Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393172
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2006-10-25
Brief Title:
Women in Steady Exercise Research Formerly Women Oxidative Stress Exercise and Estrogens WOSEE
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Women in Steady Exercise Research WISER
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WISER
Brief Summary:
RATIONALE Exercising regularly may lower the risk of breast cancer
PURPOSE This randomized clinical trial is studying how well exercise prevents breast cancer in healthy young women
PURPOSE This randomized clinical trial is studying how well exercise prevents breast cancer in healthy young women
Detailed Description:
OBJECTIVES
Primary
Compare the changes in urine levels of a stable marker of oxidative stress F_2-isoprostanes in healthy young women who undergo exercise training during 4 menstrual cycles vs no exercise
Secondary
Assess the changes in other metabolic factors that explain the association between physical activity and breast cancer including
Estrogen metabolism estrone estradiol estriol 2-OHE_1 2-OHE_2 2-MeOHE_1 2-MeOHE_2 4-OHE_1 4-OHE_2 as well as ratios of these metabolites insulin-like growth factor IGF-1 as well as IGF-binding proteins-1 -2 and -3 insulin glucose body composition including body mass index lean mass and body fat DEXA scan
OUTLINE This is a randomized controlled study Participants are stratified according to baseline body fat percentage and age 18 to 24 years vs 25 to 30 years Participants are randomized to 1 of 2 intervention arms
Arm I Participants exercise for 30 minutes 5 times a week The intensity of exercise is increased every 4 weeks The exercise regimen continues for up to 4 menstrual cycles
Arm II Participants are observed for 4 menstrual cycles Participants in both arms undergo 24-hour collection of urine on days 7 8 and 9 of menstrual cycles 1 and 6 F_2-isoprostanes are measured via gas chromatography-mass spectrometry GCMS Estrogens are also measured by GCMS and include E_1 E_2 E_3 2-OHE_1 2-OHE_2 4-OHE_1 4-OHE_2 2-MeE_1 2-MeE_2 4-MeE_1 4-MeE_2 and 16OHE_1
Participants undergo blood collection body mass measurement by dual-energy x-ray absorptiometry and a fitness assessment twice during the 6-month study
PROJECTED ACCRUAL A total of 400 participants will be accrued
Primary
Compare the changes in urine levels of a stable marker of oxidative stress F_2-isoprostanes in healthy young women who undergo exercise training during 4 menstrual cycles vs no exercise
Secondary
Assess the changes in other metabolic factors that explain the association between physical activity and breast cancer including
Estrogen metabolism estrone estradiol estriol 2-OHE_1 2-OHE_2 2-MeOHE_1 2-MeOHE_2 4-OHE_1 4-OHE_2 as well as ratios of these metabolites insulin-like growth factor IGF-1 as well as IGF-binding proteins-1 -2 and -3 insulin glucose body composition including body mass index lean mass and body fat DEXA scan
OUTLINE This is a randomized controlled study Participants are stratified according to baseline body fat percentage and age 18 to 24 years vs 25 to 30 years Participants are randomized to 1 of 2 intervention arms
Arm I Participants exercise for 30 minutes 5 times a week The intensity of exercise is increased every 4 weeks The exercise regimen continues for up to 4 menstrual cycles
Arm II Participants are observed for 4 menstrual cycles Participants in both arms undergo 24-hour collection of urine on days 7 8 and 9 of menstrual cycles 1 and 6 F_2-isoprostanes are measured via gas chromatography-mass spectrometry GCMS Estrogens are also measured by GCMS and include E_1 E_2 E_3 2-OHE_1 2-OHE_2 4-OHE_1 4-OHE_2 2-MeE_1 2-MeE_2 4-MeE_1 4-MeE_2 and 16OHE_1
Participants undergo blood collection body mass measurement by dual-energy x-ray absorptiometry and a fitness assessment twice during the 6-month study
PROJECTED ACCRUAL A total of 400 participants will be accrued
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U54CA116849 | NIH | None | None |
| UMN-0505M69867 | REGISTRY | University of Minnesota IRB | httpsreporternihgovquickSearchU54CA116849 |