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Recruiting NCT04934228

Mitigating the Pro-inflammatory Phenotype of Obesity

Phase I Interventional Blood Pressure Diabetes Obesity Insulin Resistance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydrochlorothiazide 12.5Mg Tab, Clonidine Pill, Placebo.
Who it may be relevant to
Registry conditions: Blood Pressure, Diabetes, Obesity, Insulin Resistance. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed 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

Interventions

  • Drug Hydrochlorothiazide 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
  • Drug Clonidine 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
  • Drug Placebo
    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 outcome 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 treatment [Time frame: Baseline]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • University of Kansas Medical Center — Kansas City

Identifiers

NCT: NCT04934228 · 00147099

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗