Mitigating the Pro-inflammatory Phenotype of Obesity
University of Kansas Medical Center
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.
Description
1. Using a randomized, double-blinded, parallel-design approach, we hypothesize that 4 weeks of SNA blockade (oral clonidine) will cause a significant reduction in expression of inflammatory markers in blood, endothelial cells, and central adipose compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment. 2. Determine the extent to which inflammation in the body is caused by elevated sympathetic nerve activity
Eligibility
- Age range
- 18–79 years
- Sex
- All
- Healthy volunteers
- No
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 *…
Interventions
- DrugHydrochlorothiazide 12.5Mg Tab
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
- DrugClonidine Pill
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
- DrugPlacebo
Will receive a 4 week supply (35 days) of Placebo Pills; has no active ingredients but is made to look like the study drug.
Location
- University of Kansas Medical CenterKansas City, Kansas