Category Archives: ongoing studies

MURDOCK MS Study Contributes to New Genetics Research

Genetics is a quickly growing area of medicine that has sparked thousands of headlines, and data from MURDOCK Study participants have made some of those headlines.

Genetics is the study of genes — a set of blueprints humans are born with that give people their unique qualities. Some genes determine eye color, some height, and others freckles or allergies. The role that genes play in causing illness has become a focus of research, including work by MURDOCK Study scientists like Dr. Simon Gregory, who leads the MURDOCK Multiple Sclerosis (MS) Study. The study of genes could lead to new treatment and prevention methods for many diseases.

Using data from MURDOCK MS Study participants, Gregory and his team showed that a certain gene may increase the risk of developing MS. Multiple sclerosis is a lifelong disease in which the nerves lose their insulation and stop working efficiently. This can cause numbness, fatigue, and sometimes even loss of vision and balance.

Published in the journal Cell in 2017, Gregory’s research marks a major step toward catching and treating MS early. His work would not be possible without the support and generosity of MURDOCK Study participants.

Thank you for helping us change lives!

Read a more detailed summary of the research.

Fractures and Falls Study

The Duke Clinical and Translational Science Institute (CTSI) in Kannapolis has launched the MURDOCK Fractures and Falls Study. This study aims to understand bone fracture risk in older adults with diabetes. The study will focus on the association between signals in the body and the potential for fractures. Participants will be asked to complete a survey every six months to report any fractures that occurred during that time.

Interested in enrolling? Read the requirements below and call 704-250-5861 or email transpop@duke.edu. Study team members are contacting all MURDOCK Study participants who qualify.

Principal Investigator: Dr. Richard H. Lee

Richard H. Lee

Who will be invited to take part in this research? MURDOCK Study participants who are 60 years of age or older and report having diabetes, either through self-reporting or use of medications, will be invited to participate in this study.

What will I be asked to do? People who qualify and choose to enroll in the study will be asked to complete a survey every six months to report any fracture that resulted from a fall from standing height or lower. Participants also will be asked to allow researchers access to their medical records.

How could my participation help research? The MURDOCK Fractures and Falls Study will help researchers understand signals in the body — biological markers that can be detected and measured in parts of the body like blood or urine — in older adults who have diabetes. This could help scientists develop new techniques to identify risk factors sooner, ultimately preventing more fractures in patients.
In addition, the survey includes a list of questions to assess your risk for falls, and you will receive your results upon completion. Your risk for falls is an important risk to understand and discuss with your doctor if applicable.

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Kidney Health Study

MURDOCK Kidney Health Study

The Duke Clinical and Translational Science Institute (CTSI) in Kannapolis has launched the MURDOCK Kidney Health Study. The study aims to understand factors that prevent kidney disease in people at risk. The study will focus on the relationships between diet, bacteria living within the gastrointestinal tract (known as the gut microbiota), differences in metabolism, and the risk of kidney disease. This observational study will collect biological samples and information on lifestyle factors including diet, personal health habits, environmental exposures, and more. An initial pilot phase in a small number of participants over a short period will help us design a larger, long-term study to learn about new ways to prevent kidney disease.

Compensation: Offered throughout the nine-month study.

Interested in enrolling? Read the requirements below and call 704-250-5861 or email transpop@duke.edu.

Principal Investigator: Dr. Julia Scialla

Co-Investigator: Pao-Hwa Lin, PhD

Co-Investigator: Crystal Cenell Tyson, MD

Who will be invited to take part in this research? We will enroll MURDOCK Study participants in pairs who live in the same household. One member of the pair must have diabetes, high blood pressure, or kidney disease. People with a history of severe gastrointestinal disorders, who have a history of gut or bowel surgery, or other serious health conditions will not qualify.

What will I be asked to do? People who qualify and choose to enroll in the study will be asked to complete four in-person study visits at the Duke CTSI MURDOCK Study Office in Kannapolis. The initial visit will take about two hours to complete and will include questionnaires about diet, health history, health habits, and household characteristics. We will also measure clinical factors such as your height, weight, blood pressure, and waist circumference, and collect biological samples for testing. Three follow-up visits will occur every three months and will take about 30 minutes each.

How could my participation help research? The MURDOCK Kidney Health Study will support new discoveries in kidney disease to understand the relationship between diet, gut bacteria, metabolism and kidney health. Your participation may help us understand the causes of kidney disease and develop strategies to prevent kidney disease.

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Project Baseline

What is Project Baseline?

Project Baseline is a long-term quest to map human health.  The Project Baseline Health Study, launched in 2017, is the first initiative of Project Baseline and is a collaboration among teams at Verily, Duke University School of Medicine, Stanford Medicine, and Google.

How long will the Project Baseline Health Study last? 

The Project Baseline Health Study is an observational study that will collect, organize, and analyze broad health data from approximately 10,000 participants over the course of at least four years.

What is the Project Baseline Health Study trying to find out?

The study is designed to develop a well-defined reference, or “baseline,” of good health, as well as a rich data platform that may be used to better understand the transition from health to disease. Participants are joining together with a team of experts from across academia, medicine, science, technology, engineering, and design to better understand how health can change over time. Participants are asked to visit a study site up to four times yearly, test new technologies and wearable devices daily, and participate in interactive surveys and diaries by using a smartphone, computer, or call center. Data collected include clinical, imaging, self-reported, physical, environmental, behavioral, sensor, molecular, genetic, and other health-related measurements. Biospecimens collected include blood and saliva, among others.

Want to know more? Visit www.projectbaseline.com

Principal Investigator: Dr. Svati Shah

Co-Principal Investigator: Dr. Kelly Marcom 

Kannapolis Investigator: Dr. Paul Campbell 

Learn about the Duke team in Kannapolis

 

Learn about the Duke team in Durham 

 

News Highlights

Business Insider: Verily just kicked off a study of 10,000 people to help predict when you’ll get sick >>

CNBC: Alphabet will track health data of 10,000 volunteers to ‘create a map of human health’>>

MIT Technology Review: Google’s Verily Unveils a Health Watch for Research>>

Nature: Google spin-off deploys wearable electronics for huge health study>>

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New Gene Interaction Appears to be Associated with Increased MS Risk

A person carrying variants of two particular genes could be almost three times more likely to develop multiple sclerosis, according to the latest findings from scientists at Duke Health and the University of Texas Medical Branch at Galveston.

 

The research used biological samples from the MURDOCK MS Study. The finding, published in the March 23 issue of the journal Cell, could open the way for new tests to identify people who are at greatest risk of MS and autoimmune disorders, as well as the development of novel drugs, the researchers said.
Continue reading New Gene Interaction Appears to be Associated with Increased MS Risk

Medical Records Study

Laura M. Beskow, PhD, MPH

Goal: The goal of the study is to find out what people think about researchers using medical records for health-related studies. By using focus groups and interviews, we hope to learn more about the best ways to use and protect everyone’s medical records in the future.

Principal Investigator: Laura M. Beskow, MPH, PhD, Director of the Program for Empirical Bioethics at Duke University

 

Media: Engaging the Community in Ethics of Sharing Health Care Data

UNC-NRI Male Fertility Study

steven zeisel
Steven H. Zeisel, MD, PhD

In May 2015, the MURDOCK Study provided 150 anonymous DNA samples to assist in the screening and recruitment of participants for a male fertility study run by the UNC Nutrition Research Institute. The samples were analyzed for the presence of a particular genetic variant, resulting in the identification of 13 individuals eligible for the study. Subsequently, 87 additional MURDOCK Study  samples were evaluated, yielding 7 men with the genetic marker being studied.

Two MURDOCK Study participants eventually joined the UNC-NRI study, increasing enrollment to five individuals.  Investigators are seeking a total enrollment of 10 men.

Principal Investigator: Steven H. Zeisel, MD, PhD, is the Kenan Distinguished Professor of Nutrition and Pediatrics at the University of North Carolina Chapel Hill Nutrition Research Institute (NRI) on the North Carolina Research Campus in Kannapolis.

Goal: The purpose of the research is to determine whether a common genetic variation in men causes abnormal sperm function and whether treatment with a dietary supplement (betaine) can correct this problem.

Eligibility Requirements: Men between the ages of 18 and 60 are screened for eligibility.

Study Requirements: All research procedures will be conducted at the UNC Nutrition Research Institute (NRI) at the North Carolina Research Campus (500 Laureate Way, Kannapolis, NC 28081). Prior to enrolling in the research study, you will be asked to come to the NRI in Kannapolis, NC for approximately 30 minutes. We will ask you some questions about fertility, and you will be asked to provide a blood sample to ensure that you may safely participate. You will also be asked to complete a food questionnaire. If you are eligible, the research study will last for approximately eleven weeks and consists of blood and sperm studies on day 0, day 10, day 30, day 50 and again on day 75. Study subjects will be asked to take capsules containing a dietary supplement.

Compensation: Participants will receive $600 upon completion of the research study.

To volunteer for this research study, please contact 704-250-5035 or Sperm_Study@unc.edu

Media: 

Duke-UNC collaborate on sperm study

NIDA CTN Mid Southern Node

Mid Southern Node of the NIDA Clinical Trials Network

litzy wu
Li-Tzy Wu, ScD, RN, MA

Duke-Kannapolis is excited to be part of the Mid Southern NIDA Node, a primary care practice-based research network that offers access to patient populations and clinicians who are interested in engaging in research projects and using Electronic Health Records (EHR) for research. The Mid Southern Node gained official recognition in September 2015, joining 12 other NIDA Clinical Trials Network nodes.

Dr. Li-Tzy Wu, Professor of Psychiatry and Professor of Medicine, is the Contact Node Principal Investigator and Director of the Mid Southern Node. Ms. Kimberly (Micki) Roseman is the Node Coordinator. 

Collaborators nida nodeinclude Duke University (Li-Tzy Wu, ScD, RN, MA,; Rowena Dolor, MD), Carolinas Healthcare System (Hazel Tapp, PhD; Oleg Tcheremissine, MD), University of North Carolina at Chapel Hill (Jacqueline R. Halladay, MD, MPH; Katrina Donahue, MD, MPH; Tamera Coyne-Beasley, MD, MPH, FAAP, FSAHM), and Vanderbilt University (Hilary Tindle, MD, MPH).

Current protocol involvements of the Mid Southern Node include:

  • EHR-DARE – CTN 0071 (Duke PI: Li-Tzy Wu, ScD) The Electronic Health Records Data Elements Research study was approved July 2016 and is projected to begin in August 2016. Researchers aim to identify EHR data available at healthcare facilities within the CTN in order to address critical barriers in substance use disorder research. This promises to advise planning future studies and improve research infrastructure. The target participants for this study will be researchers, clinicians, and IT professionals affiliated with each of the 13 CTN nodes.
  • Pharm-OUD-Care – CTN-0075 (Duke PI: Li-Tzy Wu, ScD) This study, Physician-Pharmacist Collaboration in the Management of Patients with Opioid Use Disorder, will explore the feasibility and acceptability of transitioning office-based buprenorphine treatment (OBBT) of adult patients with opioid use disorder (OUD) from physicians to pharmacists.  Study participants, buprenorphine prescribing physicians, and pharmacists will be compensated properly for their time and contribution.

    This new CTN-0075 protocol is seeking buprenorphine providers (physicians) and community pharmacists in North Carolina to participate in this study. Recruitment for participants is expected to start in late summer or fall.  To learn more about the opportunity to participate in this study, contact research coordinator Ms. Micki Roseman (micki.roseman@duke.edu), or principal investigator Dr. Li-Tzy Wu, ScD, RN (litzy.wu@duke.edu).

Past protocol involvements of the Mid Southern Node include:

  • SBIRT-PC – CTN 0057 (Duke PI: Li-Tzy Wu, ScD) Screening, Brief Intervention, and Referral to Treatment in Primary Care (SBIRT-PC) was an add-on study to provide tobacco, alcohol and other drug screening, brief intervention, and referral to treatment for a primary care high risk diabetic population.  Enrollment is now closed, and Duke staff completed follow-up visits in June 2016. Study staff will begin working on publications soon.
  • TAPS Tool – CTN 0059  (Duke PI: Li-Tzy Wu, ScD) The Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief screen/assessment tool was administered to 2,000 primary care patients to test efficacy. Duke participated in enrollment as part of the Southern Consortium Node prior to gaining node status. Enrollment was completed in April 2015, the primary outcome manuscript was published in Annals of Internal Medicine.

Publications:

  1. McNeely J, Wu LT, Subramaniam G, Sharma G, Cathers LA, Svikis D, Sleiter L, Russell L, Nordeck C, Sharma A, O’Grady KE, Bouk LB, Cushing C, King J, Wahle A,  Schwartz RP. Performance of the Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool for Substance Use Screening in Primary Care Patients. Annals of Internal Medicine. 2016 Nov 15; 165(10): 690-699. doi: 10.7326/M16-0317
  2. Wu LT. Zhu H, Swartz MS. Treatment utilization among persons with opioid use disorder in the United States. Drug and Alcohol Dependence. Available online 19 October 2016. http://www.sciencedirect.com/science/article/pii/S0376871616309504
  3. Wu LT, McNeely J, Subramaniam GA, Sharma G, VanVeldhuisen P, Schwartz RP. Corrigendum to “Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool” [Contemporary Clinical Trials. 2016 Jul. 19; 50: 90-97]. Contemp Clin Trials. 2016 Sep 22. pii: S1551-7144(16)30285-3. doi: 10.1016/j.cct.2016.09.001. PubMed PMID: 27665683.
  4. McNeely J, Wu LT, Subramaniam G, Sharma G, Cathers LA, Svikis D, Sleiter L, Russell L, Nordeck C, Sharma A, O’Grady KE, Bouk LB, Cushing C, King J, Wahle A,  Schwartz RP. Performance of the Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool for Substance Use Screening in Primary Care Patients. Ann Intern Med. 2016 Sep 6. doi: 10.7326/M16-0317. PubMed PMID: 27595276.
  5. Wu LT, McNeely J, Subramaniam GA, Sharma G, VanVeldhuisen P, Schwartz RP. Design of the NIDA clinical trials network validation study of tobacco, alcohol,  prescription medications, and substance use/misuse (TAPS) tool. Contemp Clin Trials. 2016 Sep;50:90-7. doi: 10.1016/j.cct.2016.07.013. PubMed PMID: 27444426;  PubMed Central PMCID: PMC5035619.
  6. Zhu H, Wu LT. Trends and Correlates of Cannabis-involved Emergency Department Visits: 2004 to 2011. J Addict Med. 2016 Aug 29. PubMed PMID: 27574753.
  7. Mannelli P, Wu LT. Primary care for opioid use disorder. Subst Abuse Rehabil. 2016 Aug 16;7:107-9. doi: 10.2147/SAR.S69715. PubMed PMID: 27574479; PubMed Central PMCID: PMC4993411.
  8. Wu LT, Zhu H, Swartz MS. Trends in cannabis use disorders among racial/ethnic population groups in the United States. Drug Alcohol Depend. 2016 Aug 1;165:181-90. doi: 10.1016/j.drugalcdep.2016.06.002.
  9. Mannelli P, Wu LT. Family substance use screening: less to hide, more to gain. Indian J Med Res. 2016 Jun;143(6):682-684. doi: 10.4103/0971-5916.191920. PubMed PMID: 27748291.
  10. Wu LT, Brady KT, Spratt SE, Dunham AA, Heidenfelder B, Batch BC, Lindblad R, VanVeldhuisen P, Rusincovitch SA, Killeen TK, Ghitza UE. Using electronic health record data for substance use Screening, Brief Intervention, and Referral to Treatment among adults with type 2 diabetes: Design of a National Drug Abuse Treatment Clinical Trials Network study. Contemp Clin Trials. 2015 Nov 10;46:30-38. doi: 10.1016/j.cct.2015.11.009. [Epub ahead of print] PubMed PMID: 26563446.
  11. Gryczynski J, Nordeck C, Mitchell SG, O’Grady KE, McNeely J, Wu LT, Schwartz RP. Reference periods in retrospective behavioral self-report: A qualitative investigation. Am J Addict. 2015 Nov 6. doi: 10.1111/ajad.12305. [Epub ahead of print] PubMed PMID: 26541893.
  12. Wu LT, Ghitza UE, Batch BC, Pencina MJ, Rojas LF, Goldstein BA, Schibler T, Dunham AA, Rusincovitch S, Brady KT. Substance use and mental diagnoses among adults with and without type 2 diabetes: Results from electronic health records data. Drug Alcohol Depend. 2015 Nov 1;156:162-9. doi: 10.1016/j.drugalcdep.2015.09.003. Epub 2015 Sep 12. PubMed PMID: 26392231.

Prostate Cancer

Goal: This study will use existing samples from more than 600 MURDOCK Study participants in hopes of better understanding why African American men more frequently have a more aggressive form of prostate cancer. Researchers want to learn more about prostate cancer at the molecular level. This study has the potential to pave the way toward developing targeted approaches for prevention and treatment of the disease that could help reduce prostate cancer disparities for African Americans and improve outcomes for men of all races with aggressive disease.

Principal Investigator: Steven R. Patierno, PhD, steven patierno Deputy Director, Duke Cancer Institute (DCI) and Director, DCI Population Sciences and Health Service, Professor of Medicine and Professor of Pharmacology and Cancer Biology, Duke University Medical Center

Lead Sub Investigator: Jennifer A. Freedman, PhD, jennifer freedmanAssistant Professor of Medicine and Chief Scientist of the Genitourinary Oncology Research Program, DCI and Duke University Medical Center

Study Information: African American men exhibit two-fold higher incidence and three-fold higher mortality rates from prostate cancer, compared with white men. In North Carolina, African American men are nearly 20% more likely to die from prostate cancer than their white counterparts. Much of this disparity remains after controlling for factors related to access to care. Previous work from the Patierno laboratory at the Duke Cancer Institute (DCI) in collaboration with the Lee laboratory at George Washington University (GWU) has used this difference between African American and white men to better understand tumor aggressiveness at the molecular level, as well as biomarkers and molecular targets that could help lead to new approaches for prevention and treatment.

The MURDOCK Study has identified more than 200 reported prostate cancer cases and will provide healthy samples for controls. Cases and controls will be confirmed via medical record, and biological specimens for confirmed cases and controls will be provided to the DCI for research and analysis.

This study represents collaboration between DTRI’s Population Health Research group, the MURDOCK Study and the Duke Cancer Institute’s GU Oncology, Cancer Control and Population Sciences and Biostatistics Programs.

Lead Postdoctoral Researcher: April Deveaux, MD, PhD, Postdoctoral Associate, Genitourinary Oncology Laboratory, Department of Medicine, DCI and Duke University Medical Center

MURDOCK Study Project Lead: Douglas Wixted, MMCi, project leader for Strategy, Infrastructure & Informatics for Duke Clinical & Translational Science Institute (CTSI) Population Health Research

Publications:

1. SEER State Fact Sheets: Prostate. Available from http://seer.cancer.gov/statfacts/html/prost.html.

2. Powell, I.J., et al., Evidence supports a faster growth rate and/or earlier transformation to clincially significant prostate cancer in black than in white American men, and influences racial progression and mortality disparity. J Ural, 2010. 183(5): p. 1792-6.

3. Powell, I.J. and A. Bollig-Fischer, Minireview: the molecular and genomic basis for prostate cancer health disparities. Mol Endocrinol, 2013. 27(6): p. 879-91

4. Wang, B.D., et al., Androgen receptor-target genes in african american prostate cancer disparities. Prostate Cancer, 2013: p. 763569.

5. Kwabi-Addo, B., et al., Identification of differentially methylated genes in normal prostate tissues from African American and Caucasian men. Clin Cancer Res, 2010. 16(14): p. 3539-47.

6. Wang, B.D., et al., Identification and Functional Validation of Reciprocal microRNA-mRNA Pairings in African American Prostate Cancer Disparities. Clin Cancer Res, 2015.

Media:

http://www.medicaldaily.com/duke-and-unc-collaborate-male-infertility-study-see-how-nutrition-affects-sperm-353144

http://www.charlotteobserver.com/news/local/community/cabarrus/article35423448.html

https://murdock-study.com/wp-content/uploads/2015/08/Duke-UNC-sperm-study-collaboration_Aug-2015.pdf

Type 2 Diabetes LIVE Study

A new Duke University study at the North Carolina Research Campus in Kannapolis will test how well a new online, interactive educational program works, compared to diabetes education on a traditional website. We are studying a program called Learning In Virtual Environments or LIVE — a social network on the Internet like a video game that allows people to talk with each other through avatars, or cartoon representations of themselves. We want to find out if this “virtual environment” is easy to use, helps patients learn more about managing their diabetes, and improves their blood sugar control. This study is funded by the National Institutes of Health and anticipates enrolling 150 participants at Duke sites.

Participants must:
Wei Pan, PhD
  • Be at least 21 years old
  • Have access to a private computer with an Internet connection
  • Come to the North Carolina Research Campus in Kannapolis for appointments
  • Read and speak English
  • Not have kidney failure, severe diabetes,uncontrolled hypertension, severe bone or joint conditions, paralysis, bleeding disorders, cancer, or take pharmacologic doses of anticoagulant medications (Warfarin)
Here’s how it works:
  • Participation lasts for 18 months. During your first visit, you will be asked to sign a consent form and then you will be randomly assigned (like the flip of a coin) to one of two study groups. You will receive a Fitbit (wireless pedometer) and instructions to record and track your physical activity for 18 months.
  • People assigned to the LIVE group will have an orientation and training on the LIVE study site. People assigned to the traditional website group will receive information about the site and online education programs.
  • Your height, weight, blood pressure, and waist circumference will be measured and you will receive a lab requisition slip for LabCorp to draw your HbA1c level and cholesterol panel after fasting for 12 hours (repeated at 6, 12 and 18 months).
  • You will receive an email with a link to an online questionnaire that you must complete within one week. On months 3, 6, 12 and 18, you will receive additional online questionnaires.
  • You will go to the diabetes virtual environment twice a week for the first 3 months and then as much as you like for the next 9 months.
  • You will be offered compensation for participating.

Questions or concerns about the study?
Call study coordinator Andrew Burd at (919) 668-2342 or
Principal Investigator: Wei Pan, PhD

MURDOCK study and more