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Validation of Plasma Exosome Biomarkers for Diabetic Bladder Dysfunction and Application in Protein Chips

Validation of Plasma Exosome Biomarkers for Diabetic Bladder Dysfunction and Application in Protein Chips

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111730
Enrollment
Unknown
Registered
2025-11-05
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Diabetic bladder dysfunction

Interventions

DBD Group:None
Non-DBD Group:None

Sponsors

Shenzhen Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Voluntarily signed informed consent. (2) Age >= 18 years. (3) DBD group and Non-DBD group: Meet diagnostic criteria for T2DM with =5 years of disease duration; Possess complete medical records including bladder symptoms and clinical data related to T2DM. (4) Healthy control group (NC group): Healthy individuals undergoing physical examinations at the same medical center, matched for gender and age with the case groups.

Exclusion criteria

Exclusion criteria: For the DBD group and Non-DBD group: (1) Presence of neuropathy caused by non-DM factors (e.g., spinal cord injury, multiple sclerosis, stroke, spina bifida, Parkinson's disease). (2) Presence of prostate disease (e.g., benign prostatic hyperplasia, prostate cancer, history of prostate surgery). (3) Presence of pelvic disease (e.g., pelvic organ prolapse, history of pelvic surgery). (4) Presence of acute metabolic complications of DM (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state). (5) Presence of severe cardiac, hepatic, pulmonary, or renal dysfunction.

Design outcomes

Primary

MeasureTime frame
Sensitivity, specificity, negative predictive value and positive predictive value of plasma exosome-specific proteins for diagnosing DBD;Sensitivity, specificity, negative predictive value and positive predictive value of protein chip diagnostics for DBD (new cohort population);

Countries

China

Contacts

Public ContactCai Wenzhi

Shenzhen Hospital, Southern Medical University

caiwzh@smu.edu.cn+86 755 2336 0006

Outcome results

None listed

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