MedicalResearch.com - Medical Research Interviews

MedicalResearch.com
Hemodialysis research, author interviews, dialysis updates and information on chronic
kidney disease and end stage renal failure.
Editor: Marie Benz, MD
info@medicalresearch.com
July 9 2013
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Asthma: Genetic Risks of Development and Course
MedicalResearch.com Interview with:
Daniel Belsky, PhD
Center for the Study of Aging and Human Development Duke University
• MedicalResearch.com: What are the main findings of the study?
• Dr. Belsky : We looked to the largest-ever genome-wide association study of asthma (that study by the GABRIEL
Consortium included more than 26,000 individuals) to identify genetic variants that could be used to construct a genetic
profile of asthma risk. We then turned to The Dunedin Multidisciplinary Health and Development Study, a unique cohort of
1,000 individuals who have been followed from birth through their fourth decade of life with extensive measurements of
asthma and related traits. We computed a “genetic risk score” for each person based on the variants identified in
GWAS. Then, we looked at who developed asthma, when they developed asthma, and what that asthma looked like in
terms of allergic response and impaired lung function.
• What we found:
• (1) People with higher genetic risk scores were more likely to develop asthma and they developed asthma earlier in life.
• (2) Among children who developed asthma, the ones at higher genetic risk were more likely to have persistent asthma
through midlife.
• (3) Genetic risk was specifically associated with allergic asthma that resulted in chronic symptoms of impaired lung function.
• (4) People with higher genetic risk score developed more severe cases of asthma. As compared to people with a lower
genetic risk, they were more often absent from school and work because of asthma and they were more likely to be
hospitalized for asthma.
• (5) The genetic risk score provided new information about asthma risk that could not be obtained from a family history.
Read the rest of the interview on MedicalResearch.com

Daniel Belsky, PhD
• MedicalResearch.com: Were any of the findings unexpected?
• Dr. Belsky : We were a little surprised to find that people with higher genetic risk scores did not necessarily have strong
family histories of asthma, and vice versa–people who had many relatives with asthma often had very low genetic risk
scores. We have seen this same pattern of results now in other studies we’ve done on smoking and obesity, and other
investigators have found similar results for type-2 diabetes and some cancers. So this lack of overlap between genotypic and
family history risk looks like a real thing. One possible explanation for this observation is that family histories capture
information about environmental risks and about interactions between genetic and environmental risk factors.
• MedicalResearch.com: What should clinicians and patients take away from your report?
• Dr. Belsky : Genetic tests to determine whether children will develop asthma or whether their asthma will remit or persist
are not yet possible. Our work suggests that genetic information may, in the future, be able to improve clinical risk
assessments. In the mean time, the genetic risk score we studied will be a useful tool for research.

Daniel Belsky, PhD
• MedicalResearch.com: What recommendations do you have for future research as a result of this study?
• Dr. Belsky : Future research should focus on the question of how genetic risks interact with environmental exposures
including pollution and other factors that affect air quality. Research is also needed to test how well our findings generalize
to non-European populations and to investigate how the genetic risks we studied affect asthma in later life.
• Citation:
• Polygenic risk and the development and course of asthma: an analysis of data from a four-decade longitudinal study
Dr Daniel W Belsky PhD,Prof Malcolm R Sears MB,Robert J Hancox MD,HonaLee Harrington BS,Renate Houts PhD,Prof Terrie
E Moffitt PhD,Karen Sugden PhD,Benjamin Williams BSc,Prof Richie Poulton PhD,Prof Avshalom Caspi PhD
The Lancet Respiratory Medicine – 28 June 2013
DOI: 10.1016/S2213-2600(13)70101-2

Prostate Cancer: Soy Supplementation Did Not Reduce Recurrence
Maarten C. Bosland, DVSc, PhD
Professor of Pathology Department of Pathology University of Illinois at Chicago
College of Medicine Chicago, IL 60612
• Dr. Bosland: Daily consumption of a supplement containing soy protein isolate for two years following radical prostatectomy
did not reduce recurrence of prostate cancer in men at high risk for this (radical prostatectomy is surgical removal of the
prostate to treat prostate cancer). The study showed that this soy supplementation was safe. It is not clear whether this
result indicates that soy does not prevent the development of prostate cancer, but men that have the disease probably do
not benefit from soy supplementation.
• Dr. Bosland:: The hypothesis was that soy supplementation reduces prostate cancer recurrence, based on epidemiologic
findings and data from animal studies. Thus, the finding of a lack of treatment effect was unexpected.
• Dr. Bosland: Men should not expect benefit from consuming soy after initial surgical treatment for prostate cancer. Men
who have received radiation treatment may also not benefit from soy. Men who consume soy for their entire life may have a
reduced risk of developing detectable prostate cancer (but this cannot be studied in a clinical trial). The study results
indicate that long-term soy consumption does appear to be safe. It is not clear whether soy is of benefit to men who have
advanced prostate cancer and are receiving hormonal treatment or chemotherapy and whether it is safe for these men.

Prostate Cancer: Soy Supplementation Did Not Reduce Recurrence
Maarten C. Bosland, DVSc, PhD
Professor of Pathology Department of Pathology University of Illinois at Chicago
College of Medicine Chicago, IL 60612
• Dr. Bosland: It would be useful to determine the benefit and safety of soy supplements in men who have advanced prostate
cancer and are receiving hormonal treatment or chemotherapy in rigorous randomized clinical trials. It is important to also
rigorously test other dietary supplements commonly used by men with prostate cancer for benefit and safety randomized
clinical trials.
• Citation:
• Effect of Soy Protein Isolate Supplementation on Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy
A Randomized Trial
• Bosland MC, Kato I, Zeleniuch-Jacquotte A, et al. Effect of Soy Protein Isolate Supplementation on Biochemical Recurrence of
Prostate Cancer After Radical Prostatectomy: A Randomized Trial. JAMA. 2013;310(2):170-178.
doi:10.1001/jama.2013.7842.

Insulin Resistance and Cardiorespiratory Fitness : Ethnic Differences
Dr Nazim Ghouri MBChB, MRCP UK
Specialty Registrar (Diabetes/Endocrinology/GIM) and Honorary Clinical Lecturer
Institute of Cardiovascular and Medical Sciences
BHF Glasgow Cardiovascular Research Centre University of Glasgow Glasgow G12 8TA
• Answer: In this study we aimed to determine the extent to which increased insulin resistance and blood sugar levels in
South Asian men, compared to white European men, living in the UK, was due to lower fitness and physical activity levels.
• We studied 100 South Asian and 100 European men aged 40-70 years living in Scotland without diagnosed diabetes and
measured their blood sugar levels, insulin resistance and other risk factors.
• The men also undertook a treadmill exercise test to determine how much oxygen their bodies were able to use during
intense exercise – a key measure of physical fitness, wore accelerometers for a week to assess their physical activity levels,
and had a detailed assessment of their body size and composition. Statistical modeling was then used to determine the
extent to which body size and composition, fitness and physical activity variables explained differences in insulin resistance
and blood sugar between South Asians and Europeans.
• The results suggested that lower fitness, together with greater body fat in South Asians, explained over 80 per cent of their
increased insulin resistance compared to white men with Low fitness being the single most important factor associated with
the increased insulin resistance and blood sugar levels in middle-aged South Asian compared to European men living in the
UK.

Insulin Resistance and Cardiorespiratory Fitness : Ethnic Differences
Dr Nazim Ghouri MBChB, MRCP UK
Specialty Registrar (Diabetes/Endocrinology/GIM) and Honorary Clinical Lecturer
Institute of Cardiovascular and Medical Sciences
BHF Glasgow Cardiovascular Research Centre University of Glasgow Glasgow G12 8TA
• Answer: The data also showed that while fitness improves with increasing physical activity, South Asians’ lower fitness values could not
be explained simply by their lower activity levels. South Asians had lower fitness levels than Europeans at all levels of physical activity,
suggesting inherent differences in body make-up.
• Answer: The fact that South Asians’ increased insulin resistance and blood sugar levels are strongly associated with their lower fitness
levels, and that increasing physical activity is the only way to increase fitness, suggests that South Asians may need to engage in greater
levels of physical activity than Europeans to achieve the same levels of fitness and minimize their diabetes risk.
• Answer: These findings have potential implications for physical activity guidance, which, at present, do not take ethnicity into account.
A number of leading doctors and scientists have already recommended that the BMI threshold for obesity in South Asian populations
should be lowered from 30 kg/m2 to 25 kg/m2, in recognition of the fact that substantially lower BMIs are needed in South Asians to
confer equivalent diabetes risk to those observed in populations of white European origin. The present data suggest that differential
physical activity guidance for South Asians may also be needed.
• Citation:
• Lower cardiorespiratory fitness contributes to increased insulin resistance and fasting glycaemia in middle-aged South Asian
compared with European men living in the UK.
• Ghouri N, Purves D, McConnachie A, Wilson J, Gill JM, Sattar N.
• BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life
Sciences, University of Glasgow, Glasgow, G12 8TA, UK,
Diabetologia. 2013 Jun 29.
[Epub ahead of print]

Diabetes in the Elderly: Indivualized Treatment with Vildagliptin (Glavus)
MedicalResearch.com Interview with: Dr David Strain, MRCP MD
Clinical senior lecturer and honorary consultant
University of Exeter Medical School
Institute of Biomedical and Clinical Science Department of Diabetes and Vascular Research
Royal Devon & Exeter Hospital Exeter EX2 5AX
• MedicalResearch.com: What is the Background of the study?
• In early 2010 recent diabetes outcome trials such as ACCORD and ADVANCE had put into question the benefit of aggressive
HbA1c reduction for all patients particularly in elderly population. After that there were several guidelines that suggested
individualizing treatment targets for elderly patients according to their age, co-morbidities, frailty and baseline HbA1c. This
featured in the Finnish guidelines and the European Working Party for the management of Diabetes in the Older Person.
However this was also completely without any evidence base. I worked with Paivi Paldanius (the final author of the paper
and a medical advisor for Novartis) to establish a pragmatic study. We both acknowledged the importance of having a
patient-centric, pragmatic and ‘real-life’ approach and as there was already evidence that DPP-4 inhibitors, in this case
vildagliptin (due to Päivi’s affiliation), had demonstrated it’s efficacious and had no tolerability issues in the elderly
population we decided to go ahead with the study.
• It was obvious that we needed to implement a holistic approach and take into account as many clinically relevant
parameters as possible, such as age, baseline HbA1c, duration of the disease, co-morbidities and frailty, for implementation
of the individualized care. Our primary goal was to request that the physicians acting as investigators would still apply their
clinical judgment based on these clinical features of each individual patient but also, follow their local guidelines as in their
daily clinical practice. This would later provide us with invaluable information and perspective when interpreting the data
and recommending implementation of the results. For assessment of frailty we screened for many different methodologies
but Prof Timo Strandberg (known expert of the field and mentioned in the acknowledgements section of our paper)
suggested to apply modified Linda Fried’s method for assessment of phenotype of frailty as this method is validated, very
pragmatic, reproducible and also feasible to be used for the first time also by a non-geriatric investigator. All investigators
were trained to follow these parameters by the protocol. We also wished to evaluate in parallel the conventional HbA1c
drop assessment in order to be able to put the potential success of our new endpoint, meeting the individualized target, into
perspective and for comparison against other standard data from other studies with DPP-4 inhibitors with elderly. We also
wished to simulate a clinical, real-world setting as much as possible and included patients who would seem representative
of most elderly T2DM patients.

Dr. Strain: The primary objectives were to determine whether the DPP-4 inhibitor, vildagliptin could achieve the
individualized targets in these elderly adults. This it did with an odds ratio of success of 3.16 after adjustment for baseline
variables.
• The secondary objectives included assessing the safety of the agent, and more importantly exploring the individualized
targets that were set. Vildagliptin appeared safe in this elderly population and was just as potent across the all age-ranges
with no new safety signals.
• Dr. Strain: There were many findings additional to the primary objectives which were significant; we observed that basic
patient education, communication about and focus on individualized target setting induced a clinically meaningful response
even in the placebo group; Indeed 27% of the patients responded to nothing more than a simple educational approach that
was individualized to their need rather than the generic “one size fits all” approach of many international guidelines.
• The overall the discontinuation rate was also much lower than anticipated in this type of population in other studies with
conventional approach. It was also somewhat surprising that the physicians were considerably influenced by stringent
HbA1c targets possibly as a result of the local recommendations and the average HbA1c target was 7.0% (53mmol/mol)
much lower than we anticipated. This is now an area of further analysis in order to determine what drove the targets that
were set. We believe this analysis will provide invaluable information for those trying to implement the recently published
guidance for the management of the older person with diabetes. The results of this study support global guidelines’
recommending individualized care, and demonstrate the feasibility of the study design, and the setting of individualized
targets.

• Dr. Strain: This study supports guidelines’ recommendations and demonstrated that the local guidelines need to be
synchronized with the international guidelines which recommend individualization of the target setting based on the clinical
features of each individual patient. The inclusion of frail elderly patients in our study will open the door for their inclusion in
future studies. The study also demonstrates that individualized targets can be used as an endpoint in a clinical study and we
trust that many studies will adapt this approach when evaluating the safety and efficacy of treatment modalities, thus follow
our lead in providing an evidence-base for global treatment guidelines for patients with T2DM.
• What was most also very interesting, however was that by individualizing the goals and setting realistic targets, then
spending time talking to patients rather than aggressively chasing targets resulted in nearly a quarter of patients achieving
better glycemic control.

• Dr. Strain: The physicians in our study seemed to be influenced by their local guidelines which might not yet have been
updated and there seems to be a gap in the application of the global guidelines. Our short term next goal is to gain a better
understand of which factors impacted target setting and if these potential barriers to more optimal treatment can be
overcome by communicating our further, secondary findings in peer reviewed journals and by educating colleagues of our
findings.
• At the University of Exeter Medical School, our longer-term aims are to carry this work forward to a longer term study using
clinically meaningful outcomes for an elderly population, such as frailty progression, hospitalizations for any cause and
quality of life, using the more conventional outcomes for secondary analyses – we believe that at the age of 75 patients are
far more interested in the quality of their remaining years rather than the quantity and this should be the principle focus of
studies
• Citation:
• Individualised treatment targets for elderly patients with type 2 diabetes using vildagliptin add-on or lone therapy
(INTERVAL): a 24 week, randomised, double-blind, placebo-controlled study
Dr W David Strain MD,Valentina Lukashevich MD,Wolfgang Kothny MD,Marie-José Hoellinger MD,Päivi Maria Paldánius
MMedSci
The Lancet – 23 May 2013
DOI: 10.1016/S0140-6736(13)60995-2

Fraility as a Predictor of Surgical Complications
MedicalResearch.com Interview with Kenneth Ogan MD
Department of Urology
Emory University School of Medicine
1365 Clifton Rd. NE, Building B, Suite 1400 Atlanta, Georgia 30322
Dr. Ogan: Surgical risk assessment is traditionally a very subjective process, and an evaluation that more accurately
measures a patient’s physiologic reserve would greatly aid in surgical decision making. In this study we sought to further
characterize frailty as an objective risk assessment tool in surgical patients. We prospectively measured the five component
frailty criteria described by Fried et al.1 (weight loss, exhaustion, low activity, grip strength, and gait speed). Patients
deemed “intermediately frail” and “frail” had twice the likelihood of experiencing any complication in the 30-day post-
operative period.
•
MedicalResearch.com: Were any of the findings unexpected?
• Dr. Ogan: We hypothesized that frailty would not be of use in minimally invasive surgery, however a subset analysis showed
frailty conferred an even greater risk of post-operative complications in patients undergoing laparoscopic and robotic
procedures.

Fraility as a Predictor of Surgical Complications
MedicalResearch.com Interview with Kenneth Ogan MD
Department of Urology
Emory University School of Medicine
1365 Clifton Rd. NE, Building B, Suite 1400 Atlanta, Georgia 30322
• Dr. Ogan: We only included major intra-abdominal operations in our study, so future research should be focused on
confirming these findings in more heterogeneous surgical populations. Additionally, a valuable study would be to determine
the impact of preoperative interventions on postoperative outcomes in frail patients.
• References
• 1. Fried LP, Tangen CM, Walston J, et al. Frailty in older adults: evidence for a phenotype. J Geront A Biol Sci Med Sci. 2001;
56:146-156.
• Citation:
• Too Frail for Surgery?: Initial Results of a Large Multidisciplinary Prospective Study Examining Pre-operative Variables
Predictive of Poor Surgical Outcomes
• Louis M. Revenig, Daniel J. Canter, Maxwell D. Taylor, Caroline Tai, John F. Sweeney, Juan M. Sarmiento, David A. Kooby,
Shishir K. Maithel, Viraj A. Master, Kenneth Ogan

Lung Cancer Screening CT Scans Can Predict Future Cardiovascular Events
Dr. Pim A. de Jong,
Department of Radiology University Medical Center Utrecht,
Heidelberglaan 100, E.01.132, 3508GA
Utrecht, the Netherlands.
• Dr. de Jong: The main findings of the study is that lung cancer screening CT scans can predict future cardiovascular events.
• MedicalResearch.com: Where any of the findings unexpected?
• Dr. de Jong: The unexpected aspect is that the CT scans were not-ECG gated, but even these non-gated scans were good
enough to quantify arterial calcifications and predict risk.
• MedicalResearch.com: What should patients and providers take home from this study?
• Dr. de Jong: The implication is that cardiovascular prediction is possible based on CT scans obtained for another indication
even when no ECG gating is
applied.
• MedicalResearch.com: What further research do you recommend as a result of your report?
• Dr. de Jong: Future research should aim to test whether events can be prevented
with medication and whether quality of life and survival can be
improved at reasonable costs. After that has been proven one could
think of implementation studies.
• Citation:
• Lung Cancer Screening CT-Based Prediction of Cardiovascular Events.
• Mets OM, Vliegenthart R, Gondrie MJ, Viergever MA, Oudkerk M, de Koning HJ, Mali WP, Prokop M, van Klaveren RJ, van der
Graaf Y, Buckens CF, Zanen P, Lammers JW, Groen HJ, Isgum I, de Jong PA.
• JACC Cardiovasc Imaging. 2013 Jun 8. pii: S1936-878X(13)00332-X. doi: 10.1016/j.jcmg.2013.02.008. [Epub ahead of print]

PAD: Home-Based Walking Exercise Intervention
MedicalResearch.com Interview with: Mary McGrae McDermott, MD
Professor of Medicine
Northwestern University Feinberg School of Medicine
Contributing Editor, JAMA
Home-Based Walking Exercise Intervention in Peripheral Artery Disease
A Randomized Clinical Trial
• Answer: The goals trial found that a group-mediated cognitive behavioral intervention significantly improved six-minute walk
performance, physical activity levels, and patient-perceived walking performance compared to a control group. The gains in six-minute
walk in the intervention group were consistent with a large meaningful change in walking performance.  were any of the findings
unexpected?  the magnitude of the gain in six-minute walk was greater than that observed in supervised treadmill exercise
interventions in people with pad. In addition, our prior work shows that a supervised treadmill exercise intervention does not
significantly increase physical activity levels in daily life. However, the current home-based intervention significantly improved physical
activity levels in daily life.
• MedicalResearch.com: What should clinicians and patients take away from your report?  
• Answer: That home-based exercise can be effective in people with peripheral artery disease.
• Answer: Our intervention required meetings at the medical center once weekly. Future research should focus on home-based exercise
interventions for people with peripheral artery disease that do not require any regular visits to the medical center.
• Citation:
• McDermott MM, Liu K, Guralnik JM, et al. Home-Based Walking Exercise Intervention in Peripheral Artery Disease: A Randomized
Clinical Trial. JAMA. 2013;310(1):57-65. doi:10.1001/jama.2013.7231.

Is Dairy intake Protective against Uterine Fibroid Risk?
Dr. Lauren A. Wise
Slone Epidemiology Center
1010 Commonwealth Avenue Boston, MA
• Dr. Wise: We found that the strong inverse association between dairy and uterine fibroids in black women in the Black
Women’s Health Study is not explained by percent European ancestry.
MedicalResearch.com: Were any of the findings unexpected?
• Dr. Wise: Yes, we expected genetic ancestry to explain the entire association because there is evidence that percent
European ancestry is both positively associated with dairy intake and inversely associated with fibroid risk.
• Dr. Wise: Dairy intake may be protective against fibroid risk.
• Dr. Wise: Given this is the first study showing an inverse association between dairy and fibroids, future studies in different
populations are needed to confirm our findings.
•
• Citation:
• Is the Observed Association Between Dairy Intake and Fibroids in African Americans Explained by Genetic Ancestry?
• Lauren A. Wise, Julie R. Palmer, Edward Ruiz-Narvaez, David E. Reich, and Lynn Rosenberg
• Am. J. Epidemiol. f
irst published online July 3, 2013 doi:10.1093/aje/kwt091

Type 2 Diabetes: Validating a Renal Risk Score
MedicalResearch.com Interview with: C Raina Elley
Associate Professor and General Practitioner,
Acting Head, Dept General Practice & Primary Health Care,
Faculty Medical and Health Sciences, University of Auckland, Private Bag 92019,
Auckland, New Zealand
• Answer: Type 2 Diabetes is the leading cause of end-stage renal failure and dialysis in many countries. Early identification of
those who are at risk within primary care could prompt more intensive intervention to control glycaemia and blood pressure
and use of ACE inhibitors or angiotensin receptor blockers to slow progression. Traditionally estimated glomerular filtration
rate and/or urine albumin creatinine ratio have been used to alert clinicians of deteriorating renal function in people with
diabetes. However, a far more accurate renal risk score has been developed that combines serum creatinine, demographic
characteristics, albuminuria, glycaemia, blood pressure, cardiovascular co-morbidity and duration of diabetes.
• The 5-year renal risk score was developed by following more than 25,000 people with type 2 diabetes in New Zealand for a
median of 7.3 years (equivalent to 180,497 person-years). The study identified those who commenced dialysis for end-stage
renal disease, received a renal transplant or died from renal failure to derive the risk score.
• Answer: The accuracy with which the risk score predicted renal events in a separate validation cohort was unexpected, with
areas under the ROC of 0.91-0.92, compared with eGFR (0.77). People with the same eGFR (e.g. a 55 year old man with an
eGFR of 58ml/min/1.73m2) could have a 5 year risk of an end stage renal event of anywhere between 0.4% and 28%.
• The significant contribution of ethnicity to risk (after controlling for other known risk factors) was also surprising. There are
possibly genetic components contributing to risk, but ethnicity may also be a marker of other risk factors, such as long-term
exposure to poverty, smoke or other differences in lifestyle risk factors.

Type 2 Diabetes: Validating a Renal Risk Score
MedicalResearch.com Interview with: C Raina Elley
Associate Professor and General Practitioner,
Acting Head, Dept General Practice & Primary Health Care,
Faculty Medical and Health Sciences, University of Auckland, Private Bag 92019,
Auckland, New Zealand
• Answer: With electronic medical records, routinely entered measures can be combined to produce risk profiles and
prompting early preventive therapy of those at greater risk. Our new renal risk score is being added to the online
cardiovascular risk calculator for people with type 2 diabetes http://www.nzssd.org.nz/cvd/ so cardiovascular and renal risk
can be assessed together. Risk scores can also be used as an educational tool for patients. Their assessment of 5-year risk or
pictorial depiction of risk can highlight an issue and help motivate change or adherence with interventions.
• Answer: Future research could assess the effectiveness of use of risk prediction and early intervention in randomized
controlled trials. Furthermore, with the paucity of interventions to slow progression to renal failure, partly due to the time it
takes to reach hard endpoints like dialysis or doubling of serum creatinine in efficacy trials, using significant change in a risk
profile that at least combines eGFR and albuminuria could allow more timely assessment of effectiveness of new
interventions. Lastly, as the racial or ethnicity profiles vary from country to country, similar studies carried out within
national or regional contexts may produce locally valid risk calculators.
• Citation:
• “Derivation and Validation of a Renal Risk Score for People with Type 2 Diabetes” in Diabetes Care, 2013,
doi:10.2337/dc13-0190 by C. Raina Elley, Tom Robinson, Simon A Moyes, Tim Kenealy, John Collins, Elizabeth Robinson,
Brandon Orr-Walker, Paul L Drury

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