NCT04934228

Mitigating the Pro-inflammatory Phenotype of Obesity

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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

Conditions

• Blood Pressure
• Diabetes
• Obesity
• Insulin Resistance
• Diuretics Drug Reactions
• Sympathetic Nerve Activity

Interventions

Type	Name	Description
DRUG	Hydrochlorothiazide 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
DRUG	Clonidine 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
DRUG	Placebo	Will receive a 4 week supply (35 days) of Placebo Pills; has no active ingredients but is made to look like the study drug.

Timeline

• Start date: 2021-07-01
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2021-06-22
• Last updated: 2025-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study