Type 2 diabetes mellitus with NAFLD/NASH
Conditions
Interventions
Implementation of FDG-PET/CT. Plain CT, plain MRI,FDG-PET/CT and Fibroscan are performed twice for six months.
Sponsors
Yokohama City University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with type 2 diabetes who fulfilled the following criteria. 1) Patients with HbA1c equal to or greater than 6.0% and lesser than 9.0%. 2) Patients treated with diet, exercise or antidiabetic medications except SGLT2 inhibitor. 3) Patients with a BMI more than 20. 4) Patients with fatty liver diagnosed by abdominal US, and who have a diagnosis of NAFLD or NASH based on the definition of the medical treatment guide of NASH, NAFLD of the Japan society of hepatology. 5) Patients that blood pressure and lipids are well controlled. 6)Having provided voluntary written consent for participation in this study.
Exclusion criteria
Exclusion criteria: -Patients corresponding to any of the following are inapplicable -Patients with a history of allergy to any component of the study medications -Patients with severe ketosis or diabetic coma. -Patients with severe infections, perioperative status, or severe trauma -Patients with severe complications( liver disease, renal disease, mental disorder, cancer) -Patients that we may be running out of plasticity of enforcement for image or analysis of the examination, for example, remarkable spinal column scoliosis -Patients who has difficulty in MRI study implementation including having a Implantable cardioverter-defibrillator and internal metal et al -Pregnancy or lactation in women -Inadequacy of usingig this therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A change in liver fat fraction after administrating a canagliflozin using MRI | — |
Secondary
| Measure | Time frame |
|---|---|
| -A change in hepatic CT HU using CT -A change in visceral and subcutaneous fat cross sectional area using CT. -A change in cross sectional area, CT HU and ratio of fat infiltration of skeletal muscles using CT. -A change in CAP and liver stiffness measurements by FibroScan. -Evaluation of the degree of FDG accumulation of liver, brain, skeletal muscles using FDGPETCT. -Changes of blood pressure, body weight, blood glucose(HbA1c,fasting plasma glucose),GA,HOMAbeta,CPRindex,insulin resistance(HOMAIR), NAFIC score, FIB4 index. | — |
Countries
Japan
Contacts
Public ContactKazuki Tajima
Yokohama City University Graduate School of Medicine Department of Endocrinology and Metabolism
Outcome results
None listed