NCT04934228PHASE1Recruiting

Mitigating the Pro-inflammatory Phenotype of Obesity

University of Kansas Medical Center

Start Date

7/1/2021

Completion Date

8/1/2027

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.

Detailed 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 Criteria

Age Range: 18 years to 79 years

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.

Interventions

DRUG

Hydrochlorothiazide 12.5Mg Tab

DRUG

Clonidine Pill

DRUG

Placebo

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Conditions

Blood PressureDiabetesObesityInsulin ResistanceDiuretics Drug ReactionsSympathetic Nerve Activity

Locations

University of Kansas Medical Center

Kansas City, Kansas 66103

United States