Effect of Lap-Band Induced Weight Loss on Serum PSA Levels - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 20, 2007

Last Updated Date

November 21, 2007

Start Date ^†

November 2007

Current Primary Outcome Measures ^†

PSA value [ Time Frame: 18 months ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00562341 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

quality of life, testosterone, esradiol, leptin, HbA1c, cholesterol, prostate volume [ Time Frame: 18 months ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Effect of Lap-Band Induced Weight Loss on Serum PSA Levels

Official Title ^†

Effect of Lap-Band Induced Weight Loss on Serum PSA Levels, Testosterone, Estrogen and Other Serum Markers

Brief Summary

The proposed prospective study aims to determine whether interpretation of PSA levels in morbidly obese men require correction due to the obesity itself.

If PSA levels are found to rise after weight loss, interpretation of PSA levels in morbidly obese men may be improved by upward correction of the PSA level. A 'correction factor' may be proposed for the interpretation of PSA levels in obese men, toward the clinical decision regarding indication for prostate biopsy.

Detailed Description

The main objective of this study is to determine whether interpretation of PSA levels in morbidly obese men require correction due to the obesity itself.

Secondary outcome measures that will be followed include the affect of obesity and weight loss on testosterone, estradiol and leptin. In as much as these might also affect PSA, we will be measuring these values as well. Also, we do not know the effects of lap-band induced weight loss on clinical outcome measures of sexual, bowel and urinary function. Thus we will aim to investigate these parameters as well.

Study Phase

Study Type ^†

Observational

Study Design ^†

Case-Only, Prospective

Condition ^†

Obesity
Prostate Cancer

Intervention ^†

Procedure: Bariatric Surgery

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

December 2009

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

obese men undergoing lap-band surgey

Exclusion Criteria:

prior diagnosis of prostate cancer, prior prostate surgery, use of 5-alpha reductase inhibitors and history prostatitsis or recurrent UTI.

Gender

Male

Ages

20 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00562341

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Maimonides Medical Center

Collaborators ^††

Investigators ^†

Principal Investigator:

Jason Wynberg, MD

MMC

Information Provided By

Maimonides Medical Center

Verification Date

September 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.