The effect of a pre-transplant diet and exercise intervention on post-transplant metabolic profile in living kidney donor transplant recipients: the SIMPLICITY trial

Not Applicable

Recruiting

• Conditions: ew-onset diabetes after kidney transplantation; Living donor kidney transplantation; New-onset diabetes after kidney transplantation; Metabolic and Endocrine - Diabetes; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12611000196943
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Recipients of living donor kidney transplant
2. 18 years or older at the time of enrolment
3. Diabetes excluded by pre-transplant oral glucose tolerance test

Exclusion Criteria

1. Contraindications to maximal exercise testing or high-intensity progressive resistance training (e.g. proliferative diabetic or hypertensive retinopathy, un-repaired aneurysm, critical aortic stenosis, recurrent symptomatic hernias, NYHA class IV congestive heart failure)
2. Inability to give informed consent
3. Patient is pregnant or breastfeeding.
4. Current participation in another clinical trial
5. Patient is unlikely or unable to comply with the visits scheduled in the protocol (e.g. due to excessive travel requirements)
6. Insufficient comprehension to understand protocols or exercise safely

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean afternoon blood glucose, as measured by continuous glucose monitor[12pm - 6pm for the first six days post transplant];Overall mean glucose, as measured by continuous glucose monitor[For the first six days post transplant];Percentage excursion of glucose >11mmol/L[For the first six days post transplant]