Results from a US study suggest that bariatric surgery is associated with significant reductions in medication and general healthcare costs in patients with Type 2 diabetes.

“Health insurance should cover bariatric surgery because of its health and cost benefits,” suggest the researchers.

These results are in agreement with previous studies demonstrating a significant reduction in or resolution of Type 2 diabetes symptoms following bariatric surgery, as reported by MedWire News.

Martin Makary (The Johns Hopkins University School of Medicine, Baltimore, Maryland) and colleagues followed-up 2235 patients with Type 2 diabetes who underwent bariatric surgery in seven US states between 2002 and 2005. Their pre- and post-operative use of diabetes medication and yearly healthcare costs were assessed using administrative claims data.

Writing in the Archives of Surgery, the team reports that 74.7% of the cohort had stopped using diabetes medication therapy at 6 months, 80.6% at 1 year, and 84.5% at 2 years after surgery.

Overall, a significant reduction in use of diabetes medication was observed for all drug classes.

The median cost of bariatric surgery was US $29,959 (€23,369) per person.

Following surgery, yearly total healthcare costs increased by 9.7% in year 1, but decreased by 34.2% in year 2 and by 70.5% in year 3, relative to pre-surgery costs. This translated to an approximate US $4498 (€3509) reduction in annual healthcare costs by year 3 compared with pre-surgery.

“Future research may help elucidate the role of bariatric surgery in general medical care by studying its effect on common operations, maternal and neonatal outcomes, and long-term health outcomes,” write Makary et al.

“Ultimately, bariatric surgery - or a future less-invasive variant - could play a key role in the management of common medical conditions, such as heart disease and diabetes-related organ failure.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

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Adolescent girls with Type 1 diabetes who have poor glycemic control are at increased risk for oligomenorrhea, show study findings.

The researchers also found that diabetic girls had later menarche and a generally higher rate of oligomenorrhea compared with nondiabetic girls.

Women with Type 1 diabetes have a higher frequency of menstrual problems than nondiabetic women, but links with glycemic control are less clear.

In this study, Anna Deltsidou (Technological Educational Institute, Lamia, Greece) and colleagues recruited 81 female adolescent Type 1 diabetics, aged 15 years on average, and 205 age-matched healthy controls.

Menstruation data were collected by questionnaire, and the investigators defined oligomenorrhea as having a menstrual cycle longer than 36 days 5/6 times in the previous year.

Girls with Type 1 diabetes had a significantly greater age at menarche compared with healthy controls, at a mean of 12.2 versus 11.7 years.

The team also found that diabetic girls were 7.8 times more likely to have oligomenorrhea compared with healthy controls.

Further analysis within the Type 1 diabetic group showed that each incidence of hypoglycemia and each 1% increase in glycated hemoglobin (HbA1c) increased the risk for oligomenorrhea 5.3 and 4.8 fold, respectively.

“Several reasons may explain the high frequency of menstrual disorders in adolescents with type 1 diabetes, such as a relative decrease in luteinizing hormone pulsatility, or delay in the appearance of the positive estrogen feedback loop on the hypothalamic-pituitary axis,” write the authors in the European Journal of Obstetrics and Gynecology and Reproductive Biology.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

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Anti-glutamic acid decarboxylase antibodies (GADA) predict progression to insulin deficiency in Korean patients with Type 2 diabetes, researchers have revealed.

Among GADA-positive patients, a high titer of the antibodies and low body mass index (BMI) was associated with this progression.

Type 1 diabetes is characterized by the destruction of pancreatic ?-cells, making measurement of serum islet autoantibodies helpful for diagnosis, say the researchers from the University of Ulsan College of Medicine in Seoul, South Korea.

In addition, they note that previous studies have found that GADA antibodies predict the need for insulin treatment within 6 years in patients clinically diagnosed with Type 2 diabetes.

To investigate further, the team retrospectively analyzed data on 87 GADA-positive and 87 age- and gender-matched GADA-negative patients with Type 2 diabetes who visited a medical center outpatient clinic between August 1998 and December 2002.

During a period of 6 years, 2.3% of GADA-negative and 42.5% of GADA-positive patients had progressed to insulin deficiency, defined as a fasting serum C-peptide concentration of less than 0.20 nmol/l.

The rate of progression to insulin deficiency was higher in the 24 GADA-positive patients subclassified with a high titer of at least 250 WHO units/ml than in the 63 who were GADA positive but had a lower titer, at 75.0% versus 30.2%, respectively.

Multivariate analysis in GADA-positive patients revealed that a high titer of the antibodies and low BMI at diagnosis were independently and significantly associated with progression to insulin deficiency, with odds ratios of 1.90 and 1.64, respectively.

Reporting in the journal Diabetic Medicine, Ki-Up Lee and colleagues conclude: “Routine measurement of GADA in young, lean patients with Type 2 diabetes is recommended to assess the risk of progression to insulin deficiency.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

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Metformin use lowers mortality in patients with Type 2 diabetes and atherothrombosis, show results from the REACH registry.

Metformin is known to be effective for treating overweight patients with Type 2 diabetes and reducing their mortality, but it tends not to be used as a therapy in patients who also have cardiovascular disease (CVD) due to concerns about its safety.

Ronan Roussel (INSERM, Paris, France) and colleagues investigated the potential mortality benefits of metformin treatment in 19,691 patients with Type 2 diabetes and atherothrombosis participating in the Reduction of Atherothrombosis for Continued Health (REACH) Registry.

At baseline, 7457 patients were using metformin and 12,234 were not (controls). The participants were followed up for 2 years for all-cause mortality.

As reported in the Archives of Internal Medicine, the team found that 2-year mortality rates in the metformin group were a significant 24% lower than in the control group, at 6.3% versus 9.8%.

The researchers note that this reduction in mortality was consistent and significant across subgroups, including patients with congestive heart failure (31% reduction), those older than 65 years (23% reduction), and those with an estimated creatinine clearance of 30-60 ml/min/1.73 m² (36% reduction).

“Our findings provide data sufficiently pertinent and consistent to initiate a properly defined and powered randomized controlled trial to confirm the effect of metformin use on survival,” write Roussel et al.

They add that such a trial would also “assess definitively the benefits and risks of metformin use as a means of prevention of secondary cardiovascular disorders among patients having diabetes with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial disease.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

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Being born before 35 weeks of gestation increases the risk for developing Type 2 diabetes in later life, report researchers.

Previous research has shown a link between low birth weight and increased adulthood Type 2 diabetes risk, but less is known about the risks associated with preterm birth.

To investigate, Eero Kajantie (University of Helsinki, Finland) and colleagues analyzed data from 12,813 men and women from the Helsinki Birth Cohort, which includes individuals born between 1934 and 1944.

Overall, 652 individuals in the cohort developed diabetes after the age of 40 years. Participants who were born before 35 weeks gestation were a significant 68% more likely to have developed diabetes than those who were born later.

The association was still apparent, although attenuated slightly, following adjustment for birth weight relative to length of gestation, at an increased risk of 59% for those born preterm versus those who were not.

Discussing possible mechanisms for this association, Kajantie and team say that “several putative mechanisms could underlie an association between preterm birth and Type 2 diabetes.”

They explain: “Studies in children and young adults born preterm at very low birth weight (<1500 g) show increased indexes of impaired glucose regulation from an early age onwards.”

“Our results reinforce previous suggestions that preterm birth is a risk factor for Type 2 diabetes later in life,” conclude the authors in the journal Diabetes Care.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

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Low levels of magnesium are associated with an increased incidence of diabetes, show results from the CARDIA study.

These findings support those from previous research suggesting that increased intake of magnesium may reduce the risk for diabetes, as reported by MedWire News.

Ka He (University of North Carolina at Chapel Hill, USA) and colleagues carried out a study of 4497 US adults aged 18-30 years and with no diabetes at baseline who were enrolled in the Coronary Artery Risk Development in Young Adults (CARDIA) study between 1985 and 1986.

The participants were followed up for 20 years for incident diabetes based on their baseline quintiles for magnesium intake, namely, a median of 99.9, 121.0, 140.1, 162.1, and 201.5 mg/1000 kcal in quintiles 1 to 5, respectively.

The team found that those in the highest quintile for magnesium intake at baseline were a significant 47% less likely to develop diabetes over the follow-up period than those in the lowest quintile.

Magnesium intake was also consistently and significantly inversely associated with high-sensitivity C-reactive protein, interleukin-6, fibrinogen, and the homeostasis model assessment of insulin resistance.

“The potential beneficial effects of magnesium intake on the risk of diabetes may be explained by the favorable effects of magnesium on systemic inflammation and insulin resistance,” say He et al.

“Further large-scale clinical trials are needed to establish causal inference and elucidate the mechanisms behind this potential benefit,” they conclude.

The results are published in the journal Diabetes Care.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

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Study results show that ethnicity, duration of diabetes, baseline demographics, and ongoing pharmacotherapy, but not access to private drug insurance coverage, all influence glycated hemoglobin (HbA1c) target attainment in Type 2 diabetes.

The recommended target HbA1c in patients with Type 2 diabetes is 7.0% or below. Lawrence Leiter (University of Toronto, Ontario, Canada) and colleagues investigated factors influencing attainment of this target in 5280 Canadian patients with Type 2 diabetes and a HbA1c above 7.0%.

The patients were followed up for 12 months. Median HbA1c was 7.8% at baseline and 7.1% at 12 months. A significant 48% of the patients achieved a HbA1c target of 7.0% or below.

As reported in the journal Diabetes Care, the team found that patients who were older, of Asian or Black ethnicity, or who had a longer duration of diabetes were more likely to achieve the target HbA1c during the study.

Having a lower baseline HbA1c, body mass index, low-density lipoprotein cholesterol, and blood pressure also increased the chances of achieving the HbA1c target at study completion, as did taking angiotensin receptor blockers and a lower number of antihyperglycemic agents.

The researchers note, however, that having access to private compared with public insurance coverage of drug therapy did not significantly affect target accomplishment.

“In a large Canadian cohort of Type 2 diabetic patients not meeting glycemic targets, nearly 50% achieved the guideline-recommended HbA1c at or below 7.0% target after 12 months in a physician based practice optimization strategy,” write the authors.

They conclude: “Patient demography, cardiometabolic health, and ongoing pharmacotherapy, but not access to private drug insurance coverage, contribute to the care gap in Type 2 diabetes.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

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Investigators have shown that high levels of the T-lymphocyte CD4⁺CD28^null, a rare long-lived subset thought to have pro-atherogenic and plaque-destabilizing properties, are present in patients with diabetes.

This may explain the increased cardiovascular (CV) risk observed in patients with diabetes, say the researchers.

Giovanna Liuzzo (Catholic University, Rome, Italy) and colleagues assessed levels of these lymphocytes in 111 patients with Type 2 diabetes and 175 nondiabetics, 51 and 115 of whom had acute coronary syndrome (ACS), respectively.

The team found that diabetics with and without ACS had significantly higher levels of CD4⁺CD28^null than nondiabetics with and without ACS, at 12.7% and 3.1% versus 3.9% and 1.5%, respectively.

Notably, patients with diabetes but without ACS at baseline who had CD4⁺CD28^null levels above 4% had a significantly higher 36-month event-free survival than those with levels at or below 4%.

Similarly, among patients with ACS, the lowest 36-month event-free survival was in those with a CD4⁺CD28^null level above 4% at baseline.

“Understanding the mechanisms responsible for the expansion of CD4⁺CD28^null T-cells in diabetes mellitus, and the properties of CD4⁺CD28^null T-cells able to precipitate vascular damage in this population might turn out to be clinically relevant,” comment Liuzzo et al in the European Heart Journal.

“Our study, although with the limitations acknowledged above, offers an interesting piece of evidence on the complex mechanisms responsible for the severely increased cardiovascular risk of diabetic patients, highlighting the importance of altered adaptive immune response in the pathogenesis of ACS.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2011

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Individuals with Type 2 diabetes and insulin resistance have low levels of vitamin D, show study results.

Winfried März (Synlab, Centre of Laboratory Diagnostics, Heidelberg, Germany) presented a poster describing the findings at the European Association for the Study of Diabetes 45th Annual Meeting in Vienna, Austria.

She and her colleagues recruited 3290 individuals who were participating in the LUdwigshafen RIsk and Cardiovascular Health (LURIC) study. They measured levels of 25-hydroxyvitamin D (vitamin D) in all participants, as well as fasting glucose and fasting insulin levels, in order to calculate the homeostasis model of insulin resistance (HOMA-IR).

Levels of vitamin D were significantly lower in patients with Type 2 diabetes than those with normal or impaired glucose metabolism.

More specifically, median vitamin D levels were 16.8, 16.4, 14.9, and 12.7 ng/ml in patients with normoglycemia (n=1415), impaired glucose metabolism (n=827), newly diagnosed Type 2 diabetes (n=476), and previously known Type 2 diabetes (n=572), respectively.

Further analysis revealed a significant inverse association between vitamin D and HOMA-IR.

“Concerning possible mechanisms, we know that the beta cells of the pancreas express the vitamin D receptor and there are data showing that vitamin D seems to stimulate insulin secretion in the beta cells of the pancreas,” commented März to MedWire News.

“Concerning vitamin D and insulin resistance, there is evidence that there is some kind of upregulation of the insulin receptor,” said März. “But there are really many possible molecular mechanisms that could explain this.”

“These results suggest that vitamin D supplementation might be useful for the prevention and/or treatment of Type 2 diabetes mellitus,” conclude the authors.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2009

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Results from an updated meta-analysis published in the Archives of Internal Medicine indicate that rosiglitazone therapy is associated with an increased risk for myocardial infarction (MI), but not cardiovascular (CV) mortality.

The results add weight to recent suggestions by some researchers that rosiglitazone should be withdrawn from the market or placed under severe restrictions, as reported by MedWire News.

Steven Nissen and Kathy Wolski from the Cleveland Clinic in Ohio, USA, included all randomized controlled trials of rosiglitazone with a duration of at least 24 weeks and similar treatment periods for rosiglitazone and the control drug.

In total, 56 trials were included with a combined cohort of 35,531 patients: 19,509 who received rosiglitazone and 16,022 who received control therapy (any drug other than rosiglitazone including placebo).

They found that rosiglitazone therapy was associated with a 28% increased relative risk for MI versus control therapy.

However, CV mortality was not significantly increased in rosiglitazone treated patients compared with those treated with control therapy.

“The results of the current meta-analysis suggest an unfavorable benefit to risk ratio for rosiglitazone use,” write the authors.

They add that the implication of these results warrant further discussion as “even a modest increase in the risk of MI in a diabetic population would have serious consequences.”

A US Food and Drug Administration (FDA) advisory committee recently voted to keep rosiglitazone on the market, at least until results from the ongoing Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) trial are released. A similar review is currently being carried out by the European Medicines Agency.

The FDA committee also voted for the addition of increased safety warnings to the rosiglitazone drug label, but exact changes have yet to be finalized.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

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US FDA vote to keep rosiglitazone on the market
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Rosiglitazone increases risk for new-onset heart failure