Effect of Canagliflozin on Liver Inflammation Damage in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver Disease

Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Study ID
NCT05513729
Status
Unknown

Conditions

  • Type 2 Diabetes Mellitus With Complication

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin — DRUG
    According to the guideline of type 2 diabetes，canagliflozin will be given to 40 patients with type 2 diabetes combined with NAFLD as first-line choice if accompanied with indicators of high risk or established atherosclerotic cardiovascular disease, chronic kidney disease or heart failure, independently of HbA1c level. It can be also given to T2DM combined with NAFLD if their HbA1c above target.
  • Pioglitazone — DRUG
    According to the newest guideline of Diabetes，pioglitazone will be given to 40 patients with T2DM combined with NAFLD if their HbA1c above target.

Study Details

Type 2 diabetes mellitus (T2DM) is always accompanied with nonalcoholic fatty liver disease (NAFLD).This prospective study was designed to reveal the potential clinical application and underlying mechanisms of canagliflozin in the treatment of type 2 diabetes combined with nonalcoholic fatty liver disease.

Key Dates

Start date
Aug 18, 2022
Status verified
Aug 2022
Primary completion
Dec 31, 2023
Completion
Mar 1, 2024

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Canagliflozin treatment group
    40 patients with T2DM combined with NAFLD will be assigned to receive canagliflozin on top of metformin monotherapy according to clinical guideline of type 2 diabetes as experimental group.
  • Arm: Pioglitazone treatment group
    40 patients with T2DM combined with NAFLD will be assigned to receive pioglitazone on top of metformin monotherapy according to clinical guideline of type 2 diabetes as experimental group. as placebo comparator group.

Primary Outcome Measure

Plasma cholesteryl ester transfer protein(CETP) concentration(ug/mL) [ Time Frame: 24 weeks after the date of enrollment ]

Central Contacts