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Reversing Glucose and Lipid-mediated Vascular Dysfunction

Early Phase 1
Recruiting
Conditions
Hypertension
Blood Pressure
Interventions
Drug: Dextrose 20 % in 500 ML Injection
Drug: Saline
Registration Number
NCT04832009
Lead Sponsor
University of Kansas Medical Center
Brief 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.

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
46
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Glucose InfusionSalineHyperglycemia (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.
Glucose InfusionDextrose 20 % in 500 ML InjectionHyperglycemia (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 InfusionSalineHyperlipidemia (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.
Glucose InfusionAscorbic 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 InfusionIntralipidHyperlipidemia (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.
Lipid InfusionAscorbic 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.
Primary Outcome Measures
NameTimeMethod
Efficacy of Infusion of Ascorbic Acid120 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Kansas Medical Center

🇺🇸

Kansas City, Kansas, United States

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