NCT01816997

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 18, 2013

Status Verified

November 1, 2013

Enrollment Period

5.9 years

First QC Date

December 28, 2012

Last Update Submit

November 15, 2013

Conditions

Diabetes

Keywords

StatinsGlucose homeostasisDiabetesImpaired fasting glucose

Outcome Measures

Primary Outcomes (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.

    6 months

Secondary Outcomes (5)

  • Some biomarkers of diabetes

    6 months

  • Progression of glucose homeostasis

    5 to 10 years.

  • Chronic complications of diabetes

    Up to 10 years

  • Incidence of diabetes

    5 to 10 years.

  • Chronic complications of diabetes

    Up to 10 years

Study Arms (3)

Control

PLACEBO COMPARATOR

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

Drug: Control

Pravastatin

ACTIVE COMPARATOR

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

Rosuvastatin

EXPERIMENTAL

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

Interventions

PravastatinDRUG

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.

Also known as: Pravastatin (Mevalotin)
Pravastatin
RosuvastatinDRUG

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.

Also known as: Crestor
Rosuvastatin
ControlDRUG

placebo

Also known as: placebo
Control

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • A1C \>7.0%
  • hr 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taipei, 11217, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38810093DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

PravastatinRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsSulfonamidesAmidesFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Harn-Shen Chen, MD, PhD

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harn-Shen Chen, MD, PhD

CONTACT

886-2-28757515chenhs@vghtpe.gov.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Taipei Veterans General Hospital

Study Record Dates

First Submitted

December 28, 2012

First Posted

March 22, 2013

Study Start

January 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2022

Last Updated

November 18, 2013

Record last verified: 2013-11

Locations

TW(1)