Antidiabetic Effects on Intrahepatic Fat

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School87 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Alcoholic Fatty Liver Disease Type2 Diabetes

Interventions

LiraglutideDRUG

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

MetforminDRUG

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

GliclazideDRUG

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

Eligibility

Sex: ALLMin age: 17 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Intrahepatic fat

intrahepatic fat change from baseline by quantitative ultrasound

Time frame: -7±3days; 168±3days

Secondary Outcomes

Liver function

serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST)

Time frame: -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)

Time frame: -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

Time frame: -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

Time frame: -7±3days; 168±3days

Glucose control

fasting blood glucose (FBG), postprandial blood glucose (PBG)

Time frame: 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

Time frame: -7±3days; 84±3days; 168±3days

Body composition

fat mass and lean tissue were measured by dual-energy X-ray absorptiometry

Data from ClinicalTrials.gov

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