One-year Prospective Observational Study of BMI Change Effect of 5-alpha Reductase Inhibitor in Korean BPH Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00472251
Recruitment Status : Completed
First Posted : May 11, 2007
Last Update Posted : July 21, 2011
Seoul National University Bundang Hospital
Information provided by:
Seoul National University Hospital

Brief Summary:
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.

Condition or disease
Benign Prostatic Hyperplasia

Detailed Description:

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

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: One-year Prospective Observational Study of BMI Change Effect of 5-alpha Reductase Inhibitor in Korean BPH Patients
Study Start Date : May 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

Primary Outcome Measures :
  1. body mass index [ Time Frame: after 1 year of treatment ]

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We recruited men aged 45-75 years with moderate to severe symptomatic BPH (IPSS > 7 and a peak urinary flow rate of < 15 mL/s),an enlarged prostate (≥30 mL on TRUS), a PSA level of <10 ng/mL, and no evidence of prostate cancer (on a DRE or TRUS) among patients who visited our clinic.

Inclusion Criteria:

  • Male patients with symptomatic BPH
  • Prostate volume of 30 cm3 or greater measured by transrectal ultrasound
  • International Prostatic Symptom Score(IPSS) of 9 or greater
  • Maximum urinary flow rate (Qmax) of 15ml/s or less
  • No definite evidence of prostate cancer (on transrectal ultrasound, DRE, or etc.)
  • Given Informed consent

Exclusion Criteria:

  • Post-void residual more than 250 mL
  • History of cancer (including prostate cancer) or previous prostatic surgery
  • Acute urinary retention within 3 months of enrollment
  • Chronic alcohol abuser and heavy smoker (> 10 cigarettes/day)
  • History of/current drug abuse including laxatives
  • Any previous 5 ARI administration
  • Type 1 DM or Type 2 DM regardless of treatment
  • Clinically significant endocrine diseases at investigator's discretion including thyroid diseases.
  • History of /current bulimia or anorexia nervosa
  • Regular use of following prohibited medicines within 3 months prior to screening; A. Medicines which can affect salt/water retention such as diuretics, calcium channel blockers, gabapentin, pregabalin, etc B. Medicines which can affect body weight such as sibutramine, orlistat, phentermine, amphetamine, etc.

C. Anti-thyroid medication, thyroxine, cyproheptadine, tranquilizers, systemic corticosteroids, testosterone supplement, or other medications that are known to affect body weight or BMI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00472251

Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Kyunggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Principal Investigator: Sang Eun Lee, MD, PhD Seoul National University Bundang Hospital

Responsible Party: Sang Eun Lee/Professor, Seoul National University Bundang Hospital Identifier: NCT00472251     History of Changes
Other Study ID Numbers: CRT110446
First Posted: May 11, 2007    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011

Keywords provided by Seoul National University Hospital:
body mass index

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs