A Phase 4 interventional study of Pravastatin and Rosuvastatin in Diabetes, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-11-18.
Sponsored by Taipei Veterans General Hospital, Taiwan · Phase 4, Interventional, and Health services research
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.
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.
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 160 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
IFG subjects with total cholesterol less than 200 mg/dL will be served as controls.
Drug: Control
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
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
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.
Also known as: Pravastatin (Mevalotin)
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.
Also known as: Crestor
placebo
Also known as: placebo
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.
Time frame: 6 months
Some biomarkers of diabetes
Such as GLP-1, GIP, IGF-1, HbA1c, FPG etc.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Up to 10 years
This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rosuvastatin
Taipei Veterans General Hospital, Taiwan →