An increased risk of incident diabetes with statin therapy have been reported in several studies. However, it is not recommended to limit the use of statin for this reason since the absolute risk increase was small, and the cardiovascular event rate reduction with statins overweighed the risk of new diabetes (Scatter N et al. Lancet, 2010). Moreover, each statin may have different effect on the development of incident diabetes. In the West of Scotland Coronary Prevention Study, pravastatin therapy reduced the hazard of becoming diabetic by 30%. Also, with pravastatin use, an increase in adiponectin level, which is related to the improvement in insulin sensitivity, has been reported. In this clinical trial, the investigators are aiming to evaluate the effect of pravastatin on insulin resistance, insulin secretion, glycemic control, and adiponectin level in participants with prediabetes or early diabetes by assigning them in a 24 weeks of pravastatin therapy group or in a placebo group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Pravastatin 40mg once daily for 24 weeks and nutritional education by a nutritionist
Pill manufactured to mimic pravastatin 40mg tablet once daily for 24 weeks and nutritional education by a nutritionist
Only nutritional education by a nutritionist
Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea
Insulin resistance assessed by HOMA-IR (homeostatic model assessment index for insulin resistance)
compared to the HOMA-IR level calculated at the initial visit (at the beginning of the 24 weeks of medication period)
Time frame: at the end of the 24 weeks of medication period
Insulin resistance assessed by Matsuda index calculated through 75g oral glucose tolerance test
calculated according to a method described in a previous study (Matsuda M et al. Diabetes Care, 1999), compared to the results at the initial visit (at the beginning of the 24 weeks of medication period). It takes 120 minutes to perform 75g oral glucose tolerance test
Time frame: at the end of the 24 weeks of medication period
Insulin secretion capacity assessed by insulinogenic index (INS index) during 75g oral glucose tolerance test
the ratio relating enhancement of circulating insulin in 30min \[in pmol/L\] to magnitude of corresponding glycemic stimulus in 30min \[in mmol/L\] during the oral glucose tolerance test (H.S. Seltze et al. J. Clin. Investig., 1967), compared to the results at the initial visit (at the beginning of the 24 weeks of medication period)
Time frame: at the end of the 24 weeks of medication period
Insulin resistance assessed by the quantitative insulin sensitivity check index (QUICKI)
calculated using fasting insulin in uIU/mL and fasting plasma glucose in mg/dL according to the method described in a previous study (A. Katz et al. J. Clin. Endocrinol. Metab., 2000), compared to the results at the initial visit (at the beginning of the 24 weeks of medication period)
Time frame: at the end of the 24 weeks of medication period
Insulin secretory capacity relative to insulin resistance assessed by the oral disposition index
calculated according to a method described in a previous study (K.M. Utzschneider et al.Diabetes Care, 2008), compared to the results at the initial visit (at the beginning of the 24 weeks of medication period)
Time frame: at the end of the 24 weeks of medication period
Glycemic control evaluated by fasting glucose level (mg/dL)
compared to the values at the initial visit
Time frame: at the end of the 24 weeks of medication period
Glycemic control evaluated by hemoglobin A1C (%)
compared to the values at the initial visit
Time frame: at the end of the 24 weeks of medication period
Plasma adioponectin level (μg/ml), an adipocyte-derived insulin-sensitizing hormone level
compared to the values at the initial visit
Time frame: at the end of the 24 weeks of medication period
Biomarkers predicting cardiovascular diseases, assessed by high sensitive C-reactive protein (hsCRP) (mg/dL)
compared to the values at the initial visit
Time frame: at the end of the 24 weeks of medication period
Biomarkers predicting cardiovascular diseases, assessed by plasminogen activator inhibitor-1 (PAI-1) (ng/mL)
compared to the values at the initial visit
Time frame: at the end of the 24 weeks of medication period
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