NAFLD( Non-alcoholic Fatty Liver Disease )
Conditions
Brief summary
To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a Chinese herb formula.
Detailed description
1\) Liver fat (measured by CT scan) and liver function assessed by liver enzymes levels; 2) Insulin sensitivity measured by HOMA index, oral glucose tolerance test (OGTT) and a euglycaemic hyperinsulinaemic clamp (with stable isotopes) in a subset of the subjects; 3) Plasma lipid profile and non esterified fatty acids (NEFA) concentration; 4) Circulating levels of adipokines.
Interventions
DRUGChinese herb (YiQiSanJu)
Chinese herb formula:Huangqi,huanglian,yinchen,ect
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* subjects with NAFLD(nonalcoholic fatty liver disease) (criteria of Society of Hepatology, Chinese Medical Association, 2002.10), * aged 18-65 * alcohol consumption less than 40g/week; * liver/spleen (L/S) ratio no more than 1 by CT scan.
Exclusion criteria
* ALT more than twice the upper end of the normal range * viral hepatitis * total parenteral alimentation or secondary liver disease such as hepatocirrhosis, autoimmune hepatitis, metabolic liver disease or drug induced liver disease * severe cardiovascular or renal dysfunction * Subjects with diabetes (fasting glucose more than or equal to 7.0mmol/L or postprandial glucose more than or equal to 11.1mmol/L) * Subjects treated with statins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The CT ratio of liver/spleen | 12 weeks | CT imaging has been used to assess hepatic steatosis and has been validated in relation to liver biopsy .The ratio of liver to spleen (L/S ratio) for CT attenuation values is an index, with a L/S ratio\<1 considered to represent fatty liver . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lipid profile | 12 weeks | Plasma lipids including triglyceride (TG,mmol/L), total cholesterol, low-density lipoprotein (LDL.mmol/L), high-density lipoprotein (HDL,mmol/L), apolipoprotein A (ApoA,mmol/L), apolipoprotein B (ApoB,mmol/L) and lipoprotein (a) (Lp(a),mmol/L). (Automatic biochemical analyzer) |
| HOMA index | 12 weeks | HOMA index(FBG\*INSULIN/22.5) |
| adiponectin | 12 weeks | adiponectin(pg/ml,Enzyme-linked immunosorbent assay) |
| IL-6(interleukin 6) | 12 weeks | interleukin 6(pg/ml,Enzyme-linked immunosorbent assay) |
| hs-CRP (C-reactive protein) | 12 weeks | high sensitivity C-reactive protein(mg/L,Enzyme-linked immunosorbent assay) |
| TNFα( tumor necrosis factor-α) | 12 weeks | tumor necrosis factor-α(ng/L,Enzyme-linked immunosorbent assay) |
| leptin | 12 weeks | leptin(ng/ml,Enzyme-linked immunosorbent assay) |
| liver function | 12 weeks | Liver function enzymes- alanine aminotransferase (ALT,U/L), aspartate aminotransferase (AST,U/L) and γ-glutamyltransferase (GGT,U/L) and total bilirubin (TBI,μmol/L), albumin/globin (A/G)(Automatic biochemical analyzer) |
| BMI(Body Mass Index ) | 12 weeks | Body Mass Index,(weight/height\^2) |
| NEFA(nonesterified fatty acid) | 12 weeks | Insulin sensitivity of lipolysis using NEFA concentrations(μmol/L).(Enzyme-linked immunosorbent assay) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Routine blood | 12 weeks | automatic blood analyzer. White Blood Cell Count:/L; Red Blood Cell Count:/L; Hemoglobin:g/L; Platelets:/L; neutrophilic granulocyte:％. |
| Routine urine examination | 12 weeks | automatic urine analyzer. Color,odor,specific gravity,pH,Protein(g/L),Glucose(+-). |
| Routine stool examination | 12 weeks | automatic stool analyzer. Color, white blood cell(/Visual Fields), red blood cell(/Visual Fields), bacteria(/Visual Fields),occult blood(+-) |
| electrocardiography | 12 weeks | automatic electrocardiograph machine |
| chest x-ray check | 12 weeks | diagnostic X-ray apparatus |
| renal function | 12 weeks | creatinine(umol/L) ,usea nitrogen(mmol/l) and uric acid(umol/L)(Automatic biochemical analyzer) |
Outcome results
None listed