NCT04715022 Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
| NCT ID | NCT04715022 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Kansas Medical Center |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 23 participants |
| Start Date | 2021-06-17 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 23 participants in total. It began in 2021-06-17 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Contact & Investigator
Seth Holwerda, PhD
PRINCIPAL INVESTIGATOR
University of Kansas Medical Center
Frequently Asked Questions
Who can join the NCT04715022 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 65 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04715022 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04715022 currently recruiting?
Yes, NCT04715022 is actively recruiting participants. Contact the research team at sholwerda@kumc.edu for enrollment information.
Where is the NCT04715022 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT04715022 clinical trial?
NCT04715022 is sponsored by University of Kansas Medical Center. The principal investigator is Seth Holwerda, PhD at University of Kansas Medical Center. The trial plans to enroll 23 participants.