The purpose of this trial is to investigate whether a combined dietary and exercise intervention, added to standard care, reduces the expected frequency of insulin resistance in kidney transplant recipients on tacrolimus.
A Pilot Trial of the Effect of Dietary and Exercise Intervention on Insulin Resistance and Metabolic Parameters in de Novo Renal Transplant Recipients on Prograf (Tacrolimus)
Renal TransplantationGrafting, Kidney
Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measures:
- Proportion of patients with insulin resistance, as defined by a homeostasis model assessment (HOMA-IR) of >1 at 6 months.
Secondary Outcome Measures:
- Proportion of patients with composite endpoint of impaired fasting glycaemia (IFG) /impaired glucose tolerance (IGT) /diabetes mellitus (DM) at 6 months.
This study will investigate the effect of a supervised diet and exercise program on the risk of developing diabetes and other related conditions after kidney transplantation. The exercise and diet intervention will include a 6-month program of weight lifting exercises (progressive resistance training) which will be completed three times each week and individualised dietary advice from a qualified dietician. Diabetes is very common following transplantation, developing in up to one-third of kidney transplant recipients. The development of diabetes requires treatment and places those affected at an increased risk of other complications including reduced transplant survival. This is a prospective (subjects are identified and then followed forward in time), single-arm, multicentre, interventional pilot study of the effects of a combined dietary and exercise intervention on glucose metabolism. The subject population includes kidney transplant recipients who have been assigned a tacrolimus-based immunosuppression regimen. The study will include the following evaluations of safety and tolerability; adverse events will be reported by the patient for the duration of the study, a physical examination will be completed by the investigator at each study visit, laboratory investigations and an ECG will be performed at each study visit.
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and above
- Genders Eligible for Study: Both
- Received a living-donor or dead-donor, blood type compatible kidney transplant
- Patient has sufficiently recovered from surgery to tolerate an intensive exercise evaluation
- Patient is 18 years or older at the time of transplantation
- Patient has been initiated on tacrolimus (Prograf)
- No significant disease or disability that prevents taking part in a diet or exercise regime (e.g. cardiac instability, including unstable angina and/or other unstable disease, severe cognitive impairment)
- No significant post-surgical complications that prevent participation in the exercise component of the study (e.g. wound dehiscence or infection)
- No 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, New York Heart Association (NYHA) class IV congestive heart failure)
- No mobility problems
- Patient does not require ongoing systemic immunosuppressive therapy for an indication other than renal transplant e.g. rheumatoid arthritis, and this dose is higher than that required for their kidney disease
- Camperdown, 2050, Australia; Recruiting
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