Transduction of Sympathetic Neural Activity in Human Obesity Without Hypertension

NCT06626113 | Recruiting DMC FDA Drug

• 1 other identifier: VITAMINC
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Sympathetic transduction

  2 hours

Study Arms (1)

Obese

Drug: ascorbic acid

Interventions

ascorbic acid DRUG

ascorbic acid

Obese

Eligibility Criteria

• Age: 18 Years - 79 Years
• Gender Eligibility Details: self-reported
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Obese

You may qualify if:

• 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

You may not qualify if:

• Currently taking a statin or antihypertension medication
• Hyperlipidemia: Fasting triglycerides \< 250 mg/dL
• Hypertension: \>130/80 mmHg
• History of heart disease (e.g., myocardial infarction, stent)
• History of vascular disease (e.g., bypass, stroke)
• Individuals with narrow angle glaucoma

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Seth Holwerda

CONTACT

9729223230; sethholwerda@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: August 1, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

US (1)