A prospective Randomized study comparing the effects of Empagliflozin versus Sitagliptin on Intra hepatic lipid content and hepatic insulin resistance in type 2 diabetes patients / Resistance study

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2017
INTERVENTION: Group A: Administer empagliflozin Patients in this empagliflozin group take empagliflozin 10 mg once a day orally before or after breakfast, and continue it for 12 weeks. Group B: Administer sitagliptin Patients begin with sitagliptin 50 mg a day, in principle, and increase the dose to 100 mg from their observation point of the 4th week, if it is possible. They also take sitagliptin orally once a day before or after breakfast, and continue it for 12 weeks. CONDITION: Type 2 Diabetes Mellitus PRIMARY OUTCOME: Evaluation of the following value changed from the baseline and the percent change: ; * Amount of hepatic lipid accumulation (measured by MRI, Proton MRS) SECONDARY OUTCOME: Evaluation of the following values changed from the baseline and the percent change: ; 1. Liver insulin sensitivity (measured by the hyperinsulinemic‐euglycemic clamp technique) ; 2. Muscle, adipose insulin sensitivity (measured by the hyperinsulinemic‐euglycemic clamp technique); 3. Hepatic fibrosis index (Type IV collagen 7s, ferritin, PIIIP, hyaluronic acid) ; 4. Liver gluconeogenesis index (cortisol); 5. Epithelial cell apoptosis index (CK18 fragment); 6. Hepatokine (hepatic hormone ) index (FGF21, Fetuin A); 7.Other index related to liver (Hepatocyte growth factor, insulin‐like growth factor 1/IGF‐1) ; 8. Adipose amount (intraperitoneal adipose amount, subcutaneous fat amount) by CT scans; 9. Body weight, whole‐body adipose amount, fat removal quantity, bone and muscle mass by DEXA scans; 10. Physical activity level; 11. Scores of the questionnaires answered by patients INCLUSION CRITERIA: Patients who meet all of the following criteria are included in this study. 1. Type 2 diabetic patients with HbA1c below 10% at the time of consenting 2. Female and male patients are 20 years old or older and younger than 75 years old 3. Patients who can take liver biopsy for the purpose of evaluation or diagnosis of non‐alcohol fatty liver disease 4. Patients with BMI 22 kg/m2 or higher 5. Patients who can provide their written consent for participation of this study
Epistemonikos ID: b137ca3953aeb5339436f557ef17b013f329564d
First added on: Aug 23, 2024