TrialGlobe

Clinical trial

Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)

Recruiting now · Phase 1, Phase 2 · 1 countries · Registry ID NCT04715022

Recruiting nowPhase 1, Phase 2Interventional

What this study is about

The main purpose of research is to examine and understanding the development of hypertension in obese adults with insulin resistance. Findings from our studies will identify unique mechanisms that can be targeted to limit increases in vascular dysfunction and reduce the excessively high prevalence of hypertension and risk for cardiovascular disease (CVD). This study is testing the health of the blood vessels and the activity of the nerves that control the blood vessels in adults with insulin resistance. The extent to which ascorbic acid (Vitamin C) improves the function of the blood vessels will be determined. The primary outcome is blood pressure, which is the result of blood vessel health and activity of the nerves, and the reduction in blood pressure that is observed with ascorbic acid.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age35 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionHypertension, Cardiovascular Diseases

Full registry criteria

Inclusion Criteria: 1. Obese: BMI \>30 m/kg2 2. Middle-aged: 35-65 years 3. Participants must be willing and able to discontinue taking any vitamin C or E supplements or omega-3 fatty acids beginning 2 weeks prior. 4. Able and willing to provide written informed consent Exclusion Criteria: 1. Diabetes mellitus: fasting glucose \< 1267 mg/dL and/or HbA1c \< 6.5% 2. Currently taking a statin or antihypertension medication 3. Hyperlipidemia: Fasting triglycerides \< 250 mg/dL 4. Hypertension: \<130/80 mmHg 5. History of heart disease (e.g., myocardial infarction, stent) 6. History of vascular disease (e.g., bypass, stroke)

Treatments and study arms

Ascorbic acid solution (American Regent Laboratories Inc.)

Drug

Ascorbic acid solution (American Regent Laboratories Inc.) will be obtained from the KU Investigational Pharmacy located in the KU Clinical Research Center where studies will take place. A priming bolus of 0.06 g ascorbic acid/kg fat free mass (FFM) dissolved in 100 mL of saline will be infused intravenously at 5 mL/min for 20 minutes, followed immediately by a "drip-infusion" of 0.02 g/kg FFM dissolved in 30 mL of saline administered over 2 hours at 0.5 mL/min.

Saline

Drug

Placebo (saline) will be administered

Primary outcomes

Efficacy of infusion of ascorbic acid30 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.

Efficacy of infusion of ascorbic acid60 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.

Efficacy of infusion of ascorbic acid90 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.

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Kansas Medical Center🇺🇸 Kansas City, Kansas, United States
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Davina ClonchContact
Email · Call 913-226-6009
Megan GangwishContact
Email · Call 913-444-0949