- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00492661
A Pilot Trial to Evaluate the Effect of Diet and Exercise in Renal Transplant Recipients on Tacrolimus (PRIDE)
May 24, 2013 updated by: Janssen-Cilag Pty Ltd
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), single-arm, multi-center (conducted in more than 1 center), interventional pilot study of the effects of a combined dietary and exercise intervention on glucose metabolism.
The duration of this study will be 6 months and will include following visits: Baseline, Week 4, Week 12, and Week 24.
Dietary compliance will be evaluated with a 3-day food record and during weekly telephone conversations and face-to-face visits with a dietician.
Exercise compliance will be measured using an exercise log presented to the co-ordinator at the end of each month.
Primarily, participants with insulin resistance will be assessed by Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) of greater than 1 at 6 months.
Participants' safety and tolerability will be monitored throughout the study.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Camperdown, Australia
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Camperdown N/A, Australia
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Clayton, Australia
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Perth, Australia
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Woodville, Australia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Insulin Resistance
Time Frame: Week 24
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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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Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Impaired Fasting Glycaemia (IFG)
Time Frame: Week 24
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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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Week 24
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Percentage of Participants With Impaired Glucose Tolerance (IGT)
Time Frame: Week 24
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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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Week 24
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Percentage of Participants With Diabetes Mellitus (DM)
Time Frame: Week 24
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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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Week 24
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Beta Cell Function
Time Frame: Baseline, Week 4, Week 12, and Week 24
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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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Baseline, Week 4, Week 12, and Week 24
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Number of Participants With Acute Rejection, Graft Loss and Death
Time Frame: Week 24
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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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Week 24
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Body Mass Index (BMI)
Time Frame: Baseline, Week 4, Week 12 and Week 24
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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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Baseline, Week 4, Week 12 and Week 24
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Bone Mineral Density
Time Frame: Baseline and Week 24
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Bone mineral density is measured by Dual-Energy X-ray Absorptiometry (DEXA).
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Baseline and Week 24
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Waist to Hip Ratio (WHR)
Time Frame: Baseline, Week 4, Week 12 and Week 24
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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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Baseline, Week 4, Week 12 and Week 24
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Body Composition: Percent Body Fat
Time Frame: Baseline and Week 24
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Body fat will be assessed by DEXA scan.
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Baseline and Week 24
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Body Composition: Lean Mass, Bone Mass and Adjusted Weight
Time Frame: Baseline and Week 24
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Body composition lean mass and bone mass will be assessed by DEXA scan.
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Baseline and Week 24
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Body Composition: T Score (Full Body) and Z Score (Full Body)
Time Frame: Baseline and Week 24
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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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Baseline and Week 24
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Blood Pressure: Systolic and Diastolic Pressure
Time Frame: Baseline, Week 4, Week 12 and Week 24
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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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Baseline, Week 4, Week 12 and Week 24
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Lipid Profile
Time Frame: Baseline, Week 4, Week 12, and Week 24
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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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Baseline, Week 4, Week 12, and Week 24
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Hemoglobin A, Glycosylated (HbA1c)
Time Frame: Baseline, Week 4, Week 12 and Week 24
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Measurement of the change in HbA1c will be performed in fasted state and in local laboratories.
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Baseline, Week 4, Week 12 and Week 24
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Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline, Week 4, Week 12 and Week 24
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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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Baseline, Week 4, Week 12 and Week 24
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36-Item Short-Form (SF-36) Score - Health Survey
Time Frame: Baseline, Week 12 and Week 24
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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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Baseline, Week 12 and Week 24
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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
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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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Week 4, Week 12 and Week 24
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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
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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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Week 4, Week 12 and Week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (ACTUAL)
June 1, 2010
Study Completion (ACTUAL)
June 1, 2010
Study Registration Dates
First Submitted
June 25, 2007
First Submitted That Met QC Criteria
June 25, 2007
First Posted (ESTIMATE)
June 27, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
May 27, 2013
Last Update Submitted That Met QC Criteria
May 24, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR013702
- OTH/506TRA4004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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