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

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 Overview

• Status: Unknown
• Conditions: Diabetes
• Intervention / Treatment: Drug: Control; Drug: Pravastatin; Drug: Rosuvastatin

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Harn-Shen Chen, MD, PhD; Phone Number: 886-2-28757515

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control; IFG subjects with total cholesterol less than 200 mg/dL will be served as controls.	Drug: Control; placebo; Other Names: placebo
ACTIVE_COMPARATOR: 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: 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.; Other Names: Pravastatin (Mevalotin)
EXPERIMENTAL: 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.	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.; Other Names: Crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Some biomarkers of diabetes	Such as GLP-1, GIP, IGF-1, HbA1c, FPG etc.	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.	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	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.	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.	Up to 10 years

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: December 28, 2012
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (ESTIMATE): March 22, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 18, 2013
• Last Update Submitted That Met QC Criteria: November 15, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Diabetes; Statins; Impaired fasting glucose; Glucose homeostasis
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Pravastatin
• Other Study ID Numbers: VGHIRB 2011-10-005IA