The Statins on Glucose Homeostasis in Subjects With Impaired Fasting Glucose

Phase 4

• Conditions: Diabetes
• Interventions: Drug: Control; Drug: Pravastatin; Drug: Rosuvastatin

• Registration Number: NCT01816997
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-12-28
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-22
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-15
• Last Update Posted: 2013-11-18
• Primary Completion: 2017-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Age 35-70 years old
2. Fasting blood glucose 100-125 mg/dL

Exclusion Criteria

1. A1C >7.0%
2. 2hr glucose during OGTT >200 mg/dL
3. Total cholesterol >280 mg/dL
4. Previous diabetic history, coronary artery disease
5. Allergy to rosuvastatin or parvastatin
6. Baseline ALT more than 3 times UNL
7. Serum Cr > 2.0 mg/dL
8. Pregnancy, breast feeding or plan to be pregnant woman.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	IFG subjects with total cholesterol less than 200 mg/dL will be served as controls.
Pravastatin	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.
Rosuvastatin	Rosuvastatin	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.

Primary Outcome Measures

Name	Time	Method
Glucose homeostasis	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Chronic complications of diabetes	Up to 10 years	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.
Some biomarkers of diabetes	6 months	Such as GLP-1, GIP, IGF-1, HbA1c, FPG etc.
Progression of glucose homeostasis	5 to 10 years.	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.
Incidence of diabetes	5 to 10 years.	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.

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan