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

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

Inclusion Criteria4

  • Obese: BMI \>30 m/kg2
  • Middle-aged: 35-65 years
  • 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 Criteria6

  • Diabetes mellitus: fasting glucose \< 1267 mg/dL and/or HbA1c \< 6.5%
  • Currently taking a statin or antihypertension medication
  • Hyperlipidemia: Fasting triglycerides \< 250 mg/dL
  • Hypertension: \<130/80 mmHg
  • History of heart disease (e.g., myocardial infarction, stent)
  • History of vascular disease (e.g., bypass, stroke)

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


Locations(1)

University of Kansas Medical Center

Kansas City, Kansas, United States

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NCT04715022


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