Glucose and Fat Impact on Vascular Health

(REGAL Trial)

Overseen By Seth W Holwerda, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Kansas Medical Center

Must not be taking: Vitamin C, Vitamin E, Omega-3

Disqualifiers: Diabetes, Smoking, Hyperlipidemia, Hypertension, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 visits

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Seth W. W Holwerda, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are not considered "lean," with a BMI (body mass index) below 25 kg/m

Your body processes insulin and sugar normally, as determined by specific blood tests.

Your blood pressure should be lower than 140 over 90.

Exclusion Criteria

You are currently smoking or have smoked in the past 3 months.

Your blood triglyceride levels should be less than 250 mg/dL after fasting.

Your blood pressure is higher than 130/80 mmHg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive I.V. glucose or lipid infusion with ascorbic acid or placebo

2 visits

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ascorbic acid
• Dextrose 20 % in 500 ML Injection
• Intralipid
• Saline

Trial Overview 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.

How Is the Trial Designed?

Group I: Lipid Infusion Experimental Treatment 3 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 Infusion Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+