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Study on the treatment of stachyose in patients with type 2 diabetic nephropathy

Study on the treatment of stachyose in patients with type 2 diabetic nephropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089400
Enrollment
Unknown
Registered
2024-09-08
Start date
2024-09-15
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

diabetic kidney disease

Interventions

stachyose group:Oral stachyose 5g,Bid

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ?Patients with confirmed type 2 diabetes, aged 18-80 years, BMI =30 kg/m2; ?HbA1C =9%; ?Clinical diagnosis of chronic kidney disease, at least 6 months to meet the criteria for persistent proteinuria (at least 2 examinations), 30 mg/g = urinary albumin to creatinine ratio (UACR) =1000mg/g, and glomerular filtration rate (eGFR) =60ml/min/1.73m2; ?The maximum tolerated dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin-receptor blockers (ARBs) was taken for at least 4 weeks before enrollment.

Exclusion criteria

Exclusion criteria: ?Patients taking SGLT2 inhibitors, GLP1 receptor agonists, or finelidone with renal protection; ?Patients with chronic kidney disease of other known etiologies, such as autosomal polycystic kidney disease, lupus nephritis, ANCA-associated vasculitis, etc.; ?Known severe liver disease: AST/ALT more than 3 times the upper normal limit or total bilirubin more than 2 times the upper normal limit; ?Known severe cardiovascular and cerebrovascular disease: NYHA Class 3 or 4 heart failure, acute cardiovascular event, stroke, epilepsy, or thromboembolic event within 1 year; ?Patients with known history of severe hematological diseases, malignant tumors (within 5 years), organ transplant history, and immunosuppressant use; ?In patients with uncontrolled refractory hypertension, systolic blood pressure (SBP) =180mmHg and/or diastolic blood pressure (DBP) =100mmHg; ?Patients with blood potassium level > 5.5mmol/L; ?Women who are pregnant, planning pregnancy or breastfeeding; ? Patients who are allergic or intolerant to oligosaccharides; ? Any medical condition that the investigator believes poses a safety risk to study participants, confuses efficacy or safety assessments, or interferes with study participation.

Design outcomes

Primary

MeasureTime frame
UACR;TNF-a;IL-6;AGEs;NGAL;KIM-1;

Secondary

MeasureTime frame
HbA1c;Creatinine;Serum lipid;

Countries

China

Contacts

Public ContactQin Guijun

The First Affiliated Hospital of Zhengzhou University

hyqingj@zzu.edu.cn+86 135 9886 0123

Outcome results

None listed

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