Source: OKLAHOMA STATE UNIVERSITY submitted to
OSTEOPOROSIS RISK IN OKLAHOMA NATIVE AMERICAN WOMEN: THE ROLE OF INFLAMMATION AND DIABETES
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
TERMINATED
Funding Source
Reporting Frequency
Annual
Accession No.
0215234
Grant No.
(N/A)
Project No.
OKL02690
Proposal No.
(N/A)
Multistate No.
(N/A)
Program Code
(N/A)
Project Start Date
Aug 1, 2008
Project End Date
Sep 30, 2010
Grant Year
(N/A)
Project Director
Smith, B. J.
Recipient Organization
OKLAHOMA STATE UNIVERSITY
(N/A)
STILLWATER,OK 74078
Performing Department
Human Sciences
Non Technical Summary
To date, most of the osteoporosis-related research has focused on Caucasian populations with limited information available for other high risk ethnic groups such as Native Americans. Native American women may be considered "high risk" because they are more likely to smoke, have low dietary calcium intake, compromised vitamin D status, are less likely to perform regular weight-bearing exercise and may have a greater rate of bone loss following menopause than other ethnic populations. Additionally, recent evidence suggests that despite the fact that individuals with type II diabetes may have higher bone mineral density at weight-bearing skeletal sites, diabetes is associated with suppressed vitamin D status and increased fracture incidence, especially of the hip, spine and foot. One potential explanation for the link between diabetes and compromised bone health is the underlying inflammatory processes. Due to the prevalence of diabetes among Native Americans, this population likely to be at even greater risk of osteoporosis than their Caucasian counterparts. Therefore, this study is designed to begin to examine the relationship some of these lifestyle factors in a cohort of Native American women and its relationship to bone mineral density and overall risk for osteoporosis.
Animal Health Component
(N/A)
Research Effort Categories
Basic
(N/A)
Applied
100%
Developmental
(N/A)
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
7026099101060%
7026099109040%
Goals / Objectives
The objectives of this study are: 1) To determine the extent to which serum vitamin D status (e.g. serum 25-hydroxy vitamin D3 and 1,25-dihydroxy vitamin D3) and inflammatory mediators such as C-reactive protein, tumor necrosis factor (TNF)-alpha and differential leukocyte counts predict BMD at baseline and change in BMD over a one year period; and 2) To evaluate the influence of lifestyle factors (e.g. dietary intake, physical activity history, smoking history), body composition, reproductive and medical history on osteoporosis risk.
Project Methods
We will analyze baseline and year 1 follow-up data on a subset of 100 Native American women participants (>50 yrs) recruited to undergo osteoporosis risk assessment. This assessment includes medical history, anthropometrics, bone density scans of the total body, hip, spine and forearm, dietary and physical activity assessment, and a blood draw. Relevant medical history will be obtained at baseline and at the 1 year follow-up. This information will include reproductive history, surgical history, previous diagnoses, and medication and supplement use. Height and weight will be recorded at each visit. Bone mineral density and body composition will be determined as a result of dual energy x-ray absorptiometry scans (DXA). Dietary assessment will be accomplished using a 3-day food record, analyzed using Food Processor II (ESHA Research) and supplemented with the Food and Nutrient Database for Dietary Studies 1.0. Physical activity patterns will be assessed at baseline and at the 1-year follow-up visit using the Lifetime Physical Activity Questionnaire which allows for the assessment of physical activity at various times across the lifespan. A complete blood count will be performed on whole blood to obtain leukocyte and differential counts. Analyses will be performed on stored sera samples from the study participants at baseline and year 1 using commercially available assays. These assays will include serum C-reactive protein and TNF-alpha as indicators of inflammation, and vitamin D metabolites. For those individuals who indicate they have been previously diagnosed with diabetes, we will request hemoglobin A1c laboratory values from their medical records as an indicator of glucose control from their clinic medical record. Descriptive statistics will be calculated for all variables and will include means, standard deviations, medians, minima and maxima. Hierarchical regression analysis will be utilized to analyze the continuous predictors and outcomes as well as change scores between baseline and the 1-year follow-up. Repeated measures ANOVA will be performed to detect differences between baseline and year 1 time points, followed by pair-wise comparisons. α will be set at 5% for statistical significance. The data will be analyzed using PC SAS version 9.1.

Progress 08/01/08 to 09/30/10

Outputs
OUTPUTS: Activities: This project was designed to study the extent to which inflammation, vitamin D status, type 2 diabetes and certain lifestyle factors (e.g. physical activity and dietary habits) influence Native American women's risk for osteoporosis. Overall, enrollment for the study was completed (n=300) and we have 120 participants that have done their year 1 follow-up visit, which has exceeded the projection for this project. Events: The results of this study have been disseminated at five different venues within the state of Oklahoma, one national and one international meeting. The state events have included: 1) DASNR (Division of Agricultural Sciences and Natural Resources) Day at the Oklahoma state Capitol, Osteoporosis Risk in Oklahoma Native American Women: The Role of Inflammation and Diabetes; 2) University of Oklahoma Health Sciences Center, Department of Nutritional Sciences Fall Colloquium address (Recent Advances Reveal New Roles for Nutrition in Bone Health); 3) the North Central Oklahoma Dietetic Association Fall meeting, Osteoporosis Update: The Obesity and Diabetes Connection; 4) the Native American Research Conference on Health (NARCH), Type II Diabetes, Tribal Heritage and Bone Health in Native American Women; and 5) the Oklahoma State University Freshman Scholars Research Colloquium, Impact of Physical Activity Performed During Puberty and Early Adulthood on Bone Mineral Density in Native American Women 50yrs of Age and Older. The national presentation was given at the American Society of Bone and Mineral Research in Denver, Colorado entitled, Baseline Assessment of Osteoporosis Risk in Oklahoma Native American Women, and the international presentation, Effect of Type II Diabetes and Tribal Heritage on Bone Health in Native American Women was given at the American Society of Bone and Mineral Research in Montreal Canada. Dissemination: After each visit, participants received educational materials about osteoporosis and lifestyle factors that can reduce the risk for osteoporosis through appropriate weight-bearing exercise and good nutritional practices that support bone health. Participants were encouraged to read the materials and share the information with friends and members of their family. PARTICIPANTS: Dr. Brenda Smith coordinated, supervised and was involved in all phases of the work related to the project. She has been responsible for data management, oversight of biochemical assays and data analysis, and presentations resulting from this work. This project resulted in an enrollment rate that exceeded the project recruitment goal, 7 presentations, and the opportunity for 2 graduate students and 2 undergraduate students to include this experience as a portion of their training in her laboratory. Misti Leyva is a co-investigator on the project and a doctoral student working with the PI at Oklahoma State University. She has been responsible for the day-to-day activities associated with the project including scheduling appointments, screening potential participants, performing DXA scans and the corresponding analyses, instructing participants regarding the 3-day food record, and providing educational materials to all study participants at the completion of their visits. The completion of this phase of the project will provide Misti with the necessary data to complete her doctoral degree within the next year. Collaborators: Dr. Lancer Stephens, the Special Populations Liaison at the GCRC, has been an invaluable liaison between the research team and the Indian Health Clinics that has allowed us to meet our enrollment goals. Dr. Chris Aston, the project statistician and his expertise in data analysis, has been critical as we explored the relationships between various health and lifestyle factors and osteoporosis. Dr. Janice Hermann, OSU State Nutrition Specialist who works with older adults, has been involved in working with data analysis to examine the relationship between physical activity over the course of the lifespan as it relates to bone health. Dr. Chris Taylor at Ohio State University has worked on the dietary assessment portion of the project as the food records become available. Partner Organizations: This study represents a partnership among several academic institutions, including Oklahoma State University, the University of Oklahoma Health Sciences Center and Ohio State University. Additionally, the success of the project in terms of recruitment and maintaining an active study population was in large part due to the efforts and cooperation of the Oklahoma City Area Indian Health Clinics with the support of the Indian Health Service. Training or professional development: This project has provided training opportunities for one doctoral student (Misti Leyva), one master's student (Karah Sanchez) and two undergraduate students (Jennifer Roach and Kelsey Hembree) within the Department of Nutritional Sciences at Oklahoma State University. The study has served as the focus of the dissertation for the doctoral student and a translational research training project for one MS student. It has also provided a Freshman Scholar's Research Project, which was awarded the outstanding project on the OSU Stillwater campus, and training for another undergraduate student on data entry and issues related to conducting research with human subjects. TARGET AUDIENCES: The target audiences for this study have included primarily Native American women of all ages across the state of Oklahoma as well as healthcare professionals (physicians, nurses, dietitians, diabetes educators etc.). This project has help to raise awareness about osteoporosis among Native American women, tribal leaders and healthcare professionals (physicians, dietitians, nurses etc.) who work with Native American populations. The special emphasis on examining the relationship between type 2 diabetes and osteoporosis has made health care professionals and members of the tribes aware of the increased risk for osteoporotic fracture in type 2 diabetics. Furthermore, efforts to investigate the influence of physical activity throughout the lifespan and its relationship to bone health have revealed that exercise (i.e., type and duration of exercise) during the adolescent years (i.e., menarche to 21 yrs) is particularly important with regard to overall bone health later in life. PROJECT MODIFICATIONS: Not relevant to this project.

Impacts
At the present time, the major outcome from this project has been to raise the awareness of the relationship between type 2 diabetes and bone loss, and their implications for high-risk populations such as Native American women. We anticipate that the results of this study will provide important information to clinicians and strategies that will be used by wellness programs to reduce the risk factors associated with osteoporosis for Native American women. Additionally, the success of recruitment and retention demonstrated with this project makes this database and subsequent follow-up data unique as it relates to osteoporosis in Native American populations. Because this data represents a one-of-a-kind opportunity to learn about osteoporosis and risk factors for Native Americans (e.g., type 2 diabetes, lifetime physical activity and vitamin D status), this project has been leveraged to obtain additional funds so that two-year follow-up data can be completed on all of the study population as opposed to 100 as originally proposed.

Publications

  • Smith BJ, Leyva M, Aston CE, Stephens LD, Baker MZ. 2008. Baseline Assessment of Osteoporosis Risk in Oklahoma Native American Women. JBMR 23:S318.


Progress 10/01/08 to 09/30/09

Outputs
OUTPUTS: This project is designed to determine the extent to which inflammation, vitamin D status, type 2 diabetes and certain lifestyle factors (e.g. physical activity and dietary habits) influence Native American women's risk for osteoporosis. Over the course of the first year of this project, we have completed the enrollment of study participants (n=300) and have seen ~65 participants for their second year follow-up visit. The baseline results have been disseminated at three different venues within the state of Oklahoma: 1) DASNR (Division of Agricultural Sciences and Natural Resources) Day at the Capitol, Osteoporosis Risk in Oklahoma Native American Women: The Role of Inflammation and Diabetes; 2) University of Oklahoma Health Sciences Center, Department of Nutritional Sciences Fall Colloquium address (Recent Advances Reveal New Roles for Nutrition in Bone Health), and 3) the North Central Oklahoma Dietetic Association Fall meeting, Osteoporosis Update: The Obesity and Diabetes Connection. PARTICIPANTS: Dr. Brenda Smith continues to coordinate, supervise and be involved in all phases of the work related to the project. She is responsible for data management, data analysis and presentation of the work. This past year, these activities have resulted in an enrollment rate that met the project recruitment goal, one presentation at the national American Society of Bone and Mineral Research meeting in Denver, Colorado, 3 in-state presentations to various health professional groups and state legislators, and the opportunity for 2 graduate students and 2 undergraduate students to include this experience as a portion of their training in her laboratory. Misti Leyva is a co-investigator on the project and a doctoral student working with the PI at Oklahoma State University. Misti is responsible for the day-to-day activities associated with the project including scheduling appointments, screening potential participants, performing DXA scans and the corresponding analyses, instructing participants regarding the 3-day food record, and providing educational materials to all study participants at the completion of their visits. The focus of Misti's work at the present time is to get participants to complete their follow-up visits. Furthermore, Misti gave the presentations at the DASNR Day and ASBMR meetings. Collaborators: Lancer Stephens is the Special Populations Liaison at the GCRC, continues to serve as an invaluable resource between the research team and the Indian Health Clinics that has allowed us to meet our enrollment goals. Dr. Chris Aston is the project statistician and his expertise in data analysis is critical as we begin to explore the relationships between various health and lifestyle factors and osteoporosis. Dr. Chris Taylor at Ohio State University continues to work on the dietary assessment portion of the project as the food records are available. TARGET AUDIENCES: The target audiences for this study include Native American women who are 50 years of age and older, healthcare professionals (physicians, dietitians, nurses etc.) who work with Native American populations and type 2 diabetics. PROJECT MODIFICATIONS: Not relevant to this project.

Impacts
At the present time, we have no outcomes or impacts to report, aside from the fact that the study and presentations have raised the awareness of the relationship between type 2 diabetes and bone loss, and their implications for at-risk populations such as Native American women.

Publications

  • Leyva MJ, Stephens LD, Baker MZ, Aston CE , Smith BJ. Effect of Type II Diabetes and Tribal Heritage on Bone Health in Native American Women. JBMR 2009;24 (Suppl 1): A09003253.


Progress 10/01/07 to 09/30/08

Outputs
OUTPUTS: Activities: The goal of this OAES project is to determine the extent to which immune factors, vitamin D status, diabetes and certain lifestyle factors (e.g. physical activity and dietary habits) influence Native American women's risk for osteoporosis. To accomplish this goal, baseline and 1-year follow-up data are currently being collected on a subset of women enrolled in the Oklahoma Native American Woman Osteoporosis Screening (ONAWOS) study. To date, we have enrolled a total of 212 Native American women 50 years of age and older who are eligible for health services at area Indian health clinics in the ONAWOS study with 10 participants having completed their 1-year follow-up visit. Each visit requires approximately 1.5 hours while participants complete a medical history questionnaire, bone density or dual-energy X-ray absorptiometry (DXA) scans (whole body, hip, spine and forearm), a lifetime physical activity questionnaire, and assessment of skin tone that will be used in the vitamin D analyses. Participants also have the option to provide a blood sample for biochemical measures of inflammation and select endocrine parameters, and currently 99% have agreed to this portion of the assessment. All blood samples have been centrifuged and sera stored appropriately at -80 degree C for batch analyses after the one-year follow-up is complete. In addition to the assessment, each participant receives instructions as to how to keep and return their 3-day dietary recall, and educational materials on osteoporosis-related topics. Events: In September, the PI presented some of the initial study results (i.e. baseline data on ~150 participants) at the American Society of Bone and Mineral Research (ASBMR) annual meeting in Montreal, Canada. Products & Dissemination: Because we are still in the initial data collection phase of the project, there has not been opportunity for products or significant dissemination of information related specifically to this project to occur. However, providing study participants with educational materials developed by the National Osteoporosis Foundation has not only provided this population a valuable resource on a number of issues related to osteoporosis prevention and treatment, but also increased awareness among women from several of the tribes. PARTICIPANTS: As the project leader, Dr. Brenda Smith has coordinated, supervised and been involved in all phases of the work including recruitment, data collection, data management, data analysis and presentation of the work. Misti Leyva is the Director of the Bionutrition Core at the General Clinical Research Center (GCRC) at the University of Oklahoma Health Sciences Center (OUHSC) and a doctoral student working with the PI at Oklahoma State University. Misti has been responsible for performing most of the daily activities associated with the project including screening potential participants, scheduling appointments, performing DXA scans and the corresponding analyses, instructing participants regarding the 3-day food record, and providing educational materials to all study participants at the completion of their visits. These activities are performed by Misti with assistance from the GCRC nursing staff. Additionally, Mist has been involved in data analysis and abstract preparation. Collaborators: Lancer Stephens, Special Populations Liaison at the GCRC, has served as the project liaison with the participating Indian health clinics. He has been largely responsible for success of the recruiting endeavors by creating partnerships with these clinics. He will continue to expand our contacts with various clinics that are interested in being involved in the study and facilitate communication between Dr. Smith and area clinic primary care physicians. Dr. Chris Aston is the project statistician and is the Director of Biostatistics, GCRC. His expertise in data management and analysis has been and will continue to be invaluable to the success of this research project. Dr. Aston has played a critical role in the data analysis and abstract preparation to date. Dr. Mary Zoe Baker, Department of Medicine, Endocrinology, is the physician of record on the research project and provides medical oversight should the need arise. Dr. Baker's availability for this project is important, but to date no adverse events or medical issues have been raised. Dr. Chris Taylor at Ohio State University is responsible for the dietary assessment portion of the project. His experience in dietary assessment of Native American populations is an important component of the project that will enable us to extend the dietary analyses beyond traditional nutrient assessment to the identification of key foods (or absence thereof) providing the best sources of nutrients important for bone health. Training or Professional Development: Karah Sanchez, doctoral student in the Department of Nutritional Sciences who works at the GCRC, utilized some of the de-identified bone density and physical activity data from this and another pre-clinical study as a part of a translational research training project at the University of Oklahoma Health Sciences Center. Miss Sanchez worked with Dr. Smith on the project designed to examine the effects of weight bearing vs non-weight bearing physical activity on bone health. TARGET AUDIENCES: The target audience for this project is Native American women who are 50 years of age and older who are eligible for health services at Indian health clinics in Oklahoma. Eligibility for Indian health services in most cases requires at least 25% American Indian blood quantum. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.

Impacts
Because project has just started, there are no apparent changes in knowledge or action that we have to report at this time.

Publications

  • B J Smith, M Leyva, CE Aston, LD Stephens, MZ Baker. Baseline Assessment of Osteoporosis Risk in Oklahoma Native American Women. JBMR 2008:SU303.