Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06626113
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Transduction of Sympathetic Neural Activity in Human Obesity Without Hypertension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Concomitantly Higher Resting Arterial Blood Pressure and Transduction of Sympathetic Neural Activity in Human Obesity Without Hypertension
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
In addition to chronically elevated MSNA there is a growing recognition that hypertension in states of insulin resistance and obesity may also be attributed to an increased vascular sensitivity to MSNA 1 2 13 36-38 To study this phenomenon we quantify vascular sensitivity to MSNA using an innovative moment-to-moment assessment of the blood pressure response following individual bursts of muscle sympathetic nerve activity MSNA 10 11 34 37 This approach is termed sympathetic-vascular transduction SVT We will examine the hypothesis that SVT is exaggerated in obesity and insulin resistance and is attenuated by suppression of oxidative stress Oxidative stress is the overabundance of reactive oxygen species and is another hallmark of hypertension obesity and insulin resistance Oxidative stress can be safely reduced via intravenous infusion of ascorbic acid Vit C 4 28 Therefore we will use a randomized double-blinded placebo-controlled approach to test the hypothesis that elevated SVT will be attenuated by suppression of oxidative stress via ascorbic acid IV infusion compared with saline IV infusion placebo in obese adults with insulin resistance Our study will identify a unique mechanism that can be targeted to reduce the excessively high prevalence of hypertension and risk for CVD in obesity and insulin resistance
Detailed Description:
This is a randomized double blind placebo-controlled study Eligible participants will have a total of 3 visits to the laboratory At the first experimental visit individuals will be randomized in a double-blind fashion to either ascorbic acid or placebo and the alternative treatment will be given on the subsequent study visit The KU Investigational Pharmacy will perform the blinded randomization
1 Week 1 Visit 1 Screening
2 Week 2 Visit 2 Randomization and Experimental visit
3 Week 5 Visit 3 Experimental visit
1 Week 1 Visit 1 Screening
2 Week 2 Visit 2 Randomization and Experimental visit
3 Week 5 Visit 3 Experimental visit
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