Mitigating the Pro-inflammatory Phenotype of Obesity
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Randomized, double-blinded, parallel-design approach. Randomization to either the clonidine, diuretic vs. placebo will occur determined/generated by computer generated randomization and stratified by age and sex to balance the three groups.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Placebo
KU Investigational Pharmacy will provide the drug prescription bottle with 35-day supply of placebo to the research coordinator to give to the research participant.
The placebo is an inert substance with no intended medical value and is used as a negative control for comparison with the study drug.
Participants will receive a Placebo Pill; has no active ingredients but is made to look like the study drug.
干预措施: Placebo (Drug)
Clonidine
KU Investigational Pharmacy will provide the drug prescription bottle with 35-day supply of clonidine to the research coordinator to give to the research participant.
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
干预措施: Clonidine Pill (Drug)
Hydrochlorothiazide (HCTZ)
KU Investigational Pharmacy will provide the drug prescription bottle with 35-day supply of Hydrochlorothiazide to the research coordinator to give to the research participant.
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
干预措施: Hydrochlorothiazide 12.5Mg Tab (Drug)
结局指标
主要结局
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
时间窗: 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)
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
时间窗: 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,
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
时间窗: 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
次要结局
未报告次要终点
研究者
Seth Holwerda PhD
Principal Investigator
University of Kansas Medical Center