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

NCT00472251 | Completed DMC

• 1 other identifier: CRT110446
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

dutasteride; body mass index; testosterone

Outcome Measures

Primary Outcomes (1)

• body mass index

  after 1 year of treatment

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• GlaxoSmithKline: collaborator
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

• Roehrborn CG, Lee M, Meehan A, Waldstreicher J; PLESS Study Group. Effects of finasteride on serum testosterone and body mass index in men with benign prostatic hyperplasia. Urology. 2003 Nov;62(5):894-9. doi: 10.1016/s0090-4295(03)00661-7.

  PMID: 14624915 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sang Eun Lee, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 11, 2007
• Study Start: May 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 21, 2011

Record last verified: 2011-07

Locations

KR (1)