Reversing Glucose and Lipid-mediated Vascular Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dextrose 20 % in 500 ML Injection, Intralipid, Saline, Ascorbic acid.
- Who it may be relevant to
- Registry conditions: Blood Pressure, Hypertension. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Reversing Glucose and Lipid-mediated Vascular Dysfunction (REGAL)
Overview
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.
Detailed description
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.
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 lipoprot - 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
Primary outcome measures
- 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]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Kansas Medical Center — Kansas City
Identifiers
NCT: NCT04832009 · 00147066