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Diagnostic value of salivary free testosterone in male hypogonadism with type 2 diabetes and its predictive effect on erectile dysfunction: a cross-sectional study

Diagnostic value of salivary free testosterone in male hypogonadism with type 2 diabetes and its predictive effect on erectile dysfunction: a cross-sectional study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119200
Enrollment
Unknown
Registered
2026-02-24
Start date
2025-11-15
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Type 2 diabetes, male hypogonadism, erectile dysfunction

Interventions

T2DM without MH group:None
Control group:None
T2DM with MH group:None

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Voluntary signing of the informed consent form; 2.Age >=30 and <60 years; 3.Gender: Male; 4.According to the "Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 Edition)," patients with T2DM were diagnosed as having type 2 diabetes; 5.The serum calculated free testosterone of MH patients is <0.3 nmol/L, and upon retesting after at least one week, the serum calculated free testosterone remains <0.3 nmol/L. 6.Patients who voluntarily participate in this study, can understand and sign a written informed consent form;

Exclusion criteria

Exclusion criteria: 1. Patients did not collect saliva samples between 8:00 and 10:00 am; 2. Major organ dysfunction including severe liver dysfunction (Child-Pugh class B or C, or ALT/AST > 3 times the upper limit of normal); Severe renal insufficiency (estimated glomerular filtration rate eGFR < 30 mL/min/1.73m^2); 3. known pituitary or hypothalamic lesions, primary gonadal disease (e.g., Klineuelsson's syndrome), uncontrolled thyroid dysfunction; 4. Is receiving, or has received within the past 3 months, testosterone replacement therapy, gonadotropin therapy, antiandrogen therapy, or systemic glucocorticoids (at any dose for more than 2 weeks). Use of medications that may significantly affect testosterone levels (e.g., high-dose opioids, certain antipsychotics, etc.) within the past 6 months; 5. Severe ED due to definite organic causes without expected response to PDE5i therapy (e.g., after radical pelvic surgery or radiotherapy, severe pelvic nerve injury, congenital malformation); 6. Patients with serious mental illness (such as severe depression, schizophrenia), which is judged by the investigator to be unable to reliably complete the questionnaire or affect the assessment of sexual function; 7. According to the investigator's judgment, he was not suitable to participate in the study.

Design outcomes

Primary

MeasureTime frame
Salivary free testosterone levels;The serum hormone free testosterone;

Secondary

MeasureTime frame
International Index of Erectile Function-5 (IIEF-5) scoring scale score;Body mass Index (BMI);Glycosylated hemoglobin;

Countries

China

Contacts

Public ContactCao Ying

Southern Medical University Southern Hospital

nfcy123@126.com+86 20 62787140

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026