Mitigating the Pro-inflammatory Phenotype of Obesity

Last updated: June 4, 2025
Sponsor: University of Kansas Medical Center
Overall Status: Active - Recruiting

Phase

1

Condition

Diabetes Prevention

Diabetes (Pediatric)

Diabetic Macular Edema

Treatment

Hydrochlorothiazide 12.5Mg Tab

Placebo

Clonidine Pill

Clinical Study ID

NCT04934228
00147099
  • Ages 18-79
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Hydrochlorothiazide 12.5Mg Tab
Phase: 1
Study Start date:
July 01, 2021
Estimated Completion Date:
August 01, 2027

Study 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

Connect with a study center

  • University of Kansas Medical Center

    Kansas City, Kansas 66103
    United States

    Active - Recruiting

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