Effect of Pravastatin in the Subjects With Prediabetes or Early Diabetes
Diabetes Mellitus, Prediabetic State
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Pravastatin, Insulin Resistance
Eligibility Criteria
Inclusion Criteria:
Subjects have early diabetes mellitus or prediabetes. Early diabetes mellitus or prediabetes are defined according to the following criteria; Subjects have two or more of the following three, or they have one of them at the initial test and the repeat test.
- hemoglobin A1C 5.7-9.0%
- fasting plasma glucose level 100mg/dL or more
- plasma glucose level 140mg/dL or more at 2 hours after 75g oral glucose tolerance test
Subjects have one of the following three;
- Low-density lipoprotein cholesterol (LDL-cholesterol) 130mg/dL or more, and body mass index (BMI) > 23 kg/m2,
- 10 year atherosclerotic cardiovascular disease (ASCVD) risk of 7.5% or more, which is assessed by the ASCVD-Risk-Estimator (Circulation.2014;129:S1-S45)
- In diabetic patients, LDL-cholesterol 100mg/dL or more
Exclusion Criteria:
- Hemoglobin A1C > 9.0%
- History of statin use in three months
- Use of oral antidiabetic drugs except for metformin in three months
- History of malignant diseases (cancers)
- History of coronary artery diseases, heart failure, arrhythmia, valvular heart diseases, or cerebrovascular diseases
- Pregnant
- serum creatinine level > 1.5 mg/dL
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels higher than 80 U/l
- Taking weight loss medications, corticosteroids, Angiotensin converting enzyme (ACE) inhibitors, or estrogen replacement therapy
- Chronic hepatitis B or chronic hepatitis C
Sites / Locations
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Other
Pravastatin
Placebo
Open-label control
Pravastatin 40mg tablet by mouth, once daily for 24 weeks. Also, nutritional education was provided to participants in all arms by a nutritionist, and participants were instructed to follow the educated guideline.
Placebo drug indistiguishable from pravastatin 40mg tablet, by mouth, once daily for 24 weeks. Also, nutritional education was provided to participants in all arms by a nutritionist, and participants were instructed to follow the educated guideline.
No medication. Only nutritional education was provided to participants by a nutritionist, and participants were instructed to follow the educated guideline.