Mitigating the Pro-inflammatory Phenotype of Obesity
Recruiting · NCT04934228 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Kansas Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Clonidine PillHydrochlorothiazide 12.5Mg TabPlacebo
What this trial is about
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.
Who can take part
Age range
18 Years to 79 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- University of Kansas Medical Center - Kansas City, Kansas, United States