Effect of Canagliflozin on Liver Inflammation Damage in Type 2 Diabetes Patients With Nonalcoholi… (NCT05513729) | Clinical Trial Compass
UnknownNot Applicable
Effect of Canagliflozin on Liver Inflammation Damage in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver Disease
China80 participantsStarted 2022-08-18
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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
* 8 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 in the 3 months prior to screening;
* History of more than 2 severe hypoglycemic episodes in the past 1 year;
* History or condition of any of the following: decompensated cardiac insufficiency (NYHA class III or IV); history of unstable angina, myocardi…
What they're measuring
1
Plasma cholesteryl ester transfer protein(CETP) concentration(ug/mL)
Timeframe: 24 weeks after the date of enrollment
2
The activity of CEPT in pmol/mL/min
Timeframe: Time Frame: 24 weeks after the date of enrollment
Trial details
NCT IDNCT05513729
SponsorFirst Affiliated Hospital Xi'an Jiaotong University