Type 2 Diabetes Mellitus (T2DM)
Conditions
Interventions
Treatment group:Administration of Sangzhi alkaloids
Control group:Administration of a placebo tablet identical in appearance to the Sangzhi alkaloids tablet.
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male, aged 20 to 45 years (inclusive); 2. Meeting the diagnostic criteria for type 2 diabetes mellitus as defined by the World Health Organization (WHO) or relevant Chinese guidelines, and fulfilling any one of the following criteria for poor glycemic control: random plasma glucose >= 11.1 mmol/L, or fasting plasma glucose >= 7.0 mmol/L, or a 2-hour plasma glucose >= 11.1 mmol/L during an oral glucose tolerance test (OGTT), or HbA1c >= 6.5%. 3. Meeting the diagnostic criteria for oligoasthenospermia defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (5th or current edition): sperm concentration < 15 × 106/mL, and progressive motility (PR) rate < 32%. 4. Having received at least 8 weeks of stable foundational therapy, including lifestyle intervention and/or conventional oral glucose-lowering drugs (e.g., metformin), with the regimen expected to remain stable during the study period. 5. Having a stable heterosexual partner, and the partner has fertility intentions. 6. Having fully understood the study content, voluntarily participating, and signing a written informed consent form. 7. Being able and willing to comply with all scheduled visits, examinations, treatments, and documentation requirements specified in the study protocol.
Exclusion criteria
Exclusion criteria: 1. Identified Other Etiologies for Oligoasthenospermia: Known causes of oligoasthenospermia including chromosomal abnormalities, genital tract obstruction, varicocele (Grade III or above, or requiring surgical intervention), history of cryptorchidism, mumps orchitis, reproductive system tumors, etc. Andrological/Genital System Ultrasound Examination: To screen for conditions such as severe varicocele, testicular/epididymal abnormalities, and signs of obstruction. 2. Severe Systemic Diseases: Presence of severe cardiac, hepatic, or renal insufficiency (e.g., NYHA class III–IV heart failure, ALT or AST > 3 × upper limit of normal, serum creatinine > 1.5 × upper limit of normal). 3. Diabetes-Related Complications: Occurrence of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar hyperglycemic state within the past 6 months. 4. History of Interfering Medication: Use of any medication potentially affecting sperm quality or reproductive hormones (e.g., androgens, gonadotropins, antioxidants, Chinese herbal supplements, etc.) within the past 3 months. Current or planned use of glucagon-like peptide-1 receptor agonists (e.g., semaglutide, liraglutide) for glycemic control during the study period. 5. Presence of other serious systemic diseases (e.g., active infection, malignant tumor, immune system disorders) or psychiatric disorders. 6. History of alcohol or substance abuse (defined as chronic excessive use that impacts health or social functioning). 7. Known allergy to Sangzhi alkaloids or any of its excipients. 8. Participation in any other drug or medical device clinical trials within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sperm Concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum Levels of FSH, LH, Total Testosterone, Estradiol, and Inhibin B;Sperm total count, percentage of progressively motile sperm, sperm normal morphology rate;Complete Blood Count (CBC), Blood Biochemistry;Glycated Hemoglobin (HbA1c), Fasting Blood Glucose (FBG); | — |
Countries
China
Contacts
Public ContactChenyao Deng
Peking University First Hospital
Outcome results
None listed