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

NCT05513729 | Unknown

• 1 other identifier: XJTU1AF2022LSK-319
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus With Complication

Outcome Measures

Primary Outcomes (2)

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

  Measurements of liver inflammation and damage

  24 weeks after the date of enrollment

• The activity of CEPT in pmol/mL/min

  Measurements of liver inflammation and damage

  Time Frame: 24 weeks after the date of enrollment

Secondary Outcomes (2)

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

  Baseline

• The activity of CEPT in pmol/mL/min

  Baseline

Study Arms (2)

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.

Drug: Canagliflozin

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.

Drug: Pioglitazone

Interventions

Canagliflozin DRUG

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.

Also known as: Canagliflozin tablets

Canagliflozin treatment group

Pioglitazone DRUG

According to the newest guideline of Diabetes，pioglitazone will be given to 40 patients with T2DM combined with NAFLD if their HbA1c above target.

Also known as: Pioglitazone Hydrochloride Tablets

Pioglitazone treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Type 2 Diabetes Patients With Nonalcoholic Fatty Liver Disease who have been treated with metformin monotherapy for at least 3 months.

You may qualify if:

• 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
• years old ≤ age ≤ 70 years old;
• Have a good follow-up compliance, with follow-up months ≥ 24 weeks;

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital Xi'an Jiaotong University

Xi'an, Shannxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples were collected at the enrollment and the end of the study. The serum samples were separated and stored at minus 80°C.

MeSH Terms

Interventions

Canagliflozin; Pioglitazone

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Thiazolidinediones; Thiazoles; Azoles

Study Officials

• YAYI HE

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YAYI HE

CONTACT

0086-15934880897; mailto:008099@xjtufh.edu.cn

YAYI HE

CONTACT

0086-15934880897; 008099@xjtufh.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: August 18, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: August 24, 2022

Record last verified: 2022-08

Locations

CN (1)