NCT06626113 Transduction of Sympathetic Neural Activity in Human Obesity Without Hypertension
| NCT ID | NCT06626113 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Kansas Medical Center |
| Condition | Obesity |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2022-08-01 with a primary completion date of 2026-09-01.
⚠ 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
In addition to chronically elevated MSNA, there is a growing recognition that hypertension in states of insulin resistance and obesity may also be attributed to an increased vascular sensitivity to MSNA (1, 2, 13, 36-38). To study this phenomenon, we quantify vascular sensitivity to MSNA using an innovative, moment-to-moment assessment of the blood pressure response following individual bursts of muscle sympathetic nerve activity (MSNA), (10, 11, 34, 37). This approach is termed 'sympathetic-vascular transduction (SVT).' We will examine the hypothesis that SVT is exaggerated in obesity and insulin resistance and is attenuated by suppression of oxidative stress. Oxidative stress is the overabundance of reactive oxygen species and is another hallmark of hypertension, obesity, and insulin resistance. Oxidative stress can be safely reduced via intravenous infusion of ascorbic acid (Vit C) (4, 28). Therefore, we will use a randomized, double-blinded, placebo-controlled approach to test the hypothesis that elevated SVT will be attenuated by suppression of oxidative stress via ascorbic acid I.V. infusion compared with saline I.V. infusion (placebo) in obese adults with insulin resistance. Our study will identify a unique mechanism that can be targeted to reduce the excessively high prevalence of hypertension and risk for CVD in obesity and insulin resistance.
Eligibility Criteria
Inclusion criteria: 1. Obese: BMI \>25 m/kg2 2. Elevated insulin resistance: HOMA-IR \> 2.5 (calculation based on fasting glucose and insulin concentrations in blood) 3. Middle-aged: 35-65 years 4. Participants must be willing and able to discontinue taking any vitamin C or E supplements or omega-3 fatty acids beginning 2 weeks prior. 5. Able and willing to provide written informed consent Exclusion criteria: 1. Currently taking a statin or antihypertension medication 2. Hyperlipidemia: Fasting triglycerides \< 250 mg/dL 3. Hypertension: \>130/80 mmHg 4. History of heart disease (e.g., myocardial infarction, stent) 5. History of vascular disease (e.g., bypass, stroke) 6. Individuals with narrow angle glaucoma \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06626113 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06626113 currently recruiting?
Yes, NCT06626113 is actively recruiting participants. Contact the research team at sethholwerda@gmail.com for enrollment information.
Where is the NCT06626113 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT06626113 clinical trial?
NCT06626113 is sponsored by University of Kansas Medical Center. The trial plans to enroll 60 participants.
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