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Study of Clonidine and Hydrochlorothiazide for Obesity and Hypertension

This study is looking at how two medications, Clonidine and Hydrochlorothiazide, affect inflammation in people who are obese and have high blood pressure. Researchers want to see if Clonidine, which helps calm down nerve activity, can reduce inflammation markers in your blood, blood vessel cells, and fat tissue. You might receive Clonidine, Hydrochlorothiazide (a diuretic, or 'water pill'), or a placebo (a pill with no active medicine). To join, you need to be 18-79 years old, obese (BMI over 30), have high blood pressure, and show signs of insulin resistance. The study aims to find out if Clonidine is better at reducing inflammation compared to Hydrochlorothiazide or a placebo. The current status of this study is unclear.

Study design
This is a randomized, double-blinded study with 60 planned participants. This means participants are randomly assigned to receive one of the treatments, and neither you nor the study team will know which treatment you are receiving.
What's involved
You would receive a 4-week supply (35 days) of either Hydrochlorothiazide, Clonidine, or a placebo. Blood work, endothelial cell samples (from blood vessels), and adipose tissue samples (fat tissue) will be taken at baseline.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04934228

Mitigating the Pro-inflammatory Phenotype of Obesity

Recruiting
PHASE1Ages 18–79Interventional
University of Kansas Medical Center
~60 participants
Updated 2025-06-05 on ClinicalTrials.gov
What's tested:Hydrochlorothiazide 12.5Mg TabClonidine PillPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Blood Work: Efficacy of 4-week supply of Clonidine Compared VS 4-week supply of control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment
Measured over Baseline
+7 more outcomes measured

Conditions

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

Explore related trials

HypertensionInsulin ResistanceObesity

Where it's being run

1 sites across 1 states
Kansas1

Study leadership

  • Seth W. W Holwerda, PhD · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center

Who to contact

Seth W Holwerda, Ph,D
[email protected]
9729223230
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Blood Work: Efficacy of 4-week supply of Clonidine Compared VS 4-week supply of control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatmentBaseline

    Difference in inflammatory markers in blood compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment * Norepinephrine (inflammation) Blood Test: pg/mL normal range for norepinephrine is 70 to 1700 pg/mL * Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Test: pg/mL normal values: IL-6 was 6-31 pg/mL and TNF-α 5 pg/mL, * Nitrotyrosine (Oxidative stress)

  • Endothelial Cell Sample: Efficacy of 4-week supply of Clonidine Compared VS 4-week supply of control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatmentBaseline

    Difference in endothelial cells samples compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment Endothelial cell tissue will be assessed by the KU Histology Core for markers of inflammation and oxidative stress independently from the PI's lab,

  • Adipose Tissue Sample: Efficacy of 4-week supply of Clonidine Compared VS 4-week supply of control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatmentBaseline

    Difference in central adipose compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment Adipose tissue are expected following 4 weeks of clonidine but not HCTZ or placebo

  • Blood Work: Efficacy of 4-week supply of Clonidine Compared VS 4-week supply of control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment1 Week

    The difference in electrolytes blood test of participants in the Clonidine group compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment. • Blood Test: Electrolyte check by examining potassium concentration in blood. If potassium is 3.5 millimoles per liter or lower, oral 10 mg KCL will be prescribed to subject by a physician.

  • Blood Work: Efficacy of 4-week supply of Clonidine Compared VS 4-week supply of control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment2 Week

    The difference in electrolytes blood test of participants in the Clonidine group compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment. • Blood Test: Electrolyte check by examining potassium concentration in blood. If potassium is 3.5 millimoles per liter or lower, oral 10 mg KCL will be prescribed to subject by a physician.

  • Blood Work: Efficacy of 4-week supply of Clonidine Compared VS 4-week supply of control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment4 Week

    Difference in inflammatory markers in blood, endothelial cells, and central adipose compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment * Norepinephrine (inflammation) Blood Test: pg/mL normal range for norepinephrine is 70 to 1700 pg/mL * Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Test: pg/mL normal values: IL-6 was 6-31 pg/mL and TNF-α 5 pg/mL, * Nitrotyrosine (Oxidative stress)

  • Endothelial Cell Sample: Efficacy of 4-week supply of Clonidine Compared VS 4-week supply of control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment4 Week

    Difference in endothelial cells samples compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment Endothelial cell tissue will be assessed by the KU Histology Core for markers of inflammation and oxidative stress independently from the PI's lab,

  • Adipose Tissue Sample: Efficacy of 4-week supply of Clonidine Compared VS 4-week supply of control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment4 Week

    Difference in central adipose compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment Adipose tissue are expected following 4 weeks of clonidine but not HCTZ or placebo