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NCT Number: NCT02233491

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.

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Key information

Conditions

Post Transplantation Diabetes Mellitus Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Transplantation of Kidney

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2WB, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active lifestyle intervention

Behavioral

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

Control

Other

No additional support other than lifestyle advice by clinician

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of Post-Transplantation Diabetes Mellitus

    Time frame: 6 months

  2. Incidence of Impaired Glucose Tolerance

    Time frame: 6 months

  3. Incidence of Impaired Fasting Glucose

    Time frame: 6 months

  4. Commencement of glucose-lowering therapy

    Time frame: 6 months

  5. Difference in HbA1c

    Time frame: 6 months

  6. Physical changes (weight, body mass index, waist-hip ration and triceps fold thickness)

    Time frame: 6 months

  7. Change in blood pressure

    Time frame: 6 months

  8. Change in lipid profile

    Time frame: 6 months

  9. Change in physical activity

    Time frame: 6 months

    Incremental Shuttle Walk Tests, Duke Activity Status Index and GP Physical Activity Questionnaire respectively

  10. 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)

  11. Change in creatinine

    Time frame: 6 months

  12. Change in urine albumin-creatinine ratio

    Time frame: 6 months

  13. Patient survival

    Time frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation

    Electronic tagging to national data registries

  14. Allograft survival

    Time frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation

    Electronic tagging to national data registries

  15. Hospitalization

    Time frame: 6 months and then 1-, 3-, 5- and 10-years post transplantation

    Electronic tagging to national data registries

Sponsors and collaborators

Lead sponsor

University Hospital Birmingham NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: CAVIAR

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Sep 8, 2014
Registry last updated
Jun 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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