Effect of Pravastatin in the Subjects With Prediabetes or Early Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-15

Study Completion Date

2017-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Mellitus Prediabetic State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Pravastatin

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo (for Pravastatin)

Intervention Type DRUG

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.

Group Type OTHER

Nutritional education only

Intervention Type BEHAVIORAL

Only nutritional education by a nutritionist

Interventions

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Pravastatin

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

Intervention Type DRUG

Placebo (for Pravastatin)

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

Intervention Type DRUG

Nutritional education only

Only nutritional education by a nutritionist

Intervention Type BEHAVIORAL

Other Intervention Names

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Open-label control

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No