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Glucose Solution

Glucose and Fat Impact on Vascular Health (REGAL Trial)

Phase < 1
Recruiting
Led By Seth W. W Holwerda, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes
Awards & highlights

REGAL Trial Summary

This trial will help researchers understand how blood vessels are affected by glucose and fat in people without high blood pressure.

Who is the study for?
This trial is for lean, healthy adults aged 18-79 with normal insulin sensitivity and blood pressure below 140/90 mmHg. Participants should not have diabetes, a recent history of smoking, hyperlipidemia, hypertension or any cardiovascular diseases. They must be willing to stop taking vitamin C/E supplements and omega-3s two weeks prior.Check my eligibility
What is being tested?
The study investigates how glucose and fats affect blood vessels in the context of high blood pressure development. It involves administering Intralipid (a fat emulsion), Ascorbic acid (Vitamin C), Dextrose solution, and Saline to understand their impact on vascular function.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site due to Intralipid or irritation from Ascorbic acid. Dextrose can cause high blood sugar levels if not properly monitored while Saline is generally safe but may cause mild discomfort.

REGAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of Infusion of Ascorbic Acid

REGAL Trial Design

2Treatment groups
Experimental Treatment
Group I: Lipid InfusionExperimental Treatment3 Interventions
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.
Group II: Glucose InfusionExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ascorbic acid
2018
Completed Phase 4
~650
Intralipid
2013
Completed Phase 4
~1220
Saline
2013
Completed Phase 4
~1050

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
460 Previous Clinical Trials
169,069 Total Patients Enrolled
Seth W. W Holwerda, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Dextrose 20 % in 500 ML Injection (Glucose Solution) Clinical Trial Eligibility Overview. Trial Name: NCT04832009 — Phase < 1
High Blood Pressure Research Study Groups: Glucose Infusion, Lipid Infusion
High Blood Pressure Clinical Trial 2023: Dextrose 20 % in 500 ML Injection Highlights & Side Effects. Trial Name: NCT04832009 — Phase < 1
Dextrose 20 % in 500 ML Injection (Glucose Solution) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04832009 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation admit minors as participants?

"This medical trial has a participant age range of 18 to 79, in accordance with its pre-defined inclusion criteria."

Answered by AI

Is this investigation an original one?

"A search of current clinical trials shows that 72 studies are underway for Ascorbic acid in 43 countries and 397 cities. It was first tested in 2007; the Baxter Healthcare Corporation sponsored trial included 4640 patients, with Phase 4 drug approval being achieved. Since then, 704 tests have been completed."

Answered by AI

Does this clinical trial currently have vacancies?

"As indicated on clinicaltrials.gov, this research is presently enrolling suitable participants. The information was initially posted on May 9th 2022 and has been amended as of the same date."

Answered by AI

How many individuals are involved in this trial at present?

"Affirmative. Information hosted on clinicaltrials.gov confirms that this study is actively seeking participants, which was first published on May 9th 2022 and recently updated the same date. A total of 46 volunteers must be sourced from a single medical facility."

Answered by AI

Is it possible to become a participant in this clinical experiment?

"In order to be accepted, participants must have a diagnosis of hypertension and fall within the ages of 18-79. At present, 46 volunteers are needed for this research study."

Answered by AI

What advantages does ingesting Ascorbic acid provide?

"Catarrh, ascorbic acid deficiency, and vitamin insufficiency can be remedied through Ascorbic acid supplementation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Reversing Glucose and Lipid-mediated Vascular Dysfunction
Seth Holwerda PhD 2022. "Reversing Glucose and Lipid-mediated Vascular Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04832009.
~16 spots leftby Apr 2025
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