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Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients (CAVIAR)

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ClinicalTrials.gov Identifier: NCT02233491
Recruitment Status : Completed
First Posted : September 8, 2014
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Adnan Sharif, University Hospital Birmingham NHS Foundation Trust

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Post Transplantation Diabetes Mellitus Obesity Transplantation of Kidney Behavioral: Active lifestyle intervention Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Randomised Controlled Trial Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients
Actual Study Start Date : August 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : July 2018

Arm Intervention/treatment
Placebo Comparator: Control
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.
Other: Control
No additional support other than lifestyle advice by clinician

Active Comparator: Active intervention
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.
Behavioral: Active lifestyle intervention
Active intervention will comprise reviews by a renal dietician, with cognitive behaviour therapy, to provide additional support for lifestyle intervention.




Primary Outcome Measures :
  1. Glucose metabolism [ Time Frame: 6 months ]
    Change in insulin secretion, insulin resistance and disposition index (insulin secretion x insulin sensitivity) between baseline and post-intervention


Secondary Outcome Measures :
  1. Incidence of Post-Transplantation Diabetes Mellitus [ Time Frame: 6 months ]
  2. Incidence of Impaired Glucose Tolerance [ Time Frame: 6 months ]
  3. Incidence of Impaired Fasting Glucose [ Time Frame: 6 months ]
  4. Commencement of glucose-lowering therapy [ Time Frame: 6 months ]
  5. Difference in HbA1c [ Time Frame: 6 months ]
  6. Physical changes (weight, body mass index, waist-hip ration and triceps fold thickness) [ Time Frame: 6 months ]
  7. Change in blood pressure [ Time Frame: 6 months ]
  8. Change in lipid profile [ Time Frame: 6 months ]
  9. Change in physical activity [ Time Frame: 6 months ]
    Incremental Shuttle Walk Tests, Duke Activity Status Index and GP Physical Activity Questionnaire respectively

  10. Change in psychological well-being [ Time Frame: 6 months ]
    EQ5D - quality of life and health status Beck Depression Inventory (BDI-II) Situational Motivation Scale (SMS)

  11. Change in creatinine [ Time Frame: 6 months ]
  12. Change in urine albumin-creatinine ratio [ Time Frame: 6 months ]
  13. Patient survival [ Time Frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation ]
    Electronic tagging to national data registries

  14. Allograft survival [ Time Frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation ]
    Electronic tagging to national data registries

  15. Hospitalization [ Time Frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation ]
    Electronic tagging to national data registries



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age>18, kidney allograft only, functioning allograft (not on dialysis), 3-24 months post-transplant

Exclusion Criteria:

  • Organ transplant recipient, pre-existing diabetes, pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233491


Locations
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United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B15 2WB
Sponsors and Collaborators
University Hospital Birmingham NHS Foundation Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Adnan Sharif, Consultant Nephrologist, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02233491    
Other Study ID Numbers: UBirminghamNHS
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Keywords provided by Adnan Sharif, University Hospital Birmingham NHS Foundation Trust:
PTDM
kidney transplant
lifestyle intervention
diet
exercise