Non-Alcoholic Fatty Liver Disease, Type2 Diabetes
Conditions
Keywords
Liraglutide, Metformin, Gliclazide
Brief summary
This was a 24-week single-center, open-label, parallel controlled group comparing gliclazide, liraglutide, and metformin effects on diabetes with nonalcoholic fatty liver disease.
Detailed description
Following enrollment, eligible participants were randomized (1:1:1) using computer-generated random numbers to the metformin (Glucophage, Bristol-Myers Squibb), liraglutide (Victoza, Novo Nordisk), or gliclazide (Diamicron, Servier) groups. All patients were informed about a proper diet and exercise. For the metformin group (n = 31), the dosage was 250 mg thrice a day during the first week, 500 mg thrice a day during the second week, and 1000 mg twice a day from the third week to the conclusion of the study. For the gliclazide group (n = 31), the initial dosage was 30 mg before breakfast, which was gradually titrated to a maximum of 120 mg/day to achieve a fasting capillary plasma glucose of \<7.0 mmol/L. For the liraglutide group (n = 31), the dosage was 0.6 mg/day during the first week, 1.2 mg/day during the second week, and 1.8 mg/day from the third week to the conclusion of the study.At the end of the study, data will be collected and analyzed.
Interventions
DRUGLiraglutide
the dosage of liraglutide was 0.6 mg/day during the first week, 1.2 mg/day during the second week, and 1.8 mg/day from the third week to the conclusion of the study
DRUGMetformin
the dosage of metformin was 250 mg thrice a day during the first week, 500 mg thrice a day during the second week, and 1000 mg twice a day from the third week to the conclusion of the study
DRUGGliclazide
the initial dosage of gliclazide was 30 mg before breakfast, which was gradually titrated to a maximum of 120 mg/day to achieve a fasting capillary plasma glucose of \<7.0 mmol/L
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-70 years; 2. Type 2 diabetes mellitus; 3. Not used antidiabetic drugs within 3 months; 4. HbA1c(7-10%); 5. Presence of fatty liver disease (hepatic fat content ≥ 20% by quantitative ultrasonography); 6. Female subjects：post-menopausal women, take contraceptive measures three months before the test screening and can persist throughout the experimental period; 7. Body mass index (BMI) 20-35kg/m2, and stable Weight 3 months(less than 10% volatility); 8. patients signed the informed consent.
Exclusion criteria
1. Used antidiabetic drugs or any other possible hepatic steatosis associated with drugs within the past three months; 2. Suffering from pancreatitis or other pancreatic diseases or have other similar history; 3. GLP-1 analogs or sulfonylurea allergy history; 4. Liver dysfunction (aspartate aminotransferase ≥ 2.5 times of the normalupper limit); 5. Moderate to severe renal insufficiency (eGFR\<60ml/min/1.73m2,calculated according to MDRD); 6. Female subjects drinking\> 14 units / week; male subjects drinking\> 21 units/week; 7. A history of metabolic or autoimmune liver diseases or viral hepatitis diseases; 8. A history of medullary thyroid carcinoma, multiple endocrine neoplasia 2 or family history; 9. Congestive heart failure (NYHA grade Ⅲ - Ⅳ grade); 10. Severe gastrointestinal diseases; 11. Other serious concomitant diseases; 12. Pregnant or planning pregnancy; 13. The researchers believe that the subjects with proliferative retinopathy or macular degeneration need urgentl treatment; 14. Subjects are using unknown ingredients or non herbal medicine preparations or local medicine, researchers believe that during the test the dose of traditional Chinese medicines can not be adjusted or disabled.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intrahepatic fat | -7±3days; 168±3days | intrahepatic fat change from baseline by quantitative ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver function | -7±3days; 28±3days; 84±3days; 168±3days | serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) |
| Lipid | -7±3days; 28±3days; 84±3days; 168±3days | total cholesterol (CH), triglyceride (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL) |
| Plasma glucose in standard meal tolerance test | -7±3days; 168±3days | plasma glucose was measured at 0, 30, 60, and 120 min after ingestion of the meal |
| Plasma insulin in standard meal tolerance test | -7±3days; 168±3days | plasma insulin was measured at 0, 30, 60, and 120 min after ingestion of the meal |
| HbA1c | -7±3days; 84±3days; 168±3days | glycosylated hemoglobin A 1c (HbA1c) was measured by high-performance liquid chromatography |
| Body composition | -7±3days; 168±3days | fat mass and lean tissue were measured by dual-energy X-ray absorptiometry |
| Weight | 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days | body weight |
| WC | 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days | waist circumference |
| Glucose control | 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days | fasting blood glucose (FBG), postprandial blood glucose (PBG) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with gliclazide, liraglutide or metformin adverse events as a measure of safety and tolerability | -7±3days; 0±3days; 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3day;168±3days | adverse events caused by the drugs |
Countries
China
Outcome results
None listed