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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Seoul National University Bundang Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00472251
First received: May 10, 2007
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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
Benign Prostatic Hyperplasia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • body mass index [ Time Frame: after 1 year of treatment ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: May 2006
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders 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.

Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00472251

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

Publications:
Responsible Party: Sang Eun Lee/Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00472251     History of Changes
Other Study ID Numbers: CRT110446
Study First Received: May 10, 2007
Last Updated: July 20, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
dutasteride
body mass index
testosterone

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2014