Type 2 Diabetes Mellitus Complicated with Non-alcoholic Fatty Liver Disease
Conditions
Interventions
Case series:None
Sponsors
Southern Medical University Shunde Hospital(The First People's Hospital of Shunde District, Foshan City)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Patients who meet the diagnoses of both type 2 diabetes mellitus and non-alcoholic fatty liver disease simultaneously: Diagnosis of type 2 diabetes mellitus: Conform to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (2020 Edition)", including typical diabetic symptoms (such as polydipsia, polyuria, polyphagia, weight loss, etc.), plus random blood glucose = 11.1 mmol/L and/or fasting blood glucose = 7.0 mmol/L and/or 2-hour postprandial blood glucose in OGTT = 11.1 mmol/L and/or HbA1c = 6.5%. For patients without typical diabetic symptoms, reexamination on another day is required for confirmation. Diagnosis of non-alcoholic fatty liver disease: Conform to the "Guidelines for the Diagnosis and Treatment of Non-alcoholic Fatty Liver Disease (2018 Edition)", including: a. Never drink alcohol or only drink a small amount occasionally (for men, the equivalent amount of ethanol consumed is < 30 g/d, and for women, < 20 g/d); b. Exclude specific diseases that can cause fatty liver such as viral hepatitis, autoimmune liver diseases, and drug-induced liver diseases; c. The VECT examination by Fibrosacan/fibrotouch meets the diagnostic criteria for fatty liver disease: Controlled Attenuation Parameter (CAP) = 274 dB/m. Note: VCTE (vibration-controlled transient elastography) - transient elastography. (2) Patients who are judged by the treating doctor to require treatment with Kazhuangping, and who have not received treatment with Kazhuangping, thiazolidinediones, or GLP-1 receptor agonists within 6 months; (3) Age = 18 years old; (4) Willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who have participated in any other clinical trials within the three months prior to the enrollment of this study; (2) Patients who are unable to complete the study process as required; (3) Patients with other types of diabetes, including type 1 diabetes, gestational diabetes, and special types of diabetes; (4) Patients with heart failure (NYHA class III or IV) or active cardiopulmonary diseases; (5) Pregnant and lactating women or patients who plan to become pregnant during the study period; (6) Patients with renal insufficiency (eGFR 2.5 times the upper limit of normal); (8) Patients who are using drugs related to hepatotoxicity/liver fibrosis; (9) Patients with cirrhosis whose ultrasound or TE value is > 11.5 kPa; (10) Patients with severe mental illnesses; (11) Patients who are allergic to any components in Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets; (12) Any situation that the investigator deems inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c;Alanine Transaminase;Aspartate Aminotransferase;Controlled Attenuation Parameter;Liver stiffness measurement ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The remaining glycometabolism and liver function related indicators; | — |
Countries
CHINA
Contacts
Public ContactLan Liu
Southern Medical University Shunde Hospital(The First People's Hospital of Shunde District, Foshan City)
Outcome results
None listed