Mitigating the Pro-inflammatory Phenotype of Obesity

• Status: Not yet recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas Medical Center
• Treatments: Clonidine; Hydrochlorothiazide

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.