Obesity, Post Transplantation Diabetes Mellitus, Transplantation of Kidney
Conditions
Keywords
PTDM, kidney transplant, lifestyle intervention, diet, exercise
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.
Interventions
BEHAVIORALActive lifestyle intervention
Active intervention will comprise reviews by a renal dietician, with cognitive behaviour therapy, to provide additional support for lifestyle intervention.
OTHERControl
No additional support other than lifestyle advice by clinician
Sponsors
University Hospital Birmingham NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose metabolism | 6 months | Change in insulin secretion, insulin resistance and disposition index (insulin secretion x insulin sensitivity) between baseline and post-intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Impaired Glucose Tolerance | 6 months | — |
| Incidence of Impaired Fasting Glucose | 6 months | — |
| Commencement of glucose-lowering therapy | 6 months | — |
| Difference in HbA1c | 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 lipid profile | 6 months | — |
| Incidence of Post-Transplantation Diabetes Mellitus | 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) |
| Change in creatinine | 6 months | — |
| Change in urine albumin-creatinine ratio | 6 months | — |
| 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 |
| Change in physical activity | 6 months | Incremental Shuttle Walk Tests, Duke Activity Status Index and GP Physical Activity Questionnaire respectively |
Countries
United Kingdom
Outcome results
None listed