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A big data observational study of the clinical efficacy of SGLT2i based on a single-disease platform for the treatment of obese patients with early-onset type 2 diabetic nephropathy

A big data observational study of the clinical efficacy of SGLT2i based on a single-disease platform for the treatment of obese patients with early-onset type 2 diabetic nephropathy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106905
Enrollment
Unknown
Registered
2025-07-31
Start date
2025-02-17
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Diabetes

Interventions

The group receiving hypoglycemic treatment with SGLT2i:Using SGLT2i for blood glucose control
The conventional hypoglycemic drug treatment group:Using conventional non-SGLT2i class drugs for blood glucose control
The group receiving hypoglycemic treatment with both SGLT2i and conventional hypoglycemic drugs:Using SGLT2i together with conventional hypoglycemic drugs for blood glucose control

Sponsors

Qingpu Branch of Zhongshan Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Clearly diagnosed with type 2 diabetes mellitus (T2DM) and diabetic kidney disease (DKD); 2. Baseline body mass index (BMI) 28.0 - 40.0 kg/m^2 with abdominal obesity (waist circumference >= 90 cm for men and = 85 cm for women); 3. Age 18 - 75 years old; 4. Disease duration 0 - 5 years; 5. Baseline glycated hemoglobin (HbA1c) >= 6.5%; 6. Non-naïve patients have been treated with stable doses of hypoglycemic drugs for at least 8 weeks.

Exclusion criteria

Exclusion criteria: 1. Exclusion of chronic kidney disease caused by other reasons; 2. Pregnant, planning to be pregnant or lactating women; 3. Acute complications of diabetes such as DKA or HHS occurred within the last 6 months; 4. Use of GLP-1 receptor agonists or weight loss drugs within the last 3 months; 5. Acute or chronic liver disease, or two consecutive tests of transaminase (ALT or AST) within the upper limit of the normal range 3 times or more within 4 weeks before screening, severe renal insufficiency or end-stage renal disease; 6. Significant cardiovascular and cerebrovascular events within the last 3 months before screening: congestive heart failure reaching NYHA grade III or IV, myocardial infarction, TIA, cerebral infarction, etc.; 7. History of recurrent urinary tract infections; 8. History of ketoacidosis within the last half year.

Design outcomes

Primary

MeasureTime frame
Glycosylated hemoglobin;Fasting blood glucose;Microalbuminuria;Urine microalbuminuria/creatinine ratio;Serum liquid;Grip strength;Muscle mass;6-meter walking speed;Abdominal fat;Myostatin;

Countries

China

Contacts

Public ContactMin Zhang

Qingpu Branch of Zhongshan Hospital affiliated to Fudan University

mynarrowgate@126.com+86 181 1601 6187

Outcome results

None listed

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