<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/NCT01672632</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 26040</org_study_id>
    <secondary_id>5R01DK060412</secondary_id>
    <nct_id>NCT01672632</nct_id>
  </id_info>
  <brief_title>Fat Cell Size and Overfeeding and Etopic Study</brief_title>
  <acronym>EAT</acronym>
  <official_title>Fat Cell Size and Overfeeding and Etopic Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It has been shown that large fat cells are associated with more risks for insulin resistance&#xD;
      and more cardiovascular risk factors such as high cholesterol or triglycerides.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will look at fat cell size and how it affects fat deposition, insulin resistance&#xD;
      and muscle oxidative capacity. A comparison will be made with the differences between&#xD;
      participants with larger versus smaller fat cells in insulin resistance and blood levels of&#xD;
      lipids. The study will also determine if characteristics of fat cells and muscle can predict&#xD;
      the development of weight gain-induced insulin resistance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2008</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">February 2012</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine the effect of 8-weeks 40% high fat overfeeding in 40 healthy, young adults on adipose and skeletal muscle characteristics, ectopic fat accumulation, insulin sensitivity, and metabolic flexibility.</measure>
    <time_frame>10 months</time_frame>
    <description>This study will investigate how fat cell size (independent of total fat mass) affects metabolic outcomes of overfeeding, including changes in fat deposition, insulin sensitivity and muscle oxidative capacity. It has been shown that large fat cells relative to fat mass are associated with higher risks for insulin resistance and type 2 diabetes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fat Deposition</measure>
    <time_frame>10 Months</time_frame>
    <description>Viewing of adipose tissue or body fat and skeletal muscle characteristics over a period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin Sensitivity</measure>
    <time_frame>10 months</time_frame>
    <description>Measure and monitor the natural hormone insulin becomes less effective at lowering blood sugars. The resulting increase in blood glucose may raise levels outside the normal range and cause adverse heealth effects, depending on dietary conditions or sensitivity of cells to insulin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Oxidative Capacity</measure>
    <time_frame>10 Months</time_frame>
    <description>A measure of a muscle's maximal capacity to use oxygen in microliters of oxygen consumed per gram of muscle per hour.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circadian Blood Pressure variability</measure>
    <time_frame>10 Months</time_frame>
    <description>Blood pressure and heart rate measurement: An automatic BP monitoring device (Mortara® Ambulo 2400) for ambulatory use was attached to a BP cuff to obtain blood pressure (BP) and heart rate (HR) readings at 30-min intervals during the day (6:30 AM to 9:30 PM) and 60-min intervals at night (10 PM to 6 AM) while the participants went about their activities. Data were downloaded into the database at the end of the 7-day recording span for a chronobiological analysis. This was done at baseline, post-overfeeding and at 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting Endothelial function testing</measure>
    <time_frame>10 Months</time_frame>
    <description>Endothelial function testing: Assessment of resting endothelial function was done with the participant in a fasting state, after having avoided stimulants (caffeine, tobacco, alcohol, exercise) for 12 hours, at the same fixed clock hour (range 8-10 AM), using the EndoPAT 2000 device manufactured by ITAMAR Medical®.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Over Eating</condition>
  <arm_group>
    <arm_group_label>Overfeeding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We overfed 40 young, healthy adults by 40% of their baseline energy requirements for 8 weeks. The diet consisted of 41% carbohydrate, 44% fat, and 15% protein.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Overfeeding</intervention_name>
    <description>We overfed 40 young, healthy adults by 40% of their baseline energy requirements for 8 weeks. The diet consisted of 41% carbohydrate, 44% fat, and 15% protein.</description>
    <arm_group_label>Overfeeding</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Your Body Mass Index (height to weight ratio) is 22.5 to 32.5 (inclusive).&#xD;
&#xD;
          -  You are 18-40 years of age.&#xD;
&#xD;
          -  You are willing to enroll in an 8 week overfeeding study causing a 5-8 % weight gain.&#xD;
&#xD;
          -  You are willing to eat all your meals from Pennington and only meals from Pennington&#xD;
             for approximately 10 weeks total, even when you are full. Prior to overfeeding 2 Meals&#xD;
             per day will be served at Pennington with lunch packed for at least 7 days. After that&#xD;
             time participants will receive and eat all (overfeeding) meals at PBRC for 8 weeks.&#xD;
             Post-overfeeding will consists of weight-maintenance diet for 1 week. All meals will&#xD;
             be monitored at Pennington.&#xD;
&#xD;
          -  You are willing to maintain the same level of exercise after enrollment in the study&#xD;
             throughout the length of the study.&#xD;
&#xD;
          -  You are willing to complete nutritional and activity questionnaires.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  You weight &gt; 300 lbs&#xD;
&#xD;
          -  You have a history of cardiovascular disease or diabetes.&#xD;
&#xD;
          -  You have a fasting blood glucose &gt; 110 mg/dL.&#xD;
&#xD;
          -  You have an average screening blood pressure &gt; 140/90.&#xD;
&#xD;
          -  You have liver disease.&#xD;
&#xD;
          -  You have thyroid disease.&#xD;
&#xD;
          -  Have Acid Reflux&#xD;
&#xD;
          -  Had cancer in the last 5 years (Some skin cancers OK)&#xD;
&#xD;
          -  Have HIV&#xD;
&#xD;
          -  Have had an Eating Disorders&#xD;
&#xD;
          -  You are pregnant or breastfeeding.&#xD;
&#xD;
          -  You have gained or lost more than 3kg in the last 3 months&#xD;
&#xD;
          -  You require chronic use of medications including diuretics, steroids and&#xD;
             adrenergic-stimulating agents.&#xD;
&#xD;
          -  You or a member of your family has a history of blood clots (deep vein thrombosis or&#xD;
             pulmonary embolism)&#xD;
&#xD;
          -  You have poor circulation, history of bypass operation in your legs, blood coagulation&#xD;
             disorders, diagnosed peripheral arterial or vascular disease, cramping pain in your&#xD;
             leg muscle during exercise or nerve damage to your legs&#xD;
&#xD;
          -  You have varicose veins (per discretion of MD or NP)&#xD;
&#xD;
          -  You have had previous GI surgery, obstructive disease of the GI tract, hyper motility&#xD;
             disorder or a history of problems of impairment of the gag reflex.&#xD;
&#xD;
          -  You have emotional problems such as clinical depression or other diagnosed&#xD;
             psychological conditions.&#xD;
&#xD;
          -  You are claustrophobic.&#xD;
&#xD;
          -  You have metal objects in your body such as implanted rods or surgical clips or&#xD;
             magnetic objects that are incompatible with the MRI/MRS.&#xD;
&#xD;
          -  You smoke or use tobacco products&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Ravussin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedical Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alok Gupta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedial Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Eric Ravussin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperphagia</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/NCT01672632
org study id: PBRC 26040
secondary id: 5R01DK060412
nct id: NCT01672632
lead sponsor: 
collaborator: 
has dmc: Yes
It has been shown that large fat cells are associated with more risks for insulin resistance
      and more cardiovascular risk factors such as high cholesterol or triglycerides.
This study will look at fat cell size and how it affects fat deposition, insulin resistance
      and muscle oxidative capacity. A comparison will be made with the differences between
      participants with larger versus smaller fat cells in insulin resistance and blood levels of
      lipids. The study will also determine if characteristics of fat cells and muscle can predict
      the development of weight gain-induced insulin resistance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Determine the effect of 8-weeks 40% high fat overfeeding in 40 healthy, young adults on adipose and skeletal muscle characteristics, ectopic fat accumulation, insulin sensitivity, and metabolic flexibility.
time frame: 10 months
description: This study will investigate how fat cell size (independent of total fat mass) affects metabolic outcomes of overfeeding, including changes in fat deposition, insulin sensitivity and muscle oxidative capacity. It has been shown that large fat cells relative to fat mass are associated with higher risks for insulin resistance and type 2 diabetes.
measure: Fat Deposition
time frame: 10 Months
description: Viewing of adipose tissue or body fat and skeletal muscle characteristics over a period.
measure: Insulin Sensitivity
time frame: 10 months
description: Measure and monitor the natural hormone insulin becomes less effective at lowering blood sugars. The resulting increase in blood glucose may raise levels outside the normal range and cause adverse heealth effects, depending on dietary conditions or sensitivity of cells to insulin.
measure: Muscle Oxidative Capacity
time frame: 10 Months
description: A measure of a muscle's maximal capacity to use oxygen in microliters of oxygen consumed per gram of muscle per hour.
measure: Circadian Blood Pressure variability
time frame: 10 Months
description: Blood pressure and heart rate measurement: An automatic BP monitoring device (Mortara® Ambulo 2400) for ambulatory use was attached to a BP cuff to obtain blood pressure (BP) and heart rate (HR) readings at 30-min intervals during the day (6:30 AM to 9:30 PM) and 60-min intervals at night (10 PM to 6 AM) while the participants went about their activities. Data were downloaded into the database at the end of the 7-day recording span for a chronobiological analysis. This was done at baseline, post-overfeeding and at 3 months.
measure: Resting Endothelial function testing
time frame: 10 Months
description: Endothelial function testing: Assessment of resting endothelial function was done with the participant in a fasting state, after having avoided stimulants (caffeine, tobacco, alcohol, exercise) for 12 hours, at the same fixed clock hour (range 8-10 AM), using the EndoPAT 2000 device manufactured by ITAMAR Medical®.
arm group label: Overfeeding
arm group type: Experimental
description: We overfed 40 young, healthy adults by 40% of their baseline energy requirements for 8 weeks. The diet consisted of 41% carbohydrate, 44% fat, and 15% protein.
intervention type: Other
intervention name: Overfeeding
description: We overfed 40 young, healthy adults by 40% of their baseline energy requirements for 8 weeks. The diet consisted of 41% carbohydrate, 44% fat, and 15% protein.
arm group label: Overfeeding
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Ravussin, PhD
role: Principal Investigator
affiliation: Pennington Biomedical Research Center
last name: Alok Gupta, MD
role: Principal Investigator
affiliation: Pennington Biomedial Research Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Eric Ravussin
investigator title: Principal Investigator
mesh term: Hyperphagia