Ignite Creation Date:
2024-05-06 @ 7:51 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02612714
Status:
COMPLETED
Last Update Posted:
2015-11-24
First Post:
2015-11-07
Brief Title:
Statin Lowering Testosterone and Sexual Function
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Statin Therapy is Associated With Low Testosterone and Sexual Function in Men With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None