Interactions of Thrombogenic, Lipogenic, and Inflammatory Markers in Women With the Metabolic Syndrome - Effect of Atorvastatin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Mean High Sensitivity C-reactive Protein in Blood
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages of 18-75 with Metabolic syndrome
- •Abdominal circumference > 35 in
- •Hypertriglyceridemia > 150mg/dl
- •Blood Pressure >130/85
- •Fasting Glucose >100
排除标准
- •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
研究组 & 干预措施
Atorvastatin
44 women randomized to 80 mg atorvastatin for 6weeks
干预措施: Atorvastatin (Drug)
sugar pill
44 women randomized to placebo for 6 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Mean High Sensitivity C-reactive Protein in Blood
时间窗: 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
Mean Waist Circumference
时间窗: 6 weeks
Waist circumference was measured with a ruler tape.
Mean Systolic Blood Pressure
时间窗: 6 weeks
Measured with a blood pressure cuff
Mean High Density Lipoprotein Cholesterol in Blood
时间窗: 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.
Mean Triglycerides in Blood
时间窗: 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.
Mean Diastolic Blood Pressure
时间窗: 6 weeks
Measured with a blood pressure cuff
Mean Fasting Plasma Glucose in Blood
时间窗: 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.
Mean Aspartate Aminotransferase in Blood
时间窗: 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.
Mean Leptin in Blood
时间窗: 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.
Mean Low Density Lipoprotein Cholesterol in Blood
时间窗: 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.
Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood
时间窗: 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.
Mean Soluble Intercellular Adhesion Molecule in Blood
时间窗: 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.
Mean Myeloperoxidase in Blood
时间窗: 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.
Mean Apolipoprotein B in Blood
时间窗: 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.
Mean Alanine Aminotransferase in Blood
时间窗: 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.
Mean Soluble Vascular Adhesion Molecule in Blood
时间窗: 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.
Mean Plasminogen Activator Inhibitor-1 in Blood
时间窗: 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.
次要结局
- Mean Fasting Blood Glucose in Blood(0 weeks)
- Mean Diastolic Blood Pressure(0 weeks)
- Mean Vascular Adhesion Molecule in Blood(0 weeks)
- Mean Myeloperoxidase in Blood(0 weeks)
- Mean Apolipoprotein A-1 in Blood(0 weeks)
- Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood(0 weeks)
- Mean Plasminogen Activator Inhibitor-1 in Blood(0 weeks)
- Mean Triglycerides in Blood(0 weeks)
- Mean High Density Lipoprotein Cholesterol in Blood(0 weeks)
- Mean Apolipoprotein B in Blood(0 weeks)
- Mean Waist Circumference(week 0)
- Mean Low Density Lipoprotein Cholesterol in Blood(0 weeks)
- Mean Systolic Blood Pressure(0 weeks)
- Mean Hs-C Reactive Protein in Blood(0 weeks)
- Mean Intercellular Adhesion Molecule in Blood(0 weeks)
- Mean Leptin in Blood(0 weeks)
研究者
Gladys Velarde
Principle Investigator
University of Rochester