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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.



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

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 28, 2012
Last Updated: November 15, 2013
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Diabetes Mellitus
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosuvastatin
Pravastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014