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Effect and mechanism of polyethylene glycol Losenazeptide on cardiac microangiopathy in patients with type 2 diabetes mellitus complicated with massive albuminuria

Effect and mechanism of polyethylene glycol Losenazeptide on cardiac microangiopathy in patients with type 2 diabetes mellitus complicated with massive albuminuria

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049856
Enrollment
Unknown
Registered
2021-08-10
Start date
2021-08-30
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

type 2 diabetes mellitus

Interventions

Sponsors

Tianjin Medical University Chu Hsien-l Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. The enrolled patients were informed about the whole process of the trial, participated voluntarily, signed the informed consent form, and passed the approval of the ethics clerk committee; 2. Diagnosed type 2 diabetes patients (WHO standard, 1999), aged 18 to 60 years, male or female; 3. Random urinary UACR >= 300 mg/g and or 24-hour urine protein quantification >= 3.5 g indicates increased urinary albumin excretion and macroalbuminuria. Repeat examination of UACR within 3-6 months, urinary albumin excretion increased in 2 of the 3 times, and the diagnosis can be made by excluding other factors such as infection; 4. Patients with definite diagnosis of diabetic non-proliferative retinopathy (according to the International Clinical Grading Standard of Diabetic Retinopathy (2002 edition)); 5. Normal intraocular pressure (9-21mmHg).

Exclusion criteria

Exclusion criteria: 1. Non-diabetic nephropathy: such as hypertensive nephropathy, acute and chronic glomerulonephritis, hepatitis B-related nephropathy, etc. Chronic kidney disease should be considered as a non-diabetic cause in the following cases: no diabetic retinopathy; low or rapid decline in GFR; refractory Hypertension; GFR decreased by more than 30% within 2-3 months after the start of ACEI or ARB treatment; acute increase in proteinuria or nephrotic syndrome; manifestations of urinary sediment activity; symptoms or signs of other systemic diseases; 2. Patients with abnormal renal function , the glomerular filtration rate is less than 60ml/min/1.73m2 (eGFR-EPI formula); 3. Patients diagnosed with proliferative diabetic retinopathy or patients with simple diabetes without retinopathy; 4. Those with a history of eye diseases such as glaucoma, age-related macular degeneration, and high refractive error in both eyes; 5. Liver function damage, ALT and AST are more than 2 times the upper limit of normal; 6. Patients with severe heart disease, such as unstable angina pectoris, acute myocardial infarction, and heart failure patients; 7. Patients with acute and chronic pancreatitis, biliary tract disease, family history of thyroid malignancy, etc. are not suitable for GLP-1 receptor agonists; 8. Patients with acute complications of diabetes such as diabetic ketosis, diabetic hyperosmolar hyperglycemia and recent blood sugar fluctuations; 9. Patients who are pregnant, preparing to become pregnant and breastfeeding; 10. Patients with mental disorders; 11. Patients with severe hyperlipidemia; 12. Inability to cooperate or refuse to cooperate with the patient.

Design outcomes

Primary

MeasureTime frame
Cardiac Nuclear magnetic resonance;24h holter;optical coherence tomography angiography;

Countries

China

Contacts

Public ContactShan Chunyan

Tianjin Medical University Chu Hsien-l Memorial Hospital

chunyanshan@hotmail.com+86 13820275696

Outcome results

None listed

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