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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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
- Incidence of Post-Transplantation Diabetes Mellitus [ Time Frame: 6 months ]
- Incidence of Impaired Glucose Tolerance [ Time Frame: 6 months ]
- Incidence of Impaired Fasting Glucose [ Time Frame: 6 months ]
- Commencement of glucose-lowering therapy [ Time Frame: 6 months ]
- Difference in HbA1c [ Time Frame: 6 months ]
- Physical changes (weight, body mass index, waist-hip ration and triceps fold thickness) [ Time Frame: 6 months ]
- Change in blood pressure [ Time Frame: 6 months ]
- Change in lipid profile [ Time Frame: 6 months ]
- Change in physical activity [ Time Frame: 6 months ]Incremental Shuttle Walk Tests, Duke Activity Status Index and GP Physical Activity Questionnaire respectively
- 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)
- Change in creatinine [ Time Frame: 6 months ]
- Change in urine albumin-creatinine ratio [ Time Frame: 6 months ]
- Patient survival [ Time Frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation ]Electronic tagging to national data registries
- Allograft survival [ Time Frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation ]Electronic tagging to national data registries
- Hospitalization [ Time Frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation ]Electronic tagging to national data registries
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
|University Hospitals Birmingham NHS Foundation Trust|
|Birmingham, West Midlands, United Kingdom, B15 2WB|