Type 2 Diabetes Mellitus, Non-alcoholic Fatty Liver Disease, Efficacy
Conditions
Keywords
Type 2 Diabetes Mellitus, Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, Randomized Controlled Trial, Non-alcoholic Fatty Liver Disease
Brief summary
This is an multicenter, randomized, double-blind, parallel-controlled study to evaluated the efficacy of pioglitazone hydrochloride and metformin hydrochloride tablets on the patients with newly diagnosed type 2 diabetes mellitus combined with non-alcoholic fatty liver disease.
Detailed description
Taking metformin monotherapy as a control, we evaluated the efficacy of pioglitazone hydrochloride and metformin hydrochloride tablets on hepatic fat ultrasound and liver enzyme levels, and observed whether the drug can improve fatty liver in patients with newly diagnosed type 2 diabetes combined with non-alcoholic fatty liver disease. This is an multicenter, randomized, double-blind, parallel-controlled study.
Interventions
DRUGCombination of Pioglitazone and Metformin Tablets
15mg/500mg, oral, 2/day
Oral metformin 850mg, 2/day in the control group
Sponsors
Second Affiliated Hospital of Xi'an Jiaotong University
Shaanxi Aerospace Hospital
Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd
Xi'an Gaoxin Hospital
Chang'An Hospital
Yan'an people's Hospital
Shangluo Central Hospital
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. To meet the new diagnosed type 2 diabetes patients, never received oral hypoglycemic drugs or insulin therapy; 2. In accordance with the nonalcoholic fatty liver (NAFLD) criteria for the diagnosis of patients. 3. the level of HbA1c was 7 -10.0%; 4. age 18-70, body mass index 21-35kg/m2; 5. the subjects informed consent and signed the informed consent.
Exclusion criteria
1. type 1 diabetes or secondary diabetes; 2. suffering from other liver diseases, such as hepatitis, self - free liver, etc. 3. abnormal thyroid function (in the active period), or the need for long-term oral and intravenous glucocorticoids to treat patients; 4. patients with severe renal dysfunction or renal disease (eGFR\<60); 5. in those with abnormal liver function, Alanine transaminase(ALT) or Aspartate transaminase(AST) was more than 3 times the normal upper limit. 6. people with serious gastrointestinal diseases such as peptic ulcers and chronic diarrhea; 7. patients with severe cardiopulmonary disease, cerebrovascular disease or stents; 8. hemopoietic system diseases such as serious primary diseases, hemoglobin \< 100g/L or need regular transfusion treatment; 9. pregnant, breast-feeding, women of childbearing age who are unwilling to contraception during the study period; 10. chronic cardiac insufficiency, the classification of heart function III level and above; 11. uncontrolled malignant tumor, and the history of bladder cancer. 12. acute complications of diabetes; 13. the use of other drugs for diabetes and liver disease; 14. patients who had participated in other clinical studies within three months; 15. people who have known allergies to this kind of drugs are known. 16. it is impossible to guarantee the effect or the safety judgment of the drug or the person who is unable to cooperate with the mental illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decreased of liver fat content of fatty liver after 24 weeks treatment as assessed by B-ultrasound | up to 24 weeks | Change from baseline liver fat content to up to 24 weeks after treatment |
| Change of B-cell function after 24 weeks treatment as assessed by homeostasis model assessment of insulin resistance index | up to 24 weeks | Change from baseline B-cell function to up to 24 weeks after treatment |
| Change of liver enzyme after 24 weeks treatment as assessed by blood test | up to 24 weeks | Change from baseline liver enzyme to up to 24 weeks after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decreased of HbA1c after 24 weeks treatment as assessed by blood test | up to 24 weeks | Change from baseline HbA1c to up to 24 weeks after treatment |
| Decreased of fasting blood glucose after 24 weeks treatment as assessed by blood test | up to 24 weeks | Change from baseline fasting blood glucose to up to 24 weeks after treatment |
| Change of weight and waistline after 24 weeks treatment as assessed by standard measurement | up to 24 weeks | Change from baseline weight and waistline to up to 24 weeks after treatment |
Countries
China
Outcome results
None listed