Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients
CAVIAR
A Prospective, Randomised Controlled Trial Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2014
CompletedFirst Posted
Study publicly available on registry
September 8, 2014
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJune 12, 2020
June 1, 2020
2.3 years
August 27, 2014
June 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glucose metabolism
Change in insulin secretion, insulin resistance and disposition index (insulin secretion x insulin sensitivity) between baseline and post-intervention
6 months
Secondary Outcomes (15)
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
- +10 more secondary outcomes
Study Arms (2)
Control
PLACEBO COMPARATORThis 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.
Active intervention
ACTIVE COMPARATORThis 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.
Interventions
Active intervention will comprise reviews by a renal dietician, with cognitive behaviour therapy, to provide additional support for lifestyle intervention.
Eligibility Criteria
You may qualify if:
- Age\>18, kidney allograft only, functioning allograft (not on dialysis), 3-24 months post-transplant
You may not qualify if:
- Organ transplant recipient, pre-existing diabetes, pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2WB, United Kingdom
Related Publications (1)
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.
PMID: 27550305DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Nephrologist
Study Record Dates
First Submitted
August 27, 2014
First Posted
September 8, 2014
Study Start
August 1, 2015
Primary Completion
December 1, 2017
Study Completion
July 1, 2018
Last Updated
June 12, 2020
Record last verified: 2020-06