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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomised Controlled Trial Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients

Conditions
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Post Transplantation Diabetes Mellitus, Obesity, Transplantation of Kidney

Intervention / Treatment
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* Behavioral: Active lifestyle intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>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<br>* No additional support other than lifestyle advice by clinician<br>|
| Active Comparator: Active intervention<br>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<br>* Active intervention will comprise reviews by a renal dietician, with cognitive behaviour therapy, to provide additional support for lifestyle intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose metabolism | Change in insulin secretion, insulin resistance and disposition index (insulin secretion x insulin sensitivity) between baseline and post-intervention | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Post-Transplantation Diabetes Mellitus |  | 6 months | 
| 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 | 
| Change in physical activity | Incremental Shuttle Walk Tests, Duke Activity Status Index and GP Physical Activity Questionnaire respectively | 6 months | 
| Change in psychological well-being | EQ5D - quality of life and health status Beck Depression Inventory (BDI-II) Situational Motivation Scale (SMS) | 6 months | 
| Change in creatinine |  | 6 months | 
| Change in urine albumin-creatinine ratio |  | 6 months | 
| Patient survival | Electronic tagging to national data registries | 6 months and then 1-, 3-, 5- and 10-years post transplantation | 
| Allograft survival | Electronic tagging to national data registries | 6 months and then 1-, 3-, 5- and 10-years post transplantation | 
| Hospitalization | Electronic tagging to national data registries | 6 months and then 1-, 3-, 5- and 10-years post transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTDM, kidney transplant, lifestyle intervention, diet, exercise