<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/NCT01699906</url>
  </required_header>
  <id_info>
    <org_study_id>PHO-0785</org_study_id>
    <nct_id>NCT01699906</nct_id>
  </id_info>
  <brief_title>Diet Induced Weight Loss to Reduce Inflammation in Obese Women</brief_title>
  <official_title>Diet Induced Weight Loss Reduces Inflammation and Crown-like Structures and Corrects Immune Dysfunction in Subcutaneous Adipose Tissue In Class 2-3 Obese Women: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rockefeller University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rockefeller University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breast cancer is one of the most frequently seen cancers in the United States. It occurs at&#xD;
      all ages but is particularly common in post menopausal women. Obesity increases the risk of&#xD;
      breast cancer and colon cancer among others, and when cancer develops increases the risk of&#xD;
      spread and death. Inflammation of fat tissue, the coronary blood vessels and the liver are&#xD;
      also seen with obesity. Animal experiments have shown the inflammation in fat tissue&#xD;
      increases the production of estrogen. Thus, reducing inflammation in fat tissue might lower&#xD;
      estrogen levels and reduce the risk of breast cancer in obese women as well as the spread of&#xD;
      other cancers in the body. Weight reduction in obesity has been shown in epidemiology studies&#xD;
      to lower the risk of colon cancer and in obese women to lower the risk of breast cancer.&#xD;
      However, how that occurs and how much weight loss is necessary is not known. In mice, calorie&#xD;
      restriction in obese animals has been shown to reduce inflammation in fat tissue and the&#xD;
      breast. In other studies, calorie reduction has been shown to lower the development of&#xD;
      cancer. In addition, we really do not know what starts the whole inflammation process. One&#xD;
      good possibility is that immune factors that tend to reduce inflammation are less in obesity.&#xD;
      We have shown this in the colon and this also has been suggested as occurring in fat stores.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to determine if weight loss of about 10% of initial weight lowers evidence of&#xD;
      inflammation in fat stores. It is likely that, if fat store inflammation is reduced, then&#xD;
      inflammation in breast fat also will be lower. Also, it is possible that blood immune cells&#xD;
      may be changed with weight loss and even that immune cells in skin will be affected. Since&#xD;
      vitamin D has important immune effects and vitamin D is low in obesity, we also want to study&#xD;
      what happens to this vitamin during weight loss.&#xD;
&#xD;
      This pilot study of weight loss will be done in 10 very obese post menopausal women. This&#xD;
      study will include nutritional and medical evaluation, a 3 day inpatient hospital stay eating&#xD;
      a diet providing 50% of what they were taking before starting the study and then a&#xD;
      nutritionally adequate diet that will allow them to lose about 10% of their initial weight&#xD;
      within 7 to 10 week period. They will have about 4-5 grams of fat removed by suction through&#xD;
      a syringe and a biopsy of the skin in addition to studies of blood and stool samples.&#xD;
&#xD;
      When they have completed the study with a 10% body weight loss they will be referred to a&#xD;
      nutrition clinic which can counsel them to continue a slower weight loss to an optimal level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adipose tissue inflammation via crown-like structures</measure>
    <time_frame>9 weeks</time_frame>
    <description>Diet-induced weight loss of 10% body weight will result in reduction in abdominal subcutaneous fat inflammation as measured by:&#xD;
reduction in adipocyte size determined by microscopy and of CLS number in adipose tissue.&#xD;
reduction in inflammatory gene expression determined by PCR and selected cytokine protein levels.&#xD;
increased anti-inflammatory lymphocytes determined by immunohistochemistry or by flowcytometry.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Dietary intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diet regimen to induce weight loss</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet regimen to induce weight loss</intervention_name>
    <description>Diet regimen to induce weight loss</description>
    <arm_group_label>Dietary intervention</arm_group_label>
    <other_name>Very low calorie diet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40-70 years of age&#xD;
&#xD;
          -  Post-menopausal women defined as: 24 consecutive months without a menstrual period,&#xD;
             currently not taking any medication known to induce amenorhea&#xD;
&#xD;
          -  Body Mass Index 35-50&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any bleeding disorder&#xD;
&#xD;
          -  HIV positive&#xD;
&#xD;
          -  History of previous weight loss surgery.&#xD;
&#xD;
          -  History of Inflammatory Bowel Disease&#xD;
&#xD;
          -  History of any other malignancy other than non-melanoma skin cancer in the past 5&#xD;
             years&#xD;
&#xD;
          -  Currently taking fish oil, omega-3 supplements or other herbal supplements that exceed&#xD;
             GRAS (Generally Recognized as Safe) levels&#xD;
&#xD;
          -  Currently taking any estrogen/progesterone hormones except vaginal cream&#xD;
&#xD;
          -  Smokers (or stopped &lt; 3 months ago)&#xD;
&#xD;
          -  Currently taking any medication that can alter fat stores as determined by the&#xD;
             principal investigator&#xD;
&#xD;
          -  Currently taking any weight control medication&#xD;
&#xD;
          -  Currently taking hypoglycemic medications.&#xD;
&#xD;
          -  Currently taking NSAIDS, aspirin, (if &gt; once a week, stopped &lt;30 days ago). Aspirin&#xD;
             81mg may be permitted if the Framingham Risk Score is &lt; 10&#xD;
&#xD;
          -  Currently taking anticoagulant medication or stopped &lt;30 days ago.&#xD;
&#xD;
          -  Screening fasting blood glucose &gt;165mg/dL&#xD;
&#xD;
          -  Screening thyroid function test abnormal&#xD;
&#xD;
          -  Screening LFT results &gt; 2X upper limit of normal&#xD;
&#xD;
          -  Screening creatinine &gt; 2X upper limit of normal&#xD;
&#xD;
          -  Any condition or situation which, in the opinion of the investigator, puts the patient&#xD;
             at significant risk, could complicate the study results, or may interfere&#xD;
             significantly with participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter R. Holt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Rockefeller University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Rockefeller University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>November 4, 2014</last_update_submitted>
  <last_update_submitted_qc>November 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</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/NCT01699906
org study id: PHO-0785
nct id: NCT01699906
lead sponsor: 
has dmc: No
Breast cancer is one of the most frequently seen cancers in the United States. It occurs at
      all ages but is particularly common in post menopausal women. Obesity increases the risk of
      breast cancer and colon cancer among others, and when cancer develops increases the risk of
      spread and death. Inflammation of fat tissue, the coronary blood vessels and the liver are
      also seen with obesity. Animal experiments have shown the inflammation in fat tissue
      increases the production of estrogen. Thus, reducing inflammation in fat tissue might lower
      estrogen levels and reduce the risk of breast cancer in obese women as well as the spread of
      other cancers in the body. Weight reduction in obesity has been shown in epidemiology studies
      to lower the risk of colon cancer and in obese women to lower the risk of breast cancer.
      However, how that occurs and how much weight loss is necessary is not known. In mice, calorie
      restriction in obese animals has been shown to reduce inflammation in fat tissue and the
      breast. In other studies, calorie reduction has been shown to lower the development of
      cancer. In addition, we really do not know what starts the whole inflammation process. One
      good possibility is that immune factors that tend to reduce inflammation are less in obesity.
      We have shown this in the colon and this also has been suggested as occurring in fat stores.
This study aims to determine if weight loss of about 10% of initial weight lowers evidence of
      inflammation in fat stores. It is likely that, if fat store inflammation is reduced, then
      inflammation in breast fat also will be lower. Also, it is possible that blood immune cells
      may be changed with weight loss and even that immune cells in skin will be affected. Since
      vitamin D has important immune effects and vitamin D is low in obesity, we also want to study
      what happens to this vitamin during weight loss.

      This pilot study of weight loss will be done in 10 very obese post menopausal women. This
      study will include nutritional and medical evaluation, a 3 day inpatient hospital stay eating
      a diet providing 50% of what they were taking before starting the study and then a
      nutritionally adequate diet that will allow them to lose about 10% of their initial weight
      within 7 to 10 week period. They will have about 4-5 grams of fat removed by suction through
      a syringe and a biopsy of the skin in addition to studies of blood and stool samples.

      When they have completed the study with a 10% body weight loss they will be referred to a
      nutrition clinic which can counsel them to continue a slower weight loss to an optimal level.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Adipose tissue inflammation via crown-like structures
time frame: 9 weeks
description: Diet-induced weight loss of 10% body weight will result in reduction in abdominal subcutaneous fat inflammation as measured by:
reduction in adipocyte size determined by microscopy and of CLS number in adipose tissue.
reduction in inflammatory gene expression determined by PCR and selected cytokine protein levels.
increased anti-inflammatory lymphocytes determined by immunohistochemistry or by flowcytometry.
arm group label: Dietary intervention
arm group type: Experimental
description: Diet regimen to induce weight loss
intervention type: Other
intervention name: Diet regimen to induce weight loss
description: Diet regimen to induce weight loss
arm group label: Dietary intervention
other name: Very low calorie diet
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peter R. Holt, MD
role: Principal Investigator
affiliation: The Rockefeller University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Inflammation
mesh term: Weight Loss