Actively Recruiting

Phase 1
Age: 18Years - 79Years
All Genders
ID04934228

Mitigating the Pro-inflammatory Phenotype of Obesity Using Oral Clonidine Compared with Hydrochlorothiazide and Placebo

Led by University of Kansas Medical Center · Updated on 2025-06-05

60

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether blocking sympathetic nerve activity (SNA) with oral clonidine for 4 weeks can reduce inflammatory markers in the blood, endothelial cells, and central adipose tissue. This randomized, double-blinded study compares the effect of clonidine against a blood pressure-lowering control drug (hydrochlorothiazide) and a placebo. The study aims to understand how much inflammation is caused by elevated SNA in people with obesity and hypertension. Participants are randomly assigned to one of three groups: clonidine, hydrochlorothiazide, or placebo. Each treatment is given orally for 4 weeks with clonidine dosed at 0.1 mg twice daily, hydrochlorothiazide dosed at 12.5 mg twice daily, and placebo pills designed to look like the study drugs but contain no active ingredients. All medications are supplied in 35-day pill bottles by the investigational pharmacy. During the study, participants will visit the research lab and undergo blood draws and tissue sampling at baseline, 1 week, 2 weeks, and 4 weeks to measure inflammatory markers. Blood work, endothelial cell samples, and adipose tissue samples are collected to assess the impact of the treatments. Safety and efficacy are monitored throughout the 4-week treatment period, with the total participation lasting about one month.

CONDITIONS

Brief Title

Mitigating the Pro-inflammatory Phenotype of Obesity

Who Can Participate

Age: 18Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or Female, age 18-79
  • Obese with a body mass index (BMI) greater than 30
  • Hypertensive with blood pressure over 130/80 mmHg
  • Elevated insulin resistance (HOMA-IR greater than 2.5)
  • Waist circumference over 102 cm for men and over 88 cm for women
  • Fasting glucose less than 126 mg/dL
  • Fasting triglycerides less than 250 mg/dL
  • Hemoglobin A1c less than 6.5%
  • Willing to visit the research lab and undergo blood draws
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Current use of clonidine or beta-blocker medications
  • Current smoker or history of smoking in the past 3 months
  • Hyperlipidemia with fasting triglycerides over 250 mg/dL
  • Currently taking hypertension medications
  • History of heart disease including myocardial infarction, stent, bypass, stroke, heart failure, valvular heart disease, or cardiomyopathy
  • History of neurological disorders
  • History of transplant
  • Actively participating in other studies except registry studies

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants receive a 4-week supply of oral medication: either clonidine, hydrochlorothiazide, or placebo. The purpose is to evaluate the effect on inflammatory markers related to obesity and hypertension.

Weekly visits for blood work and assessments

Trial Site Locations

Total: 1 location

1

University of Kansas Medical Center

Kansas City, Kansas, United States, 66103

Actively Recruiting

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Research Team

S

Seth W Holwerda, Ph,D

D

Davina A Clonch

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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