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Effect of pioglitazone metformin combination with liraglutide in patients with type 2 diabetes complicated with metabolometabolic fatty liver disease

Effect of pioglitazone metformin combination with liraglutide in patients with type 2 diabetes complicated with metabolometabolic fatty liver disease

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060695
Enrollment
Unknown
Registered
2022-06-08
Start date
2022-06-02
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

Type 2 diabetes mellitus with metabolism-related fatty liver disease

Interventions

control group:Pioglitazone metformin tablets
control group:Liraglutide injection
experimental group:Pioglitazone metformin tablets + Liraglutide injection

Sponsors

Shandong Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Aged between 18 and 70 (including 18 and 70); 2) 19 kg/m2 10%. 5) Willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes or other special types of diabetes; 2) Used more than two kinds of TZDs, GLP-1 receptor agonists, DPP-4 inhibitors, insulin and oral drugs within 3 months; 3) Severe liver injury with ALT and AST more than 3 times the upper limit of normal; 4) Renal impairment, glomerular filtration rate =133µmol/L, male >=135µmol/L; 5) Patients with severe heart disease, such as severe cardiomyopathy, cardiac insufficiency (New York Heart function grade ? or above), acute coronary syndrome, and old myocardial infarction Death or electrocardiogram suggests the diagnosis of the above diseases; 6) Blood pressure: SBP>=180 mmHg and/or DBP>=110 mmHg; 7) White blood cell count <=3.0×109/L or platelet count <=60×10^9/L, or definite anemia (hemoglobin: male < 120 g/L, female < 110 g/L), or other diseases of blood system; 8) Diseases of endocrine system, such as hyperthyroidism, hypothyroidism, hypercortisolism and other diseases affecting fatty liver; 9) Allergic to study drugs or frequent hypoglycemia; 10) Persons suffering from mental disorders, drug or other substance abuse; 11) Patients with diabetic ketoacidosis and hyperosmolar non-ketotic coma need insulin treatment; 12) Chronic hypoxic diseases such as emphysema and cor pulmonale; 13) Combined use of drugs that affect glucose metabolism, such as glucocorticoids; 14) Patients with tumors, especially bladder tumors, and/or a family history of bladder tumors, and/or a long history of hematuria; 15) A history of osteoporosis or non-violent fractures; 16) pregnant or breastfeeding or intending to become pregnant; 17) Have participated in clinical trials of other drugs within three months; 18) Patients deemed unsuitable for the study by the investigator.

Design outcomes

Primary

MeasureTime frame
Intrahepatic lipid content (IHL) : the hepatic fat content is detected by magnetic resonance imaging, and the relative fat content of liver cells is expressed by hydrogen proton density fat fraction value (MRI-PDFF).;

Secondary

MeasureTime frame
Liver Fibrosis score Fibrosis-4 (FIB-4);Glycosylated hemoglobin;Fasting plasma glucose;Fasting insulin;HOMA-IR;Liver enzymes (ALT, AST);subcutaneous adipose tissue;visceral adipose tissue;

Countries

China

Contacts

Public ContactJiajun zhao
jjzhao@sdu.edu.cn+86 15168889899

Outcome results

None listed

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