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- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- CAVS Clinical Research Center
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California
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San Diego, California, Estados Unidos, 92161
- VA San Diego Health Care System
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Florida
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Miami, Florida, Estados Unidos, 33136
- University of Miami Diabetes Research Institute
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University School of Medicine
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hospital Cardiovascular Division
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New York
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New York, New York, Estados Unidos, 10025
- St. Lukes Roosevelt Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania School of Medicine
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Texas
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Dallas, Texas, Estados Unidos, 75390
- University of Texas SW Medical Center at Dallas
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Houston, Texas, Estados Unidos, 77030
- Hypertension Clinical Pharmacology Baylor Clinic
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: Losartan
Losartan 100 mg 1 tab po QD
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losartan 100 mg tablets 1 tab po QD
Outros nomes:
|
Comparador de Placebo: Placebo
Placebo 1 tab po QD
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Placebo 1 po QD
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Insulin Sensitivity Utilizing the Euglycemic Hyperinsulinemic Clamp
Prazo: baseline, 8 weeks
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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
Prazo: 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.
|
baseline, 8 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in Urine Albumin/Creatine
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios do Metabolismo da Glicose
- Doenças Metabólicas
- Hiperinsulinismo
- Hiperglicemia
- Resistência a insulina
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Antiarrítmicos
- Anti-hipertensivos
- Bloqueadores dos receptores tipo 1 da angiotensina II
- Antagonistas dos Receptores da Angiotensina
- Losartana
Outros números de identificação do estudo
- 2007-P-000490
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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