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NCT04715022PHASE1, PHASE2Recruiting

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

University of Kansas Medical Center

Start Date

6/17/2021

Completion Date

8/1/2027

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

Age Range: 35 years to 65 years

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)

Interventions

DRUG

Ascorbic acid solution (American Regent Laboratories Inc.)

DRUG

Saline

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Conditions

HypertensionCardiovascular Diseases

Locations

University of Kansas Medical Center

Kansas City, Kansas 66160

United States