The Statins on Glucose Homeostasis in Subjects With Impaired Fasting Glucose

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01816997
• Other study ID #: VGHIRB 2011-10-005IA
• Status: Recruiting
• Phase: Phase 4
• First received: December 28, 2012
• Last updated: November 15, 2013
• Start date: January 2012
• Est. completion date: December 2022

Study information

• Verified date: November 2013
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Harn-Shen Chen, MD, PhD
• Phone: 886-2-28757515
• Email: chenhs[@]vghtpe.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2022
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes
• Prediabetic State

Intervention

Drug:
• Pravastatin
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.
• 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.
• Control
placebo

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Some biomarkers of diabetes	Such as GLP-1, GIP, IGF-1, HbA1c, FPG etc.	6 months	No
Secondary	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.	No
Secondary	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	No
Secondary	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.	No
Secondary	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	No