A Pilot Trial to Evaluate the Effect of Diet and Exercise in Renal Transplant Recipients on Tacrolimus

IFG is defined as a fasting venous plasma glucose concentration greater than or equal to 6.1 mmol per L but less than 7.0 mmol per L, together with a 2-hour plasma glucose concentration of less than 7.8 mmol per L.

IGT is defined as fasting venous plasma glucose of less than 7.0 mmol per L, together with a 2-hour plasma glucose of greater than or equal to 7.8 mmol per L but less than 11.1 mmol per L.

DM is defined as a fasting plasma glucose concentration greater than or equal to 7.0 mmol per L, or a 2-hour plasma glucose greater than or equal to 11.1 mmol per L.

HOMA-Beta is used to assess beta-cell function. HOMA-Beta is a measure of Beta-cell function (higher values present increased insulin secretion for a given glucose level). HOMA-Beta is calculated by the equation: HOMA-Beta=(20*FPI) divided by (FPG-3.5), where, FPI is fasting plasma insulin concentration (mU per L) and FPG is fasting plasma glucose concentration (mmol per L).

Acute rejection episodes are classified into: Spontaneously resolving - a rejection episode which is not treated with new or increased corticosteroid medication, antibodies or any other medication. Corticosteroid sensitive - a rejection episode, which is treated with new or increased corticosteroid medication only. Corticosteroid resistant - a rejection episode, which is not resolve following treatment with corticosteroids. Graft loss is defined as re-transplantation, nephrectomy, death or as dialysis ongoing at study end (or at withdrawal of the participants from the study).

BMI is a statistical measurement which compares a person's weight and height. Though it does not actually measure the percentage of body fat, it is used to estimate a healthy body weight based on participant's height. BMI is equal to weight divided by height square. Weight is measured in Kilogram and height is measured in meter.

Bone mineral density is measured by Dual-Energy X-ray Absorptiometry (DEXA).

WHR is performed using a standard medical measuring tape, with recordings documented in centimeters. Measurements will be compared against data from participating sites (where available) and against baseline. Measurement of hip circumference will be performed at the widest part of the buttocks. Measurement of the waist will be performed at the smaller circumference of the natural waist (usually just superior to the umbilicus). WHR is calculated by dividing the waist measurement by the hip measurement, and recorded to 2 decimal places.

Body fat will be assessed by DEXA scan.

Body composition lean mass and bone mass will be assessed by DEXA scan.

Body composition: T score (Full body) and Z score (full body) will be assessed by DEXA scan.

Measurement of blood pressure will be performed by using a completely automated device consisting of an inflatable cuff and oscillatory detection system. Blood pressure will be taken supine, after 5 minutes of rest.

In lipid profile total cholesterol, high-density lipoprotein (HDL) - cholesterol, low-density lipoprotein (LDL) - cholesterol and triglycerides levels will be evaluated. Measurement of the lipid profile will be performed in fasted state.

Measurement of the change in HbA1c will be performed in fasted state and in local laboratories.

The eGFR is calculated by Modification of Diet in Renal Disease (MDRD) equation is recommended by Kidney Health Australia as the calculation of choice for predicting GFR. According to MDRD equation eGFR is equal to 186*(Serum creatinine/0.095)^-1.154*age^0.203*race*sex, where the unit of serum creatinine is micro mole per L, the age is in years; race is 1.212 if African American, or 1 otherwise; and sex equals 1 if male, and 0.742 if female. eGFR will be compared against baseline.

This SF-36 standardize survey evaluates participants health by 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as Physical Component Scores (PCS) and Mental Component Scores (MCS). The score for a section is an average of the individual question scores, which are scaled 0 to 100, Higher score indicates highest level of functioning.

AAS is used for physical activity surveillance and it consists of following categories: 'sedentary' - people who are doing no activity at all; 'sufficiently active'- participation in at least 150 minutes per week; 'insufficiently active'- the remainder participants whose participation is not enough to obtain a health benefit.

Compliance with dietary advice will be measured on a categorical scale ranging from 0=no compliance to 10=full compliance. Compliance with exercise program is measured as the completion of 3 exercise sessions per week for the 6-month period.