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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00492661
Registration number
NCT00492661
Ethics application status
Date submitted
25/06/2007
Date registered
27/06/2007
Date last updated
27/05/2013
Titles & IDs
Public title
A Pilot Trial to Evaluate the Effect of Diet and Exercise in Renal Transplant Recipients on Tacrolimus
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Scientific 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)
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Secondary ID [1]
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OTH/506TRA4004
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Secondary ID [2]
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CR013702
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Universal Trial Number (UTN)
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Trial acronym
PRIDE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Renal Transplantion
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Kidney Transplantion
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tacrolimus With Diet and Exercise Intervention
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.
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Insulin Resistance
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Assessment method [1]
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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.
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Timepoint [1]
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Week 24
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Secondary outcome [1]
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Percentage of Participants With Impaired Fasting Glycaemia (IFG)
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Assessment method [1]
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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.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Percentage of Participants With Impaired Glucose Tolerance (IGT)
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Assessment method [2]
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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.
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Timepoint [2]
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Week 24
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Secondary outcome [3]
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Percentage of Participants With Diabetes Mellitus (DM)
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Assessment method [3]
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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.
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Timepoint [3]
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Week 24
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Secondary outcome [4]
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Beta Cell Function
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Assessment method [4]
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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).
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Timepoint [4]
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Baseline, Week 4, Week 12, and Week 24
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Secondary outcome [5]
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Number of Participants With Acute Rejection, Graft Loss and Death
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Assessment method [5]
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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).
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Timepoint [5]
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Week 24
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Secondary outcome [6]
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Body Mass Index (BMI)
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline, Week 4, Week 12 and Week 24
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Secondary outcome [7]
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Bone Mineral Density
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Assessment method [7]
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Bone mineral density is measured by Dual-Energy X-ray Absorptiometry (DEXA).
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Timepoint [7]
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Baseline and Week 24
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Secondary outcome [8]
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Waist to Hip Ratio (WHR)
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline, Week 4, Week 12 and Week 24
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Secondary outcome [9]
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Body Composition: Percent Body Fat
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Assessment method [9]
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Body fat will be assessed by DEXA scan.
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Timepoint [9]
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Baseline and Week 24
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Secondary outcome [10]
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Body Composition: Lean Mass, Bone Mass and Adjusted Weight
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Assessment method [10]
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Body composition lean mass and bone mass will be assessed by DEXA scan.
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Timepoint [10]
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Baseline and Week 24
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Secondary outcome [11]
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Body Composition: T Score (Full Body) and Z Score (Full Body)
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Assessment method [11]
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Body composition: T score (Full body) and Z score (full body) will be assessed by DEXA scan.
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Timepoint [11]
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Baseline and Week 24
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Secondary outcome [12]
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Blood Pressure: Systolic and Diastolic Pressure
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline, Week 4, Week 12 and Week 24
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Secondary outcome [13]
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Lipid Profile
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline, Week 4, Week 12, and Week 24
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Secondary outcome [14]
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Hemoglobin A, Glycosylated (HbA1c)
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Assessment method [14]
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Measurement of the change in HbA1c will be performed in fasted state and in local laboratories.
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Timepoint [14]
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Baseline, Week 4, Week 12 and Week 24
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Secondary outcome [15]
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Estimated Glomerular Filtration Rate (eGFR)
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Assessment method [15]
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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.
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Timepoint [15]
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Baseline, Week 4, Week 12 and Week 24
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Secondary outcome [16]
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36-Item Short-Form (SF-36) Score - Health Survey
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Assessment method [16]
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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.
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Timepoint [16]
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Baseline, Week 12 and Week 24
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Secondary outcome [17]
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Percentage of Participants who will be Sedentary, Insufficiently Active and Sufficiently Active According to Active Australia Survey (AAS)
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Assessment method [17]
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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.
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Timepoint [17]
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Week 4, Week 12 and Week 24
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Secondary outcome [18]
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Percentage of Participants Compliant With Both Dietary Advice and Exercise Program and Non-Compliant With Dietary Advice or Exercise Program
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Assessment method [18]
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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.
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Timepoint [18]
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Week 4, Week 12 and Week 24
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Eligibility
Key inclusion criteria
- Participants who has sufficiently recovered from surgery to tolerate an intensive
exercise evaluation
- Participants who have received a living-donor or cadaveric (from dead donor) renal
transplant
- Participants who has been initiated tacrolimus as first-line immunosuppressive agent
- Participants who has given informed consent forms
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants with significant disease or disability that prevents taking part in a
diet or exercise regime (e.g. cardiac instability, including unstable angina [chest
pain due to decreased oxygen being supplied to the heart] and/or other unstable
disease, severe cognitive [mental functioning] impairment)
- Participants with significant post-surgical complications that prevent participation
in the exercise component of the study (e.g. wound dehiscence [pathologic process
consisting of a partial or complete disruption of the layers of a surgical wound] or
infection)
- Participants with 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)
- Participants with non-ambulatory (mobility) status
- Participants who require ongoing systemic immunosuppressive therapy for an indication
other than renal transplant and this therapy is higher than that required for their
kidney disease
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Study design
Purpose of the study
Prevention
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2010
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Sample size
Target
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Accrual to date
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Final
55
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Camperdown N/A
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Recruitment hospital [2]
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- Camperdown
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Recruitment hospital [3]
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- Clayton
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Recruitment hospital [4]
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- Perth
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Recruitment hospital [5]
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- Woodville
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Recruitment postcode(s) [1]
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- Camperdown N/A
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Recruitment postcode(s) [2]
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- Camperdown
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Recruitment postcode(s) [3]
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- Clayton
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Recruitment postcode(s) [4]
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- Perth
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Recruitment postcode(s) [5]
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- Woodville
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen-Cilag Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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
renal (kidney) transplant recipients on tacrolimus.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00492661
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen-Cilag Pty Ltd Clinical Trial
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Address
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Janssen-Cilag Pty Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00492661
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