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Sponsored by: |
Janssen-Cilag Pty Ltd |
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Information provided by: | Janssen-Cilag Pty Ltd |
ClinicalTrials.gov Identifier: | NCT00492661 |
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.
Condition | Intervention | Phase |
---|---|---|
Renal Transplantation Transplantation, Renal Grafting, Kidney Transplantation, Kidney |
Drug: FK506 Prograf (tacrolimus) with diet and exercise intervention. |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 60 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Australia | |
Recruiting | |
Woodville, Australia, 5011 | |
Recruiting | |
Perth, Australia, 6001 | |
Recruiting | |
Camperdown N/A, Australia, 2050 | |
Recruiting | |
Clayton, Australia, 3168 |
Study Director: | Janssen-Cilag Pty Ltd Clinical Trial | Janssen-Cilag Pty Ltd |
Responsible Party: | Janssen-Cilag Pty Ltd ( Executive Director, Medical & Scientific Affairs ) |
Study ID Numbers: | CR013702 |
Study First Received: | June 25, 2007 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00492661 History of Changes |
Health Authority: | Australia: Department of Health |
weight lifting, resistance training. insulin resistance syndrome X tacrolimus Prograf Renal transplantation |
Body Weight Hyperinsulinism Metabolic Diseases Metabolic Syndrome X Immunologic Factors Tacrolimus |
Insulin Resistance Glucose Metabolism Disorders Immunosuppressive Agents Metabolic Disorder Insulin Abdominal Obesity Metabolic Syndrome |
Hyperinsulinism Metabolic Diseases Immunologic Factors Physiological Effects of Drugs Tacrolimus |
Insulin Resistance Glucose Metabolism Disorders Immunosuppressive Agents Pharmacologic Actions |