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NCT Number: NCT04934228

Mitigating the Pro-inflammatory Phenotype of Obesity

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.

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Key information

Conditions

Blood Pressure Body Weight Diabetes Diabetes Mellitus Diuretics Drug Reactions Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Sympathetic Nerve Activity

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

Location status: Recruiting

Location contact

Seth W. W Holwerda

CONTACT

[email protected]

9729223230

About this study

  • 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.
  • Determine the extent to which inflammation in the body is caused by elevated sympathetic nerve activity

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydrochlorothiazide 12.5Mg Tab

Drug

Will receive 4 week supply (35 days) of Hydrochlorothiazide Pills (12.5 mg twice a day)

Planned use in this study

  • Condition/disease indication(s): Hypertension
  • Subject population: Hypertension
  • Dose(s): 25 mg/day
  • Administration: Oral
  • Dosing regimen: 12.5 mg twice per day

Other names: Hydrochlorothiazide

Clonidine Pill

Drug

Will receive 4 week supply (35 days) of Clonidine Pills (0.1 mg twice/day)

Planned use in this study

  • Condition/disease indication(s): Vascular function and blood flow
  • Subject population: Hypertension
  • Dose(s): 0.1 mg (oral)
  • Administration: Oral
  • Dosing regimen: 0.1 mg twice daily by mouth

Other names: Clonidine

Placebo

Drug

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

Primary outcomes

  1. 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

    Time frame: Baseline

    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)

  2. 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 treatment

    Time frame: Baseline

    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,

  3. 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 treatment

    Time frame: Baseline

    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

  4. 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

    Time frame: 1 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.

  5. 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

    Time frame: 2 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.

  6. 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

    Time frame: 4 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)

  7. 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 treatment

    Time frame: 4 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,

  8. 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 treatment

    Time frame: 4 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

Study contacts

Contact information is provided by the study sponsor or research team.

Davina A Clonch

CONTACT

[email protected]

9132266009

Seth W Holwerda, Ph,D

CONTACT

[email protected]

9729223230

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Acronym: MAPLE

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jun 22, 2021
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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