RecruitingEarly Phase 1NCT04832009

Reversing Glucose and Lipid-mediated Vascular Dysfunction

Reversing Glucose and Lipid-mediated Vascular Dysfunction (REGAL)

Sponsor

University of Kansas Medical Center

Enrollment

46 participants

Start Date

May 9, 2022

Study Type

INTERVENTIONAL

Conditions

Hypertension Blood Pressure

Summary

The purpose of our study is to understand the extent to which the blood vessels are affected by glucose and fat (lipids) in lean healthy adults and if these changes in the blood vessels contribute to the development of high blood pressure.

Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how high blood sugar and high blood fat levels affect blood vessel function in healthy, lean adults without diabetes. Researchers want to understand the early mechanisms of blood vessel damage caused by diet, and whether antioxidants (vitamins C and E) can reverse this damage. **You may be eligible if...** - You are between 18 and 79 years old - You are lean (BMI below 25) - You have normal blood sugar and insulin sensitivity - Your blood pressure, cholesterol, and weight have been stable for the past 3 months - You are willing to stop taking vitamin C, vitamin E, or omega-3 supplements 2 weeks before the study **You may NOT be eligible if...** - You have diabetes (type 1 or type 2) - You are a current smoker or smoked in the last 3 months - You have high triglycerides, high blood pressure, or a history of heart disease - You are pregnant or breastfeeding - You are taking medications that could interfere with blood vessel measurements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDextrose 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.

DRUGIntralipid

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.

DRUGSaline

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.

DRUGAscorbic 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.