<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/NCT02989688</url>
  </required_header>
  <id_info>
    <org_study_id>KingCHL</org_study_id>
    <nct_id>NCT02989688</nct_id>
  </id_info>
  <brief_title>Glycaemic Response to Oral Nutrition Support During Haemodialysis</brief_title>
  <acronym>GRO-HD</acronym>
  <official_title>Glycaemic Response to Oral Nutrition Support During Haemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College Hospital NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College Hospital NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with kidney, or renal, failure require life-saving treatment with regular dialysis.&#xD;
      Dialysis is a form of treatment that simulates some kidney functions; to remove harmful waste&#xD;
      products and extra water from the blood. Almost one-third of people with kidney failure also&#xD;
      have diabetes, as diabetes is one of the leading causes of kidney disease in the United&#xD;
      Kingdom, usually due to poor blood sugar control over a long period of time. Malnutrition is&#xD;
      common in patients needing dialysis due to kidney failure causing fatigue, taste changes and&#xD;
      a build up of waste products, which can reduce appetite. Treatment of malnutrition involves&#xD;
      increasing both the energy and protein intake from food and drinks, and milk-drink style&#xD;
      specialist nutrition drinks are often given to dialysis patients due to their specific&#xD;
      dietary needs. These nutrition drinks can increase blood sugar levels and optimal control for&#xD;
      diabetes may be difficult. This research study aims to measure the blood sugar response to a&#xD;
      &quot;slow-release&quot; sugar nutrition drink specifically designed for dialysis patients, which may&#xD;
      result in a lower blood sugar level, compared to standard nutrition drinks, consumed during a&#xD;
      dialysis session. 28 patients with diabetes and having regular dialysis treatment will enrol&#xD;
      in the study. Patients will be asked to drink 1 of 3 different nutrition drinks, once a week&#xD;
      for 3 weeks during their regular dialysis treatment. Blood sugar levels will be measured from&#xD;
      the blood samples taken from the patient's circulation directly before it enters the dialysis&#xD;
      machine over 3 hours and the maximum blood sugar reading and total blood sugar response will&#xD;
      be measured. Differences between the 3 drinks will be tested statistically. The results will&#xD;
      help to advise patients with diabetes and kidney failure on the most suitable type of&#xD;
      nutrition drink to consume during dialysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with end stage kidney disease requiring dialysis are at the highest risk for&#xD;
      cardiovascular disease, and many of our dialysis population also have diabetes. Malnutrition&#xD;
      is common in patients undergoing dialysis and causes are multifactorial. Oral nutrition&#xD;
      support is the first line treatment for malnutrition, and often includes the use of liquid&#xD;
      nutrition supplements, especially in dialysis patients due to the already restricted diet&#xD;
      required to maintain electrolyte balance. Oral nutrition supplements (ONS) can raise serum&#xD;
      blood glucose levels and optimal control for diabetes may be difficult when ONS are required.&#xD;
      This study aims to evaluate the post-prandial response to a newly re-formulated slow release&#xD;
      carbohydrate renal specific oral nutrition supplement, compared to standard and&#xD;
      macro-nutrient matched ONS products, during haemodialysis, using a randomised cross-over&#xD;
      trial design. 28 patients with diabetes and end stage kidney disease undergoing haemodialysis&#xD;
      will be recruited to the study, including 8 in the pilot phase and 20 in the study. Patients&#xD;
      will be randomised in a crossover design to 3 study treatments over 3 weeks - slow release&#xD;
      CHO ONS, macronutrient matched ONS, and standard ONS. Central blood glucose levels will be&#xD;
      measured over 3 hours and the peak and mean incremental area under the curve (iAUC) of the&#xD;
      post prandial blood glucose response will be calculated for each study treatment. Differences&#xD;
      between treatments will be determined with repeated measures analysis of co-variance&#xD;
      (ANCOVA). The acute effect of different nutritional supplements on blood glucose will be&#xD;
      discussed in the context of maintaining optimal blood glucose control during dialysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood glucose response curve</measure>
    <time_frame>3 hour</time_frame>
    <description>Mean incremental area under the curve for blood glucose response to intervention over 3 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak blood glucose reading within 3 hours</measure>
    <time_frame>3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite score pre and post ONS</measure>
    <time_frame>3 hours</time_frame>
    <description>likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flavour acceptability scale for ONS product</measure>
    <time_frame>3 hours</time_frame>
    <description>likert scale</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Diabetes</condition>
  <condition>Chronic Kidney Disease</condition>
  <condition>End Stage Renal Failure on Dialysis</condition>
  <arm_group>
    <arm_group_label>modified carbohydrate drink</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dietary Supplement - renal specific slow release carbohydrate ONS (220 ml Nepro HP (Abbott Nutrition)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>macronutrient matched drink</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dietary Supplement - 125 ml Fortisip Compact Protein (Nutricia) plus 20ml Calogen (Nutricia)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard drink</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dietary Supplement - 125 ml Fortisip compact (Nutricia)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nepro HP (Abbott Nutrition)</intervention_name>
    <description>oral nutritional supplement drink with modified carbohydrate composition</description>
    <arm_group_label>modified carbohydrate drink</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fortisip compact protein 125 ml + Calogen 20ml (Nutricia)</intervention_name>
    <description>Fortisip compact protein 125 ml + Calogen 20ml (Nutricia) oral nutritional supplement drink macronutrient matched with standard carbohydrate composition</description>
    <arm_group_label>macronutrient matched drink</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fortisip compact 125 ml (Nutricia)</intervention_name>
    <description>Fortisip compact 125 ml (Nutricia) oral nutritional supplement drink - standard</description>
    <arm_group_label>standard drink</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 or type 2 diabetes&#xD;
&#xD;
          -  End stage kidney disease on haemodialysis&#xD;
&#xD;
          -  Body mass index 18.5-35kg/m2&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Infection or course of antibiotics in the last month&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helen L MacLaughlin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Lecturer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>January 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</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>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02989688
org study id: KingCHL
nct id: NCT02989688
lead sponsor: 
collaborator: 
has dmc: No
Patients with kidney, or renal, failure require life-saving treatment with regular dialysis.
      Dialysis is a form of treatment that simulates some kidney functions; to remove harmful waste
      products and extra water from the blood. Almost one-third of people with kidney failure also
      have diabetes, as diabetes is one of the leading causes of kidney disease in the United
      Kingdom, usually due to poor blood sugar control over a long period of time. Malnutrition is
      common in patients needing dialysis due to kidney failure causing fatigue, taste changes and
      a build up of waste products, which can reduce appetite. Treatment of malnutrition involves
      increasing both the energy and protein intake from food and drinks, and milk-drink style
      specialist nutrition drinks are often given to dialysis patients due to their specific
      dietary needs. These nutrition drinks can increase blood sugar levels and optimal control for
      diabetes may be difficult. This research study aims to measure the blood sugar response to a
      "slow-release" sugar nutrition drink specifically designed for dialysis patients, which may
      result in a lower blood sugar level, compared to standard nutrition drinks, consumed during a
      dialysis session. 28 patients with diabetes and having regular dialysis treatment will enrol
      in the study. Patients will be asked to drink 1 of 3 different nutrition drinks, once a week
      for 3 weeks during their regular dialysis treatment. Blood sugar levels will be measured from
      the blood samples taken from the patient's circulation directly before it enters the dialysis
      machine over 3 hours and the maximum blood sugar reading and total blood sugar response will
      be measured. Differences between the 3 drinks will be tested statistically. The results will
      help to advise patients with diabetes and kidney failure on the most suitable type of
      nutrition drink to consume during dialysis.
Patients with end stage kidney disease requiring dialysis are at the highest risk for
      cardiovascular disease, and many of our dialysis population also have diabetes. Malnutrition
      is common in patients undergoing dialysis and causes are multifactorial. Oral nutrition
      support is the first line treatment for malnutrition, and often includes the use of liquid
      nutrition supplements, especially in dialysis patients due to the already restricted diet
      required to maintain electrolyte balance. Oral nutrition supplements (ONS) can raise serum
      blood glucose levels and optimal control for diabetes may be difficult when ONS are required.
      This study aims to evaluate the post-prandial response to a newly re-formulated slow release
      carbohydrate renal specific oral nutrition supplement, compared to standard and
      macro-nutrient matched ONS products, during haemodialysis, using a randomised cross-over
      trial design. 28 patients with diabetes and end stage kidney disease undergoing haemodialysis
      will be recruited to the study, including 8 in the pilot phase and 20 in the study. Patients
      will be randomised in a crossover design to 3 study treatments over 3 weeks - slow release
      CHO ONS, macronutrient matched ONS, and standard ONS. Central blood glucose levels will be
      measured over 3 hours and the peak and mean incremental area under the curve (iAUC) of the
      post prandial blood glucose response will be calculated for each study treatment. Differences
      between treatments will be determined with repeated measures analysis of co-variance
      (ANCOVA). The acute effect of different nutritional supplements on blood glucose will be
      discussed in the context of maintaining optimal blood glucose control during dialysis.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Blood glucose response curve
time frame: 3 hour
description: Mean incremental area under the curve for blood glucose response to intervention over 3 hours
measure: Peak blood glucose reading within 3 hours
time frame: 3 hours
measure: Appetite score pre and post ONS
time frame: 3 hours
description: likert scale
measure: Flavour acceptability scale for ONS product
time frame: 3 hours
description: likert scale
arm group label: modified carbohydrate drink
arm group type: Active Comparator
description: Dietary Supplement - renal specific slow release carbohydrate ONS (220 ml Nepro HP (Abbott Nutrition)
arm group label: macronutrient matched drink
arm group type: Active Comparator
description: Dietary Supplement - 125 ml Fortisip Compact Protein (Nutricia) plus 20ml Calogen (Nutricia)
arm group label: standard drink
arm group type: Active Comparator
description: Dietary Supplement - 125 ml Fortisip compact (Nutricia)
intervention type: Dietary Supplement
intervention name: Nepro HP (Abbott Nutrition)
description: oral nutritional supplement drink with modified carbohydrate composition
arm group label: modified carbohydrate drink
intervention type: Dietary Supplement
intervention name: Fortisip compact protein 125 ml + Calogen 20ml (Nutricia)
description: Fortisip compact protein 125 ml + Calogen 20ml (Nutricia) oral nutritional supplement drink macronutrient matched with standard carbohydrate composition
arm group label: macronutrient matched drink
intervention type: Dietary Supplement
intervention name: Fortisip compact 125 ml (Nutricia)
description: Fortisip compact 125 ml (Nutricia) oral nutritional supplement drink - standard
arm group label: standard drink
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Helen L MacLaughlin, PhD
role: Principal Investigator
affiliation: Clinical Lecturer
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Kidney Failure, Chronic
sharing ipd: No