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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 minutes

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of Infusion of Ascorbic Acid

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1240