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

80 participantsStarted 2022-09-20

Plain-language summary

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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meets the diagnostic criteria for type 2 diabetes(1999 WHO criteria). * Meets the diagnostic criteria for non-alcoholic fatty liver disease (2018 Chinese Medical Association Treatment Guidelines ), and liver ultrasound showed moderate or higher fatty liver. * Metformin monotherapy for 3 months, but with poor glycemic control (7.5%≤HbA1c≤10.5%)) * Obese or overweight when screening (BMI\>24kg/m2); * 18 years old ≤ age ≤ 70 years old; * Have a good follow-up compliance, with follow-up months ≥ 24 weeks; Exclusion Criteria: * Non-type 2 diabetes: type 1 diabetes, gestational diabetes, or other specific types of diabetes; * Diabetes patients with acute and chronic complications and serious infections; Pregnant and lactating women; * Those who have allergies or toxic side effects or contraindications to canagliflozin, pioglitazone and other drugs; * Active sexually transmitted diseases such as viral hepatitis, AIDS and syphilis, and infectious diseases such as tuberculosis; * Have a weight change of more than 10% in the 3 months prior to screening; * Have used other drugs that may affect blood glucose metabolism in the past 2 months, including systemic glucocorticoids (except inhalation or topical use), growth hormone, etc.; * Have used any sodium-glucose cotransporter-2 (SGLT-2) inhibitor or thiazolidinediones; * History of more than 2 severe hypoglycemic episodes in the past 1 year; * History or condition of any of the following: decompensated cardiac in…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plasma cholesteryl ester transfer protein(CETP) concentration in ug/mL

Timeframe: 24 weeks after the date of enrollment

The activity of CEPT in pmol/mL/min

Timeframe: 24 weeks after the date of enrollment

Trial details

NCT IDNCT05422092

SponsorFirst Affiliated Hospital Xi'an Jiaotong University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01

Contact for this trial

YAYI HE

0086-15934880897 008099@xjtufh.edu.cn

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus With Complication trials