Recruiting
Early Phase 1

Observational Study

Sponsor:

University of Kansas Medical Center

Code:

NCT04832009

Conditions

Blood Pressure

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Dextrose 20 % in 500 ML Injection

Intralipid

Saline

Ascorbic acid

Study Details

Brief 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.

Conditions

Blood Pressure

Hypertension

Study ID

NCT04832009

Start date

May 9, 2022

Status verified date

Jun, 2025

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Glucose Infusion

Hyperglycemia (glucose infusion) will receive an I.V. Glucose infusion with a co-infusion of ascorbic acid or placebo at your visit 2 and the alternative treatment of ascorbic acid or placebo will be given on the subsequent study visit 3.

experimental: Lipid Infusion

Hyperlipidemia (lipid infusion) will receive an I.V. Lipid infusion with a co-infusion of ascorbic acid or placebo at your visit 2 and the alternative treatment of ascorbic acid or placebo will be given on the subsequent study visit 3.

Interventions

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.

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.

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.

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.

Primary outcome measure

  • Efficacy of Infusion of Ascorbic Acid [ Time Frame: Baseline ]
  • Efficacy of Infusion of Ascorbic Acid [ Time Frame: 30 minutes ]
  • Efficacy of Infusion of Ascorbic Acid [ Time Frame: 60 minutes ]
  • Efficacy of Infusion of Ascorbic Acid [ Time Frame: 90 minutes ]
  • Efficacy of Infusion of Ascorbic Acid [ Time Frame: 120 minutes ]

Central Contacts and Locations

Central contacts

Seth W Holwerda, PhD

9729223230sholwerda@kumc.edu

Davina A Clonch

9132266009shoggirl@gmail.com

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66103

Contacts

Seth W. W Holwerda

9729223230sholwerda@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Jun 5, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2025-06-05.