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Diabetics on Dialysis Do Better With Higher Hemoglobin A1c

Daniel M. Keller, PhD

Authors and Disclosures

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November 22, 2011 (Philadelphia, Pennsylvania) — Using data from the international Dialysis Outcomes and Practice Patterns Study (DOPPS), researchers have discovered that the desirable range for glycated hemoglobin (HbA_1c) levels is higher for diabetic patients on dialysis than guidelines recommend for the general diabetic population.
Both high and low levels were associated with an increased risk for death, Fritz Port, MD, MS, senior research scientist at Arbor Research Collaborative for Health in Michigan, reported here at Kidney Week 2011: American Society of Nephrology 44th Annual Meeting.
More than half the patients on dialysis in the United States have diabetes, so these findings affect a substantial number of people, Dr. Port pointed out.
The aim of DOPPS is to discover which dialysis practices result in the best patient outcomes. It has accumulated data on more than 38,000 patients from a representative and random sample of hemodialysis centers and patients in 12 countries.
The study involved 6383 patients with diabetes on hemodialysis who had at least 2 determinations of HbA_1c during the first 8 months. In their analysis, the investigators adjusted for factors that could affect mortality, such as age, sex, years on dialysis, poor nutrition, and country of residence.
"The range from 6% to 9% seems to be the lower range of risk. There's even an impression that you could say that from 7% to 9% is the lowest risk," Dr. Port said. The graph of hazard ratios for mortality forms a U-shaped curve, with higher mortality at the lowest and highest levels of HbA_1c. Current recommendations for the general diabetes population specify that patients try to keep their HbA_1c levels below 7%.
Mortality Risk by Level of HbA_1c

HbA1c range (%)	Estimated Hazard Ratio
<5.0	1.35
5.0–5.9	1.20
6.0–6.9	1.10
7.0–7.9	1.00 (reference)
8.0–8.9	0.95
≥9.0	1.30

When the researchers examined the medication records of the diabetic patients on hemodialysis, they found that 46% of those with HbA_1c levels below 7% were taking oral drugs or insulin. Of the patients with levels of 9% or greater, 31% were not taking antihyperglycemic drugs.
"It shows the opportunities to improve patient care by either decreasing the amount of medications in those with low hemoglobin A_1c or increasing the use of medications in those with a high hemoglobin A_1c," Dr. Port explained.
On the basis of this study and others like it, he said, the guideline recommendations for HbA_1c levels for diabetics "will likely be changed for dialysis patients, but they're not finalized yet."
Katherine Tuttle, MD, executive director of research at the Providence Sacred Heart Medical Center and professor of medicine at the University of Washington School of Medicine in Spokane, who was not involved in the study, told Medscape Medical News that the guidelines will be going out for public comment soon, probably in the next couple of months. She chairs the work group developing new clinical practice guidelines for diabetes and chronic kidney disease.
"I think it's fair to say that the recommendation for an A_1c of about 7% or less will stand for people with new-onset diabetes who are relatively young and [who have] limited comorbidities," she said. Although she cannot be specific about what the guidelines will include, she did say: "I think the guidelines will really promote individualizing therapy.... For people who are at high risk of hypoglycemia, which is most people with advanced chronic kidney disease or with limited life expectancy and multiple comorbidities, clinicians should consider a more liberal target."
Besides treatment advice, the guidelines will have a series of research recommendations. "One of them is that long-term glycemic control, such as A_1c, needs to be validated in people with advanced kidney disease, or really any kidney disease, because people with any kidney disease were excluded from the original validation studies," Dr. Tuttle said. An important area of future research is other markers of glycemic control, such as glycated albumin, "because it's not affected by red cell turnover and other abnormalities in hemoglobin," she explained.
"We shouldn't limit our scope of research.... We should be looking for better markers, particularly for this population," she advised.
DOPPS is supported by research grants from Amgen, Kyowa Hakko Kirin (in Japan), Genzyme, Abbott, and Baxter without restrictions on publications. Dr. Port is an employee of Arbor Research Collaborative for Health. Dr. Tuttle has disclosed no relevant financial relationships.
Kidney Week 2011: American Society of Nephrology 44th Annual Meeting. Abstract TH-OR065. Presented November 10, 2011.

 

Cranberry juice may reduce recurrent UTIs in children.

Reuters (12/2, Pittman) reports that according to a study published in the journal Clinical Infectious Diseases, for children who have been treated for a urinary tract infection (UTI), drinking cranberry juice every day may reduce the number of recurrent infections. Among 255 children, those who drank cranberry juice had a total of 27 infections and averaged 12 days per year taking antibiotics. In those youngsters not drinking juice, there were 47 infections, and the children averaged 18 days taking antibiotics.

Experts criticize young athletes' use of energy drinks.

USA Today (12/2, Norwood) reports that "doctors and other experts increasingly warn of misunderstandings about energy drinks' contents, lax labeling requirements and the risks of high doses of caffeine -- particularly to young athletes. In June, a clinical report in Pediatrics, the journal of the American Academy of Pediatrics, warned that 'stimulant-containing energy drinks have no place in the diets of children or adolescents.' In October, the National Federation of State High School Associations cautioned that caffeinated energy drinks -- often confused with such products as Gatorade, a fluid replacement drink -- should not be consumed before, during or after physical activity because they could raise the risk of dehydration and increase the chance of potentially fatal heat illnesses." The Food and Drug Administration, which warned makers against adding caffeine to alcoholic drinks, declined to comment on still-pending petitions to limit caffeine in energy drinks or require added label disclosures.

FDA Offers Guidance On Designing Artificial Pancreas Outpatient Trials.

On its website, ABC News  (12/1, Moisse, Carollo) reports, "The US Food and Drug Administration today issued guidance for scientists and device manufacturers seeking approval for the artificial pancreas – a portable device to help people with type 1 diabetes control their blood sugar levels." The guidance is "aimed at easing the approval process while still meeting statutory requirements for safety and effectiveness." Jeffrey Brewer, president and CEO of the Juvenile Diabetes Research Foundation and the parent of a son with type 1 diabetes, said that the group's "initial review" of the new guidance "indicates that the FDA has been responsive and listened to the recommendations of leading clinicians and researchers," and that it "lays out a rapid timetable to move from inpatient trials to outpatient trials to prove the AP's safety and efficacy, and if that turns out to be the case it is good news."

        Reuters  (12/1, Steenhuysen) reported that the artificial pancreas appears to be possible, but some advocates fear that regulators could set overly strict testing requirements that might delay its development, such as requiring a new round of testing whenever a single component of the device is facing change. The Juvenile Diabetes Research Foundation advocacy group notes, for instance, that an early Medtronic version of the artificial pancreas, the Paradigm Veo insulin pump, is sold in 50 nations but not the US, and has called the FDA "the biggest bottleneck right now."

        CQ (12/2, Adams, Subscription Publication) reports that the co-chairwomen of the Senate Diabetes Caucus, Susan Collins (R-ME) and Jeanne Shaheen (D-NH), "noted in a statement that FDA officials had promised them earlier this year that they would issue the guidance by December." Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, "said that the 64-page draft guidance was designed to be flexible," and offers device makers several options in designing trials.

        The Los Angeles Times  (12/2, Brown) "Booster Shots" blog reports that Shuren "said in a statement that the agency's guidance would 'provide maximum flexibility to manufacturers seeking to bring this device to US patients' while also assuring that the machines would be safe and effective."

        HealthDay  (12/1, Reinberg) reports that the device would combine an insulin pump and a continuous glucose monitor to monitor and control blood sugar levels for type 1 diabetes patients and "could make a huge difference" for those patients. At a Thursday news conference, Charles Zimliki, leader of the FDA's Artificial Pancreas Working Groups and Critical Path Initiative, said, "We really are trying to get these devices to the market as quickly as possible."

        MedPage Today  (12/1, Fiore) reports that the FDA's guidance addresses two variants of the artificial pancreas: "target-to-range, which keeps blood sugar levels in check when they get too low or too high, and treat-to-target, which attempts to keep levels at a constant mark." Earlier guidance from the agency in June "focused on low-glucose suspend -- an earlier generation technology that automatically shuts down an insulin pump when blood sugar gets too low."

Court Ruling Says Bone Marrow Donors May Be Compensated.

The New York Times  (12/2, B5, Pollack, Subscription Publication) reports, "A federal appeals court ruling on Thursday could make it easier for patients with diseases like leukemia to find matching bone marrow donors." The Ninth Circuit Court of Appeals "said that a federal law prohibiting payment for donated organs did not apply to stem cells extracted from circulating blood."

        "A unanimous three-judge panel of the 9th US Circuit Court of Appeals ruled that the marrow cells taken from a donor's blood were blood parts, not organ parts, and that a donor is therefore free to accept compensation for a donation," the Los Angeles Times  (12/2, Williams) reports. Plaintiffs of the lawsuit "sued US Atty. Gen. Eric H. Holder Jr., alleging that the federal law treating bone marrow in the same way as organs that can't be regenerated violates the Equal Protection Clause of the Constitution."

        The San Francisco Chronicle  (12/2, Colliver) reports this ruling challenges the National Organ Transplant Act of 1984, which "makes compensation of selling vital organs a felony punishable by up to five years in prison." The court, "which overturned a lower court ruling, limits compensation to donors who donate marrow through a newer technology that takes the cells from the person's bloodstream rather than with a needle that extracts the cells from the hip bone."

        The AP  (12/2) reports, "MoreMarrowDonors.org brought the case, seeking to offer donors $3,000 in the form of a scholarship, housing allowance or gift to charity." Also covering the story are Reuters  (12/2, Baynes) and the Wall Street Journal  (12/2, Hobson) "Health Blog."

Low Levels Of HDL Cholesterol May Not Be Linked To Increased Risk Of Heart Attack.

Reuters  (12/2, Seaman) reports that, according to a study published in the Journal of Clinical Endocrinology and Metabolism, low levels of HDL cholesterol may not be linked to increased risk of heart attack. Dr. Christopher Cannon, the editor of the American College of Cardiology's website, says that individuals with low levels of HDL cholesterol also tend to have several other risk factors for cardiovascular disease.

RSNA: A Fish a Week Keeps the Brain at Its Peak

By Kristina Fiore, Staff Writer, MedPage Today Published: November 30, 2011 Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

CHICAGO -- Eating fish at least once a week could help lower older patients' risk of developing dementia, researchers said here. Those who ate baked or broiled -- but not fried -- fish on a weekly basis had a greater volume of gray matter in areas of the brain associated with Alzheimer's disease than people who didn't eat fish as often, Cyrus Raji, MD, PhD, of the University of Pittsburgh, and colleagues reported at the Radiological Society of North America meeting here. Preserving brain volume was also associated with lower rates of developing cognitive impairment, he said. "Fish consumption benefits gray matter volume, potentially reducing the risk of [Alzheimer's disease and dementia] long-term," Raji said during a press briefing. Action Points   Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal. In this study, eating fish at least once a week appeared to help lower older patients' risk of developing dementia. Note that the study was based on MRI scans that showed greater volume of gray matter in the frontal lobes and the temporal lobes, areas of the brain associated with Alzheimer's disease. Although a National Institutes of Health panel decided last year that nothing conclusively prevents Alzheimer's disease, researchers continue to investigate whether a healthy diet, or specific components thereof, can have any beneficial effects. For their study, Raji and colleagues assessed 260 people, mean age 71, when they enrolled in the Cardiovascular Health Study between 1989 and 1990. At that time, they filled out questionnaires on dietary intake; 163 reported eating fish at least weekly, and some did so as often as four times a week. All patients had an MRI 10 years later to assess brain volume, and then had follow-up cognitive testing between 2002 and 2003. The researchers found that patients who ate fish at least once a week had greater volume in the frontal lobes and the temporal lobes, including the hippocampus and the posterior cingulate gyrus – "areas responsible for memory and learning, which are severely affected in Alzheimer's disease," Raji said. Five years after the MRI, they found that 30.8% of patients who had low fish intake had developed mild cognitive impairment or dementia, compared with just 3.2% of those who had the highest fish intake and the greatest preservation of brain volume. They also saw that 47% of patients with brain atrophy who didn't eat fish had abnormal cognition five years later compared with 28% of those who ate more fish and had more gray matter volume, Raji reported. "That's an impressive reduction in the risk of developing mild cognitive impairment of Alzheimer's," Raji said. In further analyses, the researchers found that mean scores for working memory -- a function severely impaired in Alzheimer's disease -- were significantly higher among those who ate fish weekly (P=0.02), and those findings persisted even after accounting for potential confounders (P=0.03). This "simple lifestyle choice" of eating more fish increases the brain's "resistance" to Alzheimer's disease, Raji said, potentially via a few mechanisms: Fish are rich in omega-3 fatty acids, which can help increase blood flow to the brain and can also act as an antioxidant, thereby reducing inflammation, he said. Omega-3s may also prevent the accumulation of amyloid plaques in the brain, he added. He noted that fatty fish like salmon have more omega-3s, while smaller fish, such as cod, have less. Although dietary intake of fish was measured only twice -- once at baseline and again in 1995 -- Raji said patients tended to maintain their levels of consumption, and he suspects that the observed benefits "are more likely to be observed if eating fish is a long-term habit as opposed to a short-term approach." Mary Mahoney, MD, of the University of Cincinnati, who was not involved in the study, told MedPage Today that future studies should investigate whether omega-3s specifically are leading to benefits in brain volume. "We're making the assumption" that fish is a marker for healthy lifestyle, she said. "If we could just cut to the chase and look at the protective mechanism, that would be better." Zaven Khachaturian, PhD, an Alzheimer's expert from Potomac, Md., told MedPage Today that the findings are preliminary and should be replicated in a larger sample. "It would be safe to say that this study provides another hypothesis about the possible beneficial effect of a diet rich in fish ingredients and a delay of cognitive decline," Khachaturian said. The study was supported by grants from the NHLBI, NIA, AHA, and RSNA. The researchers reported no conflicts of interest.

Primary source: Radiological Society of North America Source reference: Raji C, et al "Fish consumption, brain structure, and risk of Alzheimer's disease" RSNA 2011.