Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients
- Conditions
- ObesityTransplantation of KidneyPost Transplantation Diabetes Mellitus
- Interventions
- Other: ControlBehavioral: Active lifestyle intervention
- Registration Number
- NCT02233491
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- Age>18, kidney allograft only, functioning allograft (not on dialysis), 3-24 months post-transplant
- Organ transplant recipient, pre-existing diabetes, pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Control 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. Active intervention Active lifestyle 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.
- Primary Outcome Measures
Name Time Method Glucose metabolism 6 months Change in insulin secretion, insulin resistance and disposition index (insulin secretion x insulin sensitivity) between baseline and post-intervention
- Secondary Outcome Measures
Name Time Method Difference in HbA1c 6 months Change in lipid profile 6 months Incidence of Impaired Glucose Tolerance 6 months Commencement of glucose-lowering therapy 6 months Physical changes (weight, body mass index, waist-hip ration and triceps fold thickness) 6 months Change in blood pressure 6 months Change in urine albumin-creatinine ratio 6 months Incidence of Post-Transplantation Diabetes Mellitus 6 months Incidence of Impaired Fasting Glucose 6 months Change in physical activity 6 months Incremental Shuttle Walk Tests, Duke Activity Status Index and GP Physical Activity Questionnaire respectively
Change in creatinine 6 months Change in psychological well-being 6 months EQ5D - quality of life and health status Beck Depression Inventory (BDI-II) Situational Motivation Scale (SMS)
Patient survival 6 months and then 1-, 3-, 5- and 10-years post transplantation Electronic tagging to national data registries
Allograft survival 6 months and then 1-, 3-, 5- and 10-years post transplantation Electronic tagging to national data registries
Hospitalization 6 months and then 1-, 3-, 5- and 10-years post transplantation Electronic tagging to national data registries
Trial Locations
- Locations (1)
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, West Midlands, United Kingdom