NCT06626113Recruiting
Transduction of Sympathetic Neural Activity in Human Obesity Without Hypertension
Concomitantly Higher Resting Arterial Blood Pressure and Transduction of Sympathetic Neural Activity in Human Obesity Without Hypertension
Source: ClinicalTrials.gov · Last updated 3 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 1 Oct 2024
- Start date
- 1 Aug 2022
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- University of Kansas Medical Center
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT06626113
What you commit to
- Study type: Observational
- Planned participants: 60
- From 1 Aug 2022 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking a statin or antihypertension medication
Other illness
- Hypertension: \>130/80 mmHg
- History of heart disease (e.g., myocardial infarction, stent)
- History of vascular disease (e.g., bypass, stroke)
Lab values
- Hyperlipidemia: Fasting triglycerides \< 250 mg/dL
Other
- Individuals with narrow angle glaucoma
- \-
Who the study is looking for
- Obese: BMI \>25 m/kg2
- Elevated insulin resistance: HOMA-IR \> 2.5 (calculation based on fasting glucose and insulin concentrations in blood)
- 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
Age in the registry: 18 years to 79 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.