A Randomized Clinical Trial To Study Losartan On Endothelial Dysfunction and Insulin Resistance In Obese Patients
2018年8月9日 更新者:Mark Alan Creager, MD、Brigham and Women's Hospital
Protocol Merck 318-00: A Double-Blind, Placebo-Controlled, Randomized, Parallel, Clinical Trial To Study The Effect Of Losartan Potassium On Endothelial Dysfunction And Insulin Resistance In Obese Patients With Impaired Fasting Glucose
The main purposes of this study are to find out if the study drug losartan (Cozaar) or placebo ("sugar pill") has an effect on insulin sensitivity (how your body responds to insulin) and to measure the effect of the study drug losartan or placebo on how the arteries in your arm dilate (enlarge to carry more blood).
We hope to learn if taking losartan changes the amount of certain proteins in the blood that effect blood vessel function.
Losartan is approved by the US FDA to treat high blood pressure. It will take approximately 4 months for you to complete this study.
研究概览
研究类型
介入性
注册 (实际的)
53
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Arkansas
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Little Rock、Arkansas、美国、72205
- CAVS Clinical Research Center
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California
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San Diego、California、美国、92161
- VA San Diego Health Care System
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Florida
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Miami、Florida、美国、33136
- University of Miami Diabetes Research Institute
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University School of Medicine
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital Cardiovascular Division
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New York
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New York、New York、美国、10025
- St. Lukes Roosevelt Hospital
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania School of Medicine
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Texas
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Dallas、Texas、美国、75390
- University of Texas SW Medical Center at Dallas
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Houston、Texas、美国、77030
- Hypertension Clinical Pharmacology Baylor Clinic
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Currently taking 1 or no antihypertensive medication
- Male and female between 18 and 75 years of age
- Mean trough sitting diastolic blood pressure (SiDBP) ≥80 and < 100 mm Hg
- Mean trough sitting systolic blood pressure (SiSBP) ≥120 and <160 mm Hg
- Non-diabetic patients with fasting plasma glucose ≥100 mg/dL and <126 mg/dL
- Body mass index (BMI) >30 and <40
- Waist circumference >40 inches in males, > 35 inches in females
- A patient who is of reproductive potential and agrees to remain abstinent or use acceptable methods of birth control (intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, hormonal contraception, vasectomy) within the projected duration of the study
Exclusion Criteria:
- Secondary hypertension of any etiology (renal artery stenosis, coarctation of the aorta or pheochromocytoma, hypertension induced by oral contraceptives)
- History of malignant hypertension
- Any clinically significant renal disease including single functioning kidney, and known history of anuria. Any severe renal impairment, as manifested by serum creatinine more than 1.5 mg/dL, or proteinuria >2+ by urine dipstick
- Known sensitivity or intolerance to angiotensin II receptor antagonists
- Type I or II diabetes
- Inability or unwillingness to abstain from taking prohibited medications during the study period
- History of myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), congestive heart failure (CHF), unstable angina, transient ischemic attack (TIA), or cerebrovascular accident (CVA)
- Concomitant cardiac conditions that would make it unsafe to participate in the trial (e.g., clinically significant atrioventricular (AV) conduction disturbance, atrial flutter, atrial fibrillation, potentially life-threatening ventricular arrhythmias, decompensated valvular disease, presence of hemodynamically significant obstructive valvular disease, or cardiomyopathy)
- History of angioedema and/or organ damage from hypertension
- Serum potassium < 3.5 or > 5.5 mEq/L
- Any clinically significant laboratory value which in the investigator's judgment could be clinically significant to the outcome of this study.
- History of clinically important gastrointestinal resection or malabsorption
- Patient with a history or current evident of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate. (Including but not limited to: recent or current alcoholism, drug abuse within the prior 2 years, mental or legal incapacitation, any disease which could reasonably be expected to be fatal or life-threatening, or a history of malignancy ≤ 5 years prior to signing informed consent.)
- Currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
- Inability to be taken off all current antihypertensive medication and placed on placebo for up to 12 weeks.
- Unwillingness or unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
- Arm circumference great than 52 cm
- Smokers or former smokers who have quite less than 1 year prior to Visit 1
- Anemia (Hemoglobin < 11)
- Allergy to latex
- Deformed hands and/or fingers that would interfere with the collection of pulse volume amplitude measurements
- History of Raynaud's disease or any other vascular condition
- Bilateral mastectomy
- Aortic stenosis
- Patient is taking high doses of antioxidant supplements (vitamins, minerals, or other)
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Losartan
Losartan 100 mg 1 tab po QD
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losartan 100 mg tablets 1 tab po QD
其他名称:
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安慰剂比较:Placebo
Placebo 1 tab po QD
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Placebo 1 po QD
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Insulin Sensitivity Utilizing the Euglycemic Hyperinsulinemic Clamp
大体时间:baseline, 8 weeks
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Insulin clamp derived insulin sensitivity, as insulin stimulated glucose disposal corrected for steady state insulin level.
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baseline, 8 weeks
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Insulin Sensitivity Utilizing Endothelial Function as Assessed by Pulse Volume Amplitude
大体时间:baseline, 8 weeks
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Endothelial function assessed as the ratio of pulse volume amplitude after compared with before a reactive hyperemia stimulus, measured by peripheral (fingertip) arterial tonometry.
Reported values indicate the percentage change from Baseline in the ratio of pulse volume amplitude after compared to before the reactive hyperemia stimulus.
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baseline, 8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Urine Albumin/Creatine
大体时间:baseline, 8 weeks
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Urine was obtained to assess for the presence of microalbuminuria.
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baseline, 8 weeks
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Change in hsCRP (High-sensitivity C-reactive Protein)
大体时间:baseline, 8 weeks
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hsCRP (high-sensitivity C-reactive protein) is a marker of inflammation
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baseline, 8 weeks
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Change in VCAM-1(Vascular Cell-adhesion Molecule-1)
大体时间:baseline, 8 weeks
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VCAM-1 is an immunoglobulin-like adhesion molecule expressed on activated endothelial cells.
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baseline, 8 weeks
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Change in MCP-1 (Monocyte Chemoattractant Protein-1)
大体时间:baseline, 8 weeks
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MCP-1 is one of the key chemokines that regulate migration and infiltration of monocytes/macrophages.
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baseline, 8 weeks
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Change in Ox-LDL (Oxidized Low-density Lipoprotein)
大体时间:baseline, 8 weeks
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ox-LDL measures protein damage due to the oxidative modification of the ApoB subunit on LDL cholesterol.
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baseline, 8 weeks
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Change in F2-isoprostanes
大体时间:baseline, 8 weeks
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F2-isoprostanes is a marker of oxidative stress.
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baseline, 8 weeks
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Change in E-selectin
大体时间:baseline, 8 weeks
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E-selectin is expressed on inflamed endothelial cells in response to treatment with inflammatory cytokines.
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baseline, 8 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年5月1日
初级完成 (实际的)
2008年12月1日
研究完成 (实际的)
2008年12月1日
研究注册日期
首次提交
2008年5月8日
首先提交符合 QC 标准的
2008年5月9日
首次发布 (估计)
2008年5月12日
研究记录更新
最后更新发布 (实际的)
2018年9月6日
上次提交的符合 QC 标准的更新
2018年8月9日
最后验证
2018年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 2007-P-000490
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.