<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/NCT01694446</url>
  </required_header>
  <id_info>
    <org_study_id>Glucose 090428B</org_study_id>
    <nct_id>NCT01694446</nct_id>
  </id_info>
  <brief_title>Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose</brief_title>
  <acronym>glucose</acronym>
  <official_title>Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Increased postprandial plasma triglycerides are associated with increased cardiovascular&#xD;
      risk. Chronic consumption of carbohydrates is associated with increased levels of&#xD;
      triglycerides. Very few studies have assessed the effect of acute consumption of&#xD;
      carbohydrates on plasma triglycerides and lipoprotein production and clearance. The present&#xD;
      study aims to assess the effects of acute administration of glucose and fructose on hepatic&#xD;
      and intestinal lipoprotein production.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each subject will be studied twice 4-6 weeks apart in random order in this single blinded&#xD;
      study. A nasoduodenal tube will be sited under fluoroscopic guidance the day prior to the&#xD;
      study.In study A they will receive intraduodenal intralipid (20% at 60 ml/hour) alongside 60&#xD;
      ml/hour of 20% dextrose or fructose for 15 hours starting at 4am. In study B they will&#xD;
      receive 60 ml/hour of intraduodenal intralipid with 60ml/hour of normal saline for 15 hours&#xD;
      from 4am. A pancreatic clamp (octreotide with replacement glucose, insulin, glucagon and&#xD;
      growth hormone) will be started at 7am. From 9am an iv bolus of deuterated-glycerol&#xD;
      (d5-glycerol) along with a regular infusion of deuterated leucine (L-[5,5,5-2H3]. Regular&#xD;
      blood samples will be drawn to assess lipoprotein kinetics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of intestinal and hepatic lipoprotein production</measure>
    <time_frame>10 hours</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Hyperlipidemia</condition>
  <arm_group>
    <arm_group_label>Intraduodenal glucose or fructose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intraduodenal glucose or fructose</intervention_name>
    <arm_group_label>Intraduodenal glucose or fructose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women, aged 18 to 60 years&#xD;
&#xD;
          2. Body mass index 20 kg/m2 to 27 kg/m2&#xD;
&#xD;
          3. Hemoglobin above 130g/L.&#xD;
&#xD;
          4. Normal glucose tolerance in response to a 75g, 2-hr OGTT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has a history of hepatitis/hepatic disease that has been active within the&#xD;
             previous two years.&#xD;
&#xD;
          2. Any significant active (over the past 12 months) disease of the gastrointestinal,&#xD;
             pulmonary, neurological, renal (Cr &gt; 1.5 mg/dL), genitourinary, hematological systems,&#xD;
             or has severe uncontrolled treated or untreated hypertension (sitting diastolic BP &gt;&#xD;
             100 or systolic &gt; 180) or proliferative retinopathy&#xD;
&#xD;
          3. History of diabetes or OGTT indicative of diabetes or impaired glucose tolerance.&#xD;
&#xD;
          4. Any history of a MI or clinically significant, active, cardiovascular history&#xD;
             including a history of arrhythmia's or conduction delays on ECG, unstable angina, or&#xD;
             decompensated heart failure.&#xD;
&#xD;
          5. Any laboratory values: AST &gt; 2x ULN; ALT &gt; 2x ULN TSH &gt; 6 mU/l&#xD;
&#xD;
          6. Current addiction to alcohol or substances of abuse as determined by the investigator.&#xD;
&#xD;
          7. Mental incapacity, unwillingness or language barrier precluding adequate understanding&#xD;
             or cooperation&#xD;
&#xD;
          8. Taking any prescription or non-prescription medications at the time of the study&#xD;
&#xD;
          9. Having donated blood three months prior to and three months post study procedures&#xD;
&#xD;
         10. A pregnancy test will be performed 1 to 3 days prior to each study in all female&#xD;
             subjects. Those who test positive for pregnancy will be excluded.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Toronto General Hopital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>March 6, 2015</last_update_submitted>
  <last_update_submitted_qc>March 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intestinal lipoprotein</keyword>
  <keyword>Apo B48 and apoB100</keyword>
  <keyword>Pancreatic clamp</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipidemias</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/NCT01694446
org study id: Glucose 090428B
nct id: NCT01694446
lead sponsor: 
has dmc: No
Increased postprandial plasma triglycerides are associated with increased cardiovascular
      risk. Chronic consumption of carbohydrates is associated with increased levels of
      triglycerides. Very few studies have assessed the effect of acute consumption of
      carbohydrates on plasma triglycerides and lipoprotein production and clearance. The present
      study aims to assess the effects of acute administration of glucose and fructose on hepatic
      and intestinal lipoprotein production.
Each subject will be studied twice 4-6 weeks apart in random order in this single blinded
      study. A nasoduodenal tube will be sited under fluoroscopic guidance the day prior to the
      study.In study A they will receive intraduodenal intralipid (20% at 60 ml/hour) alongside 60
      ml/hour of 20% dextrose or fructose for 15 hours starting at 4am. In study B they will
      receive 60 ml/hour of intraduodenal intralipid with 60ml/hour of normal saline for 15 hours
      from 4am. A pancreatic clamp (octreotide with replacement glucose, insulin, glucagon and
      growth hormone) will be started at 7am. From 9am an iv bolus of deuterated-glycerol
      (d5-glycerol) along with a regular infusion of deuterated leucine (L-[5,5,5-2H3]. Regular
      blood samples will be drawn to assess lipoprotein kinetics.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Assessment of intestinal and hepatic lipoprotein production
time frame: 10 hours
arm group label: Intraduodenal glucose or fructose
arm group type: Experimental
intervention type: Other
intervention name: Intraduodenal glucose or fructose
arm group label: Intraduodenal glucose or fructose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Hyperlipidemias