Effect of Canagliflozin on Liver Inflammation Damage in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver Disease
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ClinicalTrials.gov Identifier: NCT05513729 |
Recruitment Status :
Recruiting
First Posted : August 24, 2022
Last Update Posted : August 24, 2022
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Condition or disease | Intervention/treatment |
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Type 2 Diabetes Mellitus With Complication | Drug: Canagliflozin Drug: Pioglitazone |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 80 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 6 Months |
Official Title: | Therapeutic Effects of Canagliflozin on the Liver Inflammation Damage and Lipoprotein Metabolism in Patients With Type 2 Diabetes Mellitus Combined With Nonalcoholic Fatty Liver Disease |
Actual Study Start Date : | August 18, 2022 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | March 1, 2024 |
Group/Cohort | Intervention/treatment |
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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.
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Drug: Canagliflozin
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.
Other Name: Canagliflozin tablets |
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.
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Drug: Pioglitazone
According to the newest guideline of Diabetes,pioglitazone will be given to 40 patients with T2DM combined with NAFLD if their HbA1c above target.
Other Name: Pioglitazone Hydrochloride Tablets |
- Plasma cholesteryl ester transfer protein(CETP) concentration(ug/mL) [ Time Frame: 24 weeks after the date of enrollment ]Measurements of liver inflammation and damage
- The activity of CEPT in pmol/mL/min [ Time Frame: Time Frame: 24 weeks after the date of enrollment ]Measurements of liver inflammation and damage
- Plasma cholesteryl ester transfer protein(CETP) concentration in ug/mL [ Time Frame: Baseline ]Measurements of liver inflammation and damage
- The activity of CEPT in pmol/mL/min [ Time Frame: Baseline ]Measurements of liver inflammation and damage
Biospecimen Retention: Samples Without DNA
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05513729
Contact: YAYI HE | 0086-15934880897 | mailto:008099@xjtufh.edu.cn | |
Contact: YAYI HE | 0086-15934880897 | 008099@xjtufh.edu.cn |
China, Shannxi | |
First Affiliated Hospital Xi'an Jiaotong University | Recruiting |
Xi'an, Shannxi, China, 710061 |
Principal Investigator: | YAYI HE | First Affiliated Hospital Xi'an Jiaotong University |
Responsible Party: | First Affiliated Hospital Xi'an Jiaotong University |
ClinicalTrials.gov Identifier: | NCT05513729 |
Other Study ID Numbers: |
XJTU1AF2022LSK-319 |
First Posted: | August 24, 2022 Key Record Dates |
Last Update Posted: | August 24, 2022 |
Last Verified: | August 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Hepatitis Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Complications Inflammation Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Pathologic Processes Digestive System Diseases Pioglitazone Canagliflozin Hypoglycemic Agents Physiological Effects of Drugs Sodium-Glucose Transporter 2 Inhibitors Molecular Mechanisms of Pharmacological Action |