Researchers trying to find a cure for diabetes said Thursday they had discovered a new hormone, previously unknown to medicine, that makes the very cells destroyed by the disease. It has the potential to transform the way we now care for diabetes – the No. 7 killer in the United States, the researchers said.

The new hormone, which they have named betatrophin, encourages the growth of beta cells in the pancreas. These beta cells produce insulin, which people with diabetes lack. Without insulin, sugar can build up in the blood, damaging organs and blood vessels and causing blindness, kidney failure and the loss of limbs.

So far the team at the Harvard Stem Cell Institute have only worked in mice. But they say humans make betatrophin, too, and it’s almost identical to the mouse type.

“It is very exciting to think this could turn into a treatment for people,” Dr. Douglas Melton, who led the work, told NBC News.

“We discovered that only one gene was responsible for making more of these insulin-producing beta cells. Once we were able to make the hormone as a protein, like insulin, then we would be able to administer it.”

Nearly 26 million Americans have diabetes, according to the Centers for Disease Control and Prevention. About 90 percent have type 2, which is linked to poor diet and a lack of enough exercise, although there’s a genetic component, too. Type 1 or juvenile diabetes is caused whenthe body’s immune system mistakenly attacks the pancreatic beta cells.

Both types can eventually leave patients without the ability to make insulin properly. In type 1 diabetes and some cases of type 2, patients must inject insulin when they eat to make sure the body metabolizes the food properly and doesn’t get too much or too little sugar.

It’s tricky and most people don’t get it just right. Many researchers are trying to find something better.

Melton’s lab has been focused on regenerating or replacing beta cells. His colleague Peng Yi stumbled on the new hormone and the team was astonished to find that an overlooked gene controlled production of a hormone that directly stimulates beta cell growth.

“It is rare to find a new hormone, especially one so specific,” Melton said. “I've never seen any treatment that causes such an enormous leap in beta cell replication.”

The discovery, reported in the journal Cell, is still in the very early stages, scientifically. A lot could go wrong. In a best-case scenario, Melton says, researchers will find a way to make the new hormone easily and make it into an injectable form.

“We would provide this hormone, the type 2 diabetic will make more of their own insulin-producing cells, and this will slow down, if not stop, the progression of their diabetes,” Melton says. “You might inject this hormone once a month or once a year to make more beta cells and they are going to make the insulin. If your own beta cells are making the insulin, they will act to regulate your metabolism much better than the intermittent injections diabetics do.”

Two companies -- German biotech firm Evotec and Janssen, the drug development arm of Johnson & Johnson, have licensed the discovery and are already working to try and make betatrophin into a human treatment. It’s not straightforward.

“We have been able to grow it in all kinds of cells, but we can’t get it out in soluble, usable form yet. That’s a little bit puzzling,” Melton says.

“Now, in the next year, we will make the hormone and see if we can cure type-2 diabetes in mice. We also want to see if we can forestall the onset of type-1 diabetes in mice.”

Dr. Julia Greenstein, vice president for cures at the Juvenile Diabetes Research Foundation or JDRF, says the research has the potential to change the course of diabetes treatment.

“We have known for a long time that normal beta cells proliferate and expand in a number of situations like pregnancy and obesity. We just haven’t understood the science enough to understand what proteins or hormones might be responsible for that,” said Greenstein, who was not involved in the research. The federal government, through the National Institutes of Health, paid for the Harvard team’s experiment.

Greenstein predicted that many different groups of scientists will begin to tackle the problem of making betatrophin work – or perhaps try to make a drug that would duplicate its effects. One important concern: causing cells to prolferate can lead to cancer.

Meanwhile, Melton’s not putting all of his eggs into that basket. His lab is working on a variety of ways to repair the pancreas and cure diabetes, including the use of human embryonic stem cells, which he’s working to transform into pancreatic cells.

His adult son and daughter have type-1 diabetes and he fears they wouldn’t benefit from something like betatrophin, because their pancreatic beta cells are so badly damaged already.

“They are unlikely to have enough beta cells on which this hormone can act. We need something else,” Melton says. “I am really keen to solve that problem. We are not giving up on that.”

Low levels of melatonin, a hormone involved in the regulation of sleep, may boost the risk of diabetes, a new study suggests.

Over a 12-year period women, with the lowest levels of melatonin were more than twice as likely to develop type 2 diabetes, compared to those with the highest levels of the hormone, according to a report published in the Journal of the American Medical Association Tuesday.               

While the researchers expected to find some association between melatonin and diabetes risk, they were surprised by the magnitude of what they saw, said the study’s lead author, Dr. Ciaran McMullan, a research fellow at Harvard’s Brigham and Women’s Hospital.

“What we don’t yet know is whether you can change the risk of diabetes by increasing melatonin secretion,” McMullan said.

For the new study, researchers compared 370 diabetic women to 370 women without the disorder. The women came from a larger, ongoing project known as the Nurses’ Health Study. At the beginning of that study, all participants filled out surveys that questioned them about lifestyle habits, including diet, exercise, smoking history, and sleep patterns. The women were also asked to submit a urine sample, which provided a baseline melatonin level. None of the women had type 2 diabetes at the beginning of the study.

Even after the researchers accounted for lifestyle factors, including hours of sleep, women with the lowest melatonin levels were 2.2 times as likely to develop diabetes compared to those with the highest levels.

Although melatonin was found to be a predictor of diabetes risk independent of number of hours of sleep, the hormone does have an impact on the body's daily rhythms, peaking right before a person falls asleep and declining during the night. 

It's unknown whether low melatonin levels actually caused diabetes, but other research suggests that might be the case, McMullan said. Studies have shown that melatonin supplements given to diabetes-prone rats can help stave off the disease, while also improving cholesterol and triglyceride levels. 

Receptors for melatonin are found all over the body, including the pancreas, which makes insulin, he added. The presence of the hormone receptors in the pancreas suggests melatonin might have an impact on insulin production, as well as insulin resistance, McMullan said.

Still, more research is needed before recommending melatonin supplements for people with high blood sugar levels, McMullan said.

It’s entirely possible that the melatonin levels are simply an indicator of how well a person’s internal clock is working, said Dr. Mitchell Lazar, a professor of medicine and director of the Institute for Diabetes, Obesity and Metabolism at the Perelman School of Medicine at the University of Pennsylvania.

“We’ve increasingly realized that aspects of our sleep-wake cycle, our behavioral and circadian rhythms are environmental factors that contribute to the risk for diabetes,” Lazar explained. “For example, it’s been shown in many studies that people on shift work have an increased incidence of diabetes.

“Now it could be that low melatonin causes diabetes, but it could also be possible that diabetes causes low melatonin.”

The melatonin connection to diabetes is important, “but it’s just one piece of the puzzle,” Lazar said.

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Johnson & Johnson is recalling and replacing more than 2 million meters used to measure blood glucose levels in diabetics due to a failure to operate properly at extremely high glucose readings, the company's LifeScan unit said on Monday.

In the United States, about 90,000 OneTouch Verio IQ meters are affected out of some 1.2 million units of that model being recalled worldwide, the company said.

At extremely high glucose readings of 1024 mg/dl and above, the units have failed to provide a warning of dangerously high blood sugar and will shut off, potentially delaying proper treatment, the company said.

LifeScan said it has notified the U.S. Food and Drug Administration and other health regulators of the voluntary recall, as well as registered users and healthcare professionals.

In addition to the Verio IQ model, J&J is also recalling about 670,000 of its OneTouch Verio Pro meters in Europe and 4,900 of its hospital-based OneTouch Verio Pro+ meters in the Middle East, Europe and the Asia/Pacific region.

No patient injuries have been reported in the United States related to the malfunction, the company said. LifeScan said there was one report of a serious adverse event outside the United States, but a link to the malfunctioning glucose meter had not been determined.

"We regret the inconvenience these actions may cause. However, we will always err on the side of caution and make a decision that is in the best interest of our patients," Michael Pfeifer, LifeScan's chief medical officer, said in a statement.

The company said its OneTouch Ultra model was not affected by the recall.

It said patients could continue to use the Verio IQ model until replacements arrive as long as they are aware that if the unit shuts down it could be indicative of dangerously high glucose levels.

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By Andrew M. Seaman
Reuters
People who take a certain type of diabetes drug to lower blood sugar levels may be at an increased risk of developing an inflamed pancreas, according to a new study. 

Glucagonlike peptide 1(GLP-1) therapies that include exenatide - marketed as Byetta by an alliance between Bristol-Myers Squibb and AstraZeneca - and sitagliptin - marketed as Januvia by Merck - have been linked to pancreatitis before in studies on animals and small groups of patients, said the study's lead author.

"New therapies and risks are only evaluated when studies are done. We need to know (the drugs) are effective in lowering blood sugar, but we also need to know about risks," said Dr. Sonal Singh, from the Johns Hopkins University School of Medicine in Baltimore.

Pancreatitis, which can cause life-threatening complications, is rare but more common in people with type 2 diabetes. Singh said pancreatitis occurs in about three of every 1,000 diabetes patients.

The U.S. Centers for Disease Control and Prevention estimates that there are about 19 million Americans diagnosed with diabetes, and another 7 million who have the disease but don't know it yet.

In people with type 2 diabetes, the body doesn't produce enough insulin or is resistant to what it does produce.

For the new study, published in JAMA Internal Medicine, the researchers used data on 1,269 diabetes patients between the ages of 18 and 64 years old, who were admitted to U.S. hospitals with pancreatitis in 2005 through 2008.

They compared those to 1,269 other diabetes patients who were similar, but were not hospitalized with pancreatitis.

Overall, they found 87 of the diabetes patients with pancreatitis were taking GLP-1 therapies, compared to 58 of the diabetes patients without pancreatitis.

Singh told Reuters Health that the findings show the drugs are linked to a doubling of the risk of pancreatitis - about six cases per 1,000 diabetics.

"I won't say you should be alarmed about the findings, but it's something you should consider," he said.

‘Changing treatment'

Dr. Aaron Cypess, a staff endocrinologist in the clinic of the Joslin Diabetes Center in Boston, said the new study will not change how he treats patients, but it may influence him to go over his patients' risk factors for pancreatitis.

"For me personally it's not going to change my practice pattern in terms of stopping the drugs, but we may revisit whether you're showing any of the risk factors," said Cypess, who was not involved with the new study.

In a joint statement, the American Diabetes Association and the American Association of Clinical Endocrinologists also said the new findings should not change how doctors treat diabetes patients.

"The analysis is a retrospective study using data from an administrative database. This type of analysis is not considered as robust as a prospective randomized controlled clinical trial, the gold standard for evaluating treatments," the organizations wrote in the statement.

They continue that there are nine of those "gold standard" trials in the works that should provide answers soon. 

The current study also had limitations, including that the diabetes patients hospitalized with pancreatitis tended to lead a less healthy lifestyle than those who did not have the condition.

In a commentary, Belinda Gier and Dr. Peter Butler from the University of California, Los Angeles, write supporters say the drugs are safe and offer some advantages over older medications. 

Currently, the labels for Januvia and Byetta carry warnings that there have been reports of pancreatitis in people taking the drugs.

Other side effects of Byetta include nausea and other stomach issues. For Januvia side effects also include respiratory infections and headaches. Cypess told Reuters Health both drugs are still protected by patents and can be expensive. 

Representatives from Merck and Bristol-Myers Squibb said they - along with drug regulators - actively monitor reports of adverse events in users of their drugs, and have not found evidence showing the drugs cause pancreatitis.

As weight-loss surgery has become more common over the last several years, doctors have had tantalizing clues that certain procedures bring dramatic reduction in type 2 diabetes -- beyond getting their ability to reduce the patient’s weight.

The surgery appears to have stopped damage to the pancreas, reversing the cause of diabetes as well as alleviating the symptoms, the researchers reported Tuesday in the journal Diabetes Care.

A year ago researchers at the Cleveland Clinic carried out a careful trial of 150 patients with diabetes that was not being adequately controlled. One-third got gastric bypass, one-third were given a device similar to a lap band that reduces stomach volume, and the rest received the best drug therapies. The goal was to reduce the participants’ blood sugar to below normal levels.

In the patients who got the bypass surgery the results were dramatic.

"It's pretty amazing," bariatric surgeon Dr. Philip Schauer of the Cleveland Clinic said at the time. “Many of our patients, even within hours of the operation, their blood sugar becomes normal … even before they've lost any weight at all.”

The big question was, would the results last? In a one-year follow-up study, published in the journal Diabetes Care on Tuesday, the answer is yes. "Gastric bypass surgery seems to uniquely restore pancreatic beta-cell function, presumably by targeting belly fat and modifying the hormones in the gastrointestinal tract," Dr. Sangeeta Kashyap, an endocrinologist with the Cleveland Clinic, said in a statement. "Gastric bypass remarkably targets belly fat where hormones that are toxic to the body develop."

The pancreas makes insulin, which in turn control blood sugar. People with diabetes can't control their blood sugar as well, and the excess sugar damages organs such as the eyes and kidneys. The pancreas worked again in patients who had the surgery, Kashyap says. "This is something that is very novel and something we don’t see with medications or with insulin," she said.

A gastric bypass procedure makes the stomach smaller by dividing it into two sections and connects a portion of the small intestine to one of the stomach pouches, reducing the amount of calories absorbed by the body. Curiously, another surgical procedure called sleeve gastrectomy, which also reduced stomach volume, caused the patients to lose just as much weight, but it did not bring the same dramatic reduction in diabetes.

The doctors are not sure how the bypass surgery changes the hormone balance in the body to cure the diabetes. And they hope someday they might achieve the same effect without the surgery.

The Cleveland Clinic doctors want to treat more patients before they are confident they have a cure. An estimated 26 million Americans have type 2 diabetes and it has been called one of the fastest-spreading epidemic ever.

If it continues to be successful, the main issue will be whether major surgery costing $25,000 -- and often not covered by insurance -- is too drastic a treatment. In response any doctors point out that uncontrolled diabetes often leads to kidney problems, heart attacks, strokes, amputations and death. For many diabetic patients medical costs far exceed $25,000. So, if the diabetes cannot be controlled in other ways, the surgery may become far more common.

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Big rise in diabetes, especially down South

By Genevra Pittman
Reuters

Vision loss likely related to diabetes increased by 20 percent over less than a decade in the U.S., according to a new study. 

So-called nonrefractive vision impairment - which includes glaucoma and cataracts - can't be corrected with glasses, and typically requires laser therapy or surgery. It can also lead to permanent vision loss in some cases, especially when the problem isn't identified or treated in a timely fashion.

"These are really dramatic findings, and they're kind of the tip of the iceberg of what's coming ahead," said Dr. David Friedman from the Wilmer Eye Institute of Johns Hopkins University School of Medicine in Baltimore, who worked on the study.

The researchers said that as diabetes rates continue to rise - and hit younger and younger people - some complications tied to the disease are expected to spike as well. Vision loss is especially a concern among people who have had diabetes for ten years or more.

Using data from a national health and nutrition study, Friedman's team found 1.4 percent of the 9,471 adults examined in 1999 through 2002 had nonrefractive vision impairment. That compared to 1.7 percent of the 10,480 people tested in 2005 through 2008.

Over that time, the number of study subjects who'd had diabetes for at least ten years also increased, from 2.8 percent to 3.6 percent. Among adults younger than 40, that figure more than doubled - from 0.3 percent to 0.7 percent.

The study can't prove diabetes was behind the rise in vision problems.

However, everything else linked to a higher risk of nonrefractive vision impairment - such as poverty and lack of education - was the same or better in the later study population compared to the earlier one, the researchers wrote Tuesday in the Journal of the American Medical Association.

"The only (association) that got worse and got dramatically worse is diabetes, and not just diabetes, but diabetes for a long time," Friedman told Reuters Health.

'A really alarming sign'

Vision problems related to diabetes develop when fluid accumulates in the retina, making it blurry, or when new blood vessels grow in the back of the eye due to lack of oxygen.

The type of vision loss measured in the study - worse than 20/40 in both eyes - isn't blindness, according to Friedman, but would make it harder for people to live independently and would mean many couldn't get an unrestricted driver's license.

"This is a really alarming sign," said David Musch, an epidemiologist at the University of Michigan Kellogg Eye Center in Ann Arbor, who co-wrote an editorial published with the study.

"This is probably only one of a number of signs that will be evident in the near future if we continue to have young children and adolescents be overweight and obese," he told Reuters Health, noting that more kids and adolescents are being diagnosed with what used to be considered "adult-onset" diabetes.

"This is a message to vision care providers that they're going to be seeing a lot more of these complications among a younger population," Musch added.

Friedman said screening everyone with diabetes for vision problems, as is done in England, can almost completely eliminate blindness related to the condition. However, only about half of diabetics in the U.S. currently get their eyes checked regularly.

"Hopefully what this article will do is raise awareness and in part increase the screening rate," he said. 

By Julie Steenhuysen
Reuters
A breakdown of U.S. diabetes cases shows dramatic increases in the number of people diagnosed with diabetes overall between 1995 and 2010, with especially sharp increases among people in the South and in Appalachian states.

According to a study released on Thursday by the U.S. Centers for Disease Control and Prevention, the number of diagnosed cases of diabetes grew by 50 percent or more in 42 U.S. states, and by 100 percent or more in 18 states.

In 2010, 18.8 million Americans had been diagnosed with diabetes and another 7 million had undetected diabetes, according to the CDC.

States with the largest increases over the 16-year period were Oklahoma, up 226 percent; Kentucky, up 158 percent; Georgia, up 145 percent; Alabama, up 140 percent, Washington, up 135 percent, and West Virginia, up 131 percent, according to the study published in CDC's Morbidity and Mortality Weekly Report. 

"Regionally, we saw the largest increase in diagnosed diabetes prevalence in the South, followed by the West, Midwest, and Northeast," Linda Geiss, a statistician with CDC's Division of Diabetes Translation and lead author of the report, said in a statement.

The findings reinforce data from other studies showing that southern and Appalachian states were experiencing the biggest regional gains in diabetes diagnoses, Geiss said.

Although much of the increase in the number of people diagnosed with diabetes is likely due to more people developing the condition, the study also notes that diabetes treatments have improved, which may mean that more people are living longer with their disease.

Type 2 diabetes, which can be prevented through lifestyle changes, accounts for 90 percent to 95 percent of all diabetes cases in the United States, according to the CDC.

"These rates will continue to increase until effective interventions and policies are implemented to prevent both diabetes and obesity," Ann Albright, director of CDC's Division of Diabetes Translation, said in a statement.

Globally, there are now 371 million people living with diabetes, up from 366 million a year ago, according to the latest report by the International Diabetes Federation, up from 366 million a year ago.

Without significant lifestyle changes, the group projects as many as 552 million will have diabetes by 2030. 

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Diabetes is running at record levels worldwide and half the people estimated to have the disease are, as yet, undiagnosed, according to a report on Wednesday.

The number of people living with diabetes is now put at 371 million, up from 366 million a year ago, with numbers expected to reach 552 million by 2030, the International Diabetes Federation (IDF) said.

Diabetes is often viewed as a western problem, since the vast majority of people have type 2 disease which is linked to obesity and lack of exercise.

But the disease is also spreading rapidly in poorer countries, alongside urbanization, and four out of five diabetics now live in low and middle-income countries, opening up new opportunities and challenges for the drug industry.

China alone has 92.3 million people with diabetes, more than any other nation in the world, and the hidden burden is also enormous in sub-Saharan Africa where limited healthcare means less than a fifth of cases get diagnosed.

The IDF estimates that, globally, 187 million people do not yet know they are suffering from the condition.

Diabetics have inadequate blood sugar control which can lead to serious complications, including nerve and kidney damage and blindness. Worldwide deaths from the disease are running at 4.8 million a year.

The disease is one of a number of chronic conditions - along with cancer, cardiovascular and respiratory diseases - that healthcare campaigners want included in the next set of global development goals, which will replace outgoing Millennium Developments Goals in 2015.

For the international drugmakers, diabetes offers riches, with global sales of diabetes medicines expected to reach $48-$53 billion by 2016, up from $39.2 billion in 2011, according to research firm IMS Health.

China to Africa

Tapping into the potential of increased demand in emerging markets, however, requires a twin-track approach from drug companies which have traditionally focused on pricey new therapies for rich-world markets.

These days, there is a lot more focus on high-volume but lower-margin business in developing economies, many of which are predicted to show high double-digit percentage sales growth for diabetes medicines for years to come.

The shift is already yielding results.

China, for example, is now the second-largest market behind the United States for the world's biggest maker of insulin - Danish group Novo Nordisk. It is also a major focus for rivals such as Eli Lilly, Merck & Co, and Sanofi.

Poorer countries are more difficult, especially when it comes to insulin, which must be kept cool if it is not to deteriorate. While most patients start on cheap generic diabetes pills, such as metformin, many need insulin as their disease progresses.

Still, Novo Nordisk thinks it has cracked part of the problem in Kenya, where a project using churches and other local groups has reduced the number of middlemen in the supply chain and cut the cost of a month's supply of insulin to around 500 Kenyan shillings ($6).

So far, the project only covers around 1,000 Kenyans but Jesper Hoiland, Novo's head of international operations, is confident his company's low-price model will become profitable as it increases in scale. "It will take three to five years to get to breakeven," he said in an interview.

In the meantime, similar pilot schemes are being tested in rural India and Nigeria.

Other major drugmakers like Sanofi, which has a significant presence in Africa, are also adopting "tiered" or differential pricing to open up developing world markets.

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By MyHealthNewsDaily Staff

More young and middle-aged adults are having strokes, a new study suggests.

In 1994, 12.9 percent of strokes occurred in adults between ages 20 and 55, whereas in 2005, 18.6 percent of strokes occurred in this age group, according to the study of stroke rates in a four-county region of Ohio and Kentucky.

Additionally, the data showed that the average age of people who experienced a stroke fell from 71 in 1994 to 69 in 2005.

"The reasons for this trend could be a rise in risk factors such as diabetes, obesity and high cholesterol," said study author Dr. Brett Kissela, of the University of Cincinnati College of Medicine in Ohio. However, factors such as improved diagnosis may also have contributed to the increase, he said.

"Regardless, the rising trend found in our study is of great concern for public health, because strokes in younger people translate to greater lifetime disability," Kissela said.

In the study, researchers looked at data on all stroke patients between ages 20 and 54 seen at hospitals, clinics and nursing homes during three separate, yearlong periods: July 1993 through June 1994, and the calendar years of 1999 and 2005. Only a patient's first stroke was included in the analysis.

The stroke rate among people over age 75 decreased between 1994 and 2005, according to the study, and other studies have shown a general decrease in stroke rates over recent decades. For example, the Framingham Heart Study reported a decline in stroke rates between 1950 and 2004.

"Any decline in stroke incidence is positive from a public health prospective, but reduced incidence in older ages is counterbalanced by the worrisome trend of younger strokes," Kissela and colleagues wrote in their study. Strokes at younger ages can mean a greater loss of productive life years, and greater health care expenses over time.

The new findings show that the trend toward younger stroke patients was seen in both African-Americans and Caucasians. The yearly stroke rate among African-Americans increased between 1994 and 2005 from 83 strokes to 128 strokes per 100,000 people, according to the study. Among Caucasians, the yearly stroke rate increased from 26 strokes to 48 strokes per 100,000 people over the same period.

Most of these increases were seen in a type of stroke called an ischemic stroke, which occurs when an artery bringing blood to the brain is blocked. (Another type — called a hemorrhagic stroke, which occurs when a blood vessel leaks or bursts — was less common.)

While the reasons for the increased stroke rate among younger people are not entirely clear, the researchers pointed to the findings of a separate survey of people in the region, which showed an increasing percentage had high cholesterol. Data from national surveys also show that rates of diabetes, high cholesterol, and obesity increased over the study period, they said.

"The good news is that some of the possible contributing factors to these strokes can be modified with lifestyle changes, such as diet and exercise," Kissela said.

One question raised by the study is whether the increase is partly due to better diagnoses of stroke, according to two researchers who wrote an editorial accompanying the new study in the journal. 

"The progressive adoption of MRI as a diagnostic tool during the study period challenges the validity," of comparing the stroke rates between the early 1990s and 2005, wrote Drs. Sally Sultan and Mitchell S. V. Elkind, both neurologists at Columbia University Medical Center in New York City.

While the researchers tried to account for the increased use of MRI in their study, it likely still had an effect, Sultan and Elkind said.

However, if strokes are affecting more young people, there are public health implications, they said. "If strokes occur at earlier ages, as life expectancy increases, stroke-related disability will increase even more," they wrote.

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