Hypercholesterolemia, Metabolic Syndrome
Conditions
Keywords
pitavastatin, metabolic syndrome, metabolic syndrome risk score, hypercholesterolemia
Brief summary
We will identify the influence of long-term treatment of Pitavastatin compared to non-treatment control group on the metabolic syndrome by evaluation of a change of metabolic syndrome component score. And we will additionally observe the changes of CVD risk factors like lipid profile, abdominal fat, insulin resistance and so on.
Interventions
DRUGpitavastatin
Pitavastatin 2mg daily once
BEHAVIORALLifestyle Modification
conducting mainly exercises and diet
Sponsors
JW Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18 and 75 * Patients with LDL ≥ 100mg/dL * Patients with metabolic syndrome 1. IFG: Fasting glucose ≥ 100mg/dL 2. Abdominal Obesity: Waist circumference: men≥90cm,women≥85cm 3. 1 or more of the following 1. Triglyceride ≥ 150mg/dL 2. HDL-C: men \< 40mg/dL, women \< 50mg/dL 3. Blood pressure: SBP ≥ 130mmHg or DBP ≥ 85mmHg or subject receiving anti-hypertensive treatment
Exclusion criteria
* uncontrolled hypertension (DBP ≥ 95mmHg) * taking diabetic drugs or with HbA1c \> 8% * LDL ≥ 190mg/dL or Triglyceride ≥ 400mg/dL * coronary heart disease or other diseases caused by artherosclerosis * malignancy within 6 months * Serum creatinine ≥ 2.0mg/dL * ALT or AST ≥ ULN\*2.5 * CPK ≥ ULN\*2 * hypothyroidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A change of metabolic syndrome risk component | 48week |
Secondary
| Measure | Time frame |
|---|---|
| Changes of cardiometabolic profiles : lipid profiles, hs-CRP, adiponectin, HMW adiponectin | 48week |
| Changes of abdominal visceral fat | 48week |
| Changes of insulin resistance : OGTT(75g), HOMA | 48week |
Countries
South Korea
Outcome results
None listed