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The Statins on Glucose Homeostasis in Subjects With Impaired Fasting Glucose

This study is currently recruiting participants.
Verified November 2013 by vghtpe user, Taipei Veterans General Hospital, Taiwan
Sponsor:
ClinicalTrials.gov Identifier:
NCT01816997
First Posted: March 22, 2013
Last Update Posted: November 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan
  Purpose
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.

Condition Intervention Phase
Diabetes Drug: Pravastatin Drug: Rosuvastatin Drug: Control Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Influence of Statins on Glucose Homeostasis and the Biomarkers of Diabetes in Subjects With Impaired Fasting Glucose

Resource links provided by NLM:


Further study details as provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • Glucose homeostasis [ Time Frame: 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 Outcome Measures:
  • Some biomarkers of diabetes [ Time Frame: 6 months ]
    Such as GLP-1, GIP, IGF-1, HbA1c, FPG etc.

  • Progression of glucose homeostasis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

  • Chronic complications of diabetes [ Time Frame: Up to 10 years ]

    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.



Estimated Enrollment: 160
Study Start Date: January 2012
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
IFG subjects with total cholesterol less than 200 mg/dL will be served as controls.
Drug: Control
placebo
Other Name: 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 Name: 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 Name: Crestor

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816997


Contacts
Contact: Harn-Shen Chen, MD, PhD 886-2-28757515 chenhs@vghtpe.gov.tw

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Harn-Shen Chen, MD, PhD    886-2-28757515      
Principal Investigator: Harn-Shen Chen, MD, PhD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Harn-Shen Chen, MD, PhD Taipei Veterans General Hospital, Taiwan
  More Information

Responsible Party: vghtpe user, Taipei Veterans General Hospital, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT01816997     History of Changes
Other Study ID Numbers: VGHIRB 2011-10-005IA
First Submitted: December 28, 2012
First Posted: March 22, 2013
Last Update Posted: November 18, 2013
Last Verified: November 2013

Keywords provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:
Statins
Glucose homeostasis
Diabetes
Impaired fasting glucose

Additional relevant MeSH terms:
Rosuvastatin Calcium
Pravastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents


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