Mitigating the Pro-inflammatory Phenotype of Obesity (MAPLE)

  • STATUS
    Recruiting
  • End date
    Jul 31, 2025
  • participants needed
    60
  • sponsor
    University of Kansas Medical Center
Updated on 15 July 2022
insulin
hypertension
fasting
insulin resistance
hemoglobin a1c

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.

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

Details
Condition Blood Pressure, Diabetes, Obesity, Insulin Resistance, Diuretics Drug Reactions, Sympathetic Nerve Activity
Treatment Placebo, Clonidine Pill, Hydrochlorothiazide 12.5Mg Tab
Clinical Study IdentifierNCT04934228
SponsorUniversity of Kansas Medical Center
Last Modified on15 July 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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