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HypertensionNutrition and dietDrugPhase 1, Phase 2

What this study is

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.

What's being tested

  • Ascorbic acid solution (American Regent Laboratories Inc.)

    Intervention · 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

    Intervention · DRUG

    Placebo (saline) will be administered

Study details

Official title
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance
Sponsor
University of Kansas Medical Center
Conditions
Hypertension · Cardiovascular Diseases
Enrolling
23 people
Starts
2021-06-17
Est. completion
2027-08-01
Design
Double-blind, randomized, crossover, Phase 1, Phase 2
Record
View on ClinicalTrials.gov ↗