- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 4
Kontakty i lokalizacje
Lokalizacje studiów
-
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Arkansas
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Little Rock, Arkansas, Stany Zjednoczone, 72205
- CAVS Clinical Research Center
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California
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San Diego, California, Stany Zjednoczone, 92161
- VA San Diego Health Care System
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Florida
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Miami, Florida, Stany Zjednoczone, 33136
- University of Miami Diabetes Research Institute
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Indiana
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Indianapolis, Indiana, Stany Zjednoczone, 46202
- Indiana University School of Medicine
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02115
- Brigham and Women's Hospital Cardiovascular Division
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New York
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New York, New York, Stany Zjednoczone, 10025
- St. Lukes Roosevelt Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- University of Pennsylvania School of Medicine
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Texas
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Dallas, Texas, Stany Zjednoczone, 75390
- University of Texas SW Medical Center at Dallas
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Houston, Texas, Stany Zjednoczone, 77030
- Hypertension Clinical Pharmacology Baylor Clinic
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Aktywny komparator: Losartan
Losartan 100 mg 1 tab po QD
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losartan 100 mg tablets 1 tab po QD
Inne nazwy:
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Komparator placebo: Placebo
Placebo 1 tab po QD
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Placebo 1 po QD
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Insulin Sensitivity Utilizing the Euglycemic Hyperinsulinemic Clamp
Ramy czasowe: 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
Ramy czasowe: 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.
|
baseline, 8 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Change in Urine Albumin/Creatine
Ramy czasowe: baseline, 8 weeks
|
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)
Ramy czasowe: baseline, 8 weeks
|
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)
Ramy czasowe: baseline, 8 weeks
|
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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Współpracownicy
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2007-P-000490
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na losartan
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Chinese PLA General HospitalTianjin TongRenTang Group Co., Ltd.NieznanyBiałkomocz | Kłębuszkowe zapalenie nerekChiny
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University of South FloridaNational Cancer Institute (NCI)Zakończony
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University of MiamiNational Heart, Lung, and Blood Institute (NHLBI); Flight Attendant Medical...ZakończonyPOChP | Przewlekłe zapalenie oskrzeliStany Zjednoczone
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Shanghai Jiao Tong University School of MedicineZakończonyNefropatja cukrzycowa | Cukrzyca typu 2
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Merck Sharp & Dohme LLCZakończony
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Baker Heart and Diabetes InstituteWycofane
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EMSZawieszonyNadciśnienieBrazylia
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Chulalongkorn UniversityNieznanyNiewydolność błony otrzewnowejTajlandia
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Shaw Cancer CenterSteadman Philippon Research InstituteRekrutacyjnyZwłóknienie wywołane promieniowaniemStany Zjednoczone