<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/NCT03766620</url>
  </required_header>
  <id_info>
    <org_study_id>DA14</org_study_id>
    <nct_id>NCT03766620</nct_id>
  </id_info>
  <brief_title>A Tube Feeding Study in Malnourished Population With Diabetes</brief_title>
  <official_title>A Prospective, Observational Study, of a High Calorie, High Protein Tube Feeding With Slow Release Carbohydrates and Monounsaturated Fatty Acids (MUFA), in a Malnourished Population With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Nutrition</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Nutrition</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 is a prospective, non-interventional, observational study. Malnourished subjects with&#xD;
      diabetes, who are receiving a high calorie, high protein tube feeding with slow release&#xD;
      carbohydrates and MUFA by their health care professional (HCP) per standard of care will be&#xD;
      enrolled into the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2018</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Body Weight Change</measure>
    <time_frame>Baseline to Study Exit Week 12</time_frame>
    <description>Measured in Kg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Malnutrition Universal Screening Tool (MUST)</measure>
    <time_frame>Baseline to Study Exit Week 12</time_frame>
    <description>HCP completed screening tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Global Assessment (SGA)</measure>
    <time_frame>Baseline to Study Exit Week 12</time_frame>
    <description>HCP completed nutrition assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (EuroQol EQ-5D-5L)</measure>
    <time_frame>Baseline to Study Exit Week 12</time_frame>
    <description>Subject rated health state of 5 dimensions. Each dimension has 5-levels scaled in negative direction resulting in an overall 5-digit number describing the health state; EQ VAS Score 0-100 points scaled in positive direction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose control</measure>
    <time_frame>Baseline to Study Exit Week 12</time_frame>
    <description>HbA1c levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>Baseline to Study Exit Week 12</time_frame>
    <description>BMI calculated Weight (kg)/Height (m)2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Product Compliance</measure>
    <time_frame>Baseline to Study Exit Week 12</time_frame>
    <description>Product consumption diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumin Levels</measure>
    <time_frame>Baseline to Study Exit Week 12</time_frame>
    <description>Nutrition status parameter collected per standard of care</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Functionality</measure>
    <time_frame>Baseline to Study Exit Week 12</time_frame>
    <description>Barthel Index of Activities of Daily Living; Subject completed assessment of 10 functions; Sum of scores range from 0-20 scaled in positive direction</description>
  </other_outcome>
  <other_outcome>
    <measure>Physician Product Satisfaction</measure>
    <time_frame>Baseline to Study Exit Week 12</time_frame>
    <description>Physician Completed Questionnaire; 3 to 5 category responses scaled in negative direction</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">49</enrollment>
  <condition>Malnutrition; Diabetes</condition>
  <arm_group>
    <arm_group_label>Tube Fed Participants</arm_group_label>
    <description>Individuals with diabetes and malnutrition receiving tube feed as sole source nutrition.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects, men and women who meet all enrollment criteria, will be enrolled from study&#xD;
        centers in Spain.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Voluntarily signed and dated an informed consent form, approved by an Independent&#xD;
             Ethics Committee, prior to any participation in the study&#xD;
&#xD;
          -  Considered malnourished, or at risk for malnutrition&#xD;
&#xD;
          -  Diagnosed with diabetes mellitus type 1 or 2 and treated with oral hypoglycemic&#xD;
             medications and/or exogenous insulin&#xD;
&#xD;
          -  Conforms to the requirements set forth on the study product label&#xD;
&#xD;
          -  Under the care of a health care professional for malnutrition and has recently been&#xD;
             prescribed tube feeding as a sole-source of nutrition by their health care&#xD;
             professional&#xD;
&#xD;
          -  Free living, residing in a nursing home or admitted to the hospital and has&#xD;
             anticipated length of hospital stay &gt; 3 days and &lt; 12 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe dementia or delirium, eating disorder, history of significant neurological or&#xD;
             psychiatric disorder, alcoholism, substance abuse or other conditions that may&#xD;
             interfere with study product consumption or compliance with study protocol procedures&#xD;
&#xD;
          -  Cannot safely consume the study product, or known to be allergic or intolerant to any&#xD;
             ingredient found in the study product&#xD;
&#xD;
          -  Renal or liver failure&#xD;
&#xD;
          -  Participates in another study that has not been approved as a concomitant study by AN&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Camprubi Robles, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Abbott</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Angela M Palmero, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital San Pedro de La Rioja</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital San Pedro</name>
      <address>
        <city>Logroño</city>
        <state>La Rioja</state>
        <zip>26006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Costa del Sol 3095</name>
      <address>
        <city>Marbella</city>
        <state>Málaga</state>
        <zip>29603</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Costa del Sol 3178</name>
      <address>
        <city>Marbella</city>
        <state>Málaga</state>
        <zip>29603</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Gomez-Ulla</name>
      <address>
        <city>Madrid</city>
        <zip>28047</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Médico San juan de la Cruz</name>
      <address>
        <city>Málaga</city>
        <zip>29007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <zip>47003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Valencia</name>
      <address>
        <city>València</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03766620
org study id: DA14
nct id: NCT03766620
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, non-interventional, observational study. Malnourished subjects with
      diabetes, who are receiving a high calorie, high protein tube feeding with slow release
      carbohydrates and MUFA by their health care professional (HCP) per standard of care will be
      enrolled into the study.
observational model: Cohort
time perspective: Prospective
measure: Body Weight Change
time frame: Baseline to Study Exit Week 12
description: Measured in Kg
measure: Malnutrition Universal Screening Tool (MUST)
time frame: Baseline to Study Exit Week 12
description: HCP completed screening tool
measure: Subjective Global Assessment (SGA)
time frame: Baseline to Study Exit Week 12
description: HCP completed nutrition assessment
measure: Quality of life (EuroQol EQ-5D-5L)
time frame: Baseline to Study Exit Week 12
description: Subject rated health state of 5 dimensions. Each dimension has 5-levels scaled in negative direction resulting in an overall 5-digit number describing the health state; EQ VAS Score 0-100 points scaled in positive direction
measure: Glucose control
time frame: Baseline to Study Exit Week 12
description: HbA1c levels
measure: Body Mass Index
time frame: Baseline to Study Exit Week 12
description: BMI calculated Weight (kg)/Height (m)2
measure: Product Compliance
time frame: Baseline to Study Exit Week 12
description: Product consumption diary
measure: Albumin Levels
time frame: Baseline to Study Exit Week 12
description: Nutrition status parameter collected per standard of care
measure: Functionality
time frame: Baseline to Study Exit Week 12
description: Barthel Index of Activities of Daily Living; Subject completed assessment of 10 functions; Sum of scores range from 0-20 scaled in positive direction
measure: Physician Product Satisfaction
time frame: Baseline to Study Exit Week 12
description: Physician Completed Questionnaire; 3 to 5 category responses scaled in negative direction
arm group label: Tube Fed Participants
description: Individuals with diabetes and malnutrition receiving tube feed as sole source nutrition.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maria Camprubi Robles, PhD
role: Study Chair
affiliation: Abbott
last name: Angela M Palmero, MD
role: Study Chair
affiliation: Hospital San Pedro de La Rioja
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Malnutrition
sharing ipd: Undecided