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A real-world study of the cardio- and renal protective effects of fenelidone in patients with type 2 diabetes and renal insufficiency: a single-center, prospective, observational study

A real-world study of the cardio- and renal protective effects of fenelidone in patients with type 2 diabetes and renal insufficiency: a single-center, prospective, observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076895
Enrollment
Unknown
Registered
2023-10-24
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-10-30

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

Conditions

Type 2 diabetes

Interventions

Observation group:None

Sponsors

The Third Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age =18 years old; 2. Meet the diagnostic criteria for type 2 diabetes (refer to the "China Type 2 Diabetes Prevention and Treatment Guidelines (2020 Edition)") Matches one of 1 and 2-5, or matches any two of 2-5 1) Typical symptoms of diabetes; 2) Random blood sugar =11.1mmol/L; 3) Fasting blood glucose =7.0mmol/L; 4) OGTT 2h blood glucose =11.1mmol/L; 5) Glycated hemoglobin (HbA1C) =6.5%; 3. Meet the diagnostic criteria for CKD (refer to the "Guidelines for Screening, Diagnosis, Prevention and Treatment of Chronic Kidney Disease") 1) UACR 30-<300 mg/g and eGFR=25ml/min/1.73m2; 2) UACR =300mg/g and eGFR =25ml/min/1.73m2; 4. The patient will be evaluated according to blood pressure, creatinine rise and serum potassium when enrolling, and the patient needs to receive the maximum tolerated dose of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) or Angiotensin receptor neprilysin inhibitor (ARNI) treatment for =4 weeks; 5. Baseline serum potassium =4.8 mmol.

Exclusion criteria

Exclusion criteria: 1. Combined with serious primary diseases such as digestive system, blood system, rheumatic immune system, respiratory system (such as aspartate aminotransferase (AST), alanine aminotransferase (ALT) >1.5 times the upper limit of normal value ), or known serious diseases that affect their survival (such as tumors or AIDS, etc.), or patients with mental illness, or legal disabilities; 2. Patients with severe renal insufficiency: eGFR <25ml/min/1.73m2; 3. Severe cardiac insufficiency: cardiac function is New York Heart Classification (NYHA) level IV; 4. Those who are allergic to the ingredients of the trial product; 5. Women who are pregnant, planning pregnancy or breastfeeding; 6. Those who have participated or are currently participating in other clinical studies within 1 month; 7. The researcher determines that it is not appropriate to participate in this experiment or that the interviewee is likely to be lost.

Design outcomes

Primary

MeasureTime frame
NT-proBNP;UACR;Transthoracic echocardiography;

Secondary

MeasureTime frame
Blood routine;Urine routine;Creatinine;BUN;Uric acid;Serum potassium;Fasting blood glucose;Glycated hemoglobin;Alanine aminotransferase;Aspartate aminotransferase;Electrocardiogram;Fundus photos;

Countries

China

Contacts

Public ContactZhaoqi Huang

The Third Affiliated Hospital of Guangzhou Medical University

zhaoqihuang2007@163.com+86 138 0275 0240

Outcome results

None listed

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