The Statins on Glucose Homeostasis in Subjects With Impaired Fasting Glucose

Study Overview
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Brief Summary
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Evaluate the effects of rosuvastatin (maybe the highest diabetogenic) and pravastatin (seems to be protective) on the glucose homeostasis and other biomarkers in subjects with impaired fasting glucose.

Detailed Description
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Statin therapy effectively reduces cardiovascular events. However, trial data1 and meta-analyses suggest that statins also confer increased risk of development of diabetes. In order to elucidate whether statins increase risk of diabetes, investigators conducted this study to evaluate the effects of rosuvastatin (maybe the highest diabetogenic) and pravastatin (seems to be protective) on the glucose homeostasis and other biomarkers in subjects with impaired fasting glucose.

Official Title
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The Influence of Statins on Glucose Homeostasis and the Biomarkers of Diabetes in Subjects With Impaired Fasting Glucose

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Pravastatin
* Drug: Rosuvastatin
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 35-70 years old Fasting blood glucose 100-125 mg/dL Exclusion Criteria: A1C >7.0% 2hr glucose during OGTT >200 mg/dL Total cholesterol >280 mg/dL Previous diabetic history, coronary artery disease Allergy to rosuvastatin or parvastatin Baseline ALT more than 3 times UNL Serum Cr > 2.0 mg/dL Pregnancy, breast feeding or plan to be pregnant woman.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>IFG subjects with total cholesterol less than 200 mg/dL will be served as controls. | Drug: Control<br>* placebo<br>* Other names: placebo;|
| Active Comparator: Pravastatin<br>The impaired fasting glucose (IFG) subjects with total cholesterol 200-280 mg/dL will be randomized into two groups: pravastatin 40 mg or rosuvastatin 10 mg. | Drug: Pravastatin<br>* The impaired fasting glucose (IFG) subjects with total cholesterol 200-280 mg/dL were randomized into two groups: pravastatin 40 mg or rosuvastatin 10 mg. IFG subjects with total cholesterol less than 200 mg/dL will be served as controls.<br>* Other names: Pravastatin (Mevalotin);|
| Experimental: Rosuvastatin<br>The impaired fasting glucose (IFG) subjects with total cholesterol 200-280 mg/dL will be randomized into two groups: pravastatin 40 mg or rosuvastatin 10 mg. | Drug: Rosuvastatin<br>* The impaired fasting glucose (IFG) subjects with total cholesterol 200-280 mg/dL were randomized into two groups: pravastatin 40 mg or rosuvastatin 10 mg. IFG subjects with total cholesterol less than 200 mg/dL will be served as controls.<br>* Other names: Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose homeostasis | Compare the glucose homeostasis and some biomarkers of diabetes among control, parvastatin and rosuvastatin groups. Glucose and insulin response during OGTT. Some markers of insulin resistance and insulin secretion calculated from OGTT. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Some biomarkers of diabetes | Such as GLP-1, GIP, IGF-1, HbA1c, FPG etc. | 6 months | 
| Progression of glucose homeostasis | We will repeat FPG and A1C every 6 months and OGTT every 1-2 years for up to 10 years to investigate the change of these parameters. | 5 to 10 years. | 
| Chronic complications of diabetes | Retinopathy: The change of steps on the ETDRS Severity Scales. Nephropathy: UACR and eGFR change. All-cause mortality | Up to 10 years | 
| Incidence of diabetes | We will repeat FPG and A1C every 6 months and OGTT every 1-2 years for up to 10 years to investigate the incidence of diabetes. | 5 to 10 years. | 
| Chronic complications of diabetes | Diabetic retinopathy: Development of advanced diabetic retinopathy. Advanced diabetic retinopathy was defined as development of proliferative diabetic retinopathy, retinopathy treated with laser photocoagulation or vitrectomy. Nephropathy: Development of macroalbuminuria (UACR >30 mg/mmol creatinine), a severe decline in eGFR (<30 mL/[min•1.73 m2]). Cardiovacular events: angina, myocardial infarction, heart failure, acute coronary syndrome and cerebrovascular accident. | Up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Statins, Glucose homeostasis, Diabetes, Impaired fasting glucose