Status:
UNKNOWN
Canagliflozin on Liver Inflammation Damage in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver Disease
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Type 2 Diabetes Mellitus With Complication
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 clin...
Detailed Description
Type 2 diabetes mellitus (T2DM) is one of the most important risk factors for nonalcoholic fatty liver disease (NAFLD), including nonalcoholic steatohepatitis (NASH). Thus far, there are no approved m...
Eligibility Criteria
Inclusion
- 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
- 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 insufficiency (NYHA class III or IV); history of unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stenting; uncontrolled or severe heart rhythm Disorders (such as long QT syndrome, etc.), and evaluated by the investigator to be unsuitable to participate in this clinical trial; currently accompanied by clinically significant urinary tract/reproductive infection, or a history of complicated urinary tract infection, or nearly 6 A history of recurrent urinary tract infections within a month;
- Currently known to have severe osteoporosis, or a history of secondary fractures within the past 1 year;
- Any laboratory tests meet the following criteria: fasting plasma/serum glucose ≥ 15 mmol/L; alanine aminotransferase or aspartate aminotransferase \> 3 times the upper limit of normal or total bilirubin \> 1.5 times normal Upper limit; hemoglobin \<100 g/L; glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2; fasting triglycerides \> 5.64 mmol/L (500 mg/dL);
- Has received or is receiving any other experimental drug/trial device treatment within the past 3 months;
- Other conditions deemed inappropriate by the investigator to participate in this trial.
Key Trial Info
Start Date :
September 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05422092
Start Date
September 20 2022
End Date
December 1 2023
Last Update
September 21 2022
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