NCT04934228 Mitigating the Pro-inflammatory Phenotype of Obesity
| NCT ID | NCT04934228 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Kansas Medical Center |
| Condition | Blood Pressure |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-07-01 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2021-07-01 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to examine the hypothesize that 4 weeks of sympathetic nerve activity (SNA) inhibition (oral clonidine) will cause a significant reduction in circulating blood concentrations and endothelial cell expression of inflammatory markers (e.g., TNF-α, IL-6). Our study is a prospective study using a randomized, double-blinded design to test 4 weeks of SNA blockade (oral clonidine) compared with a BP-lowering control condition (diuretic, hydrochlorothiazide) or a placebo.
Eligibility 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.
Contact & Investigator
Seth W. W Holwerda, PhD
PRINCIPAL INVESTIGATOR
University of Kansas Medical Center
Frequently Asked Questions
Who can join the NCT04934228 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Blood Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04934228 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04934228 currently recruiting?
Yes, NCT04934228 is actively recruiting participants. Contact the research team at sholwerda@kumc.edu for enrollment information.
Where is the NCT04934228 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT04934228 clinical trial?
NCT04934228 is sponsored by University of Kansas Medical Center. The principal investigator is Seth W. W Holwerda, PhD at University of Kansas Medical Center. The trial plans to enroll 60 participants.