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The influence of intestinal flora imbalance and immune inflammation on the progression of diabetes nephropathy and the randomized, single center clinical study of fenelidone intervention

The influence of intestinal flora imbalance and immune inflammation on the progression of diabetes nephropathy and the study of fenelidone intervention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079829
Enrollment
Unknown
Registered
2024-01-12
Start date
2024-01-15
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

diabetic kidney disease

Interventions

intervention group:Fenalidone
control group:no(treatment guidelines)

Sponsors

Hebei Yiling Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Type 2 diabetes patients; 2) Age range from 40 to 85 years old, regardless of gender; 3) Estimated glomerular filtration rate (eGFR)>15 ml/min/1.73 m2 (CKD-EPI formula); And or 24 hour urine protein quantity>0.5g or kidney disease symptoms in patients with diabetes and kidney disease. 4) Glycated hemoglobin (HbA1c) = 6.5%, = 12.0%; 5) Be able to understand the procedures and methods of this clinical study, correctly express willingness, voluntarily participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Non T2DM patients; 2) T2DM patients with known malignant tumors, or lactic acidosis, or ketoacidosis, or severe infections, or critically ill patients (such as organ failure, heart failure, myocardial infarction, cerebral infarction, etc.); 3) Have a history of primary thyroid disease and a history of thyroid autoimmune disease.

Design outcomes

Primary

MeasureTime frame
Intestinal flora;Systemic immune inflammation index;Urinary protein creatinine ratio;

Secondary

MeasureTime frame
Blood routine;renal function,Blood cholesterol and triglycerides;Coagulation indicators, immunoglobulins, C-reactive protein, fasting blood glucose;

Countries

China

Contacts

Public ContactLiHuiFang

Nephrology Department of Yiling Hospital Hebei

huifangli2612@126.com+86 189 3272 2069

Outcome results

None listed

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