The Statins on Glucose Homeostasis in Subjects With Impaired Fasting Glucose

Taipei Veterans General Hospital

Status and phase: Unknown; Phase 4

Conditions: Diabetes

Treatments: Drug: Rosuvastatin; Drug: Control; Drug: Pravastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01816997

VGHIRB 2011-10-005IA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

IFG subjects with total cholesterol less than 200 mg/dL will be served as controls.

Treatment:

Drug: Control

Pravastatin

Active Comparator group

Description:

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.

Treatment:

Drug: Pravastatin

Rosuvastatin

Experimental group

Description:

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.

Treatment:

Drug: Rosuvastatin