A Pilot Trial to Evaluate the Effect of Diet and Exercise in Renal Transplant Recipients on Tacrolimus
Information source: Janssen-Cilag Pty Ltd
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Transplantion; Kidney Transplantion
Intervention: Tacrolimus With Diet and Exercise Intervention (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen-Cilag Pty Ltd Official(s) and/or principal investigator(s): Janssen-Cilag Pty Ltd Clinical Trial, Study Director, Affiliation: Janssen-Cilag Pty Ltd
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.
Clinical Details
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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Percentage of Participants With Insulin Resistance
Secondary outcome: Percentage of Participants With Impaired Fasting Glycaemia (IFG)Percentage of Participants With Impaired Glucose Tolerance (IGT) Percentage of Participants With Diabetes Mellitus (DM) Beta Cell Function Number of Participants With Acute Rejection, Graft Loss and Death Body Mass Index (BMI) Bone Mineral Density Waist to Hip Ratio (WHR) Body Composition: Percent Body Fat Body Composition: Lean Mass, Bone Mass and Adjusted Weight Body Composition: T Score (Full Body) and Z Score (Full Body) Blood Pressure: Systolic and Diastolic Pressure Lipid Profile Hemoglobin A, Glycosylated (HbA1c) Estimated Glomerular Filtration Rate (eGFR) 36-Item Short-Form (SF-36) Score - Health Survey Percentage of Participants who will be Sedentary, Insufficiently Active and Sufficiently Active According to Active Australia Survey (AAS) Percentage of Participants Compliant With Both Dietary Advice and Exercise Program and Non-Compliant With Dietary Advice or Exercise Program
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Camperdown N/A, Australia
Camperdown, Australia
Clayton, Australia
Perth, Australia
Woodville, Australia
Additional Information
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)
Starting date: July 2007
Last updated: May 24, 2013
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