CClinicalTrials.gg
RecruitingNCT06626113Updated Oct 3, 2024

Transduction of Sympathetic Neural Activity in Human Obesity Without Hypertension

An observational study in Obesity, sponsored by University of Kansas Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-10-03.

Sponsored by University of Kansas Medical Center · Observational

From the registry’s dates

  • Started Aug 2022; still recruiting 4 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 79 Years
Sex
All
01

Study 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.

Read the detailed description

This is a randomized, double blind, placebo-controlled study. Eligible participants will have a total of 3 visits to the laboratory. At the first experimental visit individuals will be randomized in a double-blind fashion to either ascorbic acid or placebo and the alternative treatment will be given on the subsequent study visit. The KU Investigational Pharmacy will perform the blinded randomization.

  1. Week 1 Visit 1 Screening
  2. Week 2 Visit 2 Randomization and Experimental visit
  3. Week 5 Visit 3 Experimental visit
02

Conditions studied

  • Obesity
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 60 is below the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Obese

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

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

    -

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Obese

    Drug: ascorbic acid

Interventions

  • Drugascorbic acid

    ascorbic acid

06

What researchers measure

Primary outcomes

  1. Sympathetic transduction

    Time frame: 2 hours

07

Study locations

1 of 1 sites recruiting
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
    • Seth Holwerda · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06626113
Lead sponsor
University of Kansas Medical Center
Responsible party
Sponsor
First posted
Oct 3, 2024
Start date
Aug 1, 2022
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Oct 3, 2024

Study contacts

Seth Holwerda
Contact
sethholwerda@gmail.com
9729223230

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion