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NCT Number: NCT04832009

Reversing Glucose and Lipid-mediated Vascular Dysfunction

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.

Recruiting

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Key information

Conditions

Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

Location status: Recruiting

Location contact

Seth W. W Holwerda

CONTACT

[email protected]

9729223230

About this study

Hypertension, obesity, and insulin resistance are associated with elevated muscle sympathetic nerve activity (MSNA), which is important for blood pressure regulation. The measurement of MSNA is safely performed in humans using the microneurographic technique that involves recording sympathetic nerve activity projecting to skeletal muscle using a small microelectrode at the peroneal nerve near the knee.

The health of your blood vessels will be tested in this study, in addition to the activity of the nerves that control the blood vessels. The function of the nerves and blood vessels can be diminished by high blood glucose and lipids, and we will test the ability of a well-known antioxidant, ascorbic acid (vitamin C), to restore the function of the nerves and blood vessels.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lean: BMI < 25 kg/m
  • Normal insulin sensitivity: (calculation based on fasting glucose and insulin concentrations in blood)
  • Middle-aged: 18-79 years
  • Blood pressure: < 140 (systolic) and < 90 mmHg (diastolic
  • Weight stable (+/- 5 lbs) for the previous 3 months
  • Participants must be willing and able to discontinue taking any vitamin C or E supplements or omega-3 fatty acids beginning 2 weeks prior.
  • Able and willing to provide written informed consent

Exclusion criteria

  • Diabetes mellitus Type I or Type II: fasting glucose < 126 mg/dL and/or HbA1c < 6.5%
  • Current smoker or History of smoking in the past 3 months.
  • Hyperlipidemia: Fasting triglycerides < 250 mg/dL
  • Hypertension: >130/80 mmHg
  • History of heart disease (e.g., myocardial infarction, stent, heart attack, stroke, heart failure, valvular heart disease, cardiomyopathy)
  • History of vascular disease (e.g., bypass, stroke)

Treatment and study plan

Dextrose 20 % in 500 ML Injection

Drug

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.

Other names: Glucose

Intralipid

Drug

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.

Other names: Lipid

Saline

Drug

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.

Other names: Placebo

ascorbic acid

Drug

(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.

Primary outcomes

  1. Efficacy of Infusion of Ascorbic Acid

    Time frame: Baseline

    The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress.

  2. Efficacy of Infusion of Ascorbic Acid

    Time frame: 30 minutes

    The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress.

  3. Efficacy of Infusion of Ascorbic Acid

    Time frame: 60 minutes

    The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress.

  4. Efficacy of Infusion of Ascorbic Acid

    Time frame: 90 minutes

    The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress.

  5. Efficacy of Infusion of Ascorbic Acid

    Time frame: 120 minutes

    The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress.

Study contacts

Contact information is provided by the study sponsor or research team.

Davina A Clonch

CONTACT

[email protected]

9132266009

Seth W Holwerda, PhD

CONTACT

[email protected]

9729223230

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

Reversing Glucose and Lipid-mediated Vascular Dysfunction (REGAL)

Acronym: REGAL

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Apr 5, 2021
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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