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DiabetesPhase 4NCT01816997

The Statins on Glucose Homeostasis in Subjects With Impaired Fasting Glucose

A Phase 4 study testing Pravastatin and Rosuvastatin in people with Diabetes, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 35 to 70 years
Conditions the study is for
Diabetes
What is being tested?
Pravastatin and Rosuvastatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
1 siteTaiwan
Study dates
Jan 2012to Dec 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 35-70 years old
  • Fasting blood glucose 100-125 mg/dL

Who cannot join

  • A1C >7.0%
  • 2hr glucose during OGTT >200 mg/dL
  • Total cholesterol >280 mg/dL
  • Previous diabetic history, coronary artery disease
  • Allergy to rosuvastatin or parvastatin
  • Baseline ALT more than 3 times UNL
  • Serum Cr > 2.0 mg/dL
  • Pregnancy, breast feeding or plan to be pregnant woman.

Trial locations and contacts

1 site in 1 country.

Harn-Shen Chen, MD, PhD contact

886-2-28757515

chenhs@vghtpe.gov.tw

Taiwan1 site, 1 recruiting

  • Taipei Veterans General Hospital

    Taipei, Taipei, 11217

    Harn-Shen Chen, MD, PhD, 886-2-28757515

    Harn-Shen Chen, MD, PhD

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Conditions
Diabetes
Being tested
Pravastatin, Rosuvastatin, Control
Keywords
Statins, Glucose homeostasis, Diabetes, Impaired fasting glucose
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PravastatinDrug

    Also called Pravastatin (Mevalotin)

    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.

  • RosuvastatinDrug

    Also called Crestor

    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.

  • ControlDrug

    Also called placebo

    placebo

Study groups in NCT01816997
Study groupRoleWhat they receive
ControlPlacebo comparatorIFG subjects with total cholesterol less than 200 mg/dL will be served as controls.
Receives: Drug: Control
PravastatinActive comparatorThe 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.
Receives: Drug: Pravastatin
RosuvastatinExperimentalThe 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.
Receives: Drug: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (5)

  1. Some biomarkers of diabetes

    Such as GLP-1, GIP, IGF-1, HbA1c, FPG etc.

    Measured: 6 months

  2. 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.

    Measured: 5 to 10 years.

  3. Chronic complications of diabetes

    Retinopathy: The change of steps on the ETDRS Severity Scales. Nephropathy: UACR and eGFR change. All-cause mortality

    Measured: Up to 10 years

  4. 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.

    Measured: 5 to 10 years.

  5. 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.

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2013 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01816997
Sponsor's protocol ID
VGHIRB 2011-10-005IA
Status last verified
Nov 2013
First submitted
28 Dec 2012
Last updated
18 Nov 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38810093

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pravastatin and Rosuvastatin in people with Diabetes, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Harn-Shen Chen, MD, PhD (886-2-28757515, chenhs@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glucose homeostasis (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01816997, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2013.

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