A Pilot Trial to Evaluate the Effect of Diet and Exercise in Renal Transplant Recipients on Tacrolimus (PRIDE)
|ClinicalTrials.gov Identifier: NCT00492661|
Recruitment Status : Completed
First Posted : June 27, 2007
Last Update Posted : May 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplantion Kidney Transplantion||Drug: Tacrolimus With Diet and Exercise Intervention||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||July 2007|
|Primary Completion Date :||June 2010|
|Study Completion Date :||June 2010|
Experimental: Tacrolimus With Diet and Exercise Intervention
Participants on tacrolimus for immunosuppression (drug which suppresses the body's immune response, used in transplantation and diseases caused by disordered immunity) will be provided with intensive dietary advice and supervised progressive resistance training (PRT) for a period of 6 months. Dosage and administration of tacrolimus will be as per Investigator's discretion.
Drug: Tacrolimus With Diet and Exercise Intervention
Participants on tacrolimus for immunosuppression will be provided with intensive dietary advice and supervised for a period of 6 months. Dosage and administration of tacrolimus will be as per Investigator's discretion.
Other Name: Prograf
- Percentage of Participants With Insulin Resistance [ Time Frame: Week 24 ]Percentage of participants with insulin resistance as defined by a Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) greater than 1. HOMA uses fasting glucose and insulin (or C-peptide) to assess beta-cell function and IR. HOMA-IR is used to estimate insulin resistance. HOMA-IR is calculated by equation: HOMA-IR=fasting plasma insulin (milliunit [mU] per liter [L]) * fasting plasma glucose (millimole per liter [mmol per L]) divided by 22.5.
- Percentage of Participants With Impaired Fasting Glycaemia (IFG) [ Time Frame: Week 24 ]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.
- Percentage of Participants With Impaired Glucose Tolerance (IGT) [ Time Frame: Week 24 ]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.
- Percentage of Participants With Diabetes Mellitus (DM) [ Time Frame: Week 24 ]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.
- Beta Cell Function [ Time Frame: Baseline, Week 4, Week 12, and Week 24 ]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).
- Number of Participants With Acute Rejection, Graft Loss and Death [ Time Frame: Week 24 ]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).
- Body Mass Index (BMI) [ Time Frame: Baseline, Week 4, Week 12 and Week 24 ]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 [ Time Frame: Baseline and Week 24 ]Bone mineral density is measured by Dual-Energy X-ray Absorptiometry (DEXA).
- Waist to Hip Ratio (WHR) [ Time Frame: Baseline, Week 4, Week 12 and Week 24 ]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 Composition: Percent Body Fat [ Time Frame: Baseline and Week 24 ]Body fat will be assessed by DEXA scan.
- Body Composition: Lean Mass, Bone Mass and Adjusted Weight [ Time Frame: Baseline and Week 24 ]Body composition lean mass and bone mass will be assessed by DEXA scan.
- Body Composition: T Score (Full Body) and Z Score (Full Body) [ Time Frame: Baseline and Week 24 ]Body composition: T score (Full body) and Z score (full body) will be assessed by DEXA scan.
- Blood Pressure: Systolic and Diastolic Pressure [ Time Frame: Baseline, Week 4, Week 12 and Week 24 ]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.
- Lipid Profile [ Time Frame: Baseline, Week 4, Week 12, and Week 24 ]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.
- Hemoglobin A, Glycosylated (HbA1c) [ Time Frame: Baseline, Week 4, Week 12 and Week 24 ]Measurement of the change in HbA1c will be performed in fasted state and in local laboratories.
- Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Baseline, Week 4, Week 12 and Week 24 ]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.
- 36-Item Short-Form (SF-36) Score - Health Survey [ Time Frame: Baseline, Week 12 and Week 24 ]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.
- Percentage of Participants who will be Sedentary, Insufficiently Active and Sufficiently Active According to Active Australia Survey (AAS) [ Time Frame: Week 4, Week 12 and Week 24 ]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.
- Percentage of Participants Compliant With Both Dietary Advice and Exercise Program and Non-Compliant With Dietary Advice or Exercise Program [ Time Frame: Week 4, Week 12 and Week 24 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492661
|Camperdown N/A, Australia|
|Study Director:||Janssen-Cilag Pty Ltd Clinical Trial||Janssen-Cilag Pty Ltd|