Clinical trial NCT02233491: Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients
Official title: A Prospective, Randomised Controlled Trial Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Transplantation Diabetes Mellitus
Obesity
Transplantation of Kidney
Keywords: PTDM
kidney transplant
lifestyle intervention
diet
exercise
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-09-08
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Glucose metabolism
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of Post-Transplantation Diabetes Mellitus
timeFrame: 6 months
measure: Incidence of Impaired Glucose Tolerance
timeFrame: 6 months
measure: Incidence of Impaired Fasting Glucose
timeFrame: 6 months
measure: Commencement of glucose-lowering therapy
timeFrame: 6 months
measure: Difference in HbA1c
timeFrame: 6 months
measure: Physical changes (weight, body mass index, waist-hip ration and triceps fold thickness)
timeFrame: 6 months
measure: Change in blood pressure
timeFrame: 6 months
measure: Change in lipid profile
timeFrame: 6 months
measure: Change in physical activity
timeFrame: 6 months
measure: Change in psychological well-being
timeFrame: 6 months
measure: Change in creatinine
timeFrame: 6 months
measure: Change in urine albumin-creatinine ratio
timeFrame: 6 months
measure: Patient survival
timeFrame: 6 months and then 1-, 3-, 5- and 10-years post transplantation
measure: Allograft survival
timeFrame: 6 months and then 1-, 3-, 5- and 10-years post transplantation
measure: Hospitalization
timeFrame: 6 months and then 1-, 3-, 5- and 10-years post transplantation
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
state: West Midlands
Study officials:
References:
citation: Wilcox J, Waite C, Tomlinson L, Driscoll J, Karim A, Day E, Sharif A. Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial. Trials. 2016 Aug 22;17(1):417. doi: 10.1186/s13063-016-1543-6.