Dapagliflozin Liver Metabolism Study

JRCT ID: jRCTs051180091

Registered date:04/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 30/03/2018
• Target sample size: 100
• Study type: Interventional

Intervention(s)

once-daily SGLT2 inhibitor (dapagliflozin 5mg) as add-on to the conventional treatment
low-carbo (40-45%) diet as add-on to the conventional treatment
only conventional treatment (control)
for one week

Outcome(s)

• Primary Outcome: Hepatocellular adenosine triphosphate (ATP) concentrations
• Secondary Outcome: Hepatocellular inorganic phosphate, phosphomonoesters (PME), hepatic lipid volume fraction identified by 31P MRS, and metabolic markers identified by metabolomic analysis

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both
• Include criteria: Type 2 diabetes without the history of taking any SGLT2 inhibitors in recent three months, age between 20 and 80 years, and BMI>20
• Exclude criteria: Type 1 diabetes, secondary diabetes, severe ketosis, diabetic coma or pre-coma patients, alcoholism, severe depression or other psychological condition, malignancy, viral hepatitis, severe liver dysfunction, abnormal hemoglobinemia, severe infections diseases, pre- or post-surger, severe traumatic injury, contraindication for MRI like having metal pieces embedded in the body, pregnant or lactating woman, renal deficiency(eGFR<45mL/min/1.73m2), history of hypersensitivity to dapagliflozin, and those who are not considered to be suitable by an attending physician.

Related Information

• Primary Sponsor: Fujita Yoshihito

Source(s) of Monetary Support

AstraZeneca K.K.
Ono Pharmaceutical CO., LTD,AMED,JSPS