Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492661
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2007-06-25
Brief Title:
A Pilot Trial to Evaluate the Effect of Diet and Exercise in Renal Transplant Recipients on Tacrolimus
Sponsor:
Janssen-Cilag Pty Ltd
Organization:
Janssen-Cilag Pty Ltd
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIDE
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OTH506TRA4004 | None | None | None |