American College of Physicians: Internal Medicine — Doctors for Adults ®

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ACP DiabetesMonthly



In the News for the month of December 2012




Highlights

Type 2 diabetes may recur after gastric bypass surgery, study finds

Type 2 diabetes may recur in a significant proportion of patients who undergo gastric bypass surgery, a new study has found. More...

Primary care patients drop weight, waist size with lifestyle intervention treatments

Primary care patients in two different diabetes-prevention treatment groups lost weight, reduced waist circumference and lowered blood glucose levels, compared with a usual care group. More...

Diabetes prevalence increasing in the U.S.; new drugs in development

The prevalence of diagnosed diabetes in the United States increased from 4.5% to 8.2% from 1995 to 2010, according to a new report from the Centers for Disease Control and Prevention. More...

Diabetes' association with hearing loss examined in meta-analysis

Diabetic patients have more hearing impairments than nondiabetic patients at all ages, a meta-analysis concluded. More...


Test yourself

MKSAP Quiz: Glycemic control in the ICU

This month's quiz asks readers to evaluate a 67-year-old woman with type 2 diabetes transferred to the cardiothoracic intensive care unit after repair of an abdominal aortic aneurysm. More...


From ACP Journal Club

Intensive glucose control reduces surrogate, but not clinical, renal outcomes in type 2 diabetes

A meta-analysis included five randomized, controlled trials (with more than 28,000 patients) comparing intensive glucose control to standard glucose control in outpatients with stable type 2 diabetes. More...


Tool of the month

How can I help my patients develop healthier eating habits?

Discuss nutritional guidelines and ask your patients to think of one thing they are interested in and willing to do to improve their eating habits. More...


Keeping tabs

Spotlight on metformin

The benefits of metformin treatment were highlighted by a few intriguing studies published in the past month. More...


Physician editor: David V. O'Dell, MD, FACP



Highlights


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Type 2 diabetes may recur after gastric bypass surgery, study finds

Type 2 diabetes may recur in a significant proportion of patients who undergo gastric bypass surgery, a new study has found.

Researchers performed a retrospective cohort study among adults with type 2 diabetes, uncontrolled or controlled by medication, who had gastric bypass surgery (Roux-en-Y) at three U.S. integrated health care delivery systems between 1995 and 2008. The study's goal was to determine long-term remission and relapse rates of type 2 diabetes after gastric bypass, as well as clinical predictors. The researchers defined remission and relapse events according to use of diabetes medications (a current prescription at the time of surgery) and laboratory-measured glycemic control (hemoglobin A1c level ≥6.5% at the most recent measurement before surgery). The study results were published online Nov. 18 by Obesity Surgery.

A total of 4,434 adults, 77.1% women, met the study criteria. The average age of the study population was 49.6 years. Overall, 2,254 had complete remission of their diabetes within five years of gastric bypass surgery. Of this group, the authors report more than one-third developed diabetes again within five years of remission (median remission duration, 8.3 years). Complete remission was defined as discontinuation of diabetes medication plus fasting glucose levels below 100 mg/dL and/or hemoglobin A1c levels below 6.0% at least 90 days after the last filled prescription for diabetes medication ended. Relapse was defined as resuming a diabetes medication, having at least one hemoglobin A1c value of 6.5% or more, and/or having at least one fasting glucose measure of 126 mg/dL or more. Patients who had poor glycemic control before surgery, used insulin or had had diabetes longer were more likely to have remission and relapse. In an analysis of the 47% of the total sample who had available data on body mass index, the authors found that weight loss patterns after surgery differed according to whether patients had no diabetes remission, had remission and later relapsed, or remained in remission (P=0.03).

The study could not take variations in surgical technique into account and did not have enough data to analyze outcomes according to such factors as race/ethnicity or diabetes-related mortality, among other limitations. The researchers concluded that based on their results, a substantial proportion of patients do not experience lasting remission of diabetes after gastric bypass surgery and that "patients should be counseled that bariatric surgery alone does not reliably 'cure' diabetes." They noted, however, that "the remission rates achieved by [gastric bypass surgery] appear to be far better than what could be achieved by any other behavioral treatment." The authors also pointed out that bariatric surgery seemed to have the most lasting effect in patients with recent diabetes, and they called for further studies to help confirm these findings.


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Primary care patients drop weight, waist size with lifestyle intervention treatments

Primary care patients in two different diabetes-prevention treatment groups lost weight, reduced waist circumference and lowered blood glucose levels, compared with a usual care group.

Researchers adapted two lifestyle interventions from the Diabetes Prevention Program (DPP), which had previously shown success in clinical trials, to a primary care setting. Patients (n=241) were recruited between July 2009 and June 2010 from a clinic in Los Altos, Calif. They were at least 18 years old, had a body mass index (BMI) of 25 kg/m2 or more, and had either pre-diabetes (impaired fasting glucose of 100 to 125 mg/dL) or metabolic syndrome per American Heart Association/National Heart, Lung, and Blood Institute 2005 criteria. At baseline, patients had a mean BMI of 32 kg/m2 and a mean age of 52.9 years; 53% were male.

Patients were randomized to a coach-led, small-group intervention; a self-directed DVD intervention; or usual care. For the intervention groups, a behavioral weight-loss curriculum was used in the three-month "intensive" phase, followed by a 12-month "maintenance" phase during which both groups received lifestyle change coaching and support via e-mail and a website. Results were published online Dec. 10 by Archives of Internal Medicine.

The average change in BMI from baseline for the coach-led group was −2.2, compared to −0.9 in the usual care group (P<0.001) and −1.6 in the self-directed group (P<0.02 vs. usual care). Thirty-seven percent of patients in the coach-led group achieved the 7% weight-loss goal (P=0.003 vs. usual care) and 35.9% achieved it in the self-directed group (P=0.004 vs. usual care), compared to 14.4% in the usual care group. Improvements in waist circumference and fasting plasma glucose levels in both interventions also reached statistical significance compared with the usual group.

Study limitations include that participants were mainly of high socioeconomic status and from a single clinic, and the study didn't evaluate efficacy after 15 months or cost-effectiveness, they wrote. Women seemed to respond more favorably to the coach-led than the self-directed intervention, while men responded comparably to both, though these findings need to be confirmed, the authors noted. The two lifestyle interventions are "readily scalable and exportable" and "integrate standardized, DPP translational programs (delivered in groups or by DVD) with existing health [information technology]," for a primary care setting, the authors concluded.


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Diabetes prevalence increasing in the U.S.; new drugs in development

The prevalence of diagnosed diabetes in the United States increased from 4.5% to 8.2% from 1995 to 2010, according to a new report from the Centers for Disease Control and Prevention.

Researchers used data from the Behavioral Risk Factor Surveillance System (BRFSS) to look at trends in diabetes incidence since 1995. The BRFSS uses state-based random-digit-dialed telephone surveys to collect information on health behaviors and conditions among noninstitutionalized U.S. adults who are at least 18 years of age. The new report was published online Nov. 16 by Morbidity and Mortality Weekly Report.

In 1995, age-adjusted prevalence of diabetes was 6% or greater in three states, the District of Columbia, and Puerto Rico; by 2010, all states plus the District of Columbia and Puerto Rico had an age-adjusted prevalence of 6% or greater. In 2010, states located in the South had the highest median age-adjusted prevalence (9.8%) compared with the Midwest (7.5%), Northeast (7.3%) and West (7.3%). Alabama, Mississippi, Puerto Rico, South Carolina, Tennessee, Texas and West Virginia had the highest age-adjusted prevalence (all ≥10%), while Alaska, Colorado, Connecticut, Iowa, Minnesota, Montana, North Dakota, Oregon, South Dakota, Wisconsin, Vermont and Wyoming had the lowest age-adjusted prevalence (6.0% to 6.9%).

Forty-eight states saw an increase of at least 50% in age-adjusted prevalence between 1995 and 2010, while 18 states saw an increase of 100% or greater. The largest relative increase was seen in the South, followed by the West, the Midwest and the Northeast. The study was limited to noninstitutionalized people who had landline telephones, and the results do not consider people with undiagnosed or type 1 diabetes, the authors noted. They pointed out that the observed increase in age-adjusted prevalence is in part due to changes in diagnostic criteria, enhanced detection of undiagnosed diabetes, demographic changes in the U.S. population (e.g., aging of the population and growth of minority populations who are at greater risk for diabetes), and also probably related to improved survival in those with the disease.

The Pharmaceutical Research and Manufacturers of America recently reported that 221 new drugs for diabetes and diabetes-related diseases are either waiting for FDA approval or undergoing clinical study. Thirty-two drugs are for type 1 diabetes, 130 are for type 2, 14 are for unspecified diabetes, and 64 are for diabetes-related conditions; some drugs appear in more than one category. More details are available online.


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Diabetes' association with hearing loss examined in meta-analysis

Diabetic patients have more hearing impairments than nondiabetic patients at all ages, a meta-analysis concluded.

Researchers conducted a meta-analysis of 13 cross-sectional studies (only one prospective study had been conducted, the authors noted) that involved more than 20,000 patients. The studies, conducted in countries around the world, assessed hearing impairments by pure-tone audiometry that included at least 2 kHz of frequency range. Hearing impairment was defined as progressive, chronic, sensorineural, or without a specified cause. Results appeared online on Nov. 12 in the Journal of Clinical Endocrinology and Metabolism.

There was an overall pooled odds ratio (OR) of 2.15 (95% CI, 1.72 to 2.68) of hearing impairment for diabetic patients compared with nondiabetic ones. The increase in risk associated with diabetes was greater in younger patients (≤60 years old) compared with older patients (>60 years old) (OR, 2.61 [95% CI, 2.00 to 3.45] vs. 1.58 [95% CI, 1.38 to 1.81]; P=0.008). Controlling for global region, threshold for hearing impairment, diabetes type, age, gender, or chronic exposure to noisy environments didn't affect the strength of the association.

While hearing loss is a result of aging, researchers noted that the odds ratio remained significant when the sample was stratified by age. Limitations included that there was no ability to control residual confounders linking diabetes and hearing impairment; no data were provided on the prevalence of diabetic complications; and data were limited to adult-onset hearing impairment (although those with earlier onset might have been included).

The authors wrote, "Additional studies are needed to clarify the relationship between diabetes severity and prevalence of hearing impairment and the effect of glycemic control on hearing loss."



Test yourself


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MKSAP Quiz: Glycemic control in the ICU

A 67-year-old woman is transferred to the cardiothoracic intensive care unit (ICU) after undergoing repair of an abdominal aortic aneurysm. She has a 12-year history of type 2 diabetes mellitus.

mksap.jpg

Her blood glucose level on arrival at the ICU is 289 mg/dL (16.0 mmol/L). Although no longer on a cardiopulmonary bypass pump, she remains intubated and on vasopressors.

Which of the following is the best treatment to control her blood glucose level during her ICU stay?

A. Insulin glargine, once daily
B. Intravenous insulin infusion
C. Neutral protamine Hagedorn (NPH) insulin, twice daily
D. Regular insulin administered on a sliding scale

Click here or scroll to the bottom of the page for the answer and critique.


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From ACP Journal Club


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Intensive glucose control reduces surrogate, but not clinical, renal outcomes in type 2 diabetes

A meta-analysis included five randomized, controlled trials (with more than 28,000 patients) comparing intensive glucose control to standard glucose control in outpatients with stable type 2 diabetes. The analysis revealed that intensive glucose control reduced microalbuminuria and macroalbuminuria more than standard treatment. However, the groups did not differ on the other measured outcomes: doubling of serum creatinine level, development of end-stage renal disease (ESRD) and death from renal disease.

The study was published by Archives of Internal Medicine on May 28. The following commentary by Eugene C. Corbett Jr., MD, MACP, was published in the ACP Journal Club section of the Nov. 20 Annals of Internal Medicine.

In their meta-analysis, Coca and colleagues focused on shorter-term (albuminuria), mid-stage (creatinine doubling), and end-stage (ESRD, death) outcomes in adults with type 2 diabetes of varying durations. They concluded that intensive therapy had short-term benefits, but evidence was insufficient to determine its effects on longer-term clinical outcomes compared with standard therapy. There was a positive association between lower hemoglobin (Hb) A1c levels and reductions in microalbuminuria and macroalbuminuria. The authors discussed major limitations of the review, which included low overall rates of mid-stage and end-stage outcomes, and heterogeneity among several study characteristics.

What useful information might clinicians take away from this study? First, patients who have close to normal glucose regulation will develop less albuminuria in the short term. Second, better long-term and longitudinal evidence is needed to link albuminuria to the rate and degree of loss of nephron function over time. The results of the review by Coca and colleagues are insufficient for this purpose, especially given the lack of long-term follow-up in some of the included studies. Third, a better understanding of the methods of intensive glucose control is needed. Sustained intensive lifestyle changes alone, including weight loss and its attendant reduction in insulin resistance, accompanied by meaningful levels of regular physical activity, reverses the pathophysiologic mechanism of type 2 diabetes. This approach probably involves less treatment risk and, perhaps, better long-term outcomes than a primarily intensive pharmacologic approach to glucose regulation.

Finally, do the results of this study mean that efforts to achieve close to normal HbA1c levels in type 2 diabetes will not prevent ESRD and its complications? Given the limitations of the evidence to date, it may be too early to abandon intensive glycemic control for type 2 diabetes.



Tool of the month


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How can I help my patients develop healthier eating habits?

Ask your patients to think of one thing they are interested in and willing to do to improve their eating habits (for example, eating one additional vegetable serving a day). Discuss the nutritional guidelines below with your patients.

  • Eat more fruits and vegetables, legumes, and whole and minimally processed grains.
  • The "plate method" is a convenient way for some patients to monitor the amounts and proportions of carbohydrates, proteins, and nonstarchy vegetables in their diets. In addition, Rate Your Plate in the Diabetes Care Guide Toolkit is a handout that patients can use to quickly assess the nutritional value of their meals.
  • Limit refined carbohydrates such as pasta, white bread, and low-fiber cereal. (A minimum of 20 to 35 grams of fiber per day is recommended.)
  • Eat mono- and polyunsaturated fats (e.g., olive oil, canola oil, nuts/seeds, and fish, particularly those high in omega-3 fatty acids). Oily fish twice per week, such as salmon, herring, lake trout, sardines, and albacore tuna, is an ample source of omega-3 fatty acids.
  • Foods high in dietary cholesterol, such as egg yolks, red meat, whole-fat dairy foods, and organ meats, should be limited.

From the ACP Diabetes Care Guide.



Keeping tabs


.
Spotlight on metformin

The benefits of metformin treatment were highlighted by a few intriguing studies published in the past month.

In a Taiwanese cohort study, researchers assessed the development of affective disorder (AD) among about 60,000 patients with type 2 diabetes and 700,000 controls. Diabetic patients were categorized by their use of metformin, sulfonylureas, both, or neither. The study found that diabetics who took no oral antihyperglycemic agents had more than double the risk of depression as controls, whereas those taking either metformin or a sulfonylurea had similar risk as controls. Taking both kinds of medication was associated with an even lower risk of developing affective disorder than either drug alone (39.4 cases per 10,000 person-years). "These therapeutic regimens are feasible for most people with [type 2 diabetes] and may largely remove the risk of AD posed by diabetes," the authors concluded in BMC Medicine on Nov. 29.

A trial in England randomized 151 children and adolescents with impaired fasting glucose or impaired glucose tolerance or hyperinsulinemia to 1500 mg of metformin or placebo daily. After six months, the metformin group had reduced their body mass by a mean of 3%. At three months in, they also showed significant improvements in fasting glucose, adiponectin to leptin ratio and alanine aminotransferase, although these differences were not sustained at six months. This largest-ever study of metformin in young people showed that "a short treatment course of metformin is clinically useful, safe, and well tolerated" and may be a "useful adjunct to support lifestyle modification," the authors concluded in the Journal of Clinical Endocrinology on Nov. 21.

A case-control study at the Mayo Clinic followed 72 women with ovarian cancer who were taking metformin and compared their outcomes with 143 similar women with ovarian cancer who were not taking the drug. After multivariate analysis, women taking metformin were twice as likely to have survived ovarian cancer for five years. The survival difference was significant when the researchers looked specifically at epithelial ovarian cancer, too. Although the study couldn't prove causation, it does provide support for future trials of metformin in ovarian cancer, the authors concluded, in the journal Cancer on Dec. 3.


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MKSAP Answer and Critique



The correct answer is B. Intravenous insulin infusion. This item is available to MKSAP 15 subscribers as item 40 in the Endocrinology section. Part A of MKSAP 16 was released on July 31. More information is available online.

The intensive control of glucose levels in hospitalized patients during critical illness has garnered substantial attention over the past decade. Several randomized clinical trials have shown a benefit to patient morbidity and mortality with stringent glycemic control. Whereas the precise target remains controversial, the bulk of the data suggests that treating to achieve glucose levels between 140 and 180 mg/dL (7.8 and 10.0 mmol/L) may be optimal. In the setting of an ICU, this is best and most safely achieved through the use of intravenous insulin. Intravenous delivery of insulin allows for more rapid titration and does not rely on subcutaneus absorption, which may be diminished or delayed in patients with cardiogenic shock or other critical illnesses associated with poor peripheral circulation.

If it appears that ongoing insulin is required once this patient is ready for transfer to a general ward, she should be transitioned to an injectable regimen involving long- or intermediate-acting and rapid-acting insulins. Oral agents can be restarted before discharge as long as renal function is normal and no contraindications exist.

Insulin glargine, the dosage of which is typically adjusted every 2 to 3 days until optimal glycemic control is achieved, cannot quickly guarantee adequate control during the 1 to 2 days that this patient is likely to be in the ICU. For similar reasons, using neutral protamine Hagedorn (NPH) insulin twice daily is unlikely to be the best treatment.

Although the dosage of regular insulin can be adjusted more frequently when administered on a sliding scale, this approach to glycemic control is considered inadequate because insulin is provided only when hyperglycemia becomes established. This method is not proactive enough to result in acceptable glycemic control during an ICU stay.

Key Point

  • Intensive glycemic control is best achieved in the intensive care unit with an intravenous insulin infusion.

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A 69-year-old woman is evaluated for a lump under her arm found on self-examination. She is otherwise healthy and has no other symptoms. Medical and family histories are unremarkable, and she takes no medications. A needle aspirate of the right axillary mass reveals adenocarcinoma. Bilateral mammography and breast MRI are normal. CT scan of the chest, abdomen, and pelvis demonstrates the enlarged axillary lymph node and no other abnormalities. What is the most appropriate initial treatment?

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