RecruitingPhase 1Phase 2NCT04715022

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

Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance

Sponsor

University of Kansas Medical Center

Enrollment

23 participants

Start Date

Jun 17, 2021

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases Hypertension

Summary

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.

Eligibility

Min Age: 35 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how obesity and insulin resistance affect the nervous system and blood vessels, and whether vitamin C can help. Researchers are testing whether this antioxidant vitamin can improve how the body's nerves regulate blood flow in people who are obese. **You may be eligible if:** - You have a BMI over 30 (classified as obese) - You are between 35 and 65 years old - You are willing to stop taking vitamin C, vitamin E, or omega-3 supplements 2 weeks before the study **You may NOT be eligible if:** - You have diabetes - You are currently taking a statin (cholesterol medication) or blood pressure medication - You have high triglycerides or high blood pressure - You have a history of heart disease (such as a heart attack or stent) or vascular disease (such as a stroke or bypass surgery) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAscorbic acid solution (American Regent Laboratories Inc.)

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.

DRUGSaline

Placebo (saline) will be administered