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| Sponsored by: |
Maimonides Medical Center |
|---|---|
| Information provided by: | Maimonides Medical Center |
| ClinicalTrials.gov Identifier: | NCT00562341 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity Prostate Cancer |
Procedure: Bariatric Surgery |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | Effect of Lap-Band Induced Weight Loss on Serum PSA Levels, Testosterone, Estrogen and Other Serum Markers |
blood samples
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2009 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 1 |
Procedure: Bariatric Surgery
one time lapb-band gastric bypass surgery
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients asked to enroll will be obese men who are undergoing bariatric surgery, lap-band surgery, at Maimonides Medical Center.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Maimonides Medical Center | Recruiting |
| Brooklyn, New York, United States, 11219 | |
| Contact: Jason Wynberg jwynberg@maimonidesmed.org | |
| Principal Investigator: Jason Wynberg, MD | |
| Sub-Investigator: Danny Sherwinter, MD | |
| Sub-Investigator: Richard Savel, MD | |
| Sub-Investigator: Payam Hakimian, MD | |
| Sub-Investigator: Michael l Blute, Jr, MD | |
| Sub-Investigator: James A Kashanian, MD | |
| Principal Investigator: | Jason Wynberg, MD | MMC |
More Information
| Study ID Numbers: | 07/09/VA18 |
| Study First Received: | November 20, 2007 |
| Last Updated: | November 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00562341 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
obesity psa prostate cancer |
|
Obesity Estrogens Genital Neoplasms, Male Prostatic Diseases Overweight Urogenital Neoplasms Methyltestosterone Genital Diseases, Male Testosterone 17 beta-cypionate |
Body Weight Signs and Symptoms Testosterone Weight Loss Body Weight Changes Nutrition Disorders Overnutrition Prostatic Neoplasms |
|
Obesity Prostatic Diseases Genital Neoplasms, Male Overweight Urogenital Neoplasms Genital Diseases, Male Body Weight Signs and Symptoms |
Neoplasms Neoplasms by Site Weight Loss Body Weight Changes Nutrition Disorders Overnutrition Prostatic Neoplasms |
