Clinical trial NCT04832009: Reversing Glucose and Lipid-mediated Vascular Dysfunction
Official title: Reversing Glucose and Lipid-mediated Vascular Dysfunction (REGAL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Blood Pressure
Hypertension
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparisons of outcome variables will be made using a mixed model ANOVA.
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Efficacy of Infusion of Ascorbic Acid
timeFrame: Baseline
measure: Efficacy of Infusion of Ascorbic Acid
timeFrame: 30 minutes
measure: Efficacy of Infusion of Ascorbic Acid
timeFrame: 60 minutes
measure: Efficacy of Infusion of Ascorbic Acid
timeFrame: 90 minutes
measure: Efficacy of Infusion of Ascorbic Acid
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Seth W. W Holwerda, PhD
role: PRINCIPAL_INVESTIGATOR
References: