Effect of Caduet and TLC Intervention on Metabolic Parameters
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 53
- 主要终点
- Resolution or improvement of metabolic syndrome.
研究概览
简要总结
To evaluate the effectiveness of Caduet in addition to therapeutic life-style change (TLC) intervention in resolving metabolic syndrome fifty three individuals were randomized to TLC intervention study with or without Caduet therapy for 12 months. The participants underwent monthly visits with investigators to obtain vital signs, and to undergo TLC counseling. Metabolic parameters were measured before and after intervention.
详细描述
Single center, investigator driven, double blinded, randomized with Caduet 5/10mg vs placebo. The participants visited with investigators on a monthly bases to evaluate the BP, weight, and obtain the waist measurements, and counseling. OGTT was performed at the beginning and the end of the study. Lipid and glucose parameters were measured 5 times in duration of the study period.
Exercise physiologists and dietitians completed the baseline evaluations and provided recommendations throughout the study period in person, via phone or e-mail: per subject preference. VO2 max was measured at the beginning and end of the study. Pedometers dispensed to encourage physical activity.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BP ≥130/85
- •Metabolic syndrome per NCEP-ATP III revised (3/5 criteria)
- •Men and women age 40-65
排除标准
- •Inability to sign a consent form.
- •Unwillingness to complete the protocol for the duration of 15 months
- •Unwillingness of primary care physician to participate in the program
- •Patients already on hypercholesterolemia agent
- •Fasting plasma glucose above 126 mg/dL or current treatment for diabetes.
- •If the physician believes the patient should be started on antihypertensive regimen.
- •Creatinine clearance <50ml/min.
- •Therapy with anticoagulants
- •Pregnant/lactating women (pre-menopausal women should be on birth control pill)
- •AST/ALT > x3 upper limit of normal
- •Evidence of cholelithiasis
- •Use of oral anticoagulants
- •Recent cardiovascular event (<6months)
- •Substance abuse
- •Since there is no translator, non-English speaking subjects will not be enrolled in the study.
研究组 & 干预措施
Therapeutic Lifestyle Change+Placebo
Therapeutic Life-style change intervention with Placebo pills.
干预措施: Therapeutic Lifestyle Change (Behavioral)
Therapeutic Lifestyle Change+Placebo
Therapeutic Life-style change intervention with Placebo pills.
干预措施: Placebo (Drug)
Therapeutic Lifestyle Change+Caduet
Therapeutic Lifestyle Change intervention with Caduet pills.
干预措施: Therapeutic Lifestyle Change (Behavioral)
Therapeutic Lifestyle Change+Caduet
Therapeutic Lifestyle Change intervention with Caduet pills.
干预措施: Caduet Pill (Drug)
结局指标
主要结局
Resolution or improvement of metabolic syndrome.
时间窗: 12 months
HDL \>40mg/dl for men, \>50 mg/dl for women. Glucose \<100mg/dl Waist circumference \<40 in in men, \<35 in in women Triglycerides \<150mg/dl BP \<130/80 Attainment of 1 or more of these goals will result in resolution or improvement of metabolic syndrome
次要结局
- Weight loss(12 months)