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New Treatment for Type 1 Diabetes Shows Early Promise

A new form of treatment for type 1 diabetes that’s based on the immune system appears safe for patients in an early trial.

However, only a larger trial will show if the treatment — which uses immune cells called regulatory T cells (Tregs) — is effective against the illness, researchers said.

If the therapy does work out, it “could be a game-changer,” study first author Jeffrey Bluestone, a professor of metabolism and endocrinology at the University of California, San Francisco, said in a university news release.

“For type 1 diabetes, we’ve traditionally given immunosuppressive drugs, but this trial gives us a new way forward. By using Tregs to ‘re-educate’ the immune system, we may be able to really change the course of this disease,” he explained.

In type 1 diabetes, the immune system attacks insulin-secreting beta cells in the pancreas. Many treatments suppress the immune system, but that can lead to serious side effects, such as increasing a patient’s susceptibility to infections or cancer. About 5 percent of all cases of diabetes are type 1 disease.

According to the researchers, the new therapy uses a patient’s own regulatory T cells to protect insulin-producing beta cells in the pancreas. The approach is designed to reduce the immune system’s attack on beta cells, while still leaving the immune system strong enough to fight infections.

The patients in the first U.S. safety trial of the treatment received infusions of as many as 2.6 billion of the protective Treg cells and had no serious side effects, Bluestone’s team said.

The results of the Phase 1 trial were published in the Nov. 25 online edition of the journal Science Translational Medicine. Phase 1 trials typically only examine if a drug or intervention is safe, they are not focused on effectiveness.

The next phase of this research would be a clinical trial to test the effectiveness of the new therapy, the researchers said.

Two experts in type 1 diabetes said the approach holds real promise.

“This is a very novel approach to treatment because it deals with the route cause for type 1 diabetes — which is destruction of the insulin-producing cells of the pancreas by one’s own immune system,” said Dr. Deena Adimoolam, assistant professor of medicine, endocrinology, diabetes and bone disease at the Icahn School of Medicine at Mount Sinai in New York City.

“The use of regulatory T-cells in its early stages of clinical research appears successful,” she said, “and I hope that future trials show long-term treatment with minimal side effects.”

Dr. Minisha Sood directs inpatient diabetes care at Lenox Hill Hospital, also in New York City. She said that regulatory T cells “are known to control autoimmunity — not only in type 1 diabetes but also in a number of other autoimmune diseases. Therefore, it is believed that eventual treatments involving regulatory T cells may slow progression of or reverse the autoimmunity, which is the cause of type 1 diabetes.”

While larger trials are needed to confirm a benefit for patients, the study “did establish that immunotherapy with regulatory T cells is feasible from a safety standpoint, which is very promising,” Sood said.

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Alzheimer-Linked Brain Plaques May Also Slow Blood Flow

They’ve long been associated with Alzheimer’s disease, and now new research in animals suggests that protein plaques might slow the brain’s blood flow, as well.

Buildup of the amyloid beta protein clumps could harm the brain in multiple ways, according to a team from the University of Alabama at Birmingham.

“We have increasingly become aware that the disruption of blood flow in the brain can increase the risk of Alzheimer’s disease,” lead researcher Dr. Erik Roberson, an associate professor of neurology, said in a university news release.

He explained that scientists have long known that protein plaques known as “vascular amyloid” can build up around blood vessels, just as they do in brain tissue.

However, “we did not fully understand its effects,” Roberson said. Now, high-tech imaging “allows us to visualize how it affects the function of those vessels,” he said

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As Roberson explained, brain cells called neurons require extra glucose — brought in by the bloodstream — for energy whenever there’s a boost in brain activity. Neurons “call” for more glucose via another cell called an astrocyte. Astrocytes have tiny projections called endfeet that attach to blood vessels and tell the vessel to expand when more blood is needed.

Roberson’s team wondered if a buildup of amyloid plaque around vessels might “crowd out” the endfeet, so neural messages for more blood flow wouldn’t get through.

Using high-tech scans, the researchers “were able to determine that, yes, vascular amyloid did push the astrocytic endfeet away and interfered with normal regulation of blood vessels,” Roberson said.

This seemed confirmed in an animal model of Alzheimer’s disease, said another university researcher, Ian Kimbrough. “In locations where no vascular amyloid was present, we saw a very dramatic and robust vessel response; however, on blood vessels that were surrounded by plaque, we saw a much diminished response,” said Kimbrough, a graduate research assistant in neurobiology.

Roberson and Kimbrough explained that as the plaque buildup worsens, the vascular amyloid encircles blood vessels. Then links form between the vessels, creating a rigid “exoskeleton” that hampers the vessels’ ability to dilate or contract.

“The vessel has to be able to expand and contract, to dilate and constrict, if it’s going to regulate blood flow,” Roberson said. “If they have become rigid like a pipe, instead of having a flexible wall that can go back and forth, then they cannot do their job of regulating blood flow to the brain properly.”

This research is still in its early stages, and experts note that there’s never a guarantee that laboratory or animal studies can be replicated in humans. The study was funded by the U.S. National Institutes of Health and published Nov. 23 in the journal Brain.

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Opdivo Approved for Advanced Kidney Cancer

Opdivo (nivolumab) has been approved to treat advanced renal cell carcinoma, the most common type of kidney cancer.

The drug targets proteins that would otherwise hinder the body’s immune system in fighting cancer cells, the agency said in a news release.

Renal cell carcinoma is expected to be diagnosed in more than 61,000 Americans this year, and more than 14,000 are projected to die from it, the FDA said, citing the National Cancer Institute.

Opdivo was previously approved to treat melanoma skin cancer and non-small cell lung cancer.

The drug’s newest approval is meant for people who have had prior anti-angiogenic therapy, which is a treatment that interferes with the blood vessels that contribute to the growth of cancer cells.

Opdivo was evaluated for this purpose in a study of more than 820 people whose disease progressed despite anti-angiogenic therapy. People who took Opdivo lived an average of 25 months, compared to about 19 months among people treated with another drug, Afinitor, the agency said.

The most common side effects of Opdivo included lack of energy, cough, nausea, rash and difficulty breathing. The drug’s effects on the immune system also could cause serious problems with healthy organs, including the lung, colon, liver, kidney and brain, the FDA said.

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Adults With Heart Defects May Face Higher Risk of Stroke: Study

Adults who were born with heart defects are at increased risk for stroke, a new study finds.

“We knew there was a connection between heart failure and stroke in patients with heart defects, but we were surprised to discover it was the strongest predictor,” said senior study author Dr. Ariane Marelli, a professor of medicine at McGill University in Montreal.

However, the study did not prove that heart defects cause stroke.

For the study, researchers looked at stroke rates among more than 29,000 adults born with heart defects, and compared them with rates among people in the general population of the province of Quebec, Canada.

Those with heart defects were nine to 12 times more likely to suffer an ischemic stroke (blocked blood flow to the brain) before age 55. In addition, they were two to four times more likely to have this type of stroke between the ages of 55 and 64, the investigators found.

The strongest predictors of ischemic strokes in adults with heart defects were heart failure,  and recent heart attacks, the study authors said.

In addition, adults born with heart defects were five to six times more likely to have a bleeding (“hemorrhagic”) stroke before age 55, and two to three times more likely to have this type of stroke between the ages of 55 and 64.

Nearly 9 percent of men and 7 percent of women born with heart defects had at least one stroke before age 65, according to the study published online Nov. 23 in the journal Circulation.dt_150709_migraine_headache_brain_stroke_800x600

“Our study also suggests that other well-known risk factors for stroke — such as irregular heartbeat and high blood pressure — may be under-detected in patients born with a heart defect,” study first author Dr. Jonas Lanz, a research fellow at McGill, said in a journal news release.

The findings show the need for adults born with heart defects to make regular visits to a cardiologist, to reduce their risk of stroke, Marelli said.

These patients, along with their family and friends, should also learn the signs of stroke and know how to get professional medical help quickly if a stroke is suspected, she added.

Every year, nearly 129,000 Americans die of stroke, which is the nation’s fifth leading cause of death.

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Portrazza Approved for Advanced Lung Cancer

Portrazza (necitumumab), in combination with two other chemotherapy drugs, has been approved by the U.S. Food and Drug Administration to treat advanced squamous non-small cell lung cancer, the agency said Tuesday in a news release.

Lung cancer is the leading cause of cancer death in the United States. More than 221,000 cases are expected to be diagnosed in the U.S. this year, and more than 158,000 people are projected to die from the disease, the FDA said.

Portrazza, approved for people who haven’t had a previous therapy for squamous NSCLC, is designed to block a protein that’s frequently found on such tumors, the agency explained.

The drug was evaluated in combination with two other drugs, gemcitabine and cisplatin. Those who took the three-drug combination lived for an average of 11.5 months, compared to 9.9 months among those who took the other two drugs without Portrazza.

Portrazza’s most common side effects include skin rash and magnesium deficiency. The drug’s label includes a boxed warning that the latter can cause deadly complications on its own, including seizures and irregular heartbeat, the FDA said.

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Breast-Feeding May Cut Risk of Type 2 Diabetes for Some Women

New research suggests another potential benefit for moms who breast-feed — a lower risk of developing type 2 diabetes.

The study found that breast-feeding for more than two months was linked to around a 50 percent reduction in the odds of developing type 2 diabetes for mothers who had already experienced gestational diabetes in the past. And the longer women breast-fed, the lower the odds of type 2 diabetes, the study said.

“The main policy implication is that we need to focus our breast-feeding promotion efforts to high-risk women, those who are obese or have a pregnancy with gestational diabetes,” said study author Erica Gunderson, a senior research scientist with Kaiser Permanente Northern California.

However, this study did not show that breast-feeding caused a lower risk of type 2 diabetes; it only found an association between these factors.

The results were published online Nov. 23 in the journal Annals of Internal Medicine.

Gunderson’s team followed more than 900 women two years after they had gestational diabetes during pregnancy and gave birth. During this time, 12 percent of them developed type 2 diabetes, the study reported.

How the women fed their babies was categorized into five groups: exclusive breast-feeding, exclusive formula feeding, mostly breast-feeding (less than 6 ounces of daily formula), mostly formula (more than 17 ounces of daily formula) and mixed feeding (7 to 17 daily ounces of formula).

Moms who exclusively breast-fed their babies had a 54 percent lower risk of developing diabetes compared to moms who only used formula, the study noted. Women who fed their babies a mixture of formula and breast milk or even mostly used formula reduced the odds of type 2 diabetes by more than a third compared to formula-feeding alone, researchers found.

The length of breast-feeding also appeared related to type 2 diabetes risk, the study showed.

Breast-feeding for more than 10 months was linked to the mother’s reduced risk of diabetes by 57 percent compared to breast-feeding two months or less. Moms who breast-fed their babies somewhere between two months and 10 months had about half the risk of developing diabetes compared to those who breast-fed less than two months, according to the study.

So how might breast-feeding help reduce the risk of type 2 diabetes? In several ways, Gunderson said.

“Lactation gives the insulin-producing cells in the body a rest because they don’t have to make so much insulin to lower blood glucose,” Gunderson said. “Breast-feeding uses up glucose and fat in the blood because those nutrients are transferred from the bloodstream into the breast tissue for milk production.”

Gunderson described breast-feeding as giving the body a recovery period after pregnancy, when the body must go into overdrive with insulin production to keep blood sugar levels under control. Several other physiological mechanisms also might also explain how lactation reduces diabetes risk, she said.

Breast-feeding seems to reset the body’s metabolism after the metabolic chaos of pregnancy, said Dr. Alison Stuebe, an assistant professor of maternal-fetal medicine at the University of North Carolina School of Medicine in Chapel Hill.

The results held even with adjustments for a wide range of other factors. These factors included maternal and newborn health, lifestyle behaviors, and changes in mothers’ postpartum weight, Gunderson said.

But “this is not about weight loss,” because not all women who breast-feed lose weight, Gunderson noted. “There’s a lot of variability in how women respond to pregnancy and lactation and in terms of what their body does,” she said.

Dr. Aaron Caughey, chair of obstetrics and gynecology at Oregon Health and Science University School of Medicine in Portland, said, “Women with higher rates of pregnancy complications, including gestational diabetes mellitus, are less likely to breast-feed.

“We think the chaos of having a pregnancy complication may lead to decreased attention to focus on breast-feeding,” he said.

Women with gestational diabetes often have other complications that make breast-feeding challenging, added Dr. Sherry Ross, an obstetrician and gynecologist at Providence Saint John’s Health Center, in Santa Monica, Calif.

“Creating strategies to reduce the risk of diabetes should begin during pregnancy and continue once the baby is born,” Ross said.

“In addition to breast-feeding, other lifestyle behaviors such as weight loss, dietary changes and increasing physical activity all reduce future risk of diabetes,” she said.

And Stuebe noted that new mothers may need more support for breast-feeding.

“If we made it easier for moms to do this, it would be good for moms and babies,” Stuebe said

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Study Finds Caffeine in Pregnancy May Not Harm Babys IQ,

Moderate amounts of caffeine during pregnancy don’t appear to be linked to a child’s risk for lower IQ or behavior problems, a new study suggests.

The research included nearly 2,200 women in the United States whose caffeine intake was measured during pregnancy. The pregnancies occurred between 1959 and 1974, a period of time when coffee consumption during pregnancy was more common, according to researchers from Nationwide Children’s Hospital in Columbus, Ohio.

Children born to these women had IQ and behavioral assessments when they were 4 and 7 years old. The researchers found no evidence that mom’s caffeine consumption during pregnancy had any effect on children.41

In a previous analysis of data from the same group of women, the researchers also found that higher amounts of caffeine consumption during pregnancy was not linked to children’s risk of obesity.

“Taken as a whole, we consider our results to be reassuring for pregnant women who consume moderate amounts of caffeine or the equivalent to one or two cups of coffee per day,” said study author Dr. Mark Klebanoff in a hospital news release. He is principal investigator in the Center for Perinatal Research at Nationwide’s Research Institute.

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Study Suggests Depression More Common in Daughters of Older Mothers

Daughters who were born to older mothers may be at increased risk for stress, anxiety and depression when they reach young adulthood a new study suggests.

Researchers followed 1,200 Australians born between 1989 and 1991 for two decades. They found that daughters born to mothers who were aged 30-34 had higher levels of stress at age 20 compared with those born to younger mothers.

And daughters born to mothers older than 35 had much higher levels of stress, anxiety and depression, the study found.images

A mother’s age at the time of birth had no effect on sons, and the father’s age at the time of birth had no effect on either daughters or sons, according to the findings published recently in the Journal of Abnormal Psychology.

But scientists only observed an association between a mother’s age at childbirth and her daughter’s mental state as an adult. The study did not prove a cause-and-effect link.

“This study suggests that older maternal age is associated with symptoms of depression, anxiety and stress in young adult females,” said lead author Jessica Tearne, a doctoral student at the University of Western Australia.

She said it’s not known why daughters born to older mothers might be at increased risk for stress, anxiety and depression, but it is not necessarily biological.

“One hypothesis is difficulties may occur in the mother-daughter relationship because of a large age difference between the two,” Tearne said in a journal news release. “It may be that a 30-or-more-year age difference between mother and daughter leads to a significant difference in the value systems that may cause tensions in the relationship, leading to stress, worry and sadness in the child, particularly during the transition to young adulthood.”

It’s also possible that women who give birth after age 30 are in their 50s when their children are young adults and more likely to have age-related health problems, which could have a negative effect on their children.

Previous research has suggested that daughters are more affected by their mother’s health problems than sons.

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Ninlaro Approved for Multiple Myeloma

Ninlaro (ixazomib), in combination with two other drugs, has been approved by the U.S. Food and Drug Administration to treat people with multiple myeloma who have had at least one prior treatment with a different therapy.

Multiple myeloma is a type of cancer that forms in infection-fighting white blood cells produced in bone marrow. Symptoms include a weakened immune system and bone and kidney problems.

Ninlaro, from a class of drugs called proteasome inhibitors, is designed to block enzymes that spur the growth and survival of multiple myeloma cells, the FDA said Friday in a news release.

Almost 27,000 cases of multiple myeloma will be diagnosed in the United States this year, and more than 11,000 people are projected to die from it, the FDA said, citing the National Cancer Institute.

Ninlaro is approved in combination with another multiple myeloma drug, Revlimid (lenalidomide), and the corticosteroid drug dexamethasone. The drug combination was evaluated in clinical studies involving 722 people. Those who took Ninlaro in tandem with the other two drugs lived for more than 20 months without their disease progressing, compared with about 14 months among those who took a placebo and the other two drugs, the FDA said.

Side effects of Ninlaro included diarrhea, constipation, low blood platelets, nerve damage of the hands and feet, nausea/vomiting and back pain.

Ninlaro, the third multiple myeloma drug approved by the FDA this year, is produced by the Japanese drugmaker Takeda Pharmaceuticals.

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Exercise Can Reduce Heart Failure Risk, No Matter Your Age

Starting to exercise later in life can still reduce your risk of heart failure, and even modest increases in activity could provide some protection, researchers say.

“Our findings suggest that when it comes to exercise and heart failure, the better-later-than-never axiom rings particularly true, and that even small boosts in activity can cut risk,” senior investigator Dr. Chiadi Ndumele said in a Johns Hopkins University School of Medicine news release. He is a preventive cardiologist and assistant professor of medicine at the medical school

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The researchers studied the exercise habits of about 11,000 American men and women in a 20-year government study on aging and heart disease. All were between the ages of 45 and 64. None had heart disease at the start of the study. Activity levels were assessed on two consecutive visits over six years.

Compared to those who were inactive at both visits, people who met or exceeded recommended physical activity levels of 150 minutes of moderate exercise or 75 minutes of vigorous exercise per week at both visits were 33 percent less likely to develop heart failure, the study found. Those who were consistently getting modest amounts of exercise — less than 149 minutes of moderate activity or less than 74 minutes of vigorous activity a week — had a 20 percent lower risk, the study revealed.

But the researchers also found that inactive people who got moving to reach recommended physical activity levels at some point during the study reduced their risk of heart failure — by 22 percent. Inactive folks who increased their activity levels to about 30 minutes of walking four times a week reduced their risk by 12 percent, the researchers said.

The study was presented earlier this month at the American Heart Association’s annual meeting in Orlando, Fla. Findings presented at meetings are generally viewed as preliminary until published in a peer-reviewed journal.

Study first author Dr. Roberta Florido, a cardiology fellow at Hopkins, said in the news release, “Many people get discouraged if they don’t have the time or ability to exercise vigorously, but our findings demonstrate that every little bit of movement matters and that picking up exercise later in life is decidedly better than not moving at all.”

About 5 million Americans and 23 million people worldwide have heart failure, the researchers said.