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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

Page last updated: August 23, 2015

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