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
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- JPRN-UMIN000026791
- Lead Sponsor
- Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Toho University Omori Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 44
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
Patients who fall into any of the following criteria are excluded from participating in the study.
1. Patients with type 1 diabetes or secondary diabetes
2. Patients with BMI lower than 22 kg/m2
3. Patients with moderate to severe renal function disease or at the final stage of renal failure (eGFR lower than 45 mL/min/1.73 m2)
4. Patients who had stroke or cerebral infarction within 12 weeks before giving their consent
5. Patients with any medical history of myocardial infarction, angina pectoris, or currently with atrial fibrillation
6. Patients with any infectious disease
7. Patients with malignancy (However, those who have completed treatment and/or show no redevelopment of malignancy, as well as manifest some degree of remission can be considered to be participants of this study)
8. Patients with connective tissue disease (However, those T2DM patients who have treated with prednisolone 5 mg or less and show stable conditions can be considered to be participants of this study)
9. Patients with hepatocirrhosis
10. Patients with viral or autoimmune, or drug-induced hepatic disorder
11. Patients who are alcoholic or excessive drinkers
12. Patients who are currently pregnant, possibly pregnant, or breast-feeding during the study
13. Patients have a medical history of hypersensitivity to the study drugs
14. Patients who are in the category that the study drugs are prohibited to use
15. Patients with Hb below 12 g/dl
16. Patients with other conditions that investigators/physicians think inappropriate to be in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method