- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00675987
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.
연구 개요
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- CAVS Clinical Research Center
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California
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San Diego, California, 미국, 92161
- VA San Diego Health Care System
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Florida
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Miami, Florida, 미국, 33136
- University of Miami Diabetes Research Institute
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Indiana University School of Medicine
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hospital Cardiovascular Division
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New York
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New York, New York, 미국, 10025
- St. Lukes Roosevelt Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania School of Medicine
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Texas
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Dallas, Texas, 미국, 75390
- University of Texas SW Medical Center at Dallas
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Houston, Texas, 미국, 77030
- Hypertension Clinical Pharmacology Baylor Clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Losartan
Losartan 100 mg 1 tab po QD
|
losartan 100 mg tablets 1 tab po QD
다른 이름들:
|
위약 비교기: Placebo
Placebo 1 tab po QD
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Placebo 1 po QD
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Insulin Sensitivity Utilizing the Euglycemic Hyperinsulinemic Clamp
기간: baseline, 8 weeks
|
Insulin clamp derived insulin sensitivity, as insulin stimulated glucose disposal corrected for steady state insulin level.
|
baseline, 8 weeks
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Insulin Sensitivity Utilizing Endothelial Function as Assessed by Pulse Volume Amplitude
기간: baseline, 8 weeks
|
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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in Urine Albumin/Creatine
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2007-P-000490
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
losartan에 대한 임상 시험
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Chinese PLA General HospitalTianjin TongRenTang Group Co., Ltd.알려지지 않은
-
Teva Pharmaceuticals USA완전한
-
Torrent Pharmaceuticals Limited완전한
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Newcastle-upon-Tyne Hospitals NHS TrustNewcastle University완전한