Effect of Rosuvastatin (10mg/d) treatment of Nonalcoholic fatty liver disease (NAFLD) patients with Metabolic Syndrome (MS) but without diabetes evaluated by 1H-MRS: Exploratory study

Effect of Rosuvastatin (10mg/d) treatment of Nonalcoholic fatty liver disease (NAFLD) patients with Metabolic Syndrome (MS) but without diabetes evaluated by 1H-MRS

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-15007014

Enrollment

Unknown

Registered

2015-09-05

Start date

2015-09-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Nonalcoholic fatty liver disease(NAFLD)

Interventions

2:rosuvastatin (10mg/d) * 52 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures; 2. Men and female adults aged 18-70 years old who agree to use contraceptive methods to prevent pregnancy while enrolled in study; 3. Patients fulfilling the diagnostic criteria of MS of IDF in 2006 [Central obesity is an essential element (increased waist circumference which in Chinese men >=90cm or women>=80cm) plus any two of the following: TG >1.7mmol/L or treatment for elevated TG; HDL130mmHg, DBP >85mmHG, or treatment for hypertension; FBG>5.6mmol/L]; 4. The diagnosis of NAFLD screened by abdominal ultrasound and confirmed by 1H-MRS with IHCL>10%; 5. No diabetes history and FBG<7.0mmol/L plus HbA1C<6.5%; 6. Statins not use within past 3 moths or currently taking fibrates; 7. The patients without history of arteriosclerotic cardiovascular disease (ASCVD).

Exclusion criteria

Exclusion criteria: 1. Women plan to pregnant within 1 year or being pregnant; 2. TSH(thyroid stimulating hormone)>10uU/ml; 3. Alcohol consumption per week >14U (140g) in women or > 21U (210g) in men; 4. Positive for any of HBsAg, HCV-Ab, HIV-Ab or any other chronic or acute liver diseases; 5. ALT or AST>2ULN or TBIL >2ULN or CK >2ULN; 6. eGFR (EPI) 190mg/dL; 8. TG >5.6mmol/L; 9. Allergy history of statins; 10. Patients with active or chronic myopathy.

Design outcomes

Primary

Measure	Time frame
intrahepatocellular lipid (IHCL);	—

Countries

China

Contacts

Public ContactYu-xiu Li

liyuxiu@medmail.com.cn+86 13581705295

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026