Diabetes mellitus complicated by oligoasthenospermia? ?
Conditions
Interventions
Test Group:Sodium - Glucose Cotransporter 2 Inhibitors
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male, aged 18-45 years; 2. With a definite history of diabetes mellitus, and current blood glucose levels still meeting the diagnostic criteria for type 2 diabetes mellitus; 3. Having not taken SGLT2 inhibitor hypoglycemic drugs within the past 3 months; 4. Semen quality examination showing: sperm count <15 million/ml and/or progressive motility sperm ratio <32%; 5. Having not taken drugs that affect sperm quality within 3 months before screening; 6. Willing to receive hypoglycemic drugs and undergo regular hypoglycemic treatment (for at least 3 months); 7. Able to cooperate and complete follow-up and related examinations; 8. Voluntarily participating in this trial and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with severe diseases of major organs such as the heart, liver, kidneys, as well as disorders of the hematological or endocrine systems, evaluated based on the following criteria: (1) Cardiac diseases: Patients with decompensated heart failure or refractory hypertension; those with abnormal electrocardiogram (ECG) results during screening, where the investigator deems the abnormality clinically significant and likely to pose an unacceptable risk to the patient’s participation in this study; (2) Liver function: Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >= 2 times the upper limit of normal (ULN); (3) Renal function: Complicated with renal tubular and/or interstitial lesions, or renal insufficiency: Serum creatinine >= ULN or estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m²; (4) White blood cell (WBC) count < 3×10?/L and/or hemoglobin (Hb) < 100 g/L and/or platelet (PLT) count < 80×10?/L; (5) Other severe diseases: Such as tumors, etc. 2. Patients with mental illness or those unable to cooperate with treatment due to other reasons; 3. Patients with allergic diathesis or allergies to multiple drugs; 4. Patients with a history of diseases that may affect sperm quality, such as previous orchitis, epididymitis, mumps, or varicocele; 5. Patients with positive results in semen bacterial culture, or positive for Chlamydia trachomatis, Ureaplasma urealyticum, or Mycoplasma hominis; 6. Patients with a history of exposure to high temperatures, chemicals, physical hazards, or toxic substances within the past year; 7. Patients who have undergone X-ray or CT examinations within the past 3 months or during the enrollment period; 8. Patients with concurrent diseases in other systems who are receiving treatment with other drugs that may affect sperm quality; 9. Patients who have taken other hypoglycemic drugs within the past 3 months; 10. Patients with a previous history of allergy to this class of products; 11. Patients currently participating in other clinical studies that the investigator deems may affect the results of this trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Semen quality;gut microbiota; | — |
Countries
China
Contacts
Public ContactHui Jiang
Peking University First Hospital
Outcome results
None listed