Effect of Pravastatin in the Subjects With Prediabetes or Early Diabetes

September 11, 2018 updated by: MOON-KYU LEE, Samsung Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

    1. hemoglobin A1C 5.7-9.0%
    2. fasting plasma glucose level 100mg/dL or more
    3. plasma glucose level 140mg/dL or more at 2 hours after 75g oral glucose tolerance test

  • Subjects have one of the following three;

    1. Low-density lipoprotein cholesterol (LDL-cholesterol) 130mg/dL or more, and body mass index (BMI) > 23 kg/m2,
    2. 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)
    3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pravastatin
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.
Drug: Pravastatin
Pravastatin 40mg once daily for 24 weeks and nutritional education by a nutritionist
Placebo Comparator: Placebo
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.
Drug: Placebo (for Pravastatin)
Pill manufactured to mimic pravastatin 40mg tablet once daily for 24 weeks and nutritional education by a nutritionist
Other: Open-label control
No medication. Only nutritional education was provided to participants by a nutritionist, and participants were instructed to follow the educated guideline.
Behavioral: Nutritional education only
Only nutritional education by a nutritionist
Other Names:
  • Open-label control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at the end of the 24 weeks of medication period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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)
at the end of the 24 weeks of medication period
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)
at the end of the 24 weeks of medication period
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)
at the end of the 24 weeks of medication period
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
at the end of the 24 weeks of medication period
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
at the end of the 24 weeks of medication period
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
at the end of the 24 weeks of medication period
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
at the end of the 24 weeks of medication period
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
at the end of the 24 weeks of medication period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Daiichi Sankyo Korea Co., Ltd.

Investigators

  • Principal Investigator: Moon-Kyu Lee, MD, PhD, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2014

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

April 9, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-12-103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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