The Statins on Glucose Homeostasis in Subjects With Impaired Fasting Glucose

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Taipei Veterans General Hospital, Taiwan
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01816997
First received: December 28, 2012
Last updated: November 15, 2013
Last verified: November 2013

December 28, 2012
November 15, 2013
January 2012
December 2017   (final data collection date for primary outcome measure)
Glucose homeostasis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01816997 on ClinicalTrials.gov Archive Site
  • Some biomarkers of diabetes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Such as GLP-1, GIP, IGF-1, HbA1c, FPG etc.
  • Progression of glucose homeostasis [ Time Frame: 5 to 10 years. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Retinopathy: The change of steps on the ETDRS Severity Scales. Nephropathy: UACR and eGFR change. All-cause mortality
  • Incidence of diabetes [ Time Frame: 5 to 10 years. ] [ Designated as safety issue: No ]
    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.
  • Chronic complications of diabetes [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Such as GLP-1, GIP, IGF-1, HbA1c, FPG etc.
  • Progression of glucose homeostasis [ Time Frame: 5 to 10 years. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Retinopathy: The change of steps on the ETDRS Severity Scales. Nephropathy: UACR and eGFR change. All-cause mortality
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Diabetes
  • 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 Name: Pravastatin (Mevalotin)
  • 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 Name: Crestor
  • Drug: Control
    placebo
    Other Name: placebo
  • Placebo Comparator: Control
    IFG subjects with total cholesterol less than 200 mg/dL will be served as controls.
    Intervention: Drug: Control
  • 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.
    Intervention: Drug: Pravastatin
  • 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.
    Intervention: Drug: Rosuvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
December 2022
December 2017   (final data collection date for primary outcome measure)

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.
Both
35 Years to 70 Years
No
Contact: Harn-Shen Chen, MD, PhD 886-2-28757515 chenhs@vghtpe.gov.tw
Taiwan
 
NCT01816997
VGHIRB 2011-10-005IA
No
vghtpe user, Taipei Veterans General Hospital, Taiwan
Taipei Veterans General Hospital, Taiwan
Not Provided
Principal Investigator: Harn-Shen Chen, MD, PhD Taipei Veterans General Hospital, Taiwan
Taipei Veterans General Hospital, Taiwan
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP