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

NCT02233491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2020-06-12

No results posted yet for this study

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.

Conditions

  • Post Transplantation Diabetes Mellitus
  • Obesity
  • Transplantation of Kidney

Interventions

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

Sponsors & Collaborators

  • University Hospital Birmingham NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-12-31
Completion
2018-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02233491 on ClinicalTrials.gov