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Completed

NCT Number: NCT02754739

Effect of Pravastatin in the Subjects With Prediabetes or Early Diabetes

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pravastatin

Drug

Pravastatin 40mg once daily for 24 weeks and nutritional education by a nutritionist

Placebo (for Pravastatin)

Drug

Pill manufactured to mimic pravastatin 40mg tablet once daily for 24 weeks and nutritional education by a nutritionist

Nutritional education only

Behavioral

Only nutritional education by a nutritionist

Other names: Open-label control

Primary outcomes

  1. Insulin resistance assessed by HOMA-IR (homeostatic model assessment index for insulin resistance)

    Time frame: at the end of the 24 weeks of medication period

    compared to the HOMA-IR level calculated at the initial visit (at the beginning of the 24 weeks of medication period)

Secondary outcomes

  1. Insulin resistance assessed by Matsuda index calculated through 75g oral glucose tolerance test

    Time frame: at the end of the 24 weeks of medication period

    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

  2. Insulin secretion capacity assessed by insulinogenic index (INS index) during 75g oral glucose tolerance test

    Time frame: at the end of the 24 weeks of medication period

    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)

  3. Insulin resistance assessed by the quantitative insulin sensitivity check index (QUICKI)

    Time frame: at the end of the 24 weeks of medication period

    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)

  4. Insulin secretory capacity relative to insulin resistance assessed by the oral disposition index

    Time frame: at the end of the 24 weeks of medication period

    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)

  5. Glycemic control evaluated by fasting glucose level (mg/dL)

    Time frame: at the end of the 24 weeks of medication period

    compared to the values at the initial visit

  6. Glycemic control evaluated by hemoglobin A1C (%)

    Time frame: at the end of the 24 weeks of medication period

    compared to the values at the initial visit

  7. Plasma adioponectin level (μg/ml), an adipocyte-derived insulin-sensitizing hormone level

    Time frame: at the end of the 24 weeks of medication period

    compared to the values at the initial visit

  8. Biomarkers predicting cardiovascular diseases, assessed by high sensitive C-reactive protein (hsCRP) (mg/dL)

    Time frame: at the end of the 24 weeks of medication period

    compared to the values at the initial visit

  9. Biomarkers predicting cardiovascular diseases, assessed by plasminogen activator inhibitor-1 (PAI-1) (ng/mL)

    Time frame: at the end of the 24 weeks of medication period

    compared to the values at the initial visit

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Daiichi Sankyo Korea Co., Ltd.

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 28, 2016
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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