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

June 10, 2020 updated by: Adnan Sharif, University Hospital Birmingham NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2WB
        • University Hospitals Birmingham NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose metabolism
Time Frame: 6 months
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
Time Frame: 6 months
6 months
Incidence of Impaired Glucose Tolerance
Time Frame: 6 months
6 months
Incidence of Impaired Fasting Glucose
Time Frame: 6 months
6 months
Commencement of glucose-lowering therapy
Time Frame: 6 months
6 months
Difference in HbA1c
Time Frame: 6 months
6 months
Physical changes (weight, body mass index, waist-hip ration and triceps fold thickness)
Time Frame: 6 months
6 months
Change in blood pressure
Time Frame: 6 months
6 months
Change in lipid profile
Time Frame: 6 months
6 months
Change in physical activity
Time Frame: 6 months
Incremental Shuttle Walk Tests, Duke Activity Status Index and GP Physical Activity Questionnaire respectively
6 months
Change in psychological well-being
Time Frame: 6 months
EQ5D - quality of life and health status Beck Depression Inventory (BDI-II) Situational Motivation Scale (SMS)
6 months
Change in creatinine
Time Frame: 6 months
6 months
Change in urine albumin-creatinine ratio
Time Frame: 6 months
6 months
Patient survival
Time Frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation
Electronic tagging to national data registries
6 months and then 1-, 3-, 5- and 10-years post transplantation
Allograft survival
Time Frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation
Electronic tagging to national data registries
6 months and then 1-, 3-, 5- and 10-years post transplantation
Hospitalization
Time Frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation
Electronic tagging to national data registries
6 months and then 1-, 3-, 5- and 10-years post transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

September 5, 2014

First Posted (Estimate)

September 8, 2014

Study Record Updates

Last Update Posted (Actual)

June 12, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UBirminghamNHS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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