Clinical Research Organisation Bangalore
Changes to the expression of a gene responsible for managing important chemical messengers that keep glucose and fat metabolism in check could be behind the development of a number of cases of type 2 diabetes.
A new study has advanced earlier research that showed low levels of a protein that bound to insulin-like growth factors made it more likely that mice developed type 2 diabetes. By finding the same effect in humans, we might be able to spot the disease earlier, and maybe even prevent its onset.
Researchers from the German Institute of Human Nutrition Potsdam-Rehbruecke (DIfE) and the German Center for Diabetes Research (DZD) carried out a population-wide study on the back of their earlier studies on insulin-like growth hormone binding proteins and the genes that produce them.
Their findings suggest that for some people, type 2 diabetes could have its roots in the locking of just a single gene.
If you get your different diabetes muddled up, keep in mind type 1 is typically diagnosed early in life, and involves the loss of insulin-production thanks to the destruction of key pancreatic tissues.
Type 2, on the other hand, is a progressive illness that usually develops past middle age. It usually kicks in as a result of various dietary and lifestyle factors, though genetic influences can predispose many people to develop a resistance to insulin in the first place.
As convenient as these two categories are for the time being, diabetes is a complicated condition that we’re only beginning to fully understand (and might need a complete rewrite anyway).
This new research shows just how complex the pathology behind type 2 diabetes could be.
Insulin is the usual suspect when it comes to glucose levels going awry. It’s the key that unlocks the door for glucose to enter cells and work its magic.
But there is another hormone that helps the body metabolise sugar, called insulin-like growth factor (IGF).
Various types of binding proteins grab onto IGF in the blood-stream and mediate its effects, helping fine tune not just the uptake of glucose, but the liver’s production of fat and glycogen.
Changes to the production and distribution of these chemical handcuffs have been linked to the development of type 2 diabetes in the past, making IGF binding proteins an important target for researchers.
One binding protein in particular – IGFBP-2 – has been the subject of ongoing studies. Women who had higher concentrations of this protein in the blood were found to have a reduced risk of developing type 2 diabetes.
Studies carried out on mice suggested low levels of IGFBP-2 predisposed them to fatty liver disease, a condition closely associated with type 2 diabetes. This meant levels of the binding protein were low before the disease had taken hold.
Intriguingly, researchers had found evidence that the binding protein’s gene had been silenced by an epigenetic switch – the DNA equivalent of a padlock that can be put in place for various reasons, typically environmental ones.
Their findings suggested that the gene for IGFBP-2 in the liver was edited early in life, setting the mice up for type 2 diabetes later.
Mice models are all well and good, but for human health research what we really need is to find similar evidence in people studies.
So the same research team used data collected as part of a previous study on German health, comprised of individuals aged between 35 and 65.
From just under 28,000 individuals, the researchers matched 300 subjects who had type 2 diabetes with 300 similar controls, and then compared levels of IGFBP-2. They also analysed epigenetic changes to the protein’s gene in their blood.
Sure enough, having higher levels of IGFBP-2 was associated with a variety of factors, such as a lower BMI, smaller waist circumference, smaller fatty liver index, and a lower risk of type 2 diabetes.
But for the subjects with type 2 diabetes the same chemical padlock found in the diabetic mice was also more likely to appear, again suggesting that for many people, diabetes could be influenced, if not caused, by epigenetic changes early in life.
“This study is a good example of how translational research works: a clinical finding is taken up, analysed mechanistically in the laboratory and finally examined in a population-wide study,” says lead scientist Annette Schürmann.
Not only does this help explain some of the complexity behind the condition, it could lead to better ways of diagnosing or even preventing the disease – long before the trouble begins.
“In the future, our findings may help to identify risk potentials for type 2 diabetes even earlier and help to counteract the disease with preventive measures,” says Schürmann.
Roughly 1 in 11 adults worldwide have some form of diabetes, 90 percent of which is of the type 2 variety. Those numbers are steadily going up as well.
Finding ways to limit that growth would save a lot of lives in the future.
This research was published in Diabetes.
Health ministry to discuss quantum of compensation related to serious adverse event due to faulty medical devices
In order to compensate patients in case of serious adverse events (SAE) due to faulty medical devices, health ministry has issued a draft proposal to discuss the quantum of compensation taking into consideration the compensation related issues of Johnson & Johnson defective ASR hip replacement system cases of Indian patients.
Patients impacted by its use had in 2015 requested the Central Consumer Forum (CCF) of National Consumer Disputes Redressal Commission (NCDRC) that the amount of compensation should be equal or on par with what has been offered in the country of origin.
“The draft proposal which is going to be discussed at the forthcoming Drug Technical Advisory Board (DTAB) meet in November 2018 will also discuss introducing legal provisions under the new Medical Device (MD) Rules, 2017 for mandating companies to offer compensation to patients and also its quantum,” informed Drug Controller General of India (DCGI) Dr S Eswara Reddy.
Thousands of people across the US were implanted with defective ASR hip replacement system between 2005 and 2010, when it was finally recalled. Over 4,500 ASR Hip implant surgeries were performed in India using these defective implants from May 2004 to August 2010 before the product recall.
Due to the lack of a legal provision, the companies until now are not liable to pay compensation to the affected patients.
A health ministry expert committee headed by Arun Agarwal formed to study Johnson & Johnson faulty hip implant case which had proposed to introduce the legal provision for compensation has also recommended to create an independent registry of high risk medical devices to effectively report adverse events. Provisions will also be introduced under the law to have legal backing for issuing alerts and warnings to the manufacturer.
In August 2010, US based Johnson & Johnson Ltd subsidiary DePuy Orthopaedics Inc which is a UK based manufacturer issued a worldwide recall for the ASR XL Acetabular Hip Replacement System after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12 per cent-13 per cent) who had received the devices had to undergo revision surgery within five years of receiving it.
By then, more than 93,000 patients worldwide were fitted with an ASR hip implant. It is believed that roughly a third of those were patients in the US.
Maharashtra Food and Drug Administration (FDA) had filed an FIR at Mahim police station in 2013 against DePuy Orthopaedics Inc on the grounds that it had not taken proper remedial measures to inform patients in India who had undergone ASR implant surgery. The recall was necessitated because of defectiveness of the subjected implant, its health implications and the inadequate compensation offered by the company for corrective action.
The state FDA had also recommended the state home department to handover the case of inappropriate recall of ASR Hip Replacement Implants in India to the Central Bureau of Investigation (CBI) for further investigation in the interest of over 4000 patients impacted by its use.
You know what it feels like to be sad.
But until recently, neuroscientists knew little about what the melancholy emotion looked like from a scientific perspective.
They knew the part of the brain called the amygdala played a role, but brain scans weren’t fast enough to catch what was happening during moment-to-moment fluctuations in emotional state.
Tears Don’t Fall
That changed when a team of researchers at the University of California asked 21 epilepsy patients to carefully log their moods.
Each of those patients had been previously outfitted with tiny wires that monitored their brains’ electrical activity, making it easy for the UC team to look for patterns between their brain activity and mood.
In a new paper, published Thursday in the journal Cell, the researchers report an unexpected finding.
In most of the patients, they noticed a link between sadness and a particular neural circuit that connected the amygdala, which deals with emotional fluctuations, with the hippocampus, which helps store memories.
It makes sense, researcher Vikaas Sohal told NPR, that there would be a link between sadness and remembering bad things that have happened to you — though they haven’t yet confirmed that that’s what’s going on.
In fact, it’s still not clear whether the circuit between emotion and memory causes the feeling of sadness or the other way around.
Still, Sohal said he hopes the finding will bring comfort to patients in the form of a new explanation for what’s going on during times of sorrow:
“As a psychiatrist, it’s incredibly powerful to just be able to say to patients, ‘Hey, I know there’s something happening in your brain when you’re feeling down.'”
This article was originally published by Futurism.
Blockchain technology can tackle the spread of communicable diseases even as outbreaks do not stop at national borders, said Mohua Sengupta, EVP & Global Head of Services, 3i Infotech.
The top five advantages of Blockchain technology are greater transparency, enhanced security, improved traceability, increased efficiency with speed, and reduced cost. These are all important for reporting cross-border communicable disease cases which is a challenge the whole world is trying to grapple with, she added.
A health threat anywhere is a health threat everywhere. Efforts taken by the United Nations, World Health Organization (WHO) and Centre for Disease Control and Prevention (CDC) in conjunction with the efforts taken up by various governments, NGOs, research institutions and pharma companies have managed to reduce the impact of communicable diseases. This is where Blockchain can prevent its spread, said Sengupta.
Using Blockchain technology to record infected person’s information on a distributed ledger can allow stakeholders in different countries, conditional access to a single source of truth. A patient’s health data can be recorded on a ledger as a transaction with a time stamped audit trail. This makes communicable disease information more secure as patient data is encrypted. It can take out the inefficiencies with current reporting practices of sending emails or some other form of non-trusted way of reporting data and real time distribution of data to research centres, quarantine facilities and Points of Entries (POEs), said Sengupta.
As per 2016 WHO data, Lower Respiratory Tract Infection is the only communicable disease that features in the list of top 10 diseases causing death. Hence in today’s world, it is not enough to only focus on vaccination and cure but it is equally important to do effective reporting to control the cross border movement, she noted.
A centralized system to upload infection and infected party related data is the fastest and the most efficient way of reporting them, within and across border. But security is a major concern for any healthcare data, especially when it is about an individual, who is infected by a communicable disease. Any mistake therein can prove really expensive. Hence any system used for this purpose need to be highly secure. Not all record sharing system, using the internet, will be secure. The system might be able to share data real time but the quality of data may be questioned. They might become the hackers’ target, she said.
Blockchain technology, with its built-in security will be able to address these concerns. Each relevant party can be a node in the chain, and onboarding a node can also be monitored and approved by an International Organization, like WHO, in this particular case, given the required confidentiality. Blockchain technology has the underlying trust infrastructure built in. It doesn’t require validation by a centralized authority. Hence it is faster and real time. Furthermore, Blockchain also removes the need for any intermediary, thereby reducing the cost of operations, said Sengupta.
In fact, Blockchain has been garnering substantial attention across industries, with VC’s investing over USD 1.4 billion in the technology in the past 3 years. The World Economic Forum estimates 10% of the global GDP to be stored using Blockchain by 2027.
Two major studies released Saturday provide evidence that medications derived from fish oil are effective in protecting people from fatal heart attacks, strokes and other forms of cardiovascular disease.
The large, multiyear research efforts tested different formulations and quantities of drugs made with Omega-3 fatty acids on two groups of people: one that suffered from cardiovascular disease or diabetes and another that represented the general population.
Both studies found that people who took the drugs every day enjoyed protection against some heart and circulatory problems compared with those given a placebo.
In a look at another commonly consumed supplement, vitamin D, researchers found no effect on heart disease but saw a link to a decline in cancer deaths over time.
The research was released Saturday at the American Heart Association’s 2018 Scientific Sessions in Chicago and published in the New England Journal of Medicine.
About 43 million people in the United States take statins to lower LDL, or “bad,” cholesterol, and the drugs are credited with reducing the risk of heart attacks and strokes.
But heart disease remains the leading killer of Americans. In recent years, a long, steady decrease in heart disease deaths has slowed.
So researchers are seeking other ways to combat cardiovascular disease beyond known protective factors such as changes in diet, exercise and smoking habits.
One of the studies unveiled Saturday, named by the acronym REDUCE-IT, determined that people with cardiovascular disease who were already taking statins stood less chance of serious heart issues when they were also given two grams of the drug Vascepa (icosapent ethyl) twice a day.
The drug is a purified version of a fish-oil component that targets triglycerides, another type of fat in the blood. Elevated triglycerides can harden or thicken arteries, potentially leading to strokes and heart attacks.
People who took the drug were compared with those who were given a placebo. The study involved more than 8,000 people.
The drug is made by Amarin Corp., which sponsored the research. In September, Amarin announced that the study had met its primary goals.
Deepak L. Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital in Boston, who led the study, said the results could change the practice of cardiology in the same way that the introduction of statins did more than 30 years ago.
“Honestly, I’ve been doing clinical trials for a long time. And I’ve not been involved in a trial that has this much potential to improve the lives of perhaps tens of millions of people,” Bhatt said.
In 2007, a large study in Japan determined that the same component of fish oil used in the REDUCE-IT study showed promise in protecting against cardiovascular problems.
But that research did not compare the substance against a placebo, and was complicated by the large amount of fish in the typical Japanese diet.
The other fish-oil study released Saturday, called VITAL, looked at the effect of a different formulation of Omega-3 fatty acids in a drug called Lovaza. Researchers followed nearly 26,000 people for a median of more than five years.
The results suggested that people given the drug were 28 percent less likely to suffer heart attacks than those given a placebo, and 8 percent less likely to have a variety of cardiovascular events.
The effect was even more pronounced among African Americans, but the lead researcher said the results need further study before they can be relied upon.
People who ate fewer than 1.5 servings of fish weekly saw a drop in the number of heart attacks suffered when they increased their consumption of Omega-3s by taking the drug. The study did not find a decline in strokes.
JoAnne Manson, chief of the division of preventive medicine at Brigham and Women’s Hospital, who led the study, said it “further supports . . . the benefits of Omega-3 in heart health.”
Manson called the results “promising signals” about fish-oil consumption, but said they are not conclusive enough to compel people to begin taking the drug or fish-oil supplements.
The study also showed that the medication is safe enough that people already taking fish oil have no reason to stop, she said in an interview.
People in the study were given 840 milligrams of the key fatty acids in fish oil each day, less than is found in a typical serving of salmon.
“We would encourage starting with more fish in the diet and having at least two servings a week,” Manson said.
“One advantage of doing it through the diet . . . is that fish can replace red meat, saturated fat and processed food.”
Lovaza is manufactured by GSK, but is available in generic form. The study was sponsored by the National Institutes of Health.
The VITAL study also looked at vitamin D, which is often recommended to improve bone health in older women and for overall health in other people. It found that the vitamin had no effect on heart attacks or strokes and did not affect the incidence of cancer.
But vitamin D consumption may have some role in reducing the number of deaths from cancer two or more years later, the research showed.
Manson suggested that vitamin D may help prevent cancers from metastasising or becoming more invasive. But she said that idea needs more research.
She said people already taking modest amounts vitamin D, especially on the advice of doctors, have no reason to stop.
But she warned against taking huge doses of the vitamin, such as 5,000 or 10,000 international units a day, unless a clinician recommends it, because the safety of that practice is not known.
2018 © The Washington Post
This article was originally published by The Washington Post.