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

Obesity Clinical Trial

— CAVIAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233491
• Other study ID #: UBirminghamNHS
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: July 2018

Study information

• Verified date: June 2020
• Source: University Hospital Birmingham NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Post Transplantation Diabetes Mellitus
• Transplantation of Kidney

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.

Other:
• Control
No additional support other than lifestyle advice by clinician

Locations

Country	Name	City	State
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Birmingham NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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