The Statins on Glucose Homeostasis in Subjects With Impaired Fasting Glucose

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01816997

Enrollment

160

Registered

2013-03-22

Start date

2012-01-31

Completion date

2022-12-31

Last updated

2013-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Statins, Glucose homeostasis, Diabetes, Impaired fasting glucose

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.

Interventions

DRUGPravastatin

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.

DRUGRosuvastatin

DRUGControl

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Chronic complications of diabetes	Up to 10 years	Retinopathy: The change of steps on the ETDRS Severity Scales. Nephropathy: UACR and eGFR change. All-cause mortality
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.

Countries

Taiwan

Contacts

Primary ContactHarn-Shen Chen, MD, PhD

chenhs@vghtpe.gov.tw886-2-28757515

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026