Effect of pravastatin on the insulin resistance and HbA1c level

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000943

Enrollment

Registered

2013-11-28

Start date

2013-12-04

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Investigation product(IP) pravastatin group:pravastatin 40mg, once daily, oral use, duration of 24 weeks Placebo group:matching placebo product 40mg, once daily, oral use, duration of 24 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Among subjects who underwent comprehensive health check up at samsung medical center 1. Those of HbA1c 6.0-7.0% 2. LDL cholesterol >130mg/dl 3. BMI >23 kg/m2

Exclusion criteria

Exclusion criteria: Those with 1. HbA1c > 7.0% 2. history of use of statin within 3 month before enrollment 3. history of use of antidiabetic drug within 3 month before enrollment 4. Malignancy 5. cerebrovascular disease 6. Pregancy, lactating woman 7. Creatinine >1.5mg/dl 8. LDL 190mg/dl 9. AST or ALT > 2x ULM 10. current use of anti obesity drug 11. current use of steroid 12. current use of ACE inhibitor 13. currently taking hormone replacement theraphy(HRT) 14. positive for viral marker of HBV or HCV

Design outcomes

Primary

Measure	Time frame
change form baseline in insulin resistance marker of HOMA-IR(homeostatic model assessment of insulin resistance)	—

Secondary

Measure	Time frame
change form baseline in glucose;change form baseline HbA1C;change form baseline in adiponectin ;change form baseline in HOMA-B;change from baseline in cardiovascular risk factors	—

Countries

Korea, Republic of

Contacts

Public ContactJi Cheol Bae

Samsung Medical Center

Outcome results