A Pilot Trial to Evaluate the Effect of Diet and Exercise in Renal Transplant Recipients on Tacrolimus

NCT00492661 | Completed Phase 4

• 2 other identifiers: CR013702OTH/506TRA4004
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 4

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.

Conditions

Renal Transplantion; Kidney Transplantion

Keywords

Tacrolimus; Prograf; PRIDE

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Insulin Resistance

  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.

  Week 24

Secondary Outcomes (18)

• Percentage of Participants With Impaired Fasting Glycaemia (IFG)

  Week 24

• Percentage of Participants With Impaired Glucose Tolerance (IGT)

  Week 24

• Percentage of Participants With Diabetes Mellitus (DM)

  Week 24

• Beta Cell Function

  Baseline, Week 4, Week 12, and Week 24

• Number of Participants With Acute Rejection, Graft Loss and Death

  Week 24

Study Arms (1)

Tacrolimus With Diet and Exercise Intervention

EXPERIMENTAL

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.

Drug: Tacrolimus With Diet and Exercise Intervention

Interventions

Tacrolimus With Diet and Exercise Intervention DRUG

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.

Also known as: Prograf

Tacrolimus With Diet and Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Pty Ltd: lead

Study Sites (4)

Unknown Facility

Camperdown, Australia

Location

Unknown Facility

Clayton, Australia

Location

Unknown Facility

Perth, Australia

Location

Unknown Facility

Woodville, Australia

Location

Related Links

• 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)

MeSH Terms

Interventions

Tacrolimus; Diet

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Janssen-Cilag Pty Ltd Clinical Trial

  Janssen-Cilag Pty Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 27, 2007
• Study Start: July 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 27, 2013

Record last verified: 2013-05

Locations

AU (4)