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Идёт набор NCT04934228

Mitigating the Pro-inflammatory Phenotype of Obesity

Фаза I С лечением Blood Pressure Diabetes Obesity Insulin Resistance

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Hydrochlorothiazide 12.5Mg Tab, Clonidine Pill, Placebo.
Кому может быть актуально
Состояния в реестре: Blood Pressure, Diabetes, Obesity, Insulin Resistance. Базовые параметры: 18 лет — 79 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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

Вмешательства

  • Препарат 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
  • Препарат 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
  • Препарат 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.

Первичные конечные точки

  • 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 4 Week]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • University of Kansas Medical Center — Kansas City

Идентификаторы

NCT: NCT04934228 · 00147099

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗