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Tracking Information | |||||
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First Received Date † | June 25, 2007 | ||||
Last Updated Date | April 30, 2009 | ||||
Start Date † | July 2007 | ||||
Current Primary Outcome Measures † |
Proportion of patients with insulin resistance, as defined by a homeostasis model assessment (HOMA-IR) of >1 at 6 months. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00492661 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Proportion of patients with composite endpoint of impaired fasting glycaemia (IFG) /impaired glucose tolerance (IGT) /diabetes mellitus (DM) at 6 months. | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | PRIDE - Prograf Investigation of Diet and Exercise. A Pilot Trial of the Effect of Dietary and Exercise Intervention in Patients Who Have Received a Renal Transplant on Tacrolimus (Prograf®) | ||||
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) | ||||
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 kidney transplant recipients on tacrolimus. |
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Detailed Description | This study will investigate the effect of a supervised diet and exercise program on the risk of developing diabetes and other related conditions after kidney transplantation. The exercise and diet intervention will include a 6-month program of weight lifting exercises (progressive resistance training) which will be completed three times each week and individualised dietary advice from a qualified dietician. Diabetes is very common following transplantation, developing in up to one-third of kidney transplant recipients. The development of diabetes requires treatment and places those affected at an increased risk of other complications including reduced transplant survival. This is a prospective (subjects are identified and then followed forward in time), single-arm, multicentre, interventional pilot study of the effects of a combined dietary and exercise intervention on glucose metabolism. The subject population includes kidney transplant recipients who have been assigned a tacrolimus-based immunosuppression regimen. The study will include the following evaluations of safety and tolerability; adverse events will be reported by the patient for the duration of the study, a physical examination will be completed by the investigator at each study visit, laboratory investigations and an ECG will be performed at each study visit. |
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Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † |
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Intervention † | Drug: FK506 Prograf (tacrolimus) with diet and exercise intervention. | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 60 | ||||
Completion Date | |||||
Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | Australia | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00492661 | ||||
Responsible Party | Executive Director, Medical & Scientific Affairs, Janssen-Cilag Pty Ltd | ||||
Secondary IDs †† | |||||
Study Sponsor † | Janssen-Cilag Pty Ltd | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Janssen-Cilag Pty Ltd | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |