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Clinical Study for Intensive Glucose Control Combined With Double RAS Inhibitory Therapy for Type 2 Diabetic Nephropathy

The Efficacy and Safety of Intensive Glucose Control Combined With Double RAS Inhibitory Therapy for Type 2 Diabetic Nephropathy: a Randomized, Controlled, Single-Center Clinical Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024752
Enrollment
Unknown
Registered
2019-07-26
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-07-29

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

Conditions

Type 2 Diabetic Nephropathy

Interventions

dual RAS inhibitory therapy group:Intensive insulin therapy+Valsartan capsule 80mg + perindopril tert-butylamine tablets 4mg 1/day
ARB therapy group:Intensive insulin therapy+Valsartan capsule160mg 1/day
ACEI therapy group:Intensive insulin therapy+perindopril tert-butylamine tablets 8mg 1/day

Sponsors

Nephrology Division, the First Hospital Affiliated to Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1 Patients volunteer to participate in the study, endorse three treatment modalities, and are willing to randomly accept any of the three treatment options, and provide written informed consent; 2 Gender is not limited, aged 18 to 60 years; 3 Subjects need to meet one of the following criteria for diagnosis of diabetic nephropathy: A: meeting the diagnostic criteria for type 2 diabetes mellitus (2014 ADA diabetes diagnosis and treatment guidelines), accompanied by diabetic retinopathy, renal damage, proteinuria, in line with the clinical diagnosis of diabetic nephropathy; B: diabetic kidney confirmed by renal biopsy pathology. Histological changes of the disease; 4 The subjects did not receive ACEI/ARB (RAS inhibitor) treatment for at least 3 months before the screening period. 5 HbA1c = 500mg/g and <=5000mg/g; 7 Estimated glomerular filtration rate (eGFR) was greater than 30 mL/min/1.73 m2, calculated by CKD-EPI formula. 8 Abide by the research or follow-up procedure.

Exclusion criteria

Exclusion criteria: 1 Women who have recently had family planning, pregnancy or breastfeeding; 2 Understanding the potential risks and benefits of the study, unable to follow-up assessment as required; 3 No capacity for civil conduct; 4 History of drug or alcohol abuse; 5 Active infections; 6 Complicated with other non-diabetic nephropathy, immune diseases, connective tissue diseases, amyloidosis and those who need immunosuppressive therapy; 7 Any more complex medical problem may interfere with research behavior or lead to increased risk, such as malignant tumors, blood diseases, heart diseases, liver diseases, AIDS, viral hepatitis, etc..

Design outcomes

Primary

MeasureTime frame
UACR;

Secondary

MeasureTime frame
Serum albumin level;eGFR;suPAR;Serum creatinine level;

Countries

China

Contacts

Public ContactBingbing Shen

Nephrology Division, the First Hospital Affiliated to Army Medical University

sbbiceme1234@sina.com+86 18696550155

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026