<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/NCT03033667</url>
  </required_header>
  <id_info>
    <org_study_id>SMOF</org_study_id>
    <nct_id>NCT03033667</nct_id>
  </id_info>
  <brief_title>Conventional Fasting Versus Lipid/Carbohydrate Infusion for Coronary Bypass Patients</brief_title>
  <official_title>Comparative Study Between Conventional Fasting Versus Overnight Infusion of Lipid or Carbohydrate on Free Fatty Acid and Insulin in Obese Patients Undergoing Elective First Time On-pump Coronary Artery Bypass Grafting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparative study between conventional fasting versus overnight infusion of lipid or&#xD;
      carbohydrate on free fatty acids and insulin in obese patients undergoing elective first time&#xD;
      on-pump coronary artery bypass grafting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obese patients scheduled for bypass surgery randomly assigned to three groups:&#xD;
&#xD;
      Group I (Glucose-group): patients received 500 cc of glucose 10% containing 50 g of glucose&#xD;
      and providing patients with 200 Kcal with an osmolarity of 556 mosm/L.&#xD;
&#xD;
      Group II (Lipid-group): patients received 100 cc of lipid solution (soybean 30%, medium chain&#xD;
      triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and&#xD;
      provides patients with 200 Kcal with an osmolarity of 380 mosm/L.&#xD;
&#xD;
      Group III (Control-group): patients fasted overnight from 11 pm till 9 am except for clear&#xD;
      fluids which were allowed till 5 am.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in free fatty acids levels and insulin blood levels before and after the infusion of study solution</measure>
    <time_frame>Over an infusion period of 10 hours preoperatively</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Metabolism Disorder</condition>
  <arm_group>
    <arm_group_label>Glucose group (G group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients received 500 cc of glucose 10% that containing 50 g of glucose and provides patients with 200 Kcal with 556 mosmoles/L.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lipid Group (L group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and provides patients with 200 Kcal with osmolarity of 380 mosmoles /L.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group (C group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients was fasting overnight from 11 pm till 9 am except for clear fluids that was allowed till 5 am.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>G group</intervention_name>
    <description>patients received 500 cc of glucose 10% containing 50 g of glucose proving patients with 200 Kcal with 556 mosmoles/L</description>
    <arm_group_label>Glucose group (G group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>group L</intervention_name>
    <description>patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid which provided patients with 200 Kcal with osmolarity of 380 mosmoles /L. with a flow rate of infusion of 12.5 cc per hour</description>
    <arm_group_label>Lipid Group (L group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Group C</intervention_name>
    <description>Over night fasting with no supplementation</description>
    <arm_group_label>Control Group (C group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adult patients (&gt; 18 years) with American Society of Anesthesia (ASA) class II-III, BMI&#xD;
        30-40, and New York Heart Association (NYHA) functional capacities I-II, undergoing&#xD;
        elective on-pump coronary artery bypass grafting (CABG) using cardiopulmonary bypass (CPB).&#xD;
&#xD;
        All patients were type 1a World Health Organisation (WHO)/Fredrickson classification of&#xD;
        primary hyperlipidemias.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with diabetes mellitus&#xD;
&#xD;
          -  Patients on fibrates&#xD;
&#xD;
          -  Patients type 1,2b,3,4 and 5 WHO/Fredrickson classification of primary&#xD;
             hyperperlipidemias&#xD;
&#xD;
          -  Patients with history of allergic reactions to fish, egg yolk containing foods peanut&#xD;
             or soy products&#xD;
&#xD;
          -  Patients with carbohydrate or fat intolerance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hisham Hosny</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>perioperative fasting</keyword>
  <keyword>free fatty acids</keyword>
  <keyword>coronary bypass grfting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03033667
org study id: SMOF
nct id: NCT03033667
lead sponsor: 
has dmc: No
Comparative study between conventional fasting versus overnight infusion of lipid or
      carbohydrate on free fatty acids and insulin in obese patients undergoing elective first time
      on-pump coronary artery bypass grafting.
Obese patients scheduled for bypass surgery randomly assigned to three groups:

      Group I (Glucose-group): patients received 500 cc of glucose 10% containing 50 g of glucose
      and providing patients with 200 Kcal with an osmolarity of 556 mosm/L.

      Group II (Lipid-group): patients received 100 cc of lipid solution (soybean 30%, medium chain
      triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and
      provides patients with 200 Kcal with an osmolarity of 380 mosm/L.

      Group III (Control-group): patients fasted overnight from 11 pm till 9 am except for clear
      fluids which were allowed till 5 am.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: The change in free fatty acids levels and insulin blood levels before and after the infusion of study solution
time frame: Over an infusion period of 10 hours preoperatively
arm group label: Glucose group (G group)
arm group type: Experimental
description: patients received 500 cc of glucose 10% that containing 50 g of glucose and provides patients with 200 Kcal with 556 mosmoles/L.
arm group label: Lipid Group (L group)
arm group type: Experimental
description: patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and provides patients with 200 Kcal with osmolarity of 380 mosmoles /L.
arm group label: Control Group (C group)
arm group type: Experimental
description: patients was fasting overnight from 11 pm till 9 am except for clear fluids that was allowed till 5 am.
intervention type: Dietary Supplement
intervention name: G group
description: patients received 500 cc of glucose 10% containing 50 g of glucose proving patients with 200 Kcal with 556 mosmoles/L
arm group label: Glucose group (G group)
intervention type: Dietary Supplement
intervention name: group L
description: patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid which provided patients with 200 Kcal with osmolarity of 380 mosmoles /L. with a flow rate of infusion of 12.5 cc per hour
arm group label: Lipid Group (L group)
intervention type: Dietary Supplement
intervention name: Group C
description: Over night fasting with no supplementation
arm group label: Control Group (C group)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hisham Hosny
investigator title: assistant professor
mesh term: Metabolic Diseases
sharing ipd: Yes