Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184821
Status:
COMPLETED
Last Update Posted:
2007-04-05
First Post:
2005-09-09
Brief Title:
Ischemic Injury and Ischemic Preconditioning in Diabetes
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Acute Local Ischemic Preconditioning in Patients With Type 1 Diabetes in Vivo
Status:
COMPLETED
Status Verified Date:
2007-04
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:
None
Brief Summary:
In this proof-of-concept study forearm vulnerability to ischemic exercise is studied in patients with type 1 diabetes mellitus with and without prior ischemic preconditioning short period of ischemia that protects against subsequent ischemic exercise Annexin A5 scintigraphy is used to quantify subtle signs of mild and reversible forearm injury that results from ischemic exercise
The following hypotheses are tested
1 Patients with type 1 diabetes are not more vulnerable to ischemic injury as compared with previously studied healthy volunteers
2 Ischemic preconidtioning is still present in patients with type 1 diabetes Depending on the validity of hypothesis 2 the effect of short pharmacological interventions are studied on vulnerability to forearm ischemiareperfusion injury in the absence or presence of local forearm ischemic preconditioning
The following hypotheses are tested
1 Patients with type 1 diabetes are not more vulnerable to ischemic injury as compared with previously studied healthy volunteers
2 Ischemic preconidtioning is still present in patients with type 1 diabetes Depending on the validity of hypothesis 2 the effect of short pharmacological interventions are studied on vulnerability to forearm ischemiareperfusion injury in the absence or presence of local forearm ischemic preconditioning
Detailed Description:
All patients will be studied in supine position after an overnight fast while plasma glucose levels are monitored In the first 8 patients intravenous insulin is administered as needed to reach target glucose levels between 5-7 mmoll Patients will be subjected to 10 minutes of forearm ischemia non-dominant arm combined with handgripping at 50 of maximal force until exhaustion Upon reperfusion Tc-99m-HYNIC-Annexin A5 will be injected intravenously Targeting of annexin A5 to thenar muscle and forearm flexor muscle will be quantified as the percentage difference in radioactivity between experimental and control side This procedure will be performed twice randomized cross-over design with at least 2 week interval either with or without 10 minutes ischemia followed by 10 minutes of reperfusion prior to ischemic exercise
Depending on the results of this study substudies will be performed to study the effect of diazoxide K-ATP channel opener may mimic ischemic preconditioning glibenclamide K-ATP channel blocker may inhibit ischemic preconditioning or adenosine infusion into brachial artery of non-dominant arm as a substitute for ischemic preconditioning
Depending on the results of this study substudies will be performed to study the effect of diazoxide K-ATP channel opener may mimic ischemic preconditioning glibenclamide K-ATP channel blocker may inhibit ischemic preconditioning or adenosine infusion into brachial artery of non-dominant arm as a substitute for ischemic preconditioning
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 |
|---|---|---|---|
| 200411022 | None | None | None |