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Risk of Type 1 Diabetes in Children Related to Vitamin D and Sun

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Researchers have found that the risk of Type 1 diabetes in children may be strongly associated with Vitamin D and exposure to sunshine.

Low incidence of type 1 diabetes was noted in people living in equatorial regions, while higher incidence was noted in populations at higher latitudes where sunlight was scarcer.

Photosynthesis of vitamin D3 is set in motion by ultraviolet exposure, while this form of vitamin D is also available through diet and supplements. "This is the first study, to our knowledge, to show that higher serum levels of vitamin D are associated with reduced incidence rates of type 1 diabetes worldwide," said Cedric F. Garland, Dr. P.H., professor of Family and Preventive Medicine in the UCSD School of Medicine, and a member of the Moores UCSD Cancer Center.

About 1.5 million Americans cope with type 12 diabetes every day, and type 1 diabetes ranks second only to asthma as the most chronic disease among children. Type 1 diabetes is diagnosed in some 15,000 Americans each year, and causes blindness and kidney failure in youth and middle age.

"This research suggests that childhood type 1 diabetes may be preventable with a modest intake of vitamin D3 (1000 IU/day) for children, ideally with 5 to 10 minutes of sunlight around noontime, when good weather allows," said Garland. "Infants less than a year old should not be given more than 400 IU per day without consulting a doctor. Hats and dark glasses are a good idea to wear when in the sun at any age, and can be used if the child will tolerate them."

Even after allowing for the fact that equatorial regions will have lower per capita healthcare expenditures than more developed countries, the association of UVB irradiance to incidence of type 1 diabetes remained strong. The researchers created a graph with a vertical axis for diabetes incidence rates, and a horizontal axis for latitude. The latitudes range from -60 for the southern hemisphere, to zero for the equator, to +70 for the northern hemisphere. They then plotted incidence rates for 51 regions according to latitude. The resulting chart was a parabolic curve that looks like a smile.

In the paper the researchers call for public health action to address widespread vitamin D inadequacy in U.S. children.

"This study presents strong epidemiological evidence to suggest that we may be able to prevent new cases of type 1 diabetes," said Garland. "By preventing this disease, we would prevent its many devastating consequences."

The study was published June 5, 2008 in the online version of the scientific journal Diabetologia.

FDA Warns of Cancer Risk for Regranex in Treatment of Diabetics’ Foot and Leg Ulcers

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The U.S. Food and Drug Administration (FDA) has announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.

The WARNINGS section of the product has been updated to include a BOXED WARNING and a description of the epidemiologic data that is the basis for the revised label. These data come from a retrospective study that compared cancer incidence and cancer mortality among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not exposed. The results were consistent with no overall increase in cancer incidence among the patients exposed to Regranex. However, there was a five-fold increased risk of cancer mortality in the group exposed to three or more tubes of Regranex.

"In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex," said Susan Walker, M.D., director of the Division of Dermatological and Dental Products. "Regranex is not recommended for patients with known malignancies."

In late March, 2008 the FDA issued an Ongoing Safety Review Communication on Regranex notifying the public that it was conducting a safety review. This follow-up communication is in keeping with FDA’s commitment to notify the public of any regulatory changes with this FDA approved product.

Regranex is a medicine that is a recombinant form of human platelet-derived growth factor which is applied directly to diabetic foot and leg ulcers that are not healing. The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body. Growth factors cause cells to divide more rapidly. It is for this reason that the manufacturer continued to monitor studies begun before Regranex was approved in December 1997 for any evidence of adverse effects such as increased numbers of cancers. In a long term safety study completed in 2001, there were more deaths from cancer in people who used Regranex than in those who did not use it.

Following the report of the study completed in 2001, an additional study was performed using a health insurance database that covered the period from January, 1998 through June, 2003. This study used the database to identify two groups of patients with similar diagnoses, drug use, and use of health services, one of which used Regranex and one group that did not. The results of this study showed that deaths from cancer were higher for patients who were given three or more prescriptions for treatment with Regranex than those who were not treated with Regranex. No single type of cancer was identified, but rather deaths from all types of cancer, combined were observed.

Source: FDA, June 6, 2008

Study Illuminates How Some Bacteria Survive Antibiotic Treatment

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Some bacteria survive antibiotic treatment by activating resistance mechanisms when exposed to antibiotics, according to a recent study in the journal Molecular Cell. The results could lead to more effective antibiotics to treat a variety of infections.

“When patients are treated with antibiotics some pathogenic microbes can turn on the genes that protect them from the action of the drug,” said Alexander Mankin, professor and associate director of the University of Illinois at Chicago’s Center for Pharmaceutical Biotechnology and lead investigator of the study. “We studied how bacteria can feel the presence of erythromycin and activate production of the resistance genes.”

Sensing the presence of an antibiotic in the ribosomal tunnel, some bacteria have learned how to switch on genes that make them resistant to the drug. The phenomenon of inducible antibiotic expression was known decades ago, but the molecular mechanism was unknown. Mankin’s team of researchers include Nora Vazquez-Laslop, assistant professor in the Center for Pharmaceutical Biotechnology, and undergraduate student Celine Thum. assistant professor in the Center for Pharmaceutical Biotechnology, and undergraduate student Celine Thum.

“Combining biochemical data with the knowledge of the structure of the ribosome tunnel, we were able to identify some of the key molecular players involved in the induction mechanism,” said Vazquez-Laslop. “We only researched response to erythromycin-like drugs because the majority of the genetics were already known,” she said. “There may be other antibiotics and resistance genes in pathogenic bacteria regulated by this same mechanism. This is just the beginning.”

Source: Molecular Cell, April 24, 2008

One Quarter of All Americans Experience Daily Pain

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More than a quarter of the entire population in the United States experiences some form of pain every day. Americans spent between $2 and $6 billion on non prescription painkillers in 2007, while the cost of productivity loss attributable to pain-related conditions is estimated at $60 billion a year.

"Although much is known about the pain experienced by those with chronic illnesses, until now relatively little was known about pain in the entire U.S. population," says Arthur A. Stone, Ph.D., a Professor in the Department of Psychiatry and Behavioral Science at Stony Brook University.

"Our assessment approach allowed us to get accurate information about pain at several carefully selected times from the previous day," explains Dr. Stone, which enabled the researchers to address several new questions about pain, daily activities, and respondents’ personal characteristics.

Ten thousand people were contacted via random-digit dialing, and a total of 3,982 people were actually interviewed. To make the study results representative of the U.S. population, the data were adjusted with sample weights developed by the Gallup Organization. 29% of men and 27% of women said they experienced pain at sampled times.

The researchers also found a correlation between pain and lower income and less education: "Those with lower income or less education spent a higher proportion of time in pain and reported higher average pain than did those with higher income or more education," they wrote.

Additionally, the report found that the average pain rating increased with age, although it reached a plateau between ages of about 45 years and 75 years, with little difference between men and women.

According to Dr. Stone, "The study results expand our understanding of pain in the United States and supplement more traditional assessment approaches with a very detailed perspective on the pain people experience on a daily basis. This suggests new avenues of research that may ultimately lead to improved treatment of pain."

Study authors: Arthur A. Stone, Ph.D., Distinguished Professor and Vice Chair, Department of Psychiatry and Behavioral Science at Stony Brook University, and Alan Krueger, Ph.D., Professor, Department of Economics and the Woodrow Wilson School at Princeton University

Source: The Lancet, May 3, 2008

Early Amino Acids Speed Weight Gain in Premature Babies

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Providing amino acids to premature babies immediately after birth resulted in significant weight gain when compared with preterm babies receiving amino acids later, according to a study conducted by Nationwide Children’s Hospital.

"Many of our premature infants are born before the last trimester, when significant nutrition accumulation occurs, as well as a lot of growth," said the study’s lead author, Christina Valentine, MD, MS, RD, medical director for neonatal nutrition services at Nationwide Children’s Hospital and a fellow at The Ohio State University Medical Center. "Our findings suggest that the first 24 hours of life is a crucial time for the administration of nutrition."

The study included 440 preterm infants born between 2004 and 2006, weighing less than 1500 grams at birth. 308 infants born between 2005 and 2006 were given amino acids within 24 hours of delivery, and compared with 132 preterm infants fromm2004 who were not given the amino acid diet. Those born in 2005 and 2006 weighed significantly more at discharge – 2,342 grams -than those born in 2004, who had a mean weight of 2,242 grams.

"Preterm infants often face acute diseases immediately upon entering the world, so in years past, their nutrition has typically gone on the back burner," said Stephen Welty, MD, chief of neonatology at Nationwide Children’s Hospital and a faculty member at The Ohio State University College of Medicine. "The more we learn, the more we are realizing that nutrition should probably go on the front burner, because the evidence suggests nutrition may play a vital role in improving their overall health, even in the first few days of life."

Neonatologists at Nationwide Children’s Hospital have developed a collaborative approach to providing early, aggressive nutrition for premature infants. The neonatal nutrition team, directed by Valentine, is comprised of neonatal dieticians, lactation consultants, peer counselors, pharmacists and a diet technician. The team assesses infants on an individual basis to determine their unique nutritional needs and prescribe individualized action plans, aimed at increasing weight and warding off diseases commonly associated with preterm birth.

Source: Nationwide Children’s Hospital

Quitting Smoking Leads to Significant Reduction in Mortality Risks After 5 Years

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Women smokers who quit reduce the risk of death from heart disease within 5 years, and their risk of any other smoking-related death by 20%, according to a recent study.

"Tobacco use remains the leading preventable cause of death in the United States. Globally, approximately 5 million premature deaths were attributable to smoking in 2000. The World Health Organization projects by 2030 that tobacco-attributable deaths will annually account for 3 million deaths in industrialized countries and 7 million in developing countries," the authors write. They add that the rate of mortality risk reduction after quitting compared with continuing to smoke is uncertain.

By analyzing data from the Nurses’ Health Study, an observational study of 104,519 female participants, with follow-up from 1980 to 2004, Stacey A. Kenfield, Sc.D., of the Harvard School of Public Health, Boston and his colleagues measured the relationship between cigarette smoking and quitting smoking on mortality in women. 12,483 deaths were recorded in this group, of which 4,485 (35.9%) had never smoked, 3,602 (28.9%) were current smokers, and 4,396 (35.2%) were among past smokers.

A 13% risk reduction in mortality from any cause within the first 5 years of stopping smoking (compared with continuing to smoke), with the excess risk falling to the level of someone who had never smoked 20 years after quitting.

According to the study, "Significant trends were observed with increasing years since quitting for all major cause-specific outcomes. A more rapid decline in risk after quitting smoking compared with continuing to smoke was observed in the first 5 years for vascular diseases compared with other causes."

In regard to coronary heart disease, 61% of the full benefit of quitting was realized within the first 5 years; similarly for cerebrovascular mortality where 42% of the potential benefit was realized within the first 5 years after quitting. Death due to respiratory disease showed an 18% reduction in risk within 5 to 10 years of quitting.

Lung cancer mortality showed a 21% risk reduction during the first 5 years compared with people who did not quit, but the excess risk remained for 30 years. Past smokers with 20 to less than 30 years of not smoking showed an 87% reduction in risk of lung cancer mortality compared with continuing smokers. The researchers also found that approximately 64 percent of deaths among current smokers and 28 percent of deaths among former smokers were attributable to cigarette smoking.

"Early age at initiation is associated with an increased mortality risk so implementing and maintaining school tobacco prevention programs, in addition to enforcing youth access laws, are key preventive strategies. Effectively communicating risks to smokers and helping them quit successfully should be an integral part of public health programs," the authors conclude.

Source: Journal of the American Medical Association (JAMA), April 7, 2008 – 2008;299[17]:2037-2047

Study Shows Obesity Is a Major Risk for Heart Failure

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The results of the Multiethnic Study of Atherosclerosis (MESA) identifies "the biological effects of obesity on the heart" as a serious reason for 72 million overweight Americans to worry about their health.

Senior study investigator Joao Lima, M.D., says "Even if obese people feel otherwise healthy, there are measurable and early chemical signs of damage to their heart, beyond the well-known implications for diabetes and high blood pressure. Now there is even more reason for them to lose weight, increase their physical activity and improve their eating habits."

The development of heart failure of some 7,000 mean and women, aged 45 to 84 was followed by researchers conducting the MESA study, which started in 2000. To date, of the 79 participants who developed congestive heart failure 44% were obese with a body mass index (BMI) of 30 or more. They were also found to have higher blood levels of interleukin 6, C-reactive protein and fibrinogen, key immune system proteins involved in inflammation, than non-obese adults. An 84% greater risk of developing heart failure was accounted for by a near doubling of average interleukin 6 levels.

The links between inflammation and the combination of risk factors known as the metabolic syndrome alarmed the researchers from 5 U.S. universities.

The researchers from five universities across the United States also found alarming links between inflammation and the dangerous mix of heart disease risk factors known as the metabolic syndrome. Its combined risk factors for heart disease and diabetes—high blood pressure, elevated blood glucose levels, excess abdominal fat and abnormal cholesterol levels, and particularly obesity—double a person’s chances of developing heart failure.

"More practically, physicians need to monitor their obese patients for early signs of inflammation in the heart and to use this information in determining how aggressively to treat the condition," says Lima, a professor of medicine and radiology at the Johns Hopkins University School of Medicine and its Heart Institute. "Our results showed that when the effects of other known disease risk factors—including race, age, sex, diabetes, high blood pressure, smoking, family history and blood cholesterol levels—were statistically removed from the analysis, inflammatory chemicals in the blood of obese participants stood out as key predictors of who got heart failure," says Lima.

The study found that higher levels of interleukin 6 and a tripling of average levels of C-reactive protein in study subjects increased the possibility of heart failure by 36%.

What this tells us is that both obesity and the inflammatory markers are closely tied to each other and to heart failure," says lead researcher Hossein Bahrami, M.D., M.P.H. Bahrami, a senior cardiology research fellow at Hopkins, says "the basic evidence is building the case that inflammation may be the chemical route by which obesity targets the heart, and that inflammation may play an important role in the increased risk of heart failure in obese people, especially those with the metabolic syndrome."

Each year, nearly 300,000 Americans die from heart failure.

Source: Journal of the American College of Cardiology, May 6, 2008

Children Still At Risk from Lead Poisoning, Despite Programs Promoting Cleaning and Home Repair

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A review of studies shows that children are still at risk of lead poisoning, despite attempts to encourage home cleaning and repairs, and parental awareness.

Lead author Dr. Berlinda Yeoh, a pediatrician at Sydney Childrens’ Hospital in New south Wales, Australia, says of these attempts that "none that have been tried so far have been proven to be effective." The most common cause of lead poisoning in children is ingestion of dust from old lead paint, and Dr. Yeoh cited lead poisoning as an important health issue for children. It can, she said, contribute to behavior and growth problems, anemia, kidney damage, and other physical, cognitive and behavioral impairment.

Although the sale of lead paint in the United States was prohibited as long ago as 1978 children today can still ingest paint from peeling walls, broken plaster or old painted window sills. 12 U.S. studies, encompassing 2239 children, were examined, and analyzed 2 types of parental interventions—educational and environmental. Educational intervention taught awareness of lead poisoning and methods of preventing dust and lead exposure in the home; environmental intervention suggested making repairs, cleaning and painting.

The Cochrane Library carried the review, and the reviewers’ findings that educational programs for parents had no effect on children’s blood lead levels, which was also the case for environmental programs. Soil abatement, or the replacement of lead-contaminated soil around the home, was also analyzed and 2 studies showed that this significantly reduced childrens’ blood lead levels, although insufficient data prevented recommending these practices as effective. Even studies that combined both educational and environmental interventions failed to reduce children’s blood lead levels.

Dr. Yeoh pointed to other sources of lead exposure—at day care or relatives’ home, for example—which might make home dust removal programs ineffective.

A further reason might be lack of time to be cleaning thoroughly, said Dr. Yeoh. Based on these results, "it is difficult to support the use of the interventions examined in this review as a general population health measure, given their cost and the lack of data showing positive reductions in blood lead levels," the authors said.

Susan Buchanan, M.D., a clinical assistant professor at the University of Illinois at Chicago School of Public Health, called the review "a very thorough evaluation of current literature. It takes so little lead dust to poison a child that it doesn’t matter how clean your house is, your child is still going to have exposure to lead dust," she said.

"As adults, our neurological systems are somewhat immune to the dramatic effects of lead," Buchanan said. However, very young children often put objects in their mouths—increasing their ingestion of house dust and dirt—that in turn affects their developing neurological systems, she said.

"We have to use the knowledge we have—there is lead in dust, so as much dust removal as possible should still be recommended," she said. However, to "continue screening is critical because if high blood lead levels are caught, then health department inspectors can be used to point out obvious sources of lead in the home," Buchanan said.

The review noted that a coauthor, Bruce Lanphear, was an investigator in two of the studies included in this review.

Source: Health Behavior News Service

Sports and Exercise Reduces Breast Cancer Rates

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Women who actively participate in sports are 25% less likely to get breast cancer, though the benefits are not seen in obese women, and lean women see the lowest breast cancer rates.

The type of activity undertaken, at what time in life and the woman’s body mass index (BMI) will determine how protective the activity is against the disease.

The researchers reviewed the literature and analysed 62 studies looking at the impact of physical activity on breast cancer risk. They then examined the findings to find out how breast cancer risk appeared to be affected by type of activity, intensity of activity, when in life the activity was performed and other factors.

They found the most physically active women were least likely to get breast cancer. All types of activity reduced breast cancer risk but recreational activity reduced the risk more than physical activity undertaken as part of a job or looking after the house. Moderate and vigorous activity had equal benefits.

Women who had undertaken a lot of physical activity throughout their life had the lowest risk of breast cancer, and activity performed after the menopause had a greater effect than that performed earlier in life.

Physical activity reduced breast cancer risk in all women except the obese and had the greatest impact in lean women (BMI < 22kg/m2)

Women who were mothers, had no family history of breast cancer, were not white and had oestrogen receptor negative tumours also had a reduced risk of breast cancer.

The authors said the way in which physical activity protected against breast cancer was likely to be complex and may involve effects on sex hormones, insulin-related factors, the immune system and other hormone and cellular pathways.

Source: British Journal of Sports Medicine 2008; doi:10.1136/bjsm.2006.029132

FDA Approves NovoSeven RT Coagulation Therapy

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A new formulation of a genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood—has been approved by the FDA. The new formulation allows the product to be stored at room temperature (up to 77 degrees Fahrenheit) for up to two years.

"Approval of this product for room temperature storage creates greater flexibility in disease management for both patients and physicians," said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. "As with all FDA-approved products, the agency will monitor NovoSeven RT throughout its life cycle."

NovoSeven RT—the new formulation of NovoSeven Coagulation Factor VIIa (Recombinant)—contains sucrose and L-Methionine, which allow for storage at room temperature. This is helpful for health-care facilities with limited refrigerated space. The original formula could be stored for three years at temperatures between 36 and 46 degrees Fahrenheit.

NovoSeven RT shares the same uses as the earlier NovoSeven product. These uses include the treatment of bleeding and the prevention of surgical bleeding in patients with hemophilia A or B, who have antibodies that neutralize the action of clotting Factors VIII or IX; the treatment of bleeding and the prevention of surgical bleeding in patients with congenital Factor VII deficiency; and the prevention of surgical bleeding in patients with acquired hemophilia.

Coagulation factors are proteins found in plasma, which help blood clot. When one or more of these proteins are missing or inactive, bleeding can occur.

The most commonly observed adverse reactions with NovoSeven RT are fever, bleeding, injection site reaction, joint discomfort, headache, elevations or falls in blood pressure, nausea, vomiting, pain, swelling, and rash. Some elderly patients experienced an increased risk of arterial clotting when they were treated with NovoSeven RT outside of its approved indications.

NovoSeven RT and NovoSeven Coagulation Factor VIIa (Recombinant) are manufactured by Novo Nordisk A/S, located in Denmark.

Source: FDA, May 9, 2008