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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| medication status | Other | Rosuvastatin 5 mg qd for 6 months, Quitted rosuvastatin for 6 months, Re-administrated rosuvastatin for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| serum testosterone | The measure is a composite outcome measure consisting of multiple measures. Serum testosterone measured after 24 weeks statin treatment, after quitted statin for 24 weeks and after 24 weeks of re-administrating statin | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| sexual function evaluation | The measure is a composite outcome measure consisting of multiple measures. Sexual function measured by questionaire after 24 weeks of statin treatment, after quitted statin for 24 weeks and after 24 weeks of re-administrating statin | up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ching Jung Hsieh | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung | Kaohsiung City | Kaohsiung | 83349 | Taiwan |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D003920 | Diabetes Mellitus |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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|
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |