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Ethical Review Application for a Clinical Study on Multi-omics Biomarker Exploration in Diabetic Erectile Dysfunction

Ethical Review Application for a Clinical Study on Multi-omics Biomarker Exploration in Diabetic Erectile Dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107001
Enrollment
Unknown
Registered
2025-08-01
Start date
2025-08-01
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

Erectile dysfunction

Interventions

Disease group (Diabetic erectile dysfunction):None
Control group (Normal control):None

Sponsors

Second Xiangya Hospital of CSU
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Men aged 22 to 65; 2.It met the diagnostic criteria for diabetes of the World Health Organization (WHO) (fasting blood glucose >= 7.0mmol/L, or 2-hour postprandial blood glucose >= 11.1mmol/L, or random blood glucose >= 11.1mmol/L, accompanied by diabetic symptoms), and the course of diabetes was >= 1 year; 3.Erectile dysfunction was diagnosed based on the International Erectile Function Index -5 (IIEF-5) score (IIEF-5 score < 22 points), and erectile dysfunction caused by other definite causes (such as psychogenic, neurogenic, vascular and other non-diabetic related factors) was excluded; 4.Voluntarily participate in this study and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1.Combined with other seriously life-threatening diseases, such as advanced malignant tumors, severe heart failure, etc; 2.Drugs that affect erectile function or metabolism have been used within the past three months; 3.There is a serious mental disorder, and it is impossible to communicate normally and understand the content of informed consent; 4.The sample collection and follow-up were unable to be completed as required; 5.Those with other diseases that may affect metabolism or microbial communities, such as severe intestinal diseases or long-term antibiotic treatment; 6.Acute complications of diabetes (e.g. diabetic ketoacidosis, hypertonic hyperglycemia) are not effectively controlled;

Design outcomes

Primary

MeasureTime frame
IIEF-5 score;

Countries

China

Contacts

Public Contactxin jin

Second Xiangya Hospital of CSU

jinxinxy2@csu.edu.cn+86 177 8643 0489

Outcome results

None listed

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