Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576531
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Exercise and Prediabetes After Renal Transplantation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exercise and Prediabetes After Renal Transplantation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXPRED-II
Brief Summary:
The present clinical trial EXPRED-II is the continuation of EXPRED-I NCT04489043
Objective to evaluate the feasibility of exercise in the reversibility of prediabetes after transplantation as a first step to prevent Post-Transplant Diabetes Mellitus PTDM
Methodology a total of 50 patients with prediabetes beyond 12 months after transplantation with capacity to perform exercise will be randomized to standard life-style recommendations as per clinical practice n25 or to a stepped ad-hoc designed training intervention n25 Prediabetes will be diagnosed based on fasting glucose levels and an Oral Glucose Tolerance Test OGTT Patients randomized to exercise will start with aerobic exercise training 5 timesweek 30 minday for 12 months which may be gradually increased to 60 minday or combined with strength exercise in the last increment in case of prediabetes persistence The reversibilitypersistencerelapse of prediabetes will be measured with fasting glucose and OGTT every 3 months The study will last 12 months
Objective to evaluate the feasibility of exercise in the reversibility of prediabetes after transplantation as a first step to prevent Post-Transplant Diabetes Mellitus PTDM
Methodology a total of 50 patients with prediabetes beyond 12 months after transplantation with capacity to perform exercise will be randomized to standard life-style recommendations as per clinical practice n25 or to a stepped ad-hoc designed training intervention n25 Prediabetes will be diagnosed based on fasting glucose levels and an Oral Glucose Tolerance Test OGTT Patients randomized to exercise will start with aerobic exercise training 5 timesweek 30 minday for 12 months which may be gradually increased to 60 minday or combined with strength exercise in the last increment in case of prediabetes persistence The reversibilitypersistencerelapse of prediabetes will be measured with fasting glucose and OGTT every 3 months The study will last 12 months
Detailed Description:
None
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