Viewing Study NCT06369350



Ignite Creation Date: 2024-05-06 @ 8:23 PM
Last Modification Date: 2024-10-26 @ 3:27 PM
Study NCT ID: NCT06369350
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-04-17
First Post: 2024-04-11

Brief Title: Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion
Sponsor: Milton S Hershey Medical Center
Organization: Milton S Hershey Medical Center

Study Overview

Official Title: Effects of Vitamin B6 on the Exercise Pressor Reflex in Lower Limb Ischemia-Reperfusion
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-04
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 study we are trying to see if vitamin B6 can minimize the amplified blood pressure response to exercise following ischemia-reperfusion injury We are interested in a protein called P2X3 of which function can be blocked by vitamin B6 in the neurons of our nervous system It is very important for blood pressure regulation We would like to see if the P2X3 plays a role in patients rising blood pressure during exercise The results of the proposed studies will provide a base for those two potential economic and non-invasive inventions to improve the overall health and well-being of PAD patients
Detailed Description: The Ischemia-reperfusion IR injury is caused by a burst of reactive oxygen species ROS production during reperfusion which leads to cell damage and inflammation and further exacerbates the underlying ischemic condition PAD patients endure this pathological condition during various situations of this disease In a hindlimb IR model the blood flow in the lower extremity of the plantar muscle and gastrocnemius muscle reduced at 6 h after the femoral artery ligation and gradually restores at 18 66 and 114 h after the blood flow reperfusion in the femoral artery Meanwhile the mean arterial pressure MAP responses to static muscle contraction increased in the above blood reperfusion time courses Examining the underlying mechanisms leading to the exaggerated EPR in the IR injury of PAD will be essential to provide a fundamental base for developing effective interventions to prevent or alleviate the PAD-associated symptoms and complications The P2X3 receptor in DRG is a potential candidate for regulating this exaggerated EPR in IR Vitamin B6 can function as a blockade for the P2 receptors Therefore we hypothesize it will attenuate the exaggerated exercise pressor reflex EPR in the experimental lower limb IR procedure on healthy human participants

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
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
940567 OTHER_GRANT American Heart Association None