Diabetes risk factors develop earlier in women than men

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Guess it wasn't such a hot idea after all...

Major US Diabetes Study Partially Halted
Feb 8, 2008 - American medical researchers say they are stunned by the results of a major government study on diabetes and heart disease. They hoped to prove that a long-trusted form of treatment for lowering blood sugar would, if increased, yield even greater results.

U.S. government researchers have curtailed part of a major clinical trial on the treatment of diabetics, especially those at greatest risk. The reason: study coordinators found that aggressively lowering blood sugar as close as possible to "normal" levels appeared to increase the risk of a fatal heart attack or stroke.

The study focused on 10,000 adults with Type 2 diabetes, the most common form of the disease. The subjects also had cardiovascular disease or at least two contributing risk factors. The National Institutes of Health halted the study 18 months early after recording 257 deaths among aggressively treated patients, compared to 203 fatalities among those given more standard care.

The results suggested exactly the opposite of what researchers had hoped to prove: that pushing blood-sugar levels below current targets in high-risk diabetics would be beneficial. Researchers were unable to determine why those treated aggressively had a higher death rate. They found no link between the deaths and the drugs used in the trial, including Avandia, a drug suspected of increasing diabetics' risk of heart attacks.

Despite the uncertainty created by the trial, researchers say diabetics who control their blood sugar can reduce their risk for kidney disease, blindness, and complications leading to amputations. They say patients should still consult with their doctors before considering any change in treatment.

VOA News - Major US Diabetes Study Partially Halted

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Could Embryonic Stem Cells Cure Diabetes?...

Researchers Use Embryonic Stem Cells to Treat Diabetes
Feb. 20, 2008 - Study in Mice Shows Promise; Hurdles Remain

Doctors may be one step closer to using stem cells to cure diabetes, according to a new study by researchers at the stem cell engineering company Novacell, Inc. in San Diego who report that they managed to convert human embryonic stem cells into insulin-producing cells. Insulin is the chemical produced in the pancreas that allows the body to regulate blood-sugar levels — and it is precisely the substance that many of those with diabetes lack.

The researchers, who reported their findings in the journal Nature Biotechnology, found that when they injected these human cells into diabetic mice, the treatment alleviated diabetes in the rodents. According to Dr. Emmanuel Baetge, primary study investigator and chief scientific officer at Novocell, Inc., the new technique used by his team will provide doctors with a bulk supply of clean, uncontaminated insulin-secreting cells for use in diabetes patients.

"This is a much more controlled process, and you basically are sure of getting the same quality of cell every time you do the implant," Baetge explained. "Currently, a patient would have to wait and wait for a cadaver organ to become available, and even then there is a high risk of the cells from that organ being infected or contaminated," he said. "If we instead use embryonic stem cells then we can also make unlimited numbers of these cells and have an unlimited source that we can stockpile and have available whenever a patient is ready for it."

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Researchers Make Stem Cells That Secrete Insulin
WEDNESDAY, Feb. 20, 08 -- Scientists have found a way to convert human embryonic stem (ES) cells into cells that release insulin in response to glucose and ease a diabetes-like condition in mice, a new study says.

Further research and development of this technique could lead to a renewable source of cells for treatment of people with diabetes, according to Emmanuel Baetge, of Novocell Inc., in San Diego, and colleagues, who published their work online in the current issue ofNature Biotechnology. Type 1 and some forms of type 2 diabetes involve the loss of pancreatic beta cells, which regulate blood glucose (sugar) levels by releasing insulin, according to background information in a news release about the study.

In previous work, Baetge and the team were able to coax human ES cells part of the way toward becoming beta cells, but not far enough for them to carry out the key function of mature beta cells, which is the release of insulin in response to glucose. In this new study, the researchers transplanted immature beta cells derived from human ES cells into mice whose beta cells had been destroyed by chemical treatment. After one to three months, the transplanted cells developed into glucose-responsive, insulin-secreting cells and helped control blood glucose levels in the mice.

Previous research demonstrated that transplantation of pancreatic beta cells (within islets) can help control diabetes in humans. But the therapy relies on cells from donor pancreases, meaning that the supply of such cells is limited. That's why scientists are trying to develop alternative sources of beta cells, such as those derived from human ES cells.

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Lilly halts inhaled insulin project...

Eli Lilly drops inhaled insulin program
March. 7, 2008 - Decision is the third setback in recent months for new formulation

Eli Lilly & Co said on Friday it will terminate development of an inhaled insulin treatment for diabetes, which it was conducting in partnership with Alkermes Inc, after deciding that product's commercial potential was not strong. Biotechnology company Alkermes said earlier in the day that it expected Lilly to drop out of their program to develop an inhaled insulin treatment for diabetes. Lilly's decision marks the third setback in recent months for inhaled insulin formulations, once deemed potential blockbuster products because of their greater convenience than standard injectable insulin.

Cambridge, Massachusetts-based Alkermes, which makes the alcohol addiction drug Vivitrol, said Lilly has the right to terminate its license to the inhaled treatment, Air Insulin, at its discretion. "While Lilly may elect not to commercialize Air Insulin, Alkermes believes that the phase 3 safety and efficacy trials should be completed," Alkermes said in a statement. After Lilly's announcement, the company said it was evaluating the impact of the termination, which will become effective in 90 days.

Indianapolis-based Lilly said its decision was not due to safety concerns, "but rather was a result of increasing uncertainties in the regulatory environment, and a thorough evaluation of the evolving commercial and clinical potential of the product compared to existing medical therapies." Lilly Chief Operating Officer John Lechleiter said in a statement that the company is beginning the process of halting ongoing clinical studies.

More Eli Lilly drops inhaled insulin program - Diabetes - MSNBC.com

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Bacterial treatment for kidney stones...

Probiotic hope for kidney stones
Sunday, 9 March 2008, Treating patients with bacteria may help reduce their risk of repeatedly developing kidney stones, a study suggests.

People naturally carrying the bacterium Oxalobacter formigenes were found to be 70% less likely to have problems. Researchers at Boston University, in the US, are now investigating the possibility of using the bacteria as a "probiotic" treatment. The study features in the Journal of the American Society of Nephrology. "For some people kidney stones can be an on-going, lifelong problem" - Mr Derek Machin, Urologist

Kidney stones are small, hard lumps formed of waste products contained in the urine. They normally range in size from a grain of sand to a pearl. They can be smooth or jagged, and are usually yellow or brown. Once a kidney stone has formed in a kidney it may travel down through the other parts of the urinary system, where they can slow the flow of urine, cause infection, severe pain and even lead to kidney failure.

About three in 20 men and one in 20 women in the UK will develop a kidney stone at some point in their lifetime. They are most likely to occur in people aged 20 to 40. Up to 80% of kidney stones are predominately composed of a compound called calcium oxalate. O. formigenes breaks down oxalate in the intestinal tract and is present in a large proportion of the normal adult population.

More BBC NEWS | Health | Probiotic hope for kidney stones

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Deck being stacked in favor of Big Pharma...

Diabetes debacle
Friday, March 28, 2008 - New FDA rules threaten to hobble small biotechs

Late-stage diabetes drug trials will be longer and costlier with new FDA guidelines aimed at boosting drug safety, and some small biotechs are feeling the pinch.

The Food and Drug Administration issued draft guidelines in late February that require, among other points, that Phase III trials for type 2 diabetes drugs cover 2,500 patients and expose some 500 of them to a drug for more than 18 months. The compares to current rules of 1,500 patients, with 100 exposed to the drug for a year.

While not formal rules yet, draft guidance statements from the FDA generally are considered a done deal by pharmaceutical and biotech companies as they set up their clinical trials. That's got some companies -- especially smaller biotechs -- worried as they seek funding that will push their drugs into longer pivotal trials, which translate into a longer time investors will wait for a return on investment.

Diabetes debacle - San Francisco Business Times:

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An experimental surgery may provide relief to some diabetics...

A Surgical Cure for Diabetes?
April 13, 2008 - Doctors Think Cutting Off Part of the Small Intestine May Regulate Blood Sugar

A new, experimental surgery could make type 2 diabetes disappear in some patients. While doctors have refrained from calling it a cure, some believe a duodenal jejunal bypass may be the first step in finding a surgical solution to the country's diabetic epidemic. "We have started the ball rolling as far as surgical treatment of diabetes, and I think [it's] going to pick up speed," said Dr. Mahdu Rangraj of Sound Shore Medical Center in New Rochelle, N.Y.

Rangraj and Dr. Leonard Maffucci performed the surgical procedure as a part of a clinical trail on type 2 diabetes patient Rocco Turso. For more than six years, Turso couldn't go anywhere without a lot of medicine to treat his condition, which included three insulin shots daily and digesting several pills. Still, his condition continued to worsen. "I could see my vision was getting a little blurry. I saw in my feet that my toenails, some got a little bit yellow," he said. "The diabetes was winning, not me."

Turso fought back by becoming the first man in America to undergo the surgery for diabetes. As part of the procedure, Rangraj and Maffucci cut off the first foot of Turso's small intestine and then reattached the rest. The procedure redirects the digestive track in order to prevent food from coming in contact with the first part of the small intestine. "We're stopping the food from coming in contact with the intestine and that is what seems to work," Rangraj said.

The small intestine is where some hormones that control blood sugar levels are secreted, and Rangraj said the bypass is reversible. The 62-year-old Turso saw dramatic results almost instantly following his March 17 surgery. The day after his surgery, Turso's blood sugar levels dropped, and since then they have stabilized to normal levels. Turso said he has more energy than before.

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Inhaled insulin flops, but hope for inhaled meds
Sun., April. 13, 2008 - Companies still working to develop drugs delivered through the lungs

Inhaled insulin may be a debacle that pharmaceutical companies want to put behind them as quickly as possible, but many companies are still working to develop drugs that are delivered through the lungs. Asthma has been treated with inhalants for decades, and inhaled drugs now under development include treatments for other pulmonary diseases, like cystic fibrosis or infections of the lung, as well as a faster-onset version of an existing migraine drug.

“This is a way to deliver high concentrations of medication to the target organ,” said Kevin Corkery, senior director of the pulmonary business unit at Nektar Therapeutics, which last week abandoned its Exubera inhalable insulin program after onetime partner Pfizer Inc said clinical trials found increased cases of lung cancer. Nektar, known before 2003 as Inhale Therapeutic Systems, is developing inhalable dry powder versions of anti-infectives for treating pneumonia in the lung as well as aerosolized forms of antibiotics for patients with cystic fibrosis, a genetic disease in which the body produces a thicker-than-normal mucus that clogs the lungs and other organs.

Pfizer had already decided last year to stop marketing Exubera, which had only marginal sales despite the pitch of being more convenient than traditional insulin injections. After the world’s largest drug maker acknowledged its product was never going to see the blockbuster sales it once hoped, Eli Lilly and Novo Nordic this year also ended inhaled insulin development programs.

Tiny Mannkind Corp. remains a notable holdout, repeating this week that it remains committed to its experimental inhaled insulin, , which it believes holds advantages over the other products. “The safety issues related to inhaled insulin really center on the fact that it is a growth factor going into the lung,” said Tim Nelson, chief executive at MAP Pharmaceuticals Inc., which is developing an inhalable migraine drug and an asthma drug for toddlers and preschoolers. Insulin and related substances called insulin-like growth factors have been shown to increase the risk of developing cancer.

Impaired lung function Inhaled insulin flops, but hope for inhaled meds - Health care - MSNBC.com

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Diabetes and depression...

Study: Diabetics have elevated risk of depression
June 18, 2008 - People with diabetes are more likely to become depressed as they face a lifetime of keeping their disease in check, researchers said.

About 21 million Americans have diabetes, which requires patients to adhere to a strict diet and exercise routine and to monitor their blood sugar levels regularly, often by pricking their finger. People being treated for Type 2 diabetes, the most common form, were 52 percent more likely to develop depression than those without the disease, according to a paper published in tomorrow's Journal of the American Medical Association. The study adds to a growing body of research showing a link between depression and diabetes, researchers said. Doctors may want to consider screening those with diabetes for depression because it may affect how well patients follow recommendations and their risk of developing complications of the disease, researchers said.

"Clearly this link between diabetes and depression exists. People need to be aware of these associations," said John Buse, the American Diabetes Association's president of medicine and science, in a telephone interview today. "It's a very tough business to take care of diabetes." The researchers analyzed data from a study of 6,814 men and women who were enrolled in a three-year trial that examined risk factors for hardening of the arteries, including Type 2 diabetes and depression symptoms. Type 2 diabetes, which is linked to age, obesity and lack of exercise, accounts for as much as 95 percent of diabetes cases in the U.S. Those with the condition don't produce enough insulin or their cells ignore the insulin. Insulin is needed for the body to use sugar for energy.

Data Analysis In one analysis of the data, researchers looked at 4,847 patients with and without diabetes to see how many developed depression. In the study, 60 people of 417 with treated diabetes had symptoms of depression compared with 336 of 2,868 without diabetes. Of the 203 people with untreated diabetes, 15 developed depression symptoms. In another analysis, the researchers reviewed 5,201 men and women with or without depression to see how many developed diabetes. Those with depression symptoms were 42 percent more likely to develop diabetes than those without. The stronger the symptoms, the higher the risk of diabetes, according to researchers.

"It's important that doctors be attuned to look for both conditions in patients at risk for either diabetes or depression," lead author Sherita Hill Golden, an associate professor of medicine and epidemiology at Johns Hopkins University in Baltimore, said in a statement. "We may want to develop interventions for both treatments, instead of just one or the other." Depression may cause patients to develop behaviors that cause diabetes or make it worse, including not exercising, smoking or overeating, Golden said. Researchers need to better understand how the diseases relate to each other to improve treatments, she said.

Study: Diabetics have elevated risk of depression -- Newsday.com

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Why Diabetics Must Take Responsibility for Blood Pressure Control...

Diabetes and Your Heart
June 23, 2008 - Many Diabetics Not Getting Life-Saving Blood Pressure Treatment

A bit more bad news for diabetics that you may not have known: having a diagnosis of type 2 diabetes makes your risk of having a heart attack just the same as someone who already had a heart attack. This means it is automatically assumed that with diabetes, there may be hidden heart disease as well. In addition, a worldwide study of over 21,000 patients with diabetes found that vigorously controlling your blood sugar to get your blood sugar levels into near normal range did not lower the risk of heart attack or heart disease. For some patients, tight control of blood sugar led to more episodes of dangerously low blood sugar too. So what is a patient with diabetes to do to lower the risk of heart attack?

It turns out that controlling your blood pressure is perhaps the single most important thing you can do to reduce many of the complications from diabetes. The dangers of high blood pressure — even a few points above normal — are much greater for diabetics. The risks of heart attack, stroke, kidney disease and progressive blood vessel disease of the eyes that, if left untreated, can lead to blindness are all made greater when the blood pressure is high. Other conditions more common in diabetics, such as impotence and poor circulation to the legs, are also much worse with poorly controlled high blood pressure.

So why is it that, according to a number of studies, less then half the time doctors see a diabetic patient do the doctors make suggestions to change blood pressure medication or ask patients to come back for a blood pressure follow up — even when so much is on the line? And why do patients with diabetes all too often not know their blood pressure goals, fail to act on their own home blood pressure readings, or do not know exactly what their medications may do? Studies note that doctors often fail to ask patients about monitoring their blood pressure at home. Home readings may give a better picture of how well your blood pressure is being controlled. Some patients don't even check or monitor their blood pressure at home.

More ABC News: Healthy Dose: Diabetes and Your Heart

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Leukemia Drug May Help to Treat Strokes
June 22, 2008 - Leukemia Pill May Improve Stroke Treatment: Study
In Mice, Gleevec Reduces Bleeding in the Brain Caused by Clot-Busting Treatments

A highly effective leukemia pill may reduce complications and boost the effectiveness of a treatment for the most common type of stroke, an international team of researchers said on Sunday. Studies in mice showed giving Gleevec or imatinib, a drug made by Novartis AG, significantly reduced bleeding in the brain associated with the clot-busting drug known as tissue plasminogen activator or tPA. It also appeared to extend the time window in which the drug could be given, they said.

"You potentially could reduce the amount of side effects associated with tPA and increase the population that could receive it," said Daniel Lawrence of the University of Michigan Medical School, whose findings appear in the journal Nature Medicine. Lawrence worked with researchers from the Karolinska Institutet in Stockholm, Sweden, which plan to start testing the drug combination in humans in the next few months. The clot-buster tPA is used to dissolve blood clots in ischemic stroke, a type of stroke triggered when a blood clot impedes blood flow to the brain. These strokes account for 80 percent of the 15 million strokes that occur each year worldwide, according to the World Health Organization.

When given within the first three hours of a stroke, tPA can chew up the clot and significantly reduce death and disability. But tPA has two major drawbacks: it can cause blood to leak into the brain and it must be used within three hours after the start of the stroke. And because the drug causes bleeding, it can not be used in a more rare type of stroke known an intracerebral hemorrhage, which is caused when a blood vessel in the head ruptures.

More ABC News: Leukemia Drug May Help to Treat Strokes

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FDA urges more diabetes drugs testing...

FDA panel urges more testing for diabetes drugs
2 July `08 WASHINGTON — Diabetes drugs should face tougher safety standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended.

Advisers to the Food and Drug Administration voted 14-2 on Wednesday that all new diabetes drugs should undergo longer studies to assure they don't increase risks of heart problems. The agency currently doesn't screen for heart risks associated with diabetes drugs. The opinions from diabetes experts, cardiologists and statisticians come less than a year after the FDA was criticized for its handling of heart risks connected with a widely used GlaxoSmithKline pill. The drug was approved in 1999 but the agency didn't add a warning about potential heart risks until last November.

The majority of the panel said drug companies could begin safety testing before they submit drugs to the FDA, and finish the studies after the drugs are on the market. The testing would take an estimated five to seven years to complete, and likely cost tens of millions of dollars. At least one panelist doubted whether the proposed studies would actually uncover heart risks, and added they could delay important medical breakthroughs.

"If you wait this amount of time for testing you're going to be preventing certain drugs from getting out there that may be better than what we already have," said Dr. Eric Felner, a pediatric specialist at Emory University School of Medicine. The FDA is not required to follow the panel's advice, though it often does.

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Artificial kidney advance...

Medical breakthrough in portable dialysis machine
Sunday 13th July, 2008 - Researchers have designed an automated and wearable artificial kidney that avoids the pitfalls of traditional dialysis.

The peritoneal-based kidney is bloodless and reduces or even eliminates protein loss and other dialysis-related problems. Up to now, artificial kidney machines have been portable but not wearable.

With traditional dialysis machines, patients are hooked up to a machine for four hours, three times a week. Their blood is filtered through the machine to remove toxins and is then pumped back into the body.

The new machine will function continuously, as natural kidneys do. Because it does not involve blood circulation outside the body, it is regarded as bloodless.

Medical breakthrough in portable dialysis machine