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

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ACP DiabetesMonthly



In the News for the month of July 2012




Highlights

Fructose may beat other carbohydrates for lowering glycated blood proteins

Consuming fructose in place of other carbohydrates lowers glycated blood proteins by a clinically significant percentage, a recent meta-analysis suggests. More...

Pioglitazone associated with increased rates of bladder cancer

Pioglitazone was associated with an increased risk of bladder cancer, but rosiglitazone was not, in a large recent meta-analysis. More...

Possible link between thiazolidinediones, macular edema

Patients with type 2 diabetes who are treated with a thiazolidinedione may have an increased risk for diabetic macular edema, according to a recent study. More...


Test yourself

MKSAP Quiz: Hyperglycemia in a middle-aged man

This month's quiz asks readers to evaluate a 51-year-old man for a 9-month history of chronic abdominal pain. More...


From ACP InternistWeekly

Insulin doesn't appear to increase cancer or cardiovascular risk

Using basal insulin to normalize glucose levels in patients with early diabetes and pre-diabetes doesn't affect cardiovascular event or cancer rates, a study found. More...

Linagliptin non-inferior to glimepiride in two-year trial

Linagliptin was non-inferior to glimepiride in lowering hemoglobin A1c in type 2 diabetes patients, according to a study designed, conducted and analyzed by linagliptin's manufacturer, Boehringer Ingelheim. More...

Insulin injections, infusion pumps offer similar glucose control

Continuous insulin provides comparable glycemic control to injections, while continuous glucose monitoring is slightly superior to self-monitoring, a meta-analysis concluded. More...


From ACP Journal Club

Meta-analysis: Self-monitoring in non-insulin-treated type 2 diabetes improved HbA1c by 0.25%

A meta-analysis of randomized controlled trials of patients with non–insulin-treated type 2 diabetes found that six months of self-monitoring blood glucose reduced hemoglobin A1c levels by 0.25% more than usual care. More...


Tool of the month

Tips to help patients remember oral medications

This month's tool offers tips on helping patients remember to take their medications. More...


FDA update

New contraindication for aliskiren-containing medications

Aliskiren-containing medications are contraindicated with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients with diabetes. More...


Keeping tabs

Spotlight on bariatric surgery and diabetes

Several recent studies have analyzed the effects of bariatric surgery on diabetes and related complications. More...


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



Highlights


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Fructose may beat other carbohydrates for lowering glycated blood proteins

Consuming fructose in place of other carbohydrates lowers glycated blood proteins by a clinically significant percentage, a recent meta-analysis suggests.

Canadian researchers conducted a systematic review and meta-analysis of controlled feeding trials that lasted at least seven days in individuals with diabetes. After exclusions, they had 18 trials and 209 subjects from which to assess the effects of isocaloric exchange of oral fructose for other sources of carbohydrates. Glycemic control marker outcomes included fasting glucose, fasting insulin, and glycated blood proteins (hemoglobin A1c [HbA1c], albumin, and fructosamine). Results were published in July's Diabetes Care.

Researchers made 13 glycated blood protein comparisons among 172 subjects with type 1, type 2 or undifferentiated diabetes. Starch (77%) and sucrose (7.7%) were used as carbohydrate comparisons, with one trial using both. Replacing these carbohydrates with fructose significantly reduced the percentage of glycated blood proteins (standard mean difference, −0.27; P=0.02), with significant intertrial heterogeneity (I2 statistic=63%; P=0.001). The reduction was equivalent to an approximate 0.53% decrease in HbA1c. There were no significant effects on fasting glucose (16 comparisons, n=176) or fasting insulin (7 comparisons, n=57).

The 0.53% reduction with fructose is clinically significant, as it "exceeds the clinically meaningful threshold of ≥0.3% proposed by the U.S. Food and Drug Administration for the development of new drugs for diabetes and lies at the lower limit of efficacy expected for oral hypoglycemic agents," the researchers wrote. The benefit was seen across a dose range of 20 to 160 g/d. A dose threshold for harm needs to be considered, they added, because previous research has shown fructose may increase serum triglycerides more than other carbohydrates at doses above 60 g/d. Since most of the trials in the current meta-analysis had short follow-up, small sample size and poor quality, more studies are needed that weigh the potential glycemic benefit of fructose against adverse metabolic effects, they concluded.


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Pioglitazone associated with increased rates of bladder cancer

Pioglitazone was associated with an increased risk of bladder cancer, but rosiglitazone was not, in a large recent meta-analysis.

Researchers looked for published and unpublished randomized, controlled trials, cohort studies and case-control studies that reported incident bladder cancer among people with type 2 diabetes who used pioglitazone, rosiglitazone or any thiazolinedione through March 2012.

Results appeared online July 3 in CMAJ. Researchers found four randomized, controlled trials, five cohort studies and one case-control study, with a total of more than two million patients and 3,643 newly diagnosed cases of bladder cancer, an overall incidence of 53.1 per 100,000 person-years.

All of the five studies assessing pioglitazone reported an elevated or significantly increased risk of bladder cancer associated with any pioglitazone use, compared to those who had never used the drug. A significant association with bladder cancer was reported in one study after more than 12 months' exposure and in two studies that assessed exposure after more than 24 months, the researchers noted.

Two studies reported results of a cumulative pioglitazone dose of more than 28,000 mg. One reported a significant association (hazard ratio [HR], 1.75; 95% CI; 1.22 to 2.50) and the other reported a nonsignificant association (HR, 1.4; 95% CI, 0.96 to 2.1). A third study looked at a dose of 10,500 mg of pioglitazone and found no association.

One randomized, controlled trial found that 14 of 2,605 pioglitazone users and six of 2,633 controls had newly diagnosed bladder cancer (risk ratio [RR], 2.36; 95% CI, 0.91 to 6.13). A case/noncase study reported significantly increased odds of pioglitazone use among patients who developed bladder cancer (odds ratio, 4.30; 95% CI, 2.82 to 6.52). When the results from the three cohort studies of pioglitazone were pooled, there was a significantly increased risk of bladder cancer associated with pioglitazone (pooled RR, 1.22; 95% CI, 1.07 to 1.39; I2=0%).

No significant association with bladder cancer was observed in the two randomized, controlled trials that evaluated rosiglitazone use (pooled RR, 0.87; 95% CI, 0.34 to 2.23; I2=0%). For the thiazolidinedione drug class as a whole, four randomized, controlled trials of more than 14,000 patients found an elevated but not statistically significant association (RR, 1.45; 95% CI, 0.75 to 2.83; I2=2%).

The authors concluded, "Although the absolute risk of bladder cancer associated with pioglitazone was small, other evidence-based treatments for type 2 diabetes may be equally effective and do not carry a risk of cancer."


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Possible link between thiazolidinediones, macular edema

Patients with type 2 diabetes who are treated with a thiazolidinedione may have an increased risk for diabetic macular edema, according to a recent study.

To evaluate whether an association existed between thiazolidinediones and development of diabetic macular edema, researchers performed a retrospective cohort study of U.K. patients who had type 2 diabetes but no macular edema at baseline. Data from Jan. 1, 2000 through Nov. 30, 2009 on patients' clinical, biochemical and demographic characteristics were obtained from The Health Improvement Network (THIN) database, which includes anonymous information from some general practices in the United Kingdom. One- and 10-year outcomes were analyzed. The study results were published online June 11 by Archives of Internal Medicine.

A total of 103,368 patients were included in the study. Overall, 3,227 took thiazolidinediones and 100,141 did not. At one year, 1.3% of the thiazolidinedione users had developed diabetic macular edema compared with 0.2% of nonusers (odds ratio, 5.7; 95% CI, 4.1 to 7.9). After Cox multiple regression analysis, multiple imputation analysis and propensity score analysis, thiazolidinedione use was found to be associated with higher risk for diabetic macular edema after one year (odds ratio, 2.3; 95% CI, 1.5 to 3.6) and after 10 years (hazard ratio, 2.3; 95% CI, 1.7 to 3.0). Insulin plus a thiazolidinedione also appeared to be associated with increased risk (hazard ratio, 3.0; 95% CI, 1.5 to 5.9), while aspirin (hazard ratio, 0.6; 95% CI, 0.4 to 0.9) and angiotensin-converting enzyme inhibitors (hazard ratio, 0.4; 95% CI, 0.2 to 0.7) each appeared to be associated with decreased risk.

The authors stressed that they did not have information about patients' diabetes duration or individual exposure to thiazolidinediones. However, they concluded that risk for diabetic macular edema appears to be higher in patients taking a thiazolidinedione, particularly those who are also receiving insulin. They called for additional larger trials to more accurately determine the risks and benefits of thiazolidinediones in patients with type 2 diabetes who have or are at risk for diabetic macular edema.

An invited commentary pointed out additional study limitations that would make definitive conclusions difficult. The study authors did not consider whether between-group differences could have been due to diabetes severity, since thiazolidinediones are usually second-line drugs, and did not control for risk factors that would have been affected by thiazolidinedione therapy. In addition, the commentary authors noted, some patients may have been misclassified.

"[W]e can neither be certain that thiazolidinediones cause macular edema nor be reassured that such a risk does not exist," the commentary authors wrote. "Future studies using new-user incipient cohort designs with validated exposure and outcome definitions and appropriate adjustment for diabetes severity may provide additional information on this potential association."

In the meantime, they wrote, physicians should base therapy on individual risk-benefit profiles and should follow current drug labeling, promptly evaluating patients on thiazolidinediones for possible diabetic macular edema if visual symptoms are reported.



Test yourself


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MKSAP Quiz: Hyperglycemia in a middle-aged man

A 51-year-old man is evaluated for a 9-month history of chronic abdominal pain. He has a long-standing history of alcoholism and has been admitted to the hospital several times in the past 8 years for gastrointestinal bleeding and acute pancreatitis. A review of symptoms is positive only for a 5.5-kg (12.1-lb) weight loss over the past year. He currently takes no medications.

mksap.jpg

Vital signs are normal, and BMI is 23. Physical examination reveals a scaphoid-appearing abdomen with normal bowel sounds and diffuse abdominal tenderness to palpation without guarding.

His fasting plasma glucose level is 175 mg/dL (9.7 mmol/L), and a repeat fasting plasma glucose level is 182 mg/dL (10.1 mmol/L).

A CT scan of the abdomen reveals diffuse pancreatic calcifications.

Which of the following is the best categorization of this patient's diabetes mellitus?

A) Late-onset autoimmune diabetes of adulthood
B) Secondary diabetes
C) Type 1 diabetes
D) Type 2 diabetes

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


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From ACP InternistWeekly


.
Insulin doesn't appear to increase cancer or cardiovascular risk

Using basal insulin to normalize glucose levels in patients with early diabetes and pre-diabetes doesn't affect cardiovascular event or cancer rates, a study found.

The trial randomized more than 12,000 people with a mean age of 63.5 years who had cardiovascular risk factors plus impaired fasting glucose, impaired glucose tolerance or type 2 diabetes to receive daily basal insulin glargine or standard care, defined as treatment based on local guidelines or the investigator's best judgment. Insulin was titrated to a target fasting blood glucose level of ≤95 mg/dL in the glargine treatment group; in the standard care group, only 11% were treated with insulin, with a majority of patients (60%) being treated with metformin, and 19% not receiving any glucose-lowering agents. Median length of follow-up was 6.2 years. The study was presented at the American Diabetes Association annual meeting and published online by the New England Journal of Medicine on June 11.

The insulin and control groups had similar rates of myocardial infarction, stroke or death from cardiovascular causes (2.94 with insulin vs. 2.85 without per 100 person-years) and of a combined outcome of those events plus revascularization or hospitalization for heart failure (5.52 vs. 5.28 per 100 person-years). The incidence of new diabetes in the pre-diabetic patients, measured about three months after insulin was discontinued, was lower in the insulin group (30% vs. 35%; odds ratio, 0.80; P=0.05). However, insulin was associated with more weight gain (1.6 kg vs. −0.5 kg) and severe hypoglycemia (1.00 vs. 0.31 per 100 person-years). The rate of cancer did not differ between groups.

Researchers concluded that insulin glargine had a neutral effect on cardiovascular outcomes and cancer but increased hypoglycemia and weight. As the largest and longest study of its kind, this trial provides reassurance about previously suspected links between insulin and cardiovascular problems and cancer, the authors said. They attributed the extended benefit of diabetes reduction after insulin was discontinued to resting of the pancreas, although they noted that the durability of the effect is unknown.

The study also randomized patients to receive n-3 fatty acids or placebo, and results of that investigation, also published in the New England Journal of Medicine, showed no benefit or harm from the supplementation.


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Linagliptin non-inferior to glimepiride in two-year trial

Linagliptin was non-inferior to glimepiride in lowering hemoglobin A1c (HbA1c) in type 2 diabetes patients, according to a study designed, conducted and analyzed by linagliptin's manufacturer, Boehringer Ingelheim.

Researchers conducted a randomized, double-blind, parallel-group, active controlled, non-inferiority trial at 209 sites in 16 countries. Results appeared online June 28 at The Lancet. Study participants were aged 18 to 80 years, had type 2 diabetes and a body mass index less than 40 kg/m2, were receiving metformin at a stable dose of at least 1,500 mg/d (alone or with one other oral antidiabetic drug), and had an HbA1c of 6.5% to 10% on metformin alone or 6% to 9% on metformin and one additional oral antidiabetic drug.

After a washout period of the patients' second diabetes drugs, linagliptin (5 mg once daily) or glimepiride (initially 1 mg once daily) was added to metformin. The dose of glimepiride was increased in 1-mg increments up to a maximum of 4 mg once daily, at four-week intervals during the first 12 weeks of treatment. The dose of glimepiride was increased if the patients' self-monitored fasting plasma glucose values were greater than 6.1 mmol/L (110 mg/dL). At any time, the dose of glimepiride could be decreased to prevent hypoglycemia.

The primary efficacy endpoint was change in HbA1c from baseline to week 104. The two key secondary endpoints were occurrence of hypoglycemic episodes and change in body weight. After two years of treatment, linagliptin was non-inferior to glimepiride in reducing HbA1c. At week 104, adjusted mean changes in HbA1c from a baseline of 7.7% were −0.16% with linagliptin and −0.36% with glimepiride; the difference between treatment groups was 0.20% (97.5% CI, 0.09 to 0.30; P=0.0004).

An HbA1c of less than 7% at week 104 was achieved by 232 (30%) of 764 patients on linagliptin and 263 (35%) of 755 patients on glimepiride. An HbA1c less than 6.5% was achieved by 92 (12%) of 764 patients in the linagliptin group and 120 (16%) of 755 patients in the glimepiride group. Overall, 200 (26%) of 764 patients on linagliptin and 253 (34%) of 755 patients on glimepiride achieved an HbA1c reduction of 0.5% or greater.

There were 4.8 times fewer hypoglycemic events with linagliptin than with glimepiride (58 [7%] of 776 patients vs. 280 [36%] of 775 patients; P<0.0001). Severe hypoglycemia occurred in one patient receiving linagliptin compared with 12 patients receiving glimepiride. The proportion of patients who had an A1c less than 7% and at least one hypoglycemic event was four times lower with linagliptin than with glimepiride (31 [4%] of 776 vs. 152 [20%] of 775 patients). Body weight decreased with linagliptin (−1.4 [SE, 0.2] kg) but increased with glimepiride (1.3 [SE, 0.2] kg) from similar mean baseline values (86.0 [SE, 0.7] kg vs. 87.0 [SE, 0.6] kg).

An accompanying editorial commented that linagliptin was non-inferior to glimepiride after two years, although the non-inferiority of 0.20% was lower than the predefined criterion of 0.35%.

"Only a longer follow-up (presumably at least 4 years) would allow investigators to show whether a more durable glucose-lowering effect can be achieved with a DPP-4 inhibitor than with a sulphonylurea," the editorialists stated. "If so, stabilization of metabolic control would be of great interest by decreasing the future treatment burden for patients with diabetes, thus justifying the higher cost of DPP-4 inhibitors."


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Insulin injections, infusion pumps offer similar glucose control

Continuous insulin provides comparable glycemic control to injections, while continuous glucose monitoring is slightly superior to self-monitoring, a meta-analysis concluded.

annals.jpg

Researchers conducted a meta-analysis of 33 randomized controlled trials in children or adults with type 1 or 2 diabetes. Results of the study, funded by the Agency for Healthcare Research and Quality, were published online July 10 by Annals of Internal Medicine.

In adults with type 1 diabetes, hemoglobin A1c (HbA1c) decreased more with continuous subcutaneous insulin infusion (CSII) than with multiple daily injections (MDIs), but study authors noted that results were heavily influenced by one study where participants had higher HbA1c values at enrollment. This allowed for greater HbA1c lowering compared with other studies where participants were closer to the target at enrollment. Glycemic control and hypoglycemia were similar for the two methods for patients with type 2 disease.

The researchers noted, "In comparison with MDI, CSII yielded better satisfaction with diabetes treatment in children with type 1 diabetes, and better diabetes-specific QOL [quality of life] in adults with type 1 diabetes, but the strength of evidence on QOL effects was low. The evidence was insufficient to draw definitive conclusions about other non-glycemic outcomes."

Compared with self-monitoring of blood glucose (SMBG), real-time continuous glucose monitoring (rt-CGM) was associated with lower HbA1c values (between-arm difference of change, −0.26%; 95% CI, −0.33% to −0.19%), without any difference in severe hypoglycemia. The difference in HbA1c was statistically significant but smaller than the 0.5% difference researchers defined as clinically meaningful.

Patients with type 1 diabetes who used a sensor-augmented insulin pump had a statistically and clinically significant greater reduction in HbA1c than those using MDI/SMBG (between-arm difference in HbA1c reduction, −0.68%; 95% CI, −0.81% to −0.54%). The evidence was insufficient to draw definitive conclusions about pumps' effects on severe hypoglycemia or quality of life, the authors said.

They concluded, "From a patient-focused perspective, CSII yielded better satisfaction with diabetes treatment in children with type 1 diabetes, and better diabetes-specific QOL in adults with type 1 diabetes. These data suggest that the approach to intensive insulin therapy can be individualized to patient preference that will maximize their treatment satisfaction and QOL, as both MDI and rapid-acting analog-based CSII have similar effectiveness for glycemic control."



From ACP Journal Club


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Meta-analysis: Self-monitoring in non-insulin-treated type 2 diabetes improved HbA1c by 0.25%

A meta-analysis of randomized controlled trials of patients with non–insulin-treated type 2 diabetes found that six months of self-monitoring blood glucose reduced hemoglobin A1c (HbA1c) levels by 0.25% more than usual care (mean reduction of 0.88% vs. 0.69%).

The study was published in BMJ on Feb. 17. The following commentary by Laura Rees Willett, MD, FACP, was published in the ACP Journal Club section of the June 19 Annals of Internal Medicine:

Farmer and colleagues combined the published data on glucose self-monitoring in patients with type 2 diabetes not requiring insulin and found a very modest improvement in HbA1c (0.25%), which probably has no clinical significance. The major caveat regarding the validity of the results is that the largest included trial lost 31% of its participants to follow-up. It is difficult to know how this might have changed the results, but sensitivity analysis suggests that the effect would have been minimal.

The clear clinical message from the meta-analysis is that doctors should not routinely recommend glucose self-monitoring to patients with type 2 diabetes not treated with insulin. Self-monitoring is cumbersome and costly, and the benefit in a surrogate marker (HbA1c) is vanishingly small. It is possible that monitoring could have more benefit in selected subpopulations, such as patients needing tight glycemic control or those at higher-than-average risk for hypoglycemia, but this is unproven. Recent trials suggest that the benefits of tight glucose control are less than hoped. More patients are taking such agents as metformin, dipeptidyl peptidase-4 inhibitors, and glucagon-like peptide-1 agonists, which are associated with very low rates of hypoglycemia. It is fairly certain that the subpopulation of patients with diabetes not receiving insulin who would benefit from self-monitoring is quite small.



Tool of the month


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Tips to help patients remember oral medications

The following tips can be shared with patients to help them remember to take their medications:

  • Take at the same time each day.
  • Take when you do other routine activities (e.g., eat meals, get ready for bed).
  • Store in a pill container with days of the week.
  • Keep a dose in a purse, briefcase, or pocket.
  • Create a reminder system for doses that are especially hard to remember—for example, a watch with an alarm clock, an electronic reminder through your computer at work, or a sticky note where you will be sure to see it at the appropriate time.

From the ACP Diabetes Care Guide.



FDA update


.
New contraindication for aliskiren-containing medications

Aliskiren-containing medications are contraindicated with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients with diabetes or renal impairment because of the risk of renal impairment, hypotension and hyperkalemia, the FDA recently warned.

Brand names of aliskiren-containing medications include Amturnide, Tekturna, Tekturna HCT, Tekamlo and Valturna (which will no longer be marketed after July 2012).



Keeping tabs


.
Spotlight on bariatric surgery and diabetes

Several recent studies have analyzed the effects of bariatric surgery on diabetes and related complications.

A six-year study published in the July Diabetes Care followed gastric bypass procedures on women with body mass indexes of 30 to 35 kg/m2 and found that 88% of them achieved diabetes remission. Another abstract presented at the annual meeting of the American Society for Metabolic & Bariatric Surgery (ASMBS) reported less weight loss after surgery in black women than white women but very similar rates of remission of diabetes in both black (75%) and white (77%) women.

Remission is less likely to be maintained after surgery in patients who have had diabetes longer, according to another study (in which patients had an average disease duration of five years) presented at the annual meeting of the Endocrine Society. Taking insulin and having reduced pancreatic function before surgery also predict a lower chance of diabetes remission after surgery, according to another abstract from the ASMBS meeting.

However, gastric bypass can eliminate or reduce the risk of nephropathy, according to other recent research. Nearly 60% of obese diabetics with nephropathy had remission of nephropathy five years after surgery, and surgical patients were 50% less likely to develop new kidney problems when compared with controls in this study also presented at ASMBS.

Finally, a summary article in The Lancet described the indications for and efficacy and safety of bariatric surgical procedures, as well as the effect on glycemic control.


.


MKSAP Answer and Critique



The correct answer is B) Secondary diabetes. This item is available to MKSAP 15 subscribers as item 17 in the Endocrinology section. Part A of MKSAP 16 will be released on July 31. More information is available online.

Diabetes mellitus is generally categorized as type 1, type 2, gestational, and secondary diabetes. This patient's diabetes is the last type, which consists of a group of unrelated conditions that are associated with hyperglycemia through effects on either insulin availability or insulin sensitivity. These include various endocrine disorders, such as Cushing syndrome and acromegaly; several pancreatic conditions, such as acute and chronic pancreatitis and pancreatic cancer; drug-induced hyperglycemia; and several genetic syndromes. This patient has a history of ethanol abuse and chronic abdominal pain, which may be related to chronic pancreatitis. The most common cause of chronic pancreatitis in western industrialized countries is chronic alcohol abuse, which accounts for 50% or more of all cases. The presence of pancreatic calcifications on radiographs confirms the diagnosis. Although plain films of the abdomen will show pancreatic calcifications in some patients, most patients will require abdominal CT scans to exclude other causes of pain.

Patients with pancreatic disease causing secondary diabetes may still respond to oral sulfonylureas, and a trial of such a drug is appropriate. If there has been enough loss of beta cell mass, however, insulin therapy may be required. Because of glucagon deficiency, patients with diabetes related to pancreatic insufficiency may be predisposed to hypoglycemia.

Late-onset autoimmune diabetes of adulthood is a possibility in this patient, given his age (51 years), his lean body habitus, and the insidious onset of diabetes. However, it would be much less common than secondary diabetes in this man with confirmed chronic pancreatitis.

This patient's clinical presentation is atypical for type 1 diabetes, which usually has an acute or subacute onset and is characterized by polyuria, polydipsia, polyphagia, and weight loss.

Most patients with type 2 diabetes are obese or at least have abdominal obesity (high waist-to-hip ratio). This patient is of normal body weight, and his scaphoid-appearing abdomen makes type 2 diabetes even less likely.

Key Point

  • Secondary causes of diabetes mellitus should be considered in any patient who presents with atypical features.

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Test yourself

A 42-year-old woman is evaluated for an 8-month history of crampy abdominal pain and three loose bowel movements per day. The pain is relieved by a bowel movement. There are no nocturnal bowel movements, and there is no blood or dark tarry material in the stool. She has not had fever, night sweats, or weight loss. She has a history of Hashimoto disease and is treated with levothyroxine. Following a physical exam, rectal exam, and lab tests, what is the most appropriate next step in management?

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