Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin (PINK)
25 de abril de 2017 atualizado por: Gladys Velarde, University of Rochester
Interactions of Thrombogenic, Lipogenic, and Inflammatory Markers in Women With the Metabolic Syndrome - Effect of Atorvastatin
Little is known regarding the association of individual components of the metabolic syndrome (MBS) and prothrombotic, inflammatory and preclinical cardiac structural and functional markers in women with this syndrome. Less is known about adequate treatment as the pathological mechanism of this syndrome is not well understood.
The purpose of this study is two fold;
- To determine basic differences in biochemical and cardiovascular structural markers in women with and those without MBS and their association with the individual components of MBS.
- To determine the impact of atorvastatin to lower the risk factors of Metabolic Syndrome. Atorvastatin is one of the most effective drugs approved by the United States Food and Drug Administration (FDA) for the treatment of high cholesterol. It belongs to a class of drugs called statins and its role in primary prevention is still unclear. Thus this population seems to be an ideal group that may benefit from this intervention.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The first phase of the study is an observational phase as previously described.
The second phase was a prospective evaluation of the effect of a well known "statin" drug (Lipitor) on different biochemical factors measured in the blood.
The eligible study participants had blood work done upon enrollment and if criteria was met(according to the Adult Treatment Panel III), they were given dietary counseling (NYHA - New York Heart Association Step 1 diet) as a lead in phase.
Lab work was repeated at 3 weeks to evaluate the impact of the diet and if participant's profile still met criteria for MBS,randomization for either atorvastatin (Lipitor) 80mg or placebo (sugar pill) for 12 weeks took place.
Tipo de estudo
Intervencional
Inscrição (Real)
116
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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New York
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Rochester, New York, Estados Unidos, 14642
- University of Rochester Medical Center
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- Women between the ages of 18-75 with Metabolic syndrome
- Abdominal circumference > 35 in
- Hypertriglyceridemia > 150mg/dl
- HDL <50
- Blood Pressure >130/85
- Fasting Glucose >100
Exclusion Criteria:
- Pregnant or planning to become pregnant in the next 6-12 months
- Receiving lipid-lowing drugs
- Obstructive hepatobiliary disease or serious hepatic disease
- Diabetes, cardiovascular disease (CVD), hypothyroidism, active infection, cancer, recent surgery
- Fulfill criteria to receive statin based on LDL levels, risk factors, and Framingham risk scoring outlined on ATP111/NCEP 111 recommendations
- Documented allergic reaction to statin in past
- unexplained elevation in creatinine kinase levels > 3 times upper limit
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Atorvastatin
44 women randomized to 80 mg atorvastatin for 6weeks
|
80mg
Outros nomes:
|
|
Comparador de Placebo: sugar pill
44 women randomized to placebo for 6 weeks
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80mg
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean Low Density Lipoprotein Cholesterol in Blood
Prazo: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Triglycerides in Blood
Prazo: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Apolipoprotein B in Blood
Prazo: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood
Prazo: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
The ratio of Apo B to Apo A1 ratio was calculated.
|
6 weeks
|
|
Mean High Sensitivity C-reactive Protein in Blood
Prazo: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
The ratio of Apo B to Apo A1 ratio was calculated
|
6 weeks
|
|
Mean Waist Circumference
Prazo: 6 weeks
|
Waist circumference was measured with a ruler tape.
|
6 weeks
|
|
Mean Systolic Blood Pressure
Prazo: 6 weeks
|
Measured with a blood pressure cuff
|
6 weeks
|
|
Mean Diastolic Blood Pressure
Prazo: 6 weeks
|
Measured with a blood pressure cuff
|
6 weeks
|
|
Mean High Density Lipoprotein Cholesterol in Blood
Prazo: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Fasting Plasma Glucose in Blood
Prazo: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Aspartate Aminotransferase in Blood
Prazo: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Alanine Aminotransferase in Blood
Prazo: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Leptin in Blood
Prazo: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Soluble Intercellular Adhesion Molecule in Blood
Prazo: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Soluble Vascular Adhesion Molecule in Blood
Prazo: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Plasminogen Activator Inhibitor-1 in Blood
Prazo: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Myeloperoxidase in Blood
Prazo: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean Waist Circumference
Prazo: week 0
|
Waist circumference was measured with a ruler tape.
|
week 0
|
|
Mean Low Density Lipoprotein Cholesterol in Blood
Prazo: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Triglycerides in Blood
Prazo: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Myeloperoxidase in Blood
Prazo: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Fasting Blood Glucose in Blood
Prazo: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean High Density Lipoprotein Cholesterol in Blood
Prazo: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Intercellular Adhesion Molecule in Blood
Prazo: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Systolic Blood Pressure
Prazo: 0 weeks
|
Measured with a blood pressure cuff
|
0 weeks
|
|
Mean Diastolic Blood Pressure
Prazo: 0 weeks
|
Measured with a blood pressure cuff
|
0 weeks
|
|
Mean Vascular Adhesion Molecule in Blood
Prazo: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Apolipoprotein A-1 in Blood
Prazo: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Apolipoprotein B in Blood
Prazo: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood
Prazo: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
The ratio of Apo B to Apo A1 ratio was calculated.
|
0 weeks
|
|
Mean Hs-C Reactive Protein in Blood
Prazo: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Leptin in Blood
Prazo: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Plasminogen Activator Inhibitor-1 in Blood
Prazo: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Gladys P Velarde, MD, University of Rochester
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de novembro de 2004
Conclusão Primária (Real)
1 de dezembro de 2011
Conclusão do estudo (Real)
1 de maio de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
1 de fevereiro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de fevereiro de 2013
Primeira postagem (Estimativa)
7 de fevereiro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de junho de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de abril de 2017
Última verificação
1 de abril de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Distúrbios do Metabolismo da Glicose
- Doenças Metabólicas
- Doença
- Resistência a insulina
- Hiperinsulinismo
- Síndrome
- Síndrome metabólica
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Antimetabólitos
- Agentes Anticolesterêmicos
- Agentes Hipolipidêmicos
- Agentes Reguladores Lipídicos
- Inibidores da hidroximetilglutaril-CoA redutase
- Atorvastatina
Outros números de identificação do estudo
- Protocol No. 1988
- Grant# 2004-1035 (Número de outro subsídio/financiamento: RSRB 29937)
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 .
Ensaios clínicos em Atorvastatina
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