedure
  intervention name: Abdominal subcutaneous adipose tissue biopsy
  description: Fatty tissue biopsy- Participant will be placed in a supine position with arms placed at side while abdominal skin is marked with a skin marker and cleansed with chlorhexidine. Afterwards, the abdominal fatty tissue biopsy will be performed.
  Collect fatty tissue from young and older individuals and gather data on the effect of methionine aminopeptidase protein (MetAP2) inhibition on that fatty tissue in the laboratory.
  arm group label: Older with MetAP2 inhibition
  arm group label: Older without MetAP2 inhibition
  arm group label: Younger with MetAP2 inhibition
  arm group label: Younger without MetAP2 inhibition
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lauren Sparks, PhD
  role: Principal Investigator
  affiliation: Study Principal Investigator
  facility: 
  country: United States
  url: https://www.adventhealthresearchinstitute.com/research/translational-research
  description: Website for AdventHealth Translational Research Institute
  responsible party type: Sponsor
  sharing ipd: No
  provided document: 