Mitigating the Pro-inflammatory Phenotype of Obesity
University of Kansas Medical Center
60 participants
Jul 1, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria11
- 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 Criteria8
- 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.
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Interventions
Will receive 4 week supply (35 days) of Hydrochlorothiazide Pills (12.5 mg twice a day) Planned use in this study 1. Condition/disease indication(s): Hypertension 2. Subject population: Hypertension 3. Dose(s): 25 mg/day 4. Administration: Oral 5. Dosing regimen: 12.5 mg twice per day
Will receive 4 week supply (35 days) of Clonidine Pills (0.1 mg twice/day) Planned use in this study 1. Condition/disease indication(s): Vascular function and blood flow 2. Subject population: Hypertension 3. Dose(s): 0.1 mg (oral) 4. Administration: Oral 5. Dosing regimen: 0.1 mg twice daily by mouth
Will receive a 4 week supply (35 days) of Placebo Pills; has no active ingredients but is made to look like the study drug.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04934228