A Phase 4 interventional study of life-style intervention and Life style interventions plus concomitant use of pitavastatin. in Diabetes Mellitus and Glucose Intolerance, sponsored by Tokyo University. Completed at 1 site in Japan. Open to participants aged 30 Years to 74 Years. Per ClinicalTrials.gov, last updated 2013-09-06.
Sponsored by Tokyo University · Phase 4, Interventional, and Prevention
The purpose of this study is to evaluate the effects of pitavastatin for preventing diabetes in a population with impaired glucose tolerance.
Diabetes mellitus and its complications are major health problems globally. People with impaired glucose tolerance (IGT) are at high risk of developing diabetes. It is therefore important to focus on preventing diabetes in individuals with IGT. HMG-CoA reductase inhibitors (statins) are widely used for hypercholesterolemia, one of the most frequent metabolic disorders. However, there is no direct evidence to whether statins are beneficial for preventing diabetes. This study is designed to compare the efficacy of life-style modification versus life-style modification with pitavastatin (a statin) administration, in individuals with IGT.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 1,240 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Tokyo University is the lead sponsor of 34 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for the screening test (within 6 months before screening):
At least one of the following:
At least two of the following risk factors for impaired glucose tolerance:
Inclusion Criteria for the entry (Confirmed by screening test):
-Impaired glucose tolerance by 75g oral glucose tolerance test (fasting plasma glucose \<126 mg/dl and 2-h plasma glucose 140-199 mg/dl)
Exclusion Criteria:
Contraindication or relative contraindication of Livalo® Tab(pitavastatin calcium)
Administration of Pitavastatin
Other: life-style intervention · Drug: Life style interventions plus concomitant use of pitavastatin.
As the life-style interventions aiming to reduce the major risks of developing diabetes mellitus, instruct the following four items:(1)set diet right, (2)maintain normal weight,(3)improve physical activity,(4)normalize smoking and alcohol drinking.
Once-daily dosing of pitavastatin 1 mg(1 tablet of Livalo Tab 1 mg), or 2mg(2 tablets of Livalo Tab 1mg or 1 tablet of Livalo Tab 2mg);Dosing period of pitavastatin should be 60 months.(max.84 months).
Cumulative incidence of diabetes based on 1 positive OGTT or fasting glucose levels
Time frame: from April, 2006 to end of March, 2012
Incidence of newly developed diabetes
Time frame: from April, 2006 to end of March, 2012
Cumulative incidence of diabetes based on clinical diagnosis.
Cumulative incidence of diabetes based on clinical diagnosis defined as at least one of the following:(1) Typical symptoms of diabet plus 1 positive OGTT or fasting glucose levels, (2)HbA1c\>=6.5% plus 1 positive OGTT or fasting glucose levels, (3)2 positive OGTT or fasting glucose levels.
Time frame: from April, 2006 to end of March, 2012
Cumulative incidence of newly developed diabetes based on 1 positive OGTT or fasting glucose levels
Cumulative incidence of newly developed diabetes based on 1 positive OGTT or fasting glucose levels (from the first administration of the study drug after the randomization)
Time frame: from April, 2006 to end of March, 2012
Time until development of diabetes; Improvement in glucose tolerance
Time frame: from April, 2006 to end of March, 2012
Incidence of any cardiovascular disease (myocardial infarction, angina, congestive heart disease, coronary revascularization, cerebral hemorrhage, cerebral infarction.
Time frame: from April, 2006 to end of March, 2012
Incidence of coronary heart disease (myocardial infarction, angina, coronary revascularization)
Time frame: from April, 2006 to end of March, 2012
Incidence of coronary heart disease plus cerebral infarction
Time frame: from April, 2006 to end of March, 2012
LDL-cholesterol
Time frame: from April, 2006 to end of March, 2012
HDL-cholesterol
Time frame: from April, 2006 to end of March, 2012
Triglyceride
Time frame: from April, 2006 to end of March, 2012
RLP-cholesterol
Time frame: from April, 2006 to end of March, 2012
Adiponectin
Time frame: from April, 2006 to end of March, 2012
High sensitive CRP
Time frame: from April, 2006 to end of March, 2012
Asymmetrical dimethyl arginine (ADMA)
Time frame: from April, 2006 to end of March, 2012
Urinary 8-OHd
Time frame: from April, 2006 to end of March, 2012
Fasting plasma glucose
Time frame: from April, 2006 to end of March, 2012
2-h plasma glucose during 75g oral glucose tolerance test
Time frame: from April, 2006 to end of March, 2012
HbA1c
Time frame: from April, 2006 to end of March, 2012
Insulin
Time frame: from April, 2006 to end of March, 2012
HOMA-R
Time frame: from April, 2006 to end of March, 2012
HOMA-β
Time frame: from April, 2006 to end of March, 2012
Insulinogenic index
Time frame: from April, 2006 to end of March, 2012
Time until dropout
Time frame: from April, 2006 to end of March, 2012
Number of adverse events
Time frame: from April, 2006 to end of March, 2012
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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