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Recruiting Phase 1, Phase 2 NCT04715022

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

Trial Parameters

Condition Hypertension
Sponsor University of Kansas Medical Center
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 23
Sex ALL
Min Age 35 Years
Max Age 65 Years
Start Date 2021-06-17
Completion 2026-08-01
Interventions
Ascorbic acid solution (American Regent Laboratories Inc.)Saline

Brief 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 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)

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