Clinical trial NCT00492661: A Pilot Trial to Evaluate the Effect of Diet and Exercise in Renal Transplant Recipients on Tacrolimus
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantion
Kidney Transplantion
Keywords: Tacrolimus
Prograf
PRIDE
Lead sponsor: Janssen-Cilag Pty Ltd
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Percentage of Participants With Insulin Resistance
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With Impaired Fasting Glycaemia (IFG)
timeFrame: Week 24
measure: Percentage of Participants With Impaired Glucose Tolerance (IGT)
timeFrame: Week 24
measure: Percentage of Participants With Diabetes Mellitus (DM)
timeFrame: Week 24
measure: Beta Cell Function
timeFrame: Baseline, Week 4, Week 12, and Week 24
measure: Number of Participants With Acute Rejection, Graft Loss and Death
timeFrame: Week 24
measure: Body Mass Index (BMI)
timeFrame: Baseline, Week 4, Week 12 and Week 24
measure: Bone Mineral Density
timeFrame: Baseline and Week 24
measure: Waist to Hip Ratio (WHR)
timeFrame: Baseline, Week 4, Week 12 and Week 24
measure: Body Composition: Percent Body Fat
timeFrame: Baseline and Week 24
measure: Body Composition: Lean Mass, Bone Mass and Adjusted Weight
timeFrame: Baseline and Week 24
measure: Body Composition: T Score (Full Body) and Z Score (Full Body)
timeFrame: Baseline and Week 24
measure: Blood Pressure: Systolic and Diastolic Pressure
timeFrame: Baseline, Week 4, Week 12 and Week 24
measure: Lipid Profile
timeFrame: Baseline, Week 4, Week 12, and Week 24
measure: Hemoglobin A, Glycosylated (HbA1c)
timeFrame: Baseline, Week 4, Week 12 and Week 24
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline, Week 4, Week 12 and Week 24
measure: 36-Item Short-Form (SF-36) Score - Health Survey
timeFrame: Baseline, Week 12 and Week 24
measure: Percentage of Participants who will be Sedentary, Insufficiently Active and Sufficiently Active According to Active Australia Survey (AAS)
timeFrame: Week 4, Week 12 and Week 24
measure: Percentage of Participants Compliant With Both Dietary Advice and Exercise Program and Non-Compliant With Dietary Advice or Exercise Program
timeFrame: Week 4, Week 12 and Week 24
Other outcomes:
Locations:
city: Camperdown N/A
country: Australia
city: Camperdown
country: Australia
city: Clayton
country: Australia
city: Perth
country: Australia
city: Woodville
country: Australia
Study officials:
affiliation: Janssen-Cilag Pty Ltd
name: Janssen-Cilag Pty Ltd Clinical Trial
role: STUDY_DIRECTOR
References: