Reducing inflammation in obese patients with hypertension
Mitigating the Pro-inflammatory Phenotype of Obesity
This study is testing if a medication called clonidine can lower inflammation in obese people with high blood pressure compared to a control group.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (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 | NCT04934228 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of sympathetic nerve activity inhibition using oral clonidine over four weeks in obese individuals with hypertension. It employs a randomized, double-blinded design to compare the impact of clonidine on inflammatory markers in blood and endothelial cells against a control group receiving hydrochlorothiazide or a placebo. The goal is to determine how much inflammation is driven by elevated sympathetic nerve activity in this population.
Who should consider this trial
Good fit: Ideal candidates are obese individuals aged 18-79 with hypertension and elevated insulin resistance.
Not a fit: Patients with a history of heart disease, neurological disorders, or those currently using certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to new treatments for obesity-related inflammation and improve overall health outcomes for patients.
How similar studies have performed: While there is ongoing research into sympathetic nerve activity and inflammation, this specific approach using clonidine in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or Female, age 18-79 * Obese: BMI \> 30 m/kg2 * Hypertensive: blood pressure \>130/80 * Elevated insulin resistance (HOMA-IR \> 2.5) * Waist circ: \>102 cm (men) and \>88 cm (women) * Fasting glucose \< 126 mg/dL * Fasting triglycerides \< 250 mg/dL * HbA1c \< 6.5% * Willing to visit research lab (Fairway CTSU) * Willing to undergo a blood draw * Able to provide written informed consent Exclusion Criteria: * Current use of clonidine or beta-blockers * Current smoker or History of smoking in the past 3 months. * Hyperlipidemia: Fasting triglycerides \> 250 mg/dL * Currently taking hypertension medication * History of heart disease (e.g., myocardial infarction, stent, byass, heart attack, stroke, heart failure, valvular heart disease, cardiomyopathy) * History of neurological disorders * History of transplant * Actively participating in other studies, except for a registry study.
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, Ph,D
- 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.