Efficacy and safety of metformin plus carnitine complex(Godex) compaired with metformin monotherapy in type 2 DM and impaired glucose tolerance patients with non-alcoholic fatty liver disease.
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0000193
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 58
1) Age at least 18 years and under 80 years
2) Subjects with non-alcoholic fatty liver disease; 35U/L = ALT = 250u/L
3) 100mg/dL = fasting glucose = 300mg/dL or HbA1c > 6.5%
4) Able and willing to provide informed consent
1) Subject with current viral hepatitis(HAV, HBV, HCV), alcoholic liver disease, and other liver disease
2) Subject with allergy to study agent(s) or their formulations
3) Current levodopa medication
4) Pregnant or breastfeeding women
5) Subject who participated in any clinical studies within 30 days prior to study entry and during study
6) Subjects who were prescribed hypoglycemic agent including insulin within 30 days of screening or prior to randomization
7) Inability or unwillingness to give informed consent or abide by the study protocol
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of ALT normalization
- Secondary Outcome Measures
Name Time Method The changes and change rate of glycemic control (fasting glucose, fasting insulin, HbA1c) ;The changes of plasma ALT levels;The changes of urine 8-OHdG;The changes of mitochondria DNA copy number