Type 2 Diabetes Mellitus Complicated With Non-alcoholic Fatty Liver Disease
Conditions
Interventions
Sponsors
The 3rd Affiliated Hospital of Sun-Yat Sen University
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Recorded Type 2 diabetes diagnosed at least 3 months before the study; 2. At least 3 months treatment on a stable dose(?1500mg/d)of metformin before the study; 3. 7% 10%.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes; 2. Treatment within the last 3 months with Thiazolidinediones(TZDs), orlistat, insulin, any history of incretin based therapy or any other drugs associated with hepatic steatosis (including but not limited to glucocorticoids, tamoxifen, amiodarone or methotrexate); 3. History or current episode of pancreatitis or other disease of the pancrea; 4. Impaired liver function, defined as plasma alanine transaminase(ALT) >2.5 times of upper normal limit; 5. Moderate and severe renal insufficiency defined as MDRD eGFR14 units for women or >21 units for men; 7. Any history of liver disease including metabolic or auto-immune liver diseases or viral hepatitis; 8. History or family history of medullary thyroid cancer(MTC), or multiple endocrine neoplasia type 2(MEN-2); 9. Congestive heart failure(NYHA III~IV); 10. Severe gastric-intestinal diseases; 11. Pregnancy and/or intention of becoming pregnant; 12. Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator; Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content. Herbal traditional Chinese medicine or other local herbal medicines may, at the Investigators discretion, be continued throughout the trial at an unchanged dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intrahepatic Lipids; | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal Subcutaneous Adipose Tissue;Visceral Adipose Tissue;Body Weight;Body Mass Index;Circumstance;Heamoglobin A1c;Fasting Plasma Glucose;Postprandial Plasma Glucose;Fasting Plasma Lipid;Blood Pressure;Hypoglycemia Incidence;Adverse Event;Hematological Examination;Biochemical Test;Urine Analysis; | — |
Countries
China
Contacts
Public ContactJianping Weng
The 3rd Affiliated Hospital of Sun-Yat Sen University
Outcome results
None listed