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Based on the renal ectopic fat deposition mediated chronic hypoxia injury, to explore the early renal protection of polyethylene glycol loxenatide in newly diagnosed type 2 diabetes patients

Based on the renal ectopic fat deposition mediated chronic hypoxia injury, to explore the early renal protection of polyethylene glycol loxenatide in newly diagnosed type 2 diabetes patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046845
Enrollment
Unknown
Registered
2021-05-29
Start date
2021-05-30
Completion date
Unknown
Last updated
2022-01-10

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

Conditions

Newly diagnosed type 2 diabetes

Interventions

experimental group:Received polyethylene glycol loxenatide
control group:Received Insulin glargine

Sponsors

Tianjin Medical University Chu Hisen-I Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The diagnostic criteria for type 2 diabetes were based on the 1999 WHO criteria, and T2DM was diagnosed within 1 year; 2. Without hypoglycemic treatment; 3. Age is greater than or equal to 18 years old and less than 70 years old; 4. The HbA1c was between 7.5% and 10.5%; 5. FPG <= 13.3mmol/L; 6. BMI is between 18.5 and 45.0kg/m2; 7. eGFR is greater than or equal to 90ml/min/1.73m2, and at least two random UACR measurements within 6 months are both less than 30mg/g. eGFR uses the CKD-EPI formula (refer to http://www.nkdep.nih.gov); 8. Other treatments: including the use of stable lipid-lowering, blood pressure, anti-platelet, and other treatment programs, the treatment time is more than 3 months; 9. Voluntarily participate in and cooperate with the research and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Currently using glucocorticoids and other drugs that affect blood sugar, or using GLP-1 receptor agonists or DPP4 enzyme inhibitors within 3 months before screening; 2. Suspected of hypersensitivity to GLP-1 receptor agonists; 3. Acute complications of diabetes occurred in the past 2 months, such as diabetic ketoacidosis, hypertonic hyperglycemia syndrome, lactic acidosis, etc.; 4. Past history of immunocompromised or malignant tumors, family or personal history of type 2 multiple endocrine tumors (MEN2), familial medullary thyroid carcinoma (FMTC), or personal history of non-familial medullary thyroid carcinoma, calcitonin is greater than or Equal to 50ng/L; 5. History of acute or chronic pancreatitis; 6. Acute myocardial infarction, cerebrovascular accident or severe infection occurred within 6 months before enrollment; 7. Suffering from poorly controlled hypertension; systolic blood pressure greater than 180mmHg, systolic blood pressure greater than 110 mmHg; 8. Abnormal liver function, 3 times higher than the normal upper limit of ALT or AST 9. With MRI contraindications; 10. Women who are pregnant or planning to be pregnant, lactating or willing to have children in the near future; 11. Patients with epilepsy or claustrophobia or who are unable to cooperate with nuclear magnetic resonance examination; 12. A person who has a history of mental illness and is unable to follow the research plan and carry out research tasks.

Design outcomes

Primary

MeasureTime frame
Non-invasive quantitative fat measurement of pancreas, kidneys and other organs;Measuring the oxygenation status of kidney tissue;Renal cortex perfusion level;

Secondary

MeasureTime frame
Glomerular filtration rate;Urinary albumin creatinine ratio;

Countries

China

Contacts

Public ContactZhou Saijun

Tianjin Medical University Chu Hisen-I Memorial Hospital

zhousaijun0102@126.com+86 13920611479

Outcome results

None listed

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