Blood PressureEarly Phase 1REGALNCT04832009
Reversing Glucose and Lipid-mediated Vascular Dysfunction
A Early Phase 1 study testing Dextrose 20 % in 500 ML Injection, Intralipid and Saline in people with Blood Pressure and Hypertension, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Hypertension
- What is being tested?
- Dextrose 20 % in 500 ML Injection, Intralipid and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2022to 1 Aug 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66103
Seth W. W Holwerda, 9729223230, sholwerda@kumc.edu
About this study
Official title: Reversing Glucose and Lipid-mediated Vascular Dysfunction (REGAL)
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.
Read the 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.
- Conditions
- Blood Pressure, Hypertension
- Being tested
- Dextrose 20 % in 500 ML Injection, Intralipid, Saline, Ascorbic acid
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose 20 % in 500 ML InjectionDrug
Also called Glucose
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.
IntralipidDrug
Also called Lipid
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.
SalineDrug
Also called Placebo
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 acidDrug
(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.
| Study group | Role | What they receive |
|---|---|---|
| Glucose Infusion | Experimental | 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. Receives: Drug: Dextrose 20 % in 500 ML Injection; Drug: Saline; Drug: Ascorbic acid |
| Lipid Infusion | Experimental | 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. Receives: Drug: Intralipid; Drug: Saline; Drug: Ascorbic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Infusion of Ascorbic Acid
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.
Measured: Baseline
Efficacy of Infusion of Ascorbic Acid
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.
Measured: 30 minutes
Efficacy of Infusion of Ascorbic Acid
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.
Measured: 60 minutes
Efficacy of Infusion of Ascorbic Acid
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.
Measured: 90 minutes
Efficacy of Infusion of Ascorbic Acid
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.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start9 May 2022
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparisons of outcome variables will be made using a mixed model ANOVA.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Holwerda PhD, University of Kansas Medical Center
- Investigators
- Seth W. W Holwerda, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832009
- Sponsor's protocol ID
- 00147066
- Acronym
- REGAL
- Status last verified
- Jun 2025
- First submitted
- 31 Mar 2021
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller CG, Kovarik JC, Gangwish ME, Clonch DA, Bantis LE, Thyfault JP, Miles JM, Holwerda SW. Lipid Infusion Enhances Sympathetic Transduction via Redox-Sensitive Pathways. Hypertension. 2026 Aug 19:10.1161/HYPERTENSIONAHA.126.27191. doi: 10.1161/HYPERTENSIONAHA.126.27191. Online ahead of print.
PubMed 42615126
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversing Glucose and Lipid-mediated Vascular Dysfunction (REGAL)
- ClinicalTrials.gov ID
- NCT04832009
- Acronym / sponsor ID
- REGAL / 00147066
- Conditions
- Blood Pressure, Hypertension
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Comparisons of outcome variables will be made using a mixed model ANOVA.
| Arm | Type | Receives |
|---|---|---|
| Glucose Infusion | Experimental | Drug: Dextrose 20 % in 500 ML Injection, Drug: Saline, Drug: Ascorbic acidHyperglycemia (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. |
| Lipid Infusion | Experimental | Drug: Intralipid, Drug: Saline, Drug: Ascorbic acidHyperlipidemia (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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextrose 20 % in 500 ML InjectionAlso: GlucoseDextrose (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 | Glucose Infusion |
| IntralipidAlso: LipidIntralipid ® 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 | Lipid Infusion |
| SalineAlso: PlaceboSaline 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 | Glucose Infusion, Lipid Infusion |
| 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. | Drug | Glucose Infusion, Lipid Infusion |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Derived from this study: PubMed 42615126Miller CG, Kovarik JC, Gangwish ME, Clonch DA, Bantis LE, Thyfault JP, Miles JM, Holwerda SW. Lipid Infusion Enhances Sympathetic Transduction via Redox-Sensitive Pathways. Hypertension. 2026 Aug 19:10.1161/HYPERTENSIONAHA.126.27191. doi: 10.1161/HYPERTENSIONAHA.126.27191. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Blood Pressure
RecruitingObservational study
Philips Inflationary-Based Non-Invasive Blood Pressure Validation Study
Blood Pressure Measurement
RecruitingPhase 1
Understanding the Health Effect of a Bioactive Peptide From Egg: A Pilot Study
High Blood Sugar, High Blood Pressure
Recruiting
The Sleep2BWell Trial
Blood Pressure, Sleep Health
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Recruiting
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
Poor Sleep Quality, Gut Microbiome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seth W. W Holwerda, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dextrose 20 % in 500 ML Injection, Intralipid and Saline in people with Blood Pressure and Hypertension, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seth W Holwerda, PhD (9729223230, sholwerda@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Infusion of Ascorbic Acid (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04832009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025; AzTrials last refreshed its copy on 29 Oct 2026.