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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
130
Active intervention will comprise reviews by a renal dietician, with cognitive behaviour therapy, to provide additional support for lifestyle intervention.
No additional support other than lifestyle advice by clinician
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Glucose metabolism
Change in insulin secretion, insulin resistance and disposition index (insulin secretion x insulin sensitivity) between baseline and post-intervention
Time frame: 6 months
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
Incremental Shuttle Walk Tests, Duke Activity Status Index and GP Physical Activity Questionnaire respectively
Time frame: 6 months
Change in psychological well-being
EQ5D - quality of life and health status Beck Depression Inventory (BDI-II) Situational Motivation Scale (SMS)
Time frame: 6 months
Change in creatinine
Time frame: 6 months
Change in urine albumin-creatinine ratio
Time frame: 6 months
Patient survival
Electronic tagging to national data registries
Time frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation
Allograft survival
Electronic tagging to national data registries
Time frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation
Hospitalization
Electronic tagging to national data registries
Time frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.