Benign Prostatic Hyperplasia Clinical Trial
Official title:
One-year Prospective Observational Study of BMI Change Effect of 5-alpha Reductase Inhibitor in Korean BPH Patients
It is widely-accepted that serum testosterone level and BMI (body mass index) representative of the degree of obesity has negative correlation. Considering the fact that obesity is being mentioned as a risk factor for development of prostate cancer as well as other various life-threatening diseases (example: cardiovascular problems), the effect of BPH treatment agents on BMI is a subject that should certainly be elucidated. Meanwhile, to our knowledge, no prospective study has so far been performed on such issue in Asian population. Prior to generating hypothesis of the effect of 5 alpha reductase inhibitor on BMI, the real effect of 5 alpha reductase inhibitor on BMI change in Korean BPH patients has to be observed in real clinical practice. This study will test the effects of one-year medication of 5 alpha reductase inhibitor on BMI among Korean men with BPH.
This study is a prospective, 1-year follow-up, observational study. We are planning to
enroll 100 Korean patients with BPH. At each visit, patients' height, weight, abdominal
circumference will be checked. Laboratory parameters including fasting glucose, HbA1c, serum
testosterone, free testosterone, sex hormone-binding globulin, estradiol, maximum flow rate
(measured by flowmetry) will be tested. Blood test will be performed twice (at baseline and
at the end of study). 5mL of blood will be needed at each time from one subject. And total
IPSS score will be evaluated after 1 year of treatment of 5 ARI. At every visit, use of
above prohibited medicines and other medications will be investigated. In addition, any
surgical procedures undertaken during study period will be asked and recorded.
Subjects of study will be allocated into 3 separate groups. Group 1 will be those taking 5
alpha reductase inhibitor (dutasteride) only for 1 year. Group2 will be those who switch
from alpha blocker to dutasteride and take dutasteride for 1 year. Group 3 will be composed
of those taking both alpha blocker and dutasteride for 1 year.
composed of
;
Observational Model: Cohort, Time Perspective: Prospective
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