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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Active Comparator | 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 |
|
| Metformin | Active Comparator | the dosage of merformin 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 |
|
| Gliclazide | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intrahepatic fat | intrahepatic fat change from baseline by quantitative ultrasound | -7±3days; 168±3days |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function | serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) | -7±3days; 28±3days; 84±3days; 168±3days |
| Lipid | total cholesterol (CH), triglyceride (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with gliclazide, liraglutide or metformin adverse events as a measure of safety and tolerability | adverse events caused by the drugs | -7±3days; 0±3days; 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3day;168±3days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalong Zhu, MD,PhD | the Affiliated Drum Tower Hospital of Nanjing University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D008687 | Metformin |
| D005907 | Gliclazide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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|
| Metformin | Drug | 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 |
|
|
| Gliclazide | Drug | 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 |
|
|
| -7±3days; 28±3days; 84±3days; 168±3days |
| Plasma glucose in standard meal tolerance test | plasma glucose was measured at 0, 30, 60, and 120 min after ingestion of the meal | -7±3days; 168±3days |
| Plasma insulin in standard meal tolerance test | plasma insulin was measured at 0, 30, 60, and 120 min after ingestion of the meal | -7±3days; 168±3days |
| Glucose control | fasting blood glucose (FBG), postprandial blood glucose (PBG) | 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days |
| HbA1c | glycosylated hemoglobin A 1c (HbA1c) was measured by high-performance liquid chromatography | -7±3days; 84±3days; 168±3days |
| Body composition | fat mass and lean tissue were measured by dual-energy X-ray absorptiometry | -7±3days; 168±3days |
| Weight | body weight | 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days |
| WC | waist circumference | 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |