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Effect of Pravastatin in the Subjects With Prediabetes or Early Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02754739
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Daiichi Sankyo Korea Co., Ltd.
Information provided by (Responsible Party):
MOON-KYU LEE, Samsung Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Prediabetic State Drug: Pravastatin Drug: Placebo (for Pravastatin) Behavioral: Nutritional education only Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description: This study was initially designed as a single center, double-blind, placebo-controlled, 2-group factorial randomized trial (placebo or pravastatin 40mg once daily for 24 weeks). Subjects were randomly assigned, in a 1:1 ratio, to receive pravastatin in a blinded fashion at a dose of 40 mg once daily or placebo. However, because of the problem of expiration date of the placebo drug, the study was converted to an open-label trial, and subjects without any medications were enrolled in an open-label control group in contrast to the pravastatin group. Therefore, the study cohort comprised the pravastatin group, placebo group, and the open-label control group. The placebo group and the open-label control group were classified as the control group.
Primary Purpose: Treatment
Official Title: Effect of Pravastatin in the Subjects With Prediabetes or Early Diabetes
Actual Study Start Date : April 15, 2014
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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

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 Name: Open-label control




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754739


Locations
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Korea, Republic of
Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Daiichi Sankyo Korea Co., Ltd.
Investigators
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Principal Investigator: Moon-Kyu Lee, MD, PhD Samsung Medical Center
Publications:

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Responsible Party: MOON-KYU LEE, M.D., Ph.D., Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02754739    
Other Study ID Numbers: 2012-12-103
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Keywords provided by MOON-KYU LEE, Samsung Medical Center:
Pravastatin
Insulin Resistance
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors