This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Menopause in women has been associated with an increased risk of cardiovascular disease. Conventional HRT (Estrogen + Progestin) has been associated with an increase in CVD events. Estrogen alone has been shown to not increase or decrease events. However there is a small increased risk of stroke. Because of recent findings there is a need to study alternative therapies for prevention in postmenopausal women. Evista, or Raloxifene, in contrast to estrogen, does not stimulate breast or uterine tissues, which makes it a potential option for treatment of conditions characteristic of postmenopausal women. The purpose of this study is to determine the effect of Evista on blood flow velocity, which may have an effect on the risk of cardiovascular disease. Blood flow velocity is measured by pulsatility index with the use of the Doppler ultrasound. In this study, women will be screened by medical history and physical examination, and then randomized to either the treatment or placebo arm. Pulsatility indices will be measured at baseline, during, and after 2 and 6 ms of treatment, to determine differences in peripheral blood flow velocity between the two groups. Also, quality of life will be assessed by the use of the SF36 questionnaire. This study will investigate the effect of Evista on peripheral blood flow velocity as well as its effect on patient quality of life. Hypothesis Treatment with Evista will be associated with a reduction of the pulsatility indices and therefore an increase in blood flow in the peripheral arteries. Also, with this therapy, patients will exhibit an improved quality of life as assessed by the SF36 questionnaire. Primary Objective To investigate the effect of Evista compared to placebo on peripheral vascular blood flow velocity in postmenopausal women. Secondary Objective To investigate the effect of Evista compared to placebo on patient quality of life.Hypothesis Treatment with Evista will be associated with a reduction of the pulsatility indices and therefore an increase in blood flow in the peripheral arteries. Also, with this therapy, patients will exhibit an improved quality of life as assessed by the SF36 questionnaire.Primary Objective To investigate the effect of Evista compared to placebo on peripheral vascular blood flow velocity in postmenopausal women.Secondary Objective To investigate the effect of Evista compared to placebo on patient quality of life.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR014467-07
Application #
7608105
Study Section
Special Emphasis Panel (ZRR1-CR-8 (01))
Project Start
2007-03-01
Project End
2008-02-29
Budget Start
2007-03-01
Budget End
2008-02-29
Support Year
7
Fiscal Year
2007
Total Cost
$405
Indirect Cost
Name
University of Oklahoma Health Sciences Center
Department
Type
Schools of Medicine
DUNS #
878648294
City
Oklahoma City
State
OK
Country
United States
Zip Code
73117
Gardner, Andrew W; Montgomery, Polly S; Zhao, Yan D et al. (2018) Endothelial Cell Inflammation and Antioxidant Capacity are Associated With 6-Minute Walk Performance in Patients With Symptomatic Peripheral Artery Disease. Angiology 69:416-423
Kelly, Clare B; Hookham, Michelle B; Yu, Jeremy Y et al. (2018) Subclinical First Trimester Renal Abnormalities Are Associated With Preeclampsia in Normoalbuminuric Women With Type 1 Diabetes. Diabetes Care 41:120-127
Kelsey, Megan M; Braffett, Barbara H; Geffner, Mitchell E et al. (2018) Menstrual Dysfunction in Girls From the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study. J Clin Endocrinol Metab 103:2309-2318
Kleinberger, Jeffrey W; Copeland, Kenneth C; Gandica, Rachelle G et al. (2018) Monogenic diabetes in overweight and obese youth diagnosed with type 2 diabetes: the TODAY clinical trial. Genet Med 20:583-590
Berkowitz, Robert I; Marcus, Marsha D; Anderson, Barbara J et al. (2018) Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial. Pediatr Diabetes 19:191-198
Arslanian, Silva; El Ghormli, Laure; Kim, Joon Young et al. (2018) The Shape of the Glucose Response Curve During an Oral Glucose Tolerance Test: Forerunner of Heightened Glycemic Failure Rates and Accelerated Decline in ?-Cell Function in TODAY. Diabetes Care :
Short, Kevin R; Pratt, Lauren V; Teague, April M (2018) A single exercise session increases insulin sensitivity in normal weight and overweight/obese adolescents. Pediatr Diabetes :
Kriska, Andrea; El Ghormli, Laure; Copeland, Kenneth C et al. (2018) Impact of lifestyle behavior change on glycemic control in youth with type 2 diabetes. Pediatr Diabetes 19:36-44
Kelly, Clare B; Hookham, Michelle B; Yu, Jeremy Y et al. (2018) Response to Comment on Kelly et al. Subclinical First Trimester Renal Abnormalities Are Associated With Preeclampsia in Normoalbuminuric Women With Type 1 Diabetes. Diabetes Care 2018;41:120-127. Diabetes Care 41:e102-e103
Gardner, Andrew W; Montgomery, Polly S; Wang, Ming et al. (2018) Predictors of health-related quality of life in patients with symptomatic peripheral artery disease. J Vasc Surg 68:1126-1134

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