Clinical trial NCT00301392: Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)
Official title: Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Glucose Intolerance
Keywords: Glucose intolerance
Diabetes mellitus
Statins,HMG-CoA
Lead sponsor: Tokyo University
Sponsor class: OTHER
First posted: 2006-03-10
Enrollment: 1240
Sex: ALL
Minimum age (years): 30
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effects of pitavastatin for preventing diabetes in a population with impaired glucose tolerance.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria for the screening test (within 6 months before screening):

* LDL-cholesterol 100-159 mg/dl and/or total cholesterol 180-239 mg/dl
* At least one of the following:

  1. Fasting plasma glucose 100-125 mg/dl, and/or casual (non-fasting) plasma glucose 120-199 mg/dl, and/or HbA1c 5.5-6.0%
  2. At least two of the following risk factors for impaired glucose tolerance:

     1. Second degree relative with diabetes
     2. BMI \>= 24 kg/m2
     3. Systolic blood pressure \>=130 mmHg, and/or diastolic blood pressure \>= 85 mmHg, and/or receiving treatment for hypertension
     4. Triglyceride \>= 150 mg/dl, and/or HDL \< 40 mg/dl
* Written consent for participation in the study by their own volition after being provided sufficient explanation for the participation into this clinical trial

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:

* History of diabetes (except gestational diabetes)
* Fasting plasma glucose \>= 126 mg/dl , and/or 2-h plasma glucose \>= 200 mg/dl
* HbA1c \>= 6.5%
* Diabetic retinopathy
* Receiving with hormone replacement therapy
* Pancreatic diseases ( e.g. pancreatitis, pancreatectomy, pancreatic cancer), Endocrine diseases ( e.g. Cushing's syndrome, acromegaly, pheochromocytoma, aldosteronism, hyperthyroidism )
* Receiving statins, fibrates or anion exchange resins
* Cancer or suspected cancer
* History of gastrectomy
* History of myocardial infarction, angina, or heart failure (NYHA Class \>= III)
* Severe hypertension (SBP \>= 180 mmHg or DBP \>= 110 mmHg)
* Renal disease, including serum creatinine \>= 2.0 mg/dl
* Hepatic disease, including transaminase (ALT or AST) \>= 2 times the upper limit of normal
* Women hoping to become pregnant during the intended study period
* Contraindication or relative contraindication of Livalo® Tab(pitavastatin calcium)

  1. History of hypersensitivity to any of the ingredients of the product
  2. Severe hepatic disorder or biliary atresia
  3. Receiving cyclosporine
  4. Pregnant women, women suspected of being pregnant, or lactating women
  5. Patients receiving fibrates who also have laboratory evidence of abnormal renal function
* Familial hypercholesterolemia
* Drug abuse, alcoholism
* Individuals who are ineligible in the opinion of the investigator

Primary outcomes:
measure: Cumulative incidence of diabetes based on 1 positive OGTT or fasting glucose levels
timeFrame: from April, 2006 to end of March, 2012
Secondary outcomes:
measure: Incidence of newly developed diabetes
timeFrame: from April, 2006 to end of March, 2012
measure: Cumulative incidence of diabetes based on clinical diagnosis.
timeFrame: from April, 2006 to end of March, 2012
measure: Cumulative incidence of newly developed diabetes based on 1 positive OGTT or fasting glucose levels
timeFrame: from April, 2006 to end of March, 2012
measure: Time until development of diabetes; Improvement in glucose tolerance
timeFrame: from April, 2006 to end of March, 2012
measure: Incidence of any cardiovascular disease (myocardial infarction, angina, congestive heart disease, coronary revascularization, cerebral hemorrhage, cerebral infarction.
timeFrame: from April, 2006 to end of March, 2012
measure: Incidence of coronary heart disease (myocardial infarction, angina, coronary revascularization)
timeFrame: from April, 2006 to end of March, 2012
measure: Incidence of coronary heart disease plus cerebral infarction
timeFrame: from April, 2006 to end of March, 2012
measure: LDL-cholesterol
timeFrame: from April, 2006 to end of March, 2012
measure: HDL-cholesterol
timeFrame: from April, 2006 to end of March, 2012
measure: Triglyceride
timeFrame: from April, 2006 to end of March, 2012
measure: RLP-cholesterol
timeFrame: from April, 2006 to end of March, 2012
measure: Adiponectin
timeFrame: from April, 2006 to end of March, 2012
measure: High sensitive CRP
timeFrame: from April, 2006 to end of March, 2012
measure: Asymmetrical dimethyl arginine (ADMA)
timeFrame: from April, 2006 to end of March, 2012
measure: Urinary 8-OHd
timeFrame: from April, 2006 to end of March, 2012
measure: Fasting plasma glucose
timeFrame: from April, 2006 to end of March, 2012
measure: 2-h plasma glucose during 75g oral glucose tolerance test
timeFrame: from April, 2006 to end of March, 2012
measure: HbA1c
timeFrame: from April, 2006 to end of March, 2012
measure: Insulin
timeFrame: from April, 2006 to end of March, 2012
measure: HOMA-R
timeFrame: from April, 2006 to end of March, 2012
measure: HOMA-β
timeFrame: from April, 2006 to end of March, 2012
measure: Insulinogenic index
timeFrame: from April, 2006 to end of March, 2012
measure: Time until dropout
timeFrame: from April, 2006 to end of March, 2012
measure: Number of adverse events
timeFrame: from April, 2006 to end of March, 2012
Other outcomes:
Locations:
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo, Graduate School of Medicine
state: Tokyo
Study officials:
affiliation: Professor, Department of Metabolic Diseases, Graduate School of Medicine, the University of Tokyo.
name: Takashi Kadowaki, MD,PhD
role: STUDY_CHAIR
References: