<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/NCT02233491</url>
  </required_header>
  <id_info>
    <org_study_id>UBirminghamNHS</org_study_id>
    <nct_id>NCT02233491</nct_id>
  </id_info>
  <brief_title>Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients</brief_title>
  <acronym>CAVIAR</acronym>
  <official_title>A Prospective, Randomised Controlled Trial Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Birmingham NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Birmingham NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-transplantation diabetes mellitus (PTDM) is a common medical complication after kidney&#xD;
      transplantation, related to both transplant-specific and generic risk factors, and is&#xD;
      associated with major complications after transplantation. The current PTDM Consensus Report&#xD;
      recommends lifestyle modification (e.g. weight loss, dietary modification, structured&#xD;
      exercise program) as the first line therapy of choice. No recommendation is given with&#xD;
      regards to how such guidance should be delivered. In addition no clinical evidence exists to&#xD;
      suggest lifestyle modification provides any sustained glycaemic benefits for kidney allograft&#xD;
      recipients.&#xD;
&#xD;
      While in the general population the benefits of lifestyle modification have been well&#xD;
      documented with regards to attenuation of both pre-diabetic and diabetic states in the&#xD;
      context of randomised controlled trials, no similar level of evidence exists post kidney&#xD;
      transplantation.&#xD;
&#xD;
      This prospective randomised controlled trial is designed to compare active versus passive&#xD;
      lifestyle intervention post kidney transplantation, to determine changes in cardio-metabolic&#xD;
      risk profile over the course of the intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2015</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glucose metabolism</measure>
    <time_frame>6 months</time_frame>
    <description>Change in insulin secretion, insulin resistance and disposition index (insulin secretion x insulin sensitivity) between baseline and post-intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Post-Transplantation Diabetes Mellitus</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Impaired Glucose Tolerance</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Impaired Fasting Glucose</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Commencement of glucose-lowering therapy</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in HbA1c</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical changes (weight, body mass index, waist-hip ration and triceps fold thickness)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lipid profile</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity</measure>
    <time_frame>6 months</time_frame>
    <description>Incremental Shuttle Walk Tests, Duke Activity Status Index and GP Physical Activity Questionnaire respectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in psychological well-being</measure>
    <time_frame>6 months</time_frame>
    <description>EQ5D - quality of life and health status Beck Depression Inventory (BDI-II) Situational Motivation Scale (SMS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in creatinine</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in urine albumin-creatinine ratio</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient survival</measure>
    <time_frame>6 months and then 1-, 3-, 5- and 10-years post transplantation</time_frame>
    <description>Electronic tagging to national data registries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Allograft survival</measure>
    <time_frame>6 months and then 1-, 3-, 5- and 10-years post transplantation</time_frame>
    <description>Electronic tagging to national data registries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization</measure>
    <time_frame>6 months and then 1-, 3-, 5- and 10-years post transplantation</time_frame>
    <description>Electronic tagging to national data registries</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Post Transplantation Diabetes Mellitus</condition>
  <condition>Obesity</condition>
  <condition>Transplantation of Kidney</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group will be counselled in clinic by clinicians about the risks of glucose intolerance and will receive leaflets outlining lifestyle modification advice. The leaflets include advice on healthy eating, exercise and the importance of weight loss. However there will be no dietician referral, psychosocial intervention or focused exercise and weight loss monitoring programme. Follow up will be at routine clinic visits only where lifestyle modification advice will be reinforced as per usual clinical practise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive active lifestyle modification intervention and will consist of dietician referral, graded exercise programme and weight loss advice. The dietician will be supported by Clinical Psychology services and our collaboration with a recognised expert in behavioural change therapy. The dietician will be trained with motivational interviewing skills and psychological tools will be utilised to support the active lifestyle intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active lifestyle intervention</intervention_name>
    <description>Active intervention will comprise reviews by a renal dietician, with cognitive behaviour therapy, to provide additional support for lifestyle intervention.</description>
    <arm_group_label>Active intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>No additional support other than lifestyle advice by clinician</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt;18, kidney allograft only, functioning allograft (not on dialysis), 3-24 months&#xD;
             post-transplant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Organ transplant recipient, pre-existing diabetes, pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 2WB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Birmingham NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Adnan Sharif</investigator_full_name>
    <investigator_title>Consultant Nephrologist</investigator_title>
  </responsible_party>
  <keyword>PTDM</keyword>
  <keyword>kidney transplant</keyword>
  <keyword>lifestyle intervention</keyword>
  <keyword>diet</keyword>
  <keyword>exercise</keyword>
  <!-- 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/NCT02233491
org study id: UBirminghamNHS
nct id: NCT02233491
lead sponsor: 
has dmc: No
Post-transplantation diabetes mellitus (PTDM) is a common medical complication after kidney
      transplantation, related to both transplant-specific and generic risk factors, and is
      associated with major complications after transplantation. The current PTDM Consensus Report
      recommends lifestyle modification (e.g. weight loss, dietary modification, structured
      exercise program) as the first line therapy of choice. No recommendation is given with
      regards to how such guidance should be delivered. In addition no clinical evidence exists to
      suggest lifestyle modification provides any sustained glycaemic benefits for kidney allograft
      recipients.

      While in the general population the benefits of lifestyle modification have been well
      documented with regards to attenuation of both pre-diabetic and diabetic states in the
      context of randomised controlled trials, no similar level of evidence exists post kidney
      transplantation.

      This prospective randomised controlled trial is designed to compare active versus passive
      lifestyle intervention post kidney transplantation, to determine changes in cardio-metabolic
      risk profile over the course of the intervention.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Glucose metabolism
time frame: 6 months
description: Change in insulin secretion, insulin resistance and disposition index (insulin secretion x insulin sensitivity) between baseline and post-intervention
measure: Incidence of Post-Transplantation Diabetes Mellitus
time frame: 6 months
measure: Incidence of Impaired Glucose Tolerance
time frame: 6 months
measure: Incidence of Impaired Fasting Glucose
time frame: 6 months
measure: Commencement of glucose-lowering therapy
time frame: 6 months
measure: Difference in HbA1c
time frame: 6 months
measure: Physical changes (weight, body mass index, waist-hip ration and triceps fold thickness)
time frame: 6 months
measure: Change in blood pressure
time frame: 6 months
measure: Change in lipid profile
time frame: 6 months
measure: Change in physical activity
time frame: 6 months
description: Incremental Shuttle Walk Tests, Duke Activity Status Index and GP Physical Activity Questionnaire respectively
measure: Change in psychological well-being
time frame: 6 months
description: EQ5D - quality of life and health status Beck Depression Inventory (BDI-II) Situational Motivation Scale (SMS)
measure: Change in creatinine
time frame: 6 months
measure: Change in urine albumin-creatinine ratio
time frame: 6 months
measure: Patient survival
time frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation
description: Electronic tagging to national data registries
measure: Allograft survival
time frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation
description: Electronic tagging to national data registries
measure: Hospitalization
time frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation
description: Electronic tagging to national data registries
arm group label: Control
arm group type: Placebo Comparator
description: This group will be counselled in clinic by clinicians about the risks of glucose intolerance and will receive leaflets outlining lifestyle modification advice. The leaflets include advice on healthy eating, exercise and the importance of weight loss. However there will be no dietician referral, psychosocial intervention or focused exercise and weight loss monitoring programme. Follow up will be at routine clinic visits only where lifestyle modification advice will be reinforced as per usual clinical practise.
arm group label: Active intervention
arm group type: Active Comparator
description: This group will receive active lifestyle modification intervention and will consist of dietician referral, graded exercise programme and weight loss advice. The dietician will be supported by Clinical Psychology services and our collaboration with a recognised expert in behavioural change therapy. The dietician will be trained with motivational interviewing skills and psychological tools will be utilised to support the active lifestyle intervention.
intervention type: Behavioral
intervention name: Active lifestyle intervention
description: Active intervention will comprise reviews by a renal dietician, with cognitive behaviour therapy, to provide additional support for lifestyle intervention.
arm group label: Active intervention
intervention type: Other
intervention name: Control
description: No additional support other than lifestyle advice by clinician
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University Hospital Birmingham NHS Foundation Trust
investigator full name: Adnan Sharif
investigator title: Consultant Nephrologist