Sexual Dysfunction Clinical Trial
Official title:
Statin Therapy is Associated With Low Testosterone and Sexual Function in Men With Type 2 Diabetes
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.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
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