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Effect of dapagliflozin on liver and pancreatic fat in patients with type 2 diabetes and nonalcoholic fatty liver disease

Effect of dapagliflozin on liver and pancreatic fat in patients with type 2 diabetes and nonalcoholic fatty liver disease

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054612
Enrollment
Unknown
Registered
2021-12-21
Start date
2022-02-15
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

Type 2 diabetes and nonalcoholic fatty liver disease

Interventions

Sponsors

Xinqiao Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Liver fat content >= 5.5% assessed by magnetic resonance imaging; 3. Patients with type 2 diabetes who have been treated with metformin, due to their poor blood sugar control (glycated hemoglobin: 7.0% to 10.0%), are prompted to use other drugs in combination; 4. Body mass index: 24 kg/m2~45 kg/m2; 5. No history of drinking or drinking alcohol equivalent to ethanol <30 g/d for men and <20 g/d for women; 6. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Evidence of other forms of liver disease, including hepatitis B, hepatitis C, autoimmune hepatitis, drug-induced liver disease found based on exposure and medical history, etc.; 2. Have undergone bariatric surgery or used drugs known to cause hepatic steatosis (amiodarone, valproate, tamoxifen, methotrexate, steroids, etc.); 3. Use or replace anti-diabetic drugs (thiazolidinediones, glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors, etc.) that affect liver fat content after the intervention, or use other Sodium-glucose co-transporter-2 inhibitor; 4. HIV positive test; 5. Patients with cardiac insufficiency, renal insufficiency, malignant tumor, pregnancy and lactation, or women and men who wish to become pregnant or have children during the study; 6. Patients with a history of mental illness who cannot cooperate with the research of this project; 7. Those with contraindications to dapagliflozin (recurrent urinary tract or genital infection history, current or previous gangrene, or known allergy to the molecule); 8. Those with contraindications to magnetic resonance imaging (pacemaker, claustrophobia, foreign bodies and ferromagnetic implantable medical devices).

Design outcomes

Primary

MeasureTime frame
Magnetic Resonance Imaging liver proton density fat fraction;

Secondary

MeasureTime frame
Pancreatic fat content;Liver function;Renal function;Blood lipid;HbA1c;Fasting insulin;C peptide;Inflammatory marker;Weight;Intestinal flora;Urine microalbumin/creatinine;

Countries

China

Contacts

Public ContactXu Jing

Xinqiao Hospital of Army Medical University

12512380018@163.com+86 13512380018

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026