Examining blood vessel health in obese adults with insulin resistance using Vitamin C
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance
This study is testing if Vitamin C can help improve blood vessel health and lower blood pressure in obese adults with insulin resistance.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 35 Years to 65 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT04715022 on ClinicalTrials.gov |
What this trial studies
This study investigates how obesity and insulin resistance contribute to hypertension and cardiovascular diseases by examining blood vessel health and nerve activity in affected adults. It specifically tests the effects of ascorbic acid (Vitamin C) on improving blood vessel function and lowering blood pressure. Participants will be monitored for changes in blood pressure as a primary outcome, with the goal of identifying mechanisms to reduce vascular dysfunction. The study aims to provide insights that could lead to targeted interventions for hypertension in this population.
Who should consider this trial
Good fit: Ideal candidates are obese adults aged 35-65 with insulin resistance who are not currently taking certain supplements or medications.
Not a fit: Patients with diabetes, controlled hypertension, or a history of heart or vascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatments for hypertension in obese individuals with insulin resistance.
How similar studies have performed: Other studies have shown promising results in using Vitamin C for vascular health, but this specific approach in the context of obesity and insulin resistance is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Seth Holwerda, PhD — University of Kansas Medical Center
- Study coordinator: Seth Holwerda, PhD
- Email: sholwerda@kumc.edu
- Phone: 9729223230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.