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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-07-31

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.

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Detailed Description

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Conditions

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Post Transplantation Diabetes Mellitus Obesity Transplantation of Kidney

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

No additional support other than lifestyle advice by clinician

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.

Group Type ACTIVE_COMPARATOR

Active lifestyle intervention

Intervention Type BEHAVIORAL

Active intervention will comprise reviews by a renal dietician, with cognitive behaviour therapy, to provide additional support for lifestyle intervention.

Interventions

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Active lifestyle intervention

Active intervention will comprise reviews by a renal dietician, with cognitive behaviour therapy, to provide additional support for lifestyle intervention.

Intervention Type BEHAVIORAL