Post Transplantation Diabetes MellitusCAVIARNCT02233491
Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients
A study testing Active lifestyle intervention in people with Post Transplantation Diabetes Mellitus and Obesity, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Transplantation Diabetes Mellitus, Obesity, Transplantation of Kidney
- What is being tested?
- Active lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18, kidney allograft only, functioning allograft (not on dialysis), 3-24 months post-transplant
Who cannot join
- Organ transplant recipient, pre-existing diabetes, pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2WB
About this study
Official title: 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.
- Being tested
- Active lifestyle intervention, Control
- Keywords
- PTDM, kidney transplant, lifestyle intervention, diet, exercise
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active lifestyle interventionBehavioural
Active intervention will comprise reviews by a renal dietician, with cognitive behaviour therapy, to provide additional support for lifestyle intervention.
ControlOther
No additional support other than lifestyle advice by clinician
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 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. Receives: Other: Control |
| Active intervention | Active comparator | 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. Receives: Behavioral: Active lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose metabolism
Change in insulin secretion, insulin resistance and disposition index (insulin secretion x insulin sensitivity) between baseline and post-intervention
Measured: 6 months
Secondary outcomes (15)
Incidence of Post-Transplantation Diabetes Mellitus
Measured: 6 months
Incidence of Impaired Glucose Tolerance
Measured: 6 months
Incidence of Impaired Fasting Glucose
Measured: 6 months
Commencement of glucose-lowering therapy
Measured: 6 months
Difference in HbA1c
Measured: 6 months
Physical changes (weight, body mass index, waist-hip ration and triceps fold thickness)
Measured: 6 months
Change in blood pressure
Measured: 6 months
Change in lipid profile
Measured: 6 months
Change in physical activity
Incremental Shuttle Walk Tests, Duke Activity Status Index and GP Physical Activity Questionnaire respectively
Measured: 6 months
Change in psychological well-being
EQ5D - quality of life and health status Beck Depression Inventory (BDI-II) Situational Motivation Scale (SMS)
Measured: 6 months
Change in creatinine
Measured: 6 months
Change in urine albumin-creatinine ratio
Measured: 6 months
Patient survival
Electronic tagging to national data registries
Measured: 6 months and then 1-, 3-, 5- and 10-years post transplantation
Allograft survival
Electronic tagging to national data registries
Measured: 6 months and then 1-, 3-, 5- and 10-years post transplantation
Hospitalization
Electronic tagging to national data registries
Measured: 6 months and then 1-, 3-, 5- and 10-years post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startAug 2015
- Primary completionDec 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Transplantation Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Sharif, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233491
- Sponsor's protocol ID
- UBirminghamNHS
- Acronym
- CAVIAR
- Status last verified
- Jun 2020
- First submitted
- 27 Aug 2014
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27550305
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised Controlled Trial Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients
- ClinicalTrials.gov ID
- NCT02233491
- Acronym / sponsor ID
- CAVIAR / UBirminghamNHS
- Keywords
- PTDM, kidney transplant, lifestyle intervention, diet, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlThis 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 comparator | Behavioral: Active lifestyle interventionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age>18, kidney allograft only, functioning allograft (not on dialysis), 3-24 months post-transplant
Key exclusion criteria (1 listed)
- Organ transplant recipient, pre-existing diabetes, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active lifestyle interventionActive intervention will comprise reviews by a renal dietician, with cognitive behaviour therapy, to provide additional support for lifestyle intervention. | Behavioural | Active intervention |
| ControlNo additional support other than lifestyle advice by clinician | Other | Control |
Primary outcome
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
15 secondary outcomes
Incidence of Post-Transplantation Diabetes Mellitus
Time frame: 6 months
Incidence of Impaired Glucose Tolerance
Time frame: 6 months
Incidence of Impaired Fasting Glucose
Time frame: 6 months
Commencement of glucose-lowering therapy
Time frame: 6 months
Difference in HbA1c
Time frame: 6 months
Physical changes (weight, body mass index, waist-hip ration and triceps fold thickness)
Time frame: 6 months
Change in blood pressure
Time frame: 6 months
Change in lipid profile
Time frame: 6 months
Change in physical activity
Time frame: 6 months
Change in psychological well-being
Time frame: 6 months
Change in creatinine
Time frame: 6 months
Change in urine albumin-creatinine ratio
Time frame: 6 months
Patient survival
Time frame: 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
Hospitalization
Time frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Derived from this study: PubMed 27550305Wilcox 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.
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Liver Transplant CGM
Liver Transplant, Post Transplant Diabetes
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Continuous Glucose Monitoring (CGM) After Kidney Transplantation
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SGLT2i Effect on PTDM Development and Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients: A Randomized, Doubleblind, Placebo Controlled, National Multicenter Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active lifestyle intervention in people with Post Transplantation Diabetes Mellitus and Obesity, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose metabolism (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02233491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.