Observation on the clinical efficacy of polyethylene glycol loxenatide in the treatment of cerebral small vessel disease in patients with diabetes mellitus

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200055231

Enrollment

Unknown

Registered

2022-01-03

Start date

2022-06-01

Completion date

Unknown

Last updated

2023-01-23

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

Conditions

Diabetes

Interventions

Standard treatment group:Comprehensive management in accordance with the Chinese Diabetes Association guidelines for the prevention and treatment of type 2 diabetes, excluding the use of GLP-1R agonis

Lossenatide treatment group:Add loxenatide at a dose of 200ug, subcutaneously, once a week, or the maximum tolerated dose, under the premise of full management in the standard care group

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes who meet the diagnostic criteria for diabetes proposed by WHO in 1999; 2. Patients who also meet the diagnostic criteria for small cerebral vessels in the ''Chinese Expert Consensus on Cerebral Small Vessel Diseases''; 3. Aged over 40 years; 4. Education level of primary school and above.

Exclusion criteria

Exclusion criteria: 1. Use of GLP-1R agonist or DDP-IV inhibitor in the past 3 months; 2. Acute complications of diabetes; 3. Liver and kidney insufficiency, liver enzymes increased by more than 3 times, eGFR less than 30umol/kg.min; 4. Identify inflammatory diseases; 5. Autoimmune diseases; 6. Medullary thyroid carcinoma; 7. Family history of medullary thyroid cancer; 8. Multiple endocrine neoplasia syndrome type 2; 9. History of malignant tumor; 10. History of hereditary cerebral small vessel disease; 11. History of Alzheimer's disease; 12. History of head trauma; 13. History of cerebral hemorrhage or massive cerebral infarction; 14. History of thyroid dysfunction; 15. History of poison exposure; 16. Pregnant and lactating patients.

Design outcomes

Primary

Measure	Time frame
MRI changes of cerebral small vessel lesions;Cognitive function score;	—

Secondary

Measure	Time frame
Diabetic microvascular complications;Glycosylated hemoglobin;Body mass index;Waistline;Incidence of hypoglycemia;	—

Countries

China

Contacts

Public ContactLin Xiahong

Seventh Affiliated Hospital of Sun Yat-sen University

2413368792@qq.com+86 18965732072

Outcome results

None listed

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