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

Not Applicable

Completed

• Conditions: Obesity; Transplantation of Kidney; Post Transplantation Diabetes Mellitus

• Registration Number: NCT02233491
• Lead Sponsor: University Hospital Birmingham NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-27
• Study First Submitted QC: 2014-09-05
• Study First Posted: 2014-09-08
• Study Start: 2015-08
• Primary Completion: 2017-12
• Study Completion: 2018-07
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Glucose metabolism	6 months	Change in insulin secretion, insulin resistance and disposition index (insulin secretion x insulin sensitivity) between baseline and post-intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, West Midlands, United Kingdom