The Statins on Glucose Homeostasis in Subjects With Impaired Fasting Glucose

NCT ID: NCT01816997

Last Updated: 2013-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Statins Glucose homeostasis Diabetes Impaired fasting glucose

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

IFG subjects with total cholesterol less than 200 mg/dL will be served as controls.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

placebo

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.

Group Type ACTIVE_COMPARATOR

Pravastatin

Intervention Type DRUG

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 will be randomized into two groups: pravastatin 40 mg or rosuvastatin 10 mg.

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Control

placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pravastatin (Mevalotin) Crestor placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

vghtpe user

Taipei Veterans General Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Harn-Shen Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taipei Veterans General Hospital

Taipei, Taipei, Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Harn-Shen Chen, MD, PhD

Role: CONTACT

Phone: 886-2-28757515

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Harn-Shen Chen, MD, PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Cheng WY, Chang LH, Chen HS. The effect of statin treatment on glucose homeostasis in prediabetic individuals: A prospective, randomized, controlled trial. J Chin Med Assoc. 2024 Jul 1;87(7):664-669. doi: 10.1097/JCMA.0000000000001114. Epub 2024 May 29.

Reference Type DERIVED
PMID: 38810093 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VGHIRB 2011-10-005IA

Identifier Type: -

Identifier Source: org_study_id