NCT00170937已完成4 期
A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan and Hydrochlorothiazide Combined and Alone, in Patients With Metabolic Syndrome
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 507
- 试验地点
- 2
- 主要终点
- Change from baseline in insulin sensitivity after 16 weeks
研究概览
简要总结
The metabolic syndrome is a classification for patients with a constellation of risk factors which may include abdominal obesity, hypertension, elevated blood lipids and sugar. Three or more of these factors together constitute the metabolic syndrome and place these patients at a greater risk for the development of diabetes and cardiovascular diseases. The purpose of this study is to determine whether two common drugs to lower blood pressure, whether used separately or in combination, have different effects on blood sugar levels in patients diagnosed with the metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Waist circumference: males > 40", females > 35 "
- •MSSBP ≥ 130 mmHg but ≤ 160 mmHg and a MSDBP ≥ 85 mmHg but ≤ 100 mmHg
- •At least one of the following criteria: - Fasting plasma glucose between 5.9 and 6.9 mmol/L; - Serum triglycerides > 150 mg/dL; - LDL Cholesterol: - < 40 mg/dL males; - < 50 mg/dL females
排除标准
- •MSSBP> 180 mmHg or MSDBP > 110 mmHg
- •Inability to discontinue all prior antihypertensives for a period of 4 weeks.
- •History of diabetes
- •History of stroke, transient ischemic attack or myocardial infarction.
- •Significant weight change > 10 lbs during screening period
- •Patients taking a diuretic for 3 months prior to screening.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change from baseline in insulin sensitivity after 16 weeks
次要结局
- Change from baseline in lipid profile after 16 weeks
- Change from baseline in markers of inflammation and thrombosis after 16 weeks
- Change from baseline in a measurement of beta cell function after 16 weeks
- Change from baseline in fasting plasma glucose and fasting insulin after 16 weeks
- Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 16 weeks
研究者
研究点 (2)
Loading locations...
相似试验
撤回
不适用
Insulin Resistance and Insulin SecretionDiabetes Mellitus, Type 2NCT00073294National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Unknown
不适用
Effects of Moderate Altitude Training on Metabolic Parameters in Voluntary Study Participants With Metabolic SyndromeMetabolic SyndromeNCT02013947Pure Mountain Solda40
已完成
不适用
Peds Metabolic Syndrome in PsoriasisPsoriasisMetabolic SyndromeNCT00930592Tufts Medical Center42
已完成
2 期
Acetylcarnitine and Insulin SensitivityType 2 Diabetes MellitusNCT00393770Mario Negri Institute for Pharmacological Research43
已完成
不适用
Study: Diet and Exercise Study to Improve Brain Blood Flow: Blood Flow Improvement TrialPreDiabetesNCT03117829University of Wisconsin, Madison30