A Randomized Clinical Trial To Study Losartan On Endothelial Dysfunction and Insulin Resistance In Obese Patients
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.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Arkansas
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Little Rock、Arkansas、アメリカ、72205
- CAVS Clinical Research Center
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California
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San Diego、California、アメリカ、92161
- VA San Diego Health Care System
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Florida
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Miami、Florida、アメリカ、33136
- University of Miami Diabetes Research Institute
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- Indiana University School of Medicine
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Brigham and Women's Hospital Cardiovascular Division
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New York
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New York、New York、アメリカ、10025
- St. Lukes Roosevelt Hospital
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania School of medicine
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Texas
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Dallas、Texas、アメリカ、75390
- University of Texas SW Medical Center at Dallas
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Houston、Texas、アメリカ、77030
- Hypertension Clinical Pharmacology Baylor Clinic
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:Losartan
Losartan 100 mg 1 tab po QD
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losartan 100 mg tablets 1 tab po QD
他の名前:
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プラセボコンパレーター:Placebo
Placebo 1 tab po QD
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Placebo 1 po QD
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Insulin Sensitivity Utilizing the Euglycemic Hyperinsulinemic Clamp
時間枠: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
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in Urine Albumin/Creatine
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2007-P-000490
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