Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial

Table 1 Flowchart of study investigations

Investigations	Days post recruitment					Years post recruitment
	0	60	90	120	180	1	3	5
	Randomisation		Mid-way point		Post intervention	Post intervention	Post intervention	Post intervention
Dietitian review with clinical psychology input (if active arm)	X	X		X
Standard blood and urine tests^a	X	X	X	X	X
Baseline demographics^b	X
Clinical assessment^c	X		X		X
Patient-reported outcomes^d	X		X		X
Glucose	X	X	X	X	X
Insulin	X		X		X
Diabetes/obesity immunoassay^e	X		X		X
Triglycerides	X		X		X
Oral glucose tolerance test	X				X
HbA1c	X		X		X
Electronic capture of clinical outcomes^f						X	X	X

^aRoutine clinical blood and urine tests include renal function, tacrolimus levels, liver function tests, full blood count, urine albumin-creatinine ratio, etc.
^bExtensive baseline data including cause of end-stage kidney disease, dialysis modality, dialysis duration, family history of diabetes, gestational diabetes, hepatitis C status, etc.
^cBlood pressure, waist/hip ratio, weight, height, body mass index, bioimpedance (fluid, fat and muscle mass/index estimation), etc.
^dPatient-reported outcomes (physical activity and psychological wellbeing as highlighted above)
^eC-peptide, ghrelin, gastric inhibitory peptide (GIP), glucagon-like peptide-1 (GLP-1), glucagon, leptin, total plasminogen activator inhibitor-1 (PAI-1), resistin, visfatin and adiponectin
^fLong-term clinical outcomes (patient survival, allograft survival, cardiac events, weight, etc) via electronic tagging to University Hospital Birmingham’s electronic patient records (via Patient Registration number) and national registries (via NHS number)

ISSN: 1745-6215