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
NCT05422092
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
    40 patients with T2DM combined with NAFLD, who have poor glycemic control response to metformin monotherapy, will be randomly assigned to receive canagliflozin on top of metformin as experimental group.
  • Pioglitazone — DRUG
    40 patients with T2DM combined with NAFLD, who have poor glycemic control response to metformin monotherapy, will be randomly assigned to receive pioglitazone 45mg on top of metformin as placebo comparator group.

Study Details

Type 2 diabetes mellitus (T2DM) is always accompanied with nonalcoholic fatty liver disease (NAFLD).This prospective, randomized controlled intervention 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
Sep 20, 2022
Status verified
Jul 2022
Primary completion
Jan 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Canagliflozin treatment group
    Canagliflozin 100mg were given to the patients for 24 weeks
  • Placebo Comparator: Pioglitazone treatment group
    Pioglitazone 30mg were given to the patients and the dosage will be increased to 45mg 2 weeks later

Primary Outcome Measure

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

Central Contacts