Understanding how glucose and fat affect blood vessel health
Reversing Glucose and Lipid-mediated Vascular Dysfunction (REGAL)
This study is testing how sugar and fat in the body affect blood vessel health and blood pressure in healthy adults.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT04832009 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the impact of glucose and lipids on vascular function in lean, healthy adults and their potential role in developing high blood pressure. It will utilize the microneurographic technique to measure muscle sympathetic nerve activity, which is crucial for blood pressure regulation. Participants will receive interventions including dextrose, intralipid, saline, and ascorbic acid to assess the restoration of nerve and blood vessel function affected by high glucose and lipid levels.
Who should consider this trial
Good fit: Ideal candidates are lean adults aged 18-79 with normal insulin sensitivity and stable blood pressure below 140/90 mmHg.
Not a fit: Patients with diabetes, hypertension, or a history of cardiovascular or vascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new strategies for preventing or treating hypertension by improving vascular health.
How similar studies have performed: While the approach of using antioxidants to improve vascular function is known, this specific investigation into glucose and lipid effects in lean adults is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Lean: BMI \< 25 kg/m * Normal insulin sensitivity: (calculation based on fasting glucose and insulin concentrations in blood) * Middle-aged: 18-79 years * Blood pressure: \< 140 (systolic) and \< 90 mmHg (diastolic * Weight stable (+/- 5 lbs) for the previous 3 months * 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 Exclusion Criteria: * Diabetes mellitus Type I or Type II: fasting glucose \< 126 mg/dL and/or HbA1c \< 6.5% * Current smoker or History of smoking in the past 3 months. * Hyperlipidemia: Fasting triglycerides \< 250 mg/dL * Hypertension: \>130/80 mmHg * History of heart disease (e.g., myocardial infarction, stent, heart attack, stroke, heart failure, valvular heart disease, cardiomyopathy) * 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 W. W Holwerda, PhD — University of Kansas Medical Center
- Study coordinator: Seth W 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.