Reversing Glucose and Lipid-mediated Vascular Dysfunction

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

May 9, 2022

Primary Completion Date

August 1, 2026

Study Completion Date

August 1, 2027

Conditions
Blood PressureHypertension
Interventions
DRUG

Dextrose 20 % in 500 ML Injection

Dextrose (20% intravenous solution) will be obtained from the Investigational Pharmacy located in the KU Clinical Research Center where studies take place. After fasting for at least 8 hours, dextrose will be administered via antecubital vein at a standard rate of 4 mg/kg/min for 2 hours.

DRUG

Intralipid

Intralipid ® 20% will be obtained from the Investigational Pharmacy located in the KU Clinical Research Center where studies take place. After fasting for at least 8 hours, Intralipid ® 20% will be administered via antecubital vein at 0.75 mL/min for 2 hours Increases in circulating markers of oxidative stress peak within 2 hours of Intralipid ® 20% infusion in healthy adults (42). An initial heparin bolus of 1000 UL followed by 200 U/hr infusion will be included to activate endothelial lipoprotein lipase and accelerate hydrolysis of fatty acids.

DRUG

Saline

Saline will be obtained from the Investigational Pharmacy located in the KU Clinical Research Center where studies take place. Will be administered via antecubital vein at 75 to 150 mL/hour for 2 hours.

DRUG

Ascorbic acid

"(ASCOR) will be obtained from the KU Investigational Pharmacy located in the KU Clinical Research Center where studies will take place. A priming bolus of 0.06 g ascorbic acid/kg fat free mass (FFM) dissolved in 100 mL of saline will be infused intravenously at 5 mL/min for 20 minutes, followed immediately by a drip-infusion of 0.02 g/kg FFM dissolved in 30 mL of saline administered over 2 hours at 0.5 mL/min. The KU Investigational Pharmacy will randomize ascorbic acid or placebo (saline) for each participant."

Trial Locations (1)

66103

RECRUITING

University of Kansas Medical Center, Kansas City

All Listed Sponsors
lead

University of Kansas Medical Center

OTHER