Statin Lowering Testosterone and Sexual Function
Condition: Sexual Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Statins may decrease serum testosterone levels via decreasing cholesterol. This longitudinal
      study detected the effects of rosuvastatin on free testosterone levels and sexual function in
      men with type 2 diabetes.

      Methods:

      Investigator enroll 150 men with type 2 diabetes and hypercholesterolemia. Biochemical
      assessments include serum total cholesterol (TC), low-density lipoprotein (LDL), high-density
      lipoprotein, triglyceride, prolactin, thyroid-stimulating hormone, luteinizing hormone,
      follicle stimulating hormone, total testosterone and serum sex hormone binding globulin
      (SHBG). All parameters are measured before statin treatment, after 6 months of statin
      treatment and 6 months after discontinuing statin treatment. Scores of the sexual health
      inventory for men (SHIM) are also evaluated.
    

Detailed description: 
      Autonomic neuropathy and hypogonadism are the cause of impotence in men with diabetes.
      Hypercholesterolemia is also one of the dominant co-morbidity of diabetes. Many men with
      diabetes are being treated with statins to low down the serum levels of cholesterol. However,
      cholesterol is the major substrate for testosterone biosynthesis, statin may decrease serum
      testosterone levels via decreasing cholesterol level. In previous studies, few longitudinal
      studies with few enrolled subject were done before and with conflict results. Free
      testosterone is also not routinely used, so compromised the accuracy. The investigators will
      analyze the effect of statins on free testosterone levels in a longitudinal study of men with
      type 2 diabetes and do animal study to realize if the statin will influence the sex organ of
      rat.

      Methods:

      Investigator will enroll 150 men with type 2 diabetes and hypercholesterolemia. Clinical and
      biochemical assessments include blood pressure, HbA1C, lipid profile, height, weight, and
      waist circumference, luteinizing hormone (LH), follicle stimulating hormone (FSH) and free
      testosterone , which will be measured before statin treatment, after 3 months of statin
      treatment and then after quitted statin treatment for 3 months, and also give questionnaire
      about sex function.

      The investigators expect:

        1. Statin may potentially lead to hypogonadism or impotence In men with type 2 diabetes.

        2. The relationship between blood glucose, lipid profile, blood pressure, anthropometric
           measures and serum free testosterone levels may also be revealed.

        3. If this hypothesis is adverse, statin treatment will not influence gonadal function and
           has that side effect.
    

Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): All parameters were measured before statin treatment, after 6 months of statin treatment and 6 months after discontinuing statin treatment. Scores of the sexual health inventory for men (SHIM) were also evaluated.
Other intervention name(s): Cresto
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: diabetes; hypercholesterolemia; sexual dysfunction; statin; testosterone