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Effect and mechanism of dapagliflozin on patients with type 2 diabetes complicated with nonalcoholic fatty liver disease

Effect and mechanism of dapagliflozin on patients with type 2 diabetes complicated with nonalcoholic fatty liver disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064287
Enrollment
Unknown
Registered
2022-10-02
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes complicated with nonalcoholic fatty liver disease

Interventions

Sponsors

Yuebei People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years old, gender and nationality are not limited 2. Patients are diagnosed with type 2 diabetes according to WHO diabetes diagnostic criteria, and clinically diagnosed with nonalcoholic fatty liver disease (NAFLD diagnosis is made according to the guidelines of 2018 edition of the American Society for the study of liver diseases and NAFLD Asia Pacific Working Group); 3. Body mass index >= 22 kg / m2 and < 35 kg / m2, and previous body weight is stable (body weight change of at least 3 months <= 10%); 4. Glutamic pyruvic transaminase and glutamic oxalic transaminase <= 120 U / L; 5. All female subjects were postmenopausal or had undergone contraceptive operations, or took contraceptive measures 3 months before screening and throughout the study; 6. Understand the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Mentally disordered or unable to sign informed consent; 2. Patients with any history of liver disease other than NAFLD (including metabolic, autoimmune liver disease or viral hepatitis, alcoholic liver disease, hepatolenticular degeneration and other specific liver diseases that can lead to fatty liver) or cirrhosis; 3. Received the following drugs in the past 3 months: SGLT-2 inhibitor, thiazolidinediones, GLP-1 receptor agonist, DPP-4 inhibitor, polyene phosphatidylcholine, glycyrrhizic acid preparation, bicyclol, reduced glutathione, S-adenosylmethionine, silymarin, obecholate or ursodeoxycholic acid, betaine, fish oil, phosphodiesterase inhibitor, geferozil, tamoxifen, amiodarone, sodium valproate, methotrexate Glucocorticoids, probiotics and / or long-term antibiotic use (greater than 1 week); Or any other medication history related to fatty liver; 4. Acute complications of diabetes, such as ketoacidosis, hypertonic coma or hypoglycemia; 5. Acute infection or perioperative period; 6. Heart failure; 7. Renal insufficiency (estimated GFR = 1 month and / or whose drug compliance is less than 70%; 13. Daily alcohol intake: more than 30g for men and more than 20g for women.

Design outcomes

Primary

MeasureTime frame
CT ratio of liver / spleen;liver function;

Secondary

MeasureTime frame
blood glucose;intestinal microbiota;

Countries

China

Contacts

Public ContactXiong Zhouyi

Yuebei People's Hospital

joey10x@163.com+86 13553633785

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026