RecruitingPhase 1NCT04934228

Mitigating the Pro-inflammatory Phenotype of Obesity


Sponsor

University of Kansas Medical Center

Enrollment

60 participants

Start Date

Jul 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 79 Years

Inclusion Criteria11

  • 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 Criteria8

  • 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.

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Interventions

DRUGHydrochlorothiazide 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

DRUGClonidine 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

DRUGPlacebo

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


Locations(1)

University of Kansas Medical Center

Kansas City, Kansas, United States

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NCT04934228


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