Could a Low-Gluten Diet During Pregnancy Protect Offspring from Diabetes?

MedicalResearch.com Interview with:
Knud Josefsen, senior researcher
Bartholin Institute, Rigshospitalet,
Copenhagen K, Denmark

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In a large population of pregnant women, we found that the risk of the offspring being diagnosed with type 1 diabetes before the age of 15.6 years (the follow up period) was doubled in the group of women ingesting the highest amounts of gluten (20-66 g/day) versus the group of women ingesting the lowest amounts of gluten (0-7 g/day). For every additional 10 grams of gluten ingested, the risk for type 1 diabetes in the child increased by a factor of 1.31.

It the sense that it was a hypothesis that we specifically tested, we were not surprised. We had seen in animal experiments that a gluten-free diet during pregnancy protected the offspring from diabetes, and we wanted to see if we could prove the same pattern in humans. There could be many reasons why we would not be able to show the association, even if it was there (sample size, low quality data, covariates we could not correct for and so on), but we were off course pleasantly surprised that we found the association that we were looking for, in particular because it is quite robust Continue reading

Patients With Type II Diabetes Have Greatest Risk of Heart Failure

MedicalResearch.com Interview with:

Dr Araz Rawshani, PhD Department of Molecular and Clinical Medicine Institute of Medicine University of Gothenburg Gothenburg, Sweden

Dr. Rawshani

Dr Araz Rawshani, PhD
Department of Molecular and Clinical Medicine
Institute of Medicine
University of Gothenburg
Gothenburg, Sweden

MedicalResearch.com: What is the background for this study?

 Response: Patients with type 2 diabetes have 2 to 4 times greater risk for death and cardiovascular events compared to the general population. There are several randomized trails that encourage a range of interventions that target traditional and modifiable risk factors, such as elevated levels for glycated hemoglobin, blood pressure and low-density lipoprotein cholesterol to reduce the risk for complications of type 2 diabetes. However, there are few randomized trails that have investigated the effects of multifactorial risk factor intervention in reducing the risk for death and cardiovascular events, as compared to patients that are treated with usual care.

We set out to investigate the extent to which the excess risk associated with type 2 diabetes may be mitigated or potentially eliminated by means of evidence-based treatment and multifactorial risk factor modification. In addition, we estimated the relative importance between various risk factors and the incremental risk of death and cardiovascular events associated with diabetes. Furthermore, we investigated the association between glycated hemoglobin, systolic blood pressure and low-density lipoprotein cholesterol (LDL-C) within evidence based target ranges and the abovementioned outcomes.

Continue reading

Lupus: Phase 2 Trial of Baricitinib Improved Signs and Symptoms

MedicalResearch.com Interview with:

Daniel J. Wallace M.D., FACP, MACR Associate Director, Rheumatology Fellowship Program Board of Governors, Cedars-Sinai Medical Center Professor of Medicine, Cedars-Sinai Medical Center David Geffen School of Medicine Center at UCLA In affiliation with Attune Health  Beverly Hills, Ca 90211

Dr. Wallace

Daniel J. Wallace M.D., FACP, MACR
Associate Director, Rheumatology Fellowship Program
Board of Governors, Cedars-Sinai Medical Center
Professor of Medicine, Cedars-Sinai Medical Center
David Geffen School of Medicine Center at UCLA
In affiliation with Attune Health
Beverly Hills, Ca 90211

MedicalResearch.com: What is the background for this study? What are the main findings?

 

Response: This is the first positive study of systemic lupus erythematosus (SLE) using baricitinib,  a small oral molecule that blocks the JAK system.

The human kinome consists of 500 genes and helps regulate cell surface receptor interaction. While agents that inhibit certain pathways are approved for rheumatoid arthritis and certain malignancies, this is the first study of its kind in SLE.

Continue reading

TARDOX Study: Targeting liver tumours with focused ultrasound for triggered drug delivery of thermosensitve liposomes is safe, feasible and enhances delivered dose

MedicalResearch.com Interview with:

Paul Lyon DPhil, MRCS Academic Clinical Fellow in Radiology Oxford University Hospitals NHS Foundation Trust Oxford, UK

Dr. Lyon

Paul Lyon DPhil, MRCS
Academic Clinical Fellow in Radiology
Oxford University Hospitals NHS Foundation Trust
Oxford, UK

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Delivering therapeutic doses of systemic chemotherapy to solid tumours, whilst ensuring side effects remain tolerable, has a presented a long-standing and unsolved challenge in oncology. With the advent of smart nanomedicines for clinical use, such as Lyso-Thermosensitive Liposomal Doxorubicin (LTLD, ThermoDox®, Celsion, USA), which has been formulated to release its doxorubicin content at 2.5°C above body temperature, there is now opportunity for targeted tumour therapy in combination with therapeutic devices.

Much like a magnifying glass can focus energy from the sun to burn a hole in paper, ultrasound can be focused deep within the body to induce therapeutic effects in tumours, including ablation, hyperthermia and other bioeffects. Since its inception in the 1940s, focused (or therapeutic) ultrasound has evolved and is now FDA-approved for a variety of indications including ablation of several tumour types, virtue of being safe, non-invasive and non-ionising.

Building on decades of preclinical research efforts worldwide, the TARDOX study is the first clinical trial to attempt triggered drug delivery to a target tumour non-invasively using an external focused ultrasound device. This phase 1 study which ran between March 2015-March 2017 in Oxford, UK, treated 10 patients with inoperable primary or secondary liver tumours which were either stable or refractory to previous chemotherapies. In each patient, a single intervention under general anaesthetic was performed during which a selected liver tumour was targeted and gently heated with focused ultrasound following an intravenous infusion of LTLD. Biopsies were used to determine the quantity of intratumoral doxorubicin before and after the ultrasound exposure.  Continue reading

New HIV Vaccine Advances in Phase 2 Studies

MedicalResearch.com Interview with:

Dan Barouch, M.D., Ph.D. Professor of Medicine Harvard Medical School Ragon Institute of MGH, MIT, and Harvard Director, Center for Virology and Vaccine Research Beth Israel Deaconess Medical Center Boston, MA 02215

Dr. Barouch

Dan Barouch, M.D., Ph.D.
Professor of Medicine
Harvard Medical School
Ragon Institute of MGH, MIT, and Harvard
Director, Center for Virology and Vaccine Research
Beth Israel Deaconess Medical Center
Boston, MA 02215

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study demonstrates that the mosaic Ad26/Env HIV vaccine candidate induced robust and comparable immune responses in humans and monkeys.

Moreover, the vaccine provided 67% protection against viral challenge in monkeys.   

Continue reading

Two Studies Evaluate Monoclonal Antibody Tralokinumab For Asthma

MedicalResearch.com Interview with:

Reynold A. Panettieri, Jr., M.D. Professor of Medicine, Robert Wood Johnson Medical School Vice Chancellor, Clinical & Translational Science Director, Rutgers Institute for Translational Medicine & Science Emeritus Professor of Medicine, University of Pennsylvania Child Health Institute of New Jersey Rutgers, The State University of New Jersey New Brunswick, NJ  08901

Dr. Panettieri

Reynold A. Panettieri, Jr., M.D.
Professor of Medicine, Robert Wood Johnson Medical School
Vice Chancellor, Clinical & Translational Science
Director, Rutgers Institute for Translational Medicine & Science
Emeritus Professor of Medicine, University of Pennsylvania
Child Health Institute of New Jersey
Rutgers, The State University of New Jersey
New Brunswick, NJ  08901

MedicalResearch.com: What is the background for this study?

Response: Severe asthma is characterized by Type 2 inflammation manifested by increases in IL-13, IL-4 and Il-5 levels in the airways that promotes airway hyperresponsiveness and in part irreversible airway obstruction.  These clinical manifestations profoundly increase asthma morbidity and mortality.

To address an unmet therapeutic need, Tralokinumab was developed as a monoclonal antibody targeting soluble IL-13 with the goal of improving lung function and patient reported outcomes while decreasing annual exacerbation rates.  Stratus 1 and 2 represent two identical randomized, double-blind, placebo-controlled, phase 3 clinical trials in severe asthma.  These international trials enrolled approximately 2000 subjects with severe asthma and examined whether Tralokinumab decreased annualized exacerbation rates (AER) as compared with placebo (primary outcome).

Continue reading

Obese Women Remain at Risk For Heart Disease, Even When Metabolically Healthy

MedicalResearch.com Interview with:
Nathalie Eckel, MSc

German Diabetes Center
Düsseldorf, Germany 

MedicalResearch.com: What is the background for this study?

 Response: Obesity is associated with metabolic disorders such as diabetes, high blood pressure and hypercholesterolemia, and with a higher risk of cardiovacular disease compared to normal weight. However, there is also the phenomenon of the so-called “metabolically healthy obesity” and “metabolically unhealthy normal-weight”. So far it has been unclear how metabolic risk factors change over time in metabolically healthy people depending on body weight and what cardiovascular disease risk results from this.

Continue reading

Disturbed Circadian Rhythm Associated With Poor Mental Health

MedicalResearch.com Interview with:

Laura Lyall  MA; MSc; PhD Research Associate Institute of Health and Wellbeing University of Glasgow

Dr. Lyall

Laura Lyall  MA; MSc; PhD
Research Associate
Institute of Health and Wellbeing
University of Glasgow 

MedicalResearch.com: What is the background for this study?  

Response: Previous studies have suggested a link between disturbed circadian rhythms and depression and bipolar disorder. These studies have however usually used small samples, subjective measures of circadian disruption, or have not accounted for potential confounding factors like sociodemographic and lifestyle characteristics. The UK Biobank cohort has accelerometry (activity monitor) data as well as mental health, lifestyle, BMI and sociodemographic data for over 91,000 individuals, and means we can address this question using objective measures of circadian rhythmicity on a large scale.

We derived a measure of relative amplitude from the UK Biobank’s accelerometry data, which was recorded for 7 days between 2013-2014 from around 100,000 participants. Relative amplitude reflects the distinction, in terms of activity levels, between an individual’s most active 10 hours and least active 5 hours, in an average day. If an individual is inactive during the day, or has disturbed sleep at night, the will show low relative amplitude, consistent with disturbed circadian rest-activity patterns.

Continue reading

Duchenne Muscular Dystrophy: As Survival Increases, New Focus on Quality of Life

MedicalResearch.com Interview with:
David Birnkrant, MD
Professor of Pediatrics, Case Western Reserve University School of Medicine
Director of Pediatric Pulmonology & Student Education, MetroHealth Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study updates guidance on all aspects of the multi-disciplinary care of patients with Duchenne muscular dystrophy (DMD). The project was funded by the CDC’s National Center on Birth Defects and Developmental Disabilities and the results were recently published as three articles in The Lancet Neurology. The project was guided by a 25-member steering committee. Eleven expert committees worked over a period of three years to develop guidelines based on the RAND/UCLA appropriateness method, in which assessments and interventions were evaluated for appropriateness and necessity. The recommendations update those originally published in 2010.

Duchenne muscular dystrophy is transmitted by X-linked recessive inheritance and thus affects primarily boys and men. Patients affected by DMD do not produce functional dystrophin protein, resulting in progressive weakness of skeletal, respiratory, and heart muscles, causing a shortened life span. Teens and young men may require surgery for curvature of the spine, a ventilator device to assist breathing, and a feeding tube to help ensure adequate nutrition. The approach of the various subspecialties involved in DMD management has evolved, with more anticipatory assessment and therapy, identifying and addressing predictable medical complications as early as possible for optimal patient outcomes. With this kind of multi-disciplinary care, people with DMD now live into their 30s and beyond.

Along with the emergence of new genetic and molecular therapies, the recognition that people with DMD are living longer was one of the main motivations behind the need for these updated care considerations. Patients with DMD, their families and their advocacy organizations are driving a new emphasis on optimizing quality of life, not just prolongation of survival. Thus, there was a need to address issues related to transitions of care from childhood to adulthood, coordination of care across subspecialties, and other topics related to education, vocation, independence, personal relationships, emotional health, and intimacy. The updated care considerations thus include eleven topic areas, eight of which were part of the 2010 guidelines.

These are: (1) diagnosis, (2) neuromuscular management, (3) rehabilitation management, (4) gastrointestinal and nutritional management, (5) respiratory management, (6) cardiac management, (7) orthopedic and surgical management, and (8) psychosocial management. Three topics are new: (9) primary care and emergency management, (10) endocrine management (including growth, puberty, adrenal insufficiency, and bone health), and (11) transitions of care across the lifespan.

Continue reading

Menopausal Hormone Therapy Linked To Favorable Cardiac Profile

MedicalResearch.com Interview with:

Mihir Sanghvi Academic Junior Doctor Barts Health NHS Trust

Dr. Sanghvi

Mihir Sanghvi
Academic Junior Doctor
Barts Health NHS Trust

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The effect of menopausal hormone therapy (MHT), previously known as hormone replacement therapy, on cardiovascular health in post-menopausal women remains controversial and unclear. Extensive observational data had suggested MHT to be cardioprotective, leading to MHT being routinely prescribed for both primary and secondary prevention of coronary heart disease (CHD). However, subsequent data from the Women’s Health Initiative (WHI) and Heart and Estrogen/Progestin Replacement Study (HERS) studies cast doubt on the beneficial cardiovascular effects of MHT; this was reflected in learned societies’ clinical guidance concerning MHT’s role in CHD prevention. The most recent randomised trial data on the subject arose from the Danish Osteoporosis Prevention Study, which indicated that women taking menopausal hormone therapy had a reduced risk of the composite endpoint of mortality, heart failure and myocardial infarction but the study has been subject to criticism [10]. In more recent work, again from the WHI, there was no difference in cardiovascular mortality in MHT users compared to placebo, although the authors themselves state that cause-specific mortality data should be interpreted “cautiously”.

The UK Biobank is an ongoing, large-scale, population-based study designed to examine determinants of health in middle and old age. Besides extensive collection of health questionnaire data, biological samples and physical measurements, it has incorporated cardiovascular magnetic resonance (CMR) imaging – the gold standard for analysis of cardiac structure and function – to provide detailed imaging phenotypes. At present, there is a paucity of data on the effects of  menopausal hormone therapy on left ventricular (LV) and left atrial (LA) volumes and function, alterations in which are markers of subclinical cardiovascular disease and have prognostic implications.

We found that in a large, population-based cohort of post-menopausal women free of cardiovascular disease, use of menopausal hormone therapy is not associated with adverse, subclinical changes in cardiac structure and function.

Indeed, we demonstrate significantly smaller LV and LA chamber volumes which have been linked to favorable cardiovascular outcomes in other settings.

Continue reading

Investigational Imaging Test Can Help Determine Success or Failure of Bone Marrow Transplant

MedicalResearch.com Interview with:

Kirsten Williams, M.D. Blood and marrow transplant specialist Children’s National Health System

Dr. Williams

Kirsten Williams, M.D.
Blood and marrow transplant specialist
Children’s National Health System 

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: This study addressed a life-threatening complication of bone marrow transplantation called bone marrow failure. Bone marrow transplantation has provided a cure for patients with aggressive leukemias or acquired or genetic marrow dysfunction. The process of bone marrow transplantation involves giving chemotherapy and/or radiation, which removes the diseased blood cells from the bone marrow. After this, new bone marrow stem cells are infused from a healthy individual. They travel to the bone marrow and start the slow process of remaking the blood system. Because these new cells start from infancy, it takes upwards of four to five weeks for new mature healthy cells to emerge into the blood, where they can be identified. Historically, there has been no timely way to determine if the new cells have successfully repopulated unless they can be seen in the blood compartment. This condition of bone marrow failure is life-threatening, because patients don’t have white blood cells to protect them from infection. Once bone marrow failure is diagnosed, a second new set of stem cells are infused, often after more chemotherapy is given. However, for many individuals this re-transplantation is too late, because severe infections can be fatal while waiting cells to recover.

We were the first group to use a new imaging test to understand how the newly infused bone marrow cells develop inside the patient. We have recently published a way to detect the new bone marrow cell growth as early as five days after the cells are given. We used an investigational nuclear medicine test to reveal this early cell growth, which could be detected weeks before the cells appear in the blood. This radiology test is safe, does not cause any problems and is not invasive. It is called FLT (18F-fluorothymidine) and the contrast is taken up by dividing hematopoietic stem cells. The patients could even see the growth of their new cells inside the bone marrow (which they very much enjoyed while waiting to see recovery of the cells in their blood). We could use the brightness of the image (called SUV) to determine approximately how many weeks remained before the cells were visible in the blood.

Finally, we actually could see where the new cells went after they were infused, tracking their settling in various organs and bones. Through this, we could see that cells did not travel directly to all of the bones right away as was previously thought, but rather first went to the liver and spleen, then to the mid-spine (thorax), then to the remainder of the spine and breastplate, and finally to the arms and legs. This pattern of bone marrow development is seen in healthy developing fetuses. In this case, it occurs in a similar pattern in adults undergoing bone marrow transplant.

Continue reading

What is the Biggest Modifiable Risk Factor For Dementia? Alcohol

MedicalResearch.com Interview with:
“undefined” by Iñaki Queralt is licensed under CC BY 2.0Michaël Schwarzinger, MD, PhD

Translational Health Economics Network (THEN)
Paris

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The association of heavy drinking with dementia has been known for decades. For instance, there is about no Wernicke–Korsakoff syndrome without heavy drinking and the syndrome was described in 1890. But this type of dementia is very rare. Also, heavy drinking is knowingly associated with multiple risk factors for dementia onset such as hypertension or diabetes. But heavy drinkers generally refuse to participate to cohort studies and declaration of alcohol use among participants is generally biased downward… So the study rationale is very strong, but supporting empirical evidence is quite scarce.

This nationwide study included all 31+ million adults discharged from hospitals over 6 years, i.e., 50% of the French population before 65 years old and 80% above that age. Of 1.1+ million adults diagnosed with dementia, one in twenty had an early-onset (before 65 years old). Heavy drinking was recorded in most (56%) early-onset dementia cases: two-third in men; one-third in women. In addition, the association of heavy drinking with dementia goes far beyond 65 years old, both directly (>3 times higher risk for dementia onset after controlling for more than 30 known risk factors for dementia) and indirectly as heavy drinking was associated with all other independent risk factors for dementia onset. Accordingly, heavy drinking had the largest effect on dementia risk of all independent modifiable risk factors such as hypertension or diabetes.

The effects were found whatever dementia case definition or population studies.

Continue reading

Another Obesity Paradox: Obese Males Have Survival Advantage in Melanoma

MedicalResearch.com Interview with:

This image depicts the gross appearance of a cutaneous pigmented lesion, which had been diagnosed as superficial spreading malignant melanoma (SSMM). Note the roughened edges of this mole, and its heterogeneous, mottled, multicolored appearance, which are all characteristics that should evoke suspicions about its classification.

This image depicts the gross appearance of a cutaneous pigmented lesion, which had been diagnosed as superficial spreading malignant melanoma (SSMM). Note the roughened edges of this mole, and its heterogeneous, mottled, multicolored appearance, which are all characteristics that should evoke suspicions about its classification.
CDC Image

Jennifer McQuade, M.D., lead author
Melanoma Medical Oncology
The University of Texas MD Anderson Cancer Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Melanoma is the most deadly of the common skin cancers, and for many years we lacked effective therapies for patients with disease that had spread (metastatic). Over the past 7 years, there has been FDA approval of 2 new classes of drugs that have dramatically improved the survival of patients with metastatic melanoma. Checkpoint inhibitor immunotherapies “take the brakes” off patients’ immune system to allow the immune system to eliminate the cancer. Targeted therapies turn off key molecules expressed by some tumors (BRAF mutant) that they rely on for sustained growth and division.

While these types of therapies can result in dramatic long-term disease control in some patients, others may not have any shrinkage of their tumors. Some differences may lie in the tumors themselves, but there is also increasing evidence that “host” factors such as the microbiome and lifestyle choices might influence outcomes in cancer patients.

Obesity has been associated with an increased risk of many cancers, and is in fact poised to overtake smoking as the leading preventable cause of cancer. One of the ways that obesity may increase tumor growth is by increasing levels of insulin and other growth factors which then activate a pathway called the PI3K pathway that leads to continued tumor growth. As that PI3K pathway has also been shown to cause resistance to targeted and immune therapies in melanoma, we hypothesized that obesity would be associated with worse outcomes in patients with metastatic melanoma treated with these therapies.

Continue reading

Post Exposure Doxycycline in PReP Users May Reduce Risk of Syphilis and Chlamydiae

MedicalResearch.com Interview with:

Professor Jean-Michel Molina MD Head of Department of Infectious Diseases, Hôpital Saint-Louis Paris France 

Prof. Molina

Professor Jean-Michel Molina MD
Head of Department of Infectious Diseases, Hôpital Saint-Louis
Paris France 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There is a high rate of sexually transmitted infections (STIs) among Pre-exposure prophylaxis users and we wished to assess whether post-exposure prophylaxis (PEP) with doxycycline could reduce the incidence of sexually transmitted infections in this population.

We have found indeed a high rate of STIs most of them (71%) being asymptomatic and warranting therefore systematic testing. Also PEP reduced the incidence of syphilis and chlamydiae infection by 70%, not for gonorrhea due to the high rate of detection in throat swabs without any impact of PEP.

Continue reading

Tetravalent Vaccine Proves Promising In Protecting Children From Dengue

MedicalResearch.com Interview with:
Vianney Tricou DPhil
Takeda Vaccines Pte Ltd
Singapore

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Dengue fever is a painful, debilitating mosquito-borne disease caused by any one of the four closely related dengue virus serotypes. Forty percent of the world’s population lives under the threat of dengue, with approximately 390 million infections and 20,000 deaths occurring globally each year. Dengue virus can infect people of all ages and is a leading cause of serious illness among children in some countries in Latin America and Asia. Takeda is developing a dengue vaccine candidate to safely protect children and adults living in, or traveling to, endemic areas against all four dengue virus serotypes, regardless of previous dengue virus exposure. 

Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live, attenuated dengue serotype 2 virus, which provides the genetic ‘backbone’ for all four vaccine viruses. Takeda’s ongoing Phase 2 DEN-204 study was designed to assess the safety and immunogenicity of different dose schedules of TAK-003 in approximately 1,800 healthy children and adolescents ages two through 17 years living in dengue-endemic countries in Latin America and Asia. Participants of the DEN-204 trial received either one primary dose of TAK-003, two primary doses of TAK-003 administered three months apart, one primary dose of TAK-003 followed by a booster dose one year later, or a placebo. Eighteen-month interim data showed that that TAK-003 is associated with a reduction in the incidence of dengue in the study participants. Data also showed that TAK-003 induced sustained antibody responses against all four serotypes of dengue virus, regardless of previous dengue exposure and dosing schedule.

Continue reading

Aging Population, Socio-Economic Disparities Linked To Increase in Heart Failure Incidence

MedicalResearch.com Interview with:

Prof Kazem Rahimi FRCP The George Institute for Global Health Oxford Martin School University of Oxford, Oxford

Prof. Rahimi

Prof Kazem Rahimi FRCP
The George Institute for Global Health
Oxford Martin School
University of Oxford, Oxford

MedicalResearch.com: What is the background for this study?

Response: We decided to investigate this topic because disease incidence data is very important for public health bodies; for example, for the allocation of healthcare resources or for the design and assessment of disease prevention measures.

When we reviewed the literature, we found that estimates of heart failure incidence, temporal trends, and association by patient features were scarce. Studies often referred to restricted populations (such as relatively small cohorts that may or may not be representative of the general population), or limited data sources (for example, only including patients hospitalized for their heart failure and not considering those diagnosed by clinicians outside of hospitals). Few studies reported comparable, age-standardized rates, with the result that the rates reported varied considerably across the literature.

Continue reading

HIV PreExposure Prophylaxis -PrEP- For MSM Found To Be Effective and Cost Saving

MedicalResearch.com Interview with:

Dr Valentina Cambiano PhD Institute for Global Health University College London London UK

Dr. Cambiano

Dr Valentina Cambiano PhD
Institute for Global Health
University College London
London UK

MedicalResearch.com: What is the background for this study?

Response: Pre-Exposure Prophylaxis (PrEP) which involves the use of drugs, which are used to treat HIV, in people without HIV to prevent them from getting is a critical new advance in HIV prevention. It has been shown to reduce the risk of HIV infection by 86% and the benefits heavily out-weigh any concerns. However, introducing this intervention has a cost.

When we started working on this study the National Health Services was discussing whether to introduce PrEP and if so for which populations. Unfortunately, at the moment NHS England is not providing Pre-exposure prophylaxis. However, a large study, the PrEP impact trial, funded by the NHS, has just started and this will provide PrEP to 10,000 people.

Continue reading

Personality Changes Can Signal Incomplete Recovery After Traumatic Brain Injury

MedicalResearch.com Interview with:

Prof.dr. J van der Naalt PhD Department of Neurology University Medical Center Groningen Groningen, The Netherlands

Prof J van der Naalt

Prof.dr. J van der Naalt PhD
Department of Neurology University Medical Center Groningen
Groningen, The Netherlands

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Mild traumatic brain injury occurs frequently and is one of the leading cause of morbidity in adults worldwide. It is a major social-economic problem with one in three patients had persistent complaints several months after injury that interfere with resumption of daily activities and work.

One of the most important questions concerns the finding that some patients recover without complaints and others do not after sustaining a mild traumatic brain injury. In a follow-up study with more than 1000 participants we found that personality factors are a major factor in the recovery process. In particular coping, that is the way patients adapt to persistent complaints, is important next to emotional distress and impact of the injury.

In an add-on study with fMRI we found that in the early phase after injury, the interaction between specific brain networks was temporarily changed. However, when regarding persistent posttraumatic complaints , specific personality characteristics significantly determine long term outcome.

Continue reading

Matching Time of Day To Patient’s Biorhythm May Improve Surgical Outcomes

MedicalResearch.com Interview with:
Prof David Montaigne MD

Faculté de Médecine de Lille H Warembourg
Lille, France

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It is well known for many decades that cardiovascular diseases exhibit a diurnal variation with for instance higher incidence of myocardial infarction in the early morning as opposed to the evening. Although studies on circadian gene knock-out and mutant mice argue for a biorhythm in myocardial ischemia-reperfusion tolerance, whether a biorhythm in the myocardial tolerance to ischemia, exists in humans was unclear because of conflicting reports in the context of myocardial infarction.

We demonstrated for the first time in humans that the myocardial tolerance to ischemia-reperfusion is different along the day, in line with rodent experiments performed in the early 2010s.

We demonstrated that this biorhythm is clinically meaningful and that it can be targeted as a cardioprotective strategy.

In this topic, Rever-alpha is of specific interest. It belongs at the same time to circadian genes and nuclear receptor families: being a nuclear receptor, it is a feasible pharmacological target, conversely to other circadian genes.

Continue reading

Cancer in Young Adults Disproportionately Affects Women

MedicalResearch.com Interview with:

Dr Miranda M Fidler, PhD Section of Cancer Surveillance International Agency for Research on Cancer Lyon, France 

Dr. Fidler

Dr Miranda M Fidler, PhD
Section of Cancer Surveillance
International Agency for Research on Cancer
Lyon, France 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The burden of cancer among young adults has been rarely studied in depth. To our knowledge, we describe for the first time the scale and profile of cancer incidence and mortality worldwide among 20-39 year-olds, highlighting major patterns by age, sex, development level, and geographic region.

Although cancer is less frequent than that observed at older ages, its impact remains considerable because these individuals have a large proportion of their expected lifespans remaining, contribute substantially to the economy, and play a major role in caring for their families. Worldwide, almost 1 million new cases of cancer and 400 000 cancer-related deaths occurred among young adults aged 20–39 years in 2012.

Overall, the most common cancer types in terms of new cases were female breast cancer, cervical cancer, thyroid cancer, leukemia, and colorectal cancer, and the most common types of cancer-related deaths were those due to female breast cancer, liver cancer, leukemia, and cervical cancer. The burden was disproportionately greater among women, with an estimated 633 000 new cancer cases (65% of all new cancer cases in that age group) and 194 000 cancer-related deaths (54% of all cancer-related deaths in that age group) in 2012.

Continue reading

With Increasing Westernization, Inflammatory Bowel Disease Becoming a Global Health Issue

MedicalResearch.com Interview with:

Gilaad Kaplan, MD, MPH, FRCPC Associate Professor  CIHR New Investigator & AI-HS Population Health Investigator Co-Director, Environmental Health Research Group Snyder Institute for Chronic Diseases & Institute of Public Health Departments of Medicine & Community Health Sciences University of Calgary

Dr. Kaplan

Gilaad Kaplan, MD, MPH, FRCPC
Associate Professor
CIHR New Investigator & AI-HS Population Health Investigator
Co-Director, Environmental Health Research Group
Snyder Institute for Chronic Diseases & Institute of Public Health
Departments of Medicine & Community Health Sciences
University of Calgary

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The aim of the study was to provide a global perspective on the epidemiology of the inflammatory bowel diseases in the 21st century.

During the 20th century IBD was considered a disease of the Western world. At the turn of the 21st century, IBD has become a global disease with accelerating number of cases in the developing world as it transition towards a westernized society.

Continue reading

Many US Women Face Distance Barriers To Abortion Access

MedicalResearch.com Interview with:
Jonathan Marc Bearak, PhD

Senior Research Scientist
Guttmacher Institute
New York

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Although U.S. women who live farther from abortion clinics are less likely to obtain one, no national study has examined inequality in women’s access to abortion and whether inequality in abortion access has increased as the number of abortion clinics have declined.

We found that half of women live within 11 miles of an abortion provider. However, 1 in 5 women would need to travel at least 43 miles. We found substantially greater variation within than across states, because even in relatively rural states, women and clinics were concentrated in urban areas. These disparities have persisted since at least 2000.

Continue reading

Liraglutide (SAXENDA) May Lead To Weight Loss By Slowing Stomach Emptying

MedicalResearch.com Interview with:

Prof Michael Camilleri, MD Gastroenterologist, Professor of Medicine, Pharmacology and Physiology at Mayo Clinic Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER) Mayo Clinic, Rochester, MN

Prof. Camilleri

Prof Michael Camilleri, MD
Gastroenterologist, Professor of Medicine, Pharmacology and Physiology at Mayo Clinic
Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER)
Mayo Clinic, Rochester, MN

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Liraglutide is approved for treatment of obesity; the precise mechanisms for the beneficial weight loss are unclear. We are interested to learn whether it is possible to identify people who are more likely to benefit from this treatment.

Continue reading

3-4 Servings Fruits, Vegetables and Legumes Sufficient To Reduce Cardiovascular Mortality

MedicalResearch.com Interview with:
Ms Victoria Miller
Population Health Research Institute
DBCVS Research Institut
McMaster University, Hamilton, ON
Canada

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: PURE study is prospective urban rural epidemiology study that included aged 35 to 70 years from 26 low-income, middle-income, and high-income countries on 5 continents. Data were collected at the community, household, and individual levels. Standardized questionnaires were used to collect information about demographic factors, socio-economic status (education, income, and employment), lifestyle (smoking, physical activity, and alcohol intake), health history and medication use. Standardized case-report forms were used to record data on major cardiovascular events and mortality during follow-up, which were adjudicated centrally in each country by trained physicians using standard definitions. Participants’ habitual food intake was recorded using country-specific (or region specific in India) validated food frequency questionnaires (FFQs) at baseline. The median follow up is 7.4 years and we are aiming for follow up people at least for 15 years. During 7.4 years of follow up more than 6000 CVD and 7000 mortality recorded.

Higher fruit, vegetable and legume intake is associated with a lower risk of cardiovascular, non-cardiovascular and total mortality. Our findings show the lowest risk of death in those who consume three to four servings (equivalent to 375-500 grams per day) of fruits, vegetables and legumes per day, with little additional benefit for intake beyond that range.

When examined separately, fruit intake is associated with lower risk of cardiovascular, non-cardiovascular and total mortality, while legume intake is inversely associated with non-cardiovascular and total mortality. For vegetables, raw vegetable intake is more strongly associated with lower risk of total mortality compared to cooked vegetable intake.

Continue reading

Diabetes Medication Exenatide Shows Promise In Treating Parkinson’s Disease

MedicalResearch.com Interview with:
Dr Dilan Athauda MRCP
Sobell Department of Motor Neuroscience and Movement Disorders
UCL Institute of Neurology & The National Hospital for Neurology and Neurosurgery
London

MedicalResearch.com: What is the background for this study?

Response: Exenatide is a synthetic version of a naturally occurring protein – exendin-4 – that was originally discovered by Dr John Eng in the early 1990’s in the saliva of the Gila Monster, a venomous lizard native to the Southwestern United states. He and his team were looking for bio-active peptides in insect and lizard venom that could be useful for people with Type 2 diabetes. They discovered that exendin-4 was extremely similar to a human hormone called Glucagon-like peptide-1 (GLP-1).  In humans, GLP-1 is secreted after you eat a meal to stimulate insulin secretion (and inhibit glucagon production) of which the end result is a lowering of blood sugar. Unfortunately human GLP-1 is rapidly broken down by a circulating enzyme called dipeptidyl peptidase IV (DPP-IV) and its effects only last minutes.

Importantly, it was discovered that exendin-4 is naturally resistant to the actions of this enzyme, meaning it’s effects on blood sugar control lasts much longer in the body.  These properties made it very attractive to people trying to treat people with Type 2 diabetes and following many successful randomised controlled trials of patients with Type 2 diabetes in 2005, exenatide was approved for use as a treatment.  During this time, work led by Nigel Greig’s group at the NIA showed that first evidence that exendin-4 had neuroprotective properties, and could protect neurons from a variety of stresses and could also improve growth and rescue degenerating cells. Over the next few years, various groups used exendin-4 in a variety of animal toxin models of Parkinson’s disease and showed that exendin-4 could halt the progression of Parkinsonism and prevent cell death in these models through beneficial effects on inflammation, mitochondrial function and cell survival.

Based on this encouraging pre-clinical data, Professor Foltynie supervised the first small, “open-label”, human trial of exenatide in patients with Parkinson’s disease.  The team found that patients treated with exenatide for 1 year (in addition to their usual medication) had less decline in their motor symptoms when assessed without their medication compared to the control group (just on their usual medication) and this advantage over the control group was still present 1 year after stopping the exenatide injections.  However, this trial was open-label – patients knew they were getting a (potentially beneficial) experimental therapy and so we couldn’t exclude the fact that placebo effects were explaining some of the results we saw.

As a result of the potentially beneficial results seen in this small open label trial we carried out a double-blind, placebo controlled trial.

Continue reading