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Lifestyle, Age Linked to Diabetes-related Protein

Over the last decade researchers have amassed increasing evidence that relatively low levels of a protein called sex hormone binding globulin (SHBG) can indicate an elevated risk of type 2 diabetes and metabolic syndrome years in advance.

Metabolon Announces Findings From Two Major Diabetes Outcomes Studies For its Quantose Prediabetes Test

Metabolon, Inc. a pioneering leader of advanced metabolomics, announced outcome results recently from two large-cohort studies evaluating the clinical utility of Quantose, the company’s blood test for prediabetes. The studies provided further evidence that the Quantose test identifies individuals at risk for type 2 diabetes earlier and more accurately than traditional risk factors alone.

The performance of Quantose was measured among 3,841 participants from the Relationship between Insulin Sensitivity and Cardiovascular Disease (RISC) and Botnia Prospective Study cohorts. Notably, among initially healthy participants in the RISC study with 3-year follow-up data:

  • Quantose biomarkers α-hydroxybutyrate (α-HB) and linoleoyl-glycerophosphocholine (L-GPC) independently and significantly predicted worsening glycemic control, and;
  • Quantose outperformed traditional risk measures such as fasting insulin, fasting glucose, BMI, and HOMA-IR in predicting insulin resistance and progression to impaired glucose tolerance.

In the Botnia Prospective Study with 9.5 year follow-up data:

  • Quantose biomarkers were found to predict incident type 2 diabetes independent of familial diabetes, sex, age, BMI, and fasting glucose.

These findings were published in two recent articles:

“Early Metabolic Markers of the Development of Dysglycemia and Type 2 Diabetes and Their Physiological Significance”, Diabetes; Ferrannini, Gall, et.al.; 2013; 62(5): 1730.

“A Novel Fasting Blood Test for Insulin Resistance and Prediabetes” Journal of Diabetes Science and Technology; Ferrannini, Cobb, et.al.; 2013; 7(1): 100.

The Quantose test reflects insulin resistance and detects progression to prediabetes and diabetes earlier than traditional glycemic measures such a hemoglobin A1C. The test is particularly useful in identifying prediabetic patients at greatest risk of disease progression and for whom drug, or other interventional therapy, may be appropriate. Diagnostic assessment with the Quantose test is well-aligned with the American Diabetes Association guidelines which recommend that physicians consider pharmaceutical intervention in high-risk prediabetics.

Beyond its immediate impact on the treatment of prediabetes, Quantose offers convincing evidence of the maturation of the field of metabolomics — and of the potential influence the discovery of novel metabolomic biomarkers will have on personalized medicine. Metabolon is committed to utilizing its systematic metabolomics discovery approach to develop diagnostics in the areas of metabolic, cancer and cardiovascular disease and provide biomarker research services by employing their high-throughput, advanced metabolomics platform.

“These studies are clear affirmation of Quantose value to predict early those individuals at risk for eventual onset of Type 2 diabetes which may provide clinicians the opportunity for treatment interventions that may reverse the prediabetic state.”, Eric Button, Senior Vice President of Diagnostics, Metabolon commented. Eric and other biomarker discovery experts from Metabolon will be present on July 22-24th at the 73rd Scientific Sessions of the American Diabetes Association. Visit booth #776 for more information regarding these studies or schedule an appointment with an expert to learn more about the Quantose test.

Study: Early Metabolic Markers of the Development of Dysglycemia and Type 2 Diabetes and Their Physiological Significance

Study: A Novel Fasting Blood Test for Insulin Resistance and Prediabetes

Source: Metabolon

AAPA Poster Presentation Explores Connection between Biomarkers and Science-Based Personalized Nutrition Therapy in the Management of Major Depressive Disorder

An examination of the latest genetic and physiologic biomarker research and its application in viable therapeutic options for patients with Major Depressive Disorder (MDD) was the focus of a breakthrough poster presentation which debuted at the American Academy of Physician Assistants (AAPA) annual conference, IMPACT 2013. The poster and complete study findings were presented by Ian V. Mackey, M.S., P.A.-C, Physician Assistant, Rush University Medical Center.

Building on data that shows obesity and inflammation predict poorer response to antidepressant therapy, the poster shed light on the link between biomarkers associated with conditions of inflammation, oxidative stress, and obesity and a patient’s potential response to treatment with adjunctive L-methylfolate. The presentation was aimed at helping inform and educate physician assistants (PA), who are often the first line of defense for patients presenting with MDD and critical to the proper treatment of the condition. The poster findings also come on the heels of a study published in the American Journal of Psychiatry which demonstrated twice as many patients responded when given adjunctive L-methylfolate 15mg compared to adjunctive placebo (continuation of SSRI monotherapy). In terms of tolerability, discontinuations due to adverse events were no different than placebo when adding L-methylfolate to SSRI treatment in patients with MDD.

“It’s vital that we make it a practice to assess the patient as a whole as opposed to assessing just their symptoms of MDD,” said Ian Mackey, M.S., P.A.-C. “As these findings indicate, other medical problems, concomitant medications and inflammation are becoming increasingly important in choosing the correct interventions for patients with MDD.”

Taking into account MDD can include metabolic components associated with poor Selective Serotonin Reuptake Inhibitors (SSRI) response, the poster presentation, Effect of L-methylfolate on Inflammatory Markers a Randomized Clinical Trial of Patients with Major Depression, analyzed 75 outpatients inadequately responding to an SSRI who were enrolled in a 60-day study, divided into two, 30-day evaluation periods according to Sequential Parallel Comparison Design (SPCD). Patients were randomized to receive L-methylfolate 15mg + SSRI for 60 days; placebo + SSRI for 30 days followed by L-methylfolate 15mg + SSRI for 30 days; or placebo + SSRI for 60 days. The SSRI doses remained constant during the study. Pooled 30-day results demonstrated significantly greater benefits in all-comers with adjunctive L-methylfolate 15mg + SSRI compared to placebo + SSRI (continued SSRI monotherapy). The magnitude of difference between response to adjunctive L-methylfolate and adjunctive placebo was 17.7% (p=0.04). Pooled differences in mean change on HDRS-17 and HDRS-28 were significantly greater (p=0.05 and p=0.02 respectively) with L-methylfolate superior to placebo.

Results also show that patients with SSRI-resistant MDD stratified by biomarkers of inflammation (hsCRP), oxidative stress (4-HNE) and methylation (SAM/SAH ratio) responded better to adjunctive L-methylfolate 15mg compared to adjunctive placebo. In an analysis of a priori endpoints, patients with baseline levels of hsCRP at or above the median (p=0.05) and 4-HNE (p=0.003) at or above the median and SAM/SAH ratio below the median (p=0.005) experienced a significantly greater treatment effect in favor of adjunctive L-methylfolate. In an exploratory analysis, patients with obesity defined as BMI ≥30 kg/m2 demonstrated a significantly greater treatment effect with adjunctive L-methylfolate versus adjunctive placebo (p=0.001).

The AAPA’s annual conference is focused on identifying and discussing innovative solutions that empower PAs at all stages of their careers to improve patient health. IMPACT 2013 remains the largest PA-focused Continuing Medical Education (CME) event in the world, with approximately 6,000 PAs and students in attendance. IMPACT 2013 took place May 25-29 at the Walter E. Washington Convention Center in Washington, D.C.

Source: Business Wire

New Study Proves Univfy IVF Prediction Tests More Accurate in Predicting IVF Success

Univfy Inc., a pioneer in predictive technology for health care and fertility, recently announced the publication of new research findings in Fertility & Sterility, validating the company’s Univfy PreIVF prediction tests as 1,000-times (likelihood scale) more powerful in predicting the probability of live birth in the first in vitro fertilization (IVF) treatment compared to estimates based on a woman’s age.

The peer-reviewed paper, “Personalized Prediction of First-Cycle In Vitro Fertilization Success,” shows that 86 percent of cases analyzed had significantly different probabilities of success compared to age-based estimates, and nearly 60 percent had a higher probability of live birth based on an analysis of the patients’ complete reproductive profiles. In fact, using the Univfy PreIVF prediction model, 42 percent of patients were found to have a personalized predicted success rate greater than 45 percent, while the age-control model could not differentiate these patients from others in the population.

Proven Accuracy Based on Personalized Prediction

The study is the first to validate that patient data available prior to starting IVF can be used to predict a patient’s chance of success to help her decide whether to pursue a first IVF treatment. The Univfy PreIVF test is an online data test that analyzes each individual’s fertility profile (including age, Body Mass Index (BMI), Day 3 FSH, semen analysis, and prior fertility and medical history) and compares it against data from thousands of IVF cycles to instantly deliver personalized prognosis of IVF success. The retrospective validation study analyzed anonymized IVF data aggregated from more than 13,000 first IVF cycles from three university-affiliated outpatient IVF clinics in the U.S., Canada and Spain.

Personalized Prediction of IVF Success Helps Patients

“Our research findings allow us to use known clinical predictors with much greater predictive power to support patients who are considering IVF for the first time,” said Mylene Yao, M.D., CEO and co-founder of Univfy. “Not knowing their personal chances of IVF success may cause many women to be missing out on a treatment that could be highly effective for them.”

While a higher likelihood of success is welcome news for many couples, the study also suggests predictions based on age alone, or age plus a few factors, could falsely reassure a small percentage of patients. Based on the predicted probability, the Univfy PreIVF test also reports the percentile of a patient’s chances of success, which provides a more balanced perspective to the patient and her doctor.

“An accurate prognosis is equally important for those whose likelihood of success is quite high and for those whose chances are much lower than age-based predictions,” Dr. James Grifo, Program Director of the New York University Fertility Center and Director of the Division of Reproductive Endocrinology and Professor of Obstetrics and Gynecology at the NYU School of Medicine. “Predicting the chances of IVF success for each patient may also support physicians in refining clinical protocols to improve care.”

“More accurate personalized prognoses of potential live birth outcomes with IVF can guide both patients and their physicians with treatment decisions,” said Dr. Gedis Grudzinskas, Consultant in Infertility and Gynaecology at 92 Harley Street, London Bridge Hospital, Princess Grace Hospital and Woodlands Health Centre, London, UK, and Editor of Reproductive Biomedicine Online, an international journal devoted to biomedical research on human reproduction.

Enhancing Care through Predictive Analytics

Previously, advanced predictive modeling that is rigorously validated was not accessible to patients and the broader medical community. Univfy has integrated these research processes with proprietary, analytics-powered platforms to deliver scientifically validated predictive information via a user-friendly interface to patients and providers. The Univfy platforms can also serve point-of-care prognostics or administrative needs in other areas of healthcare, outside of reproductive medicine.

Univfy offers complimentary and confidential analysis to any clinic interested in learning how closely their patient-specific success rates compare to the Univfy PreIVF model. This analysis is feasible even for small or mid-size fertility clinics.

Based on its proven model, Univfy offers two prediction tests for consumers: the Univfy PreIVF for women considering IVF for the first time, and the Univfy PredictIVF for women who have had IVF and are considering another IVF treatment. Both are online tests that patients complete in the privacy of their own home by simply entering their own individual health data. The tests are also available for use in physician offices via Univfy’s clinic platform through a business-to-business model. Semi-customization of prediction tests is also available upon request.

Study: Personalized prediction of first-cycle in vitro fertilization success

Source: Univfy

Study Suggests Link Between H. pylori Bacteria and Blood Sugar Control in Adult Type II Diabetes

A new study by researchers at NYU Langone Medical Center reveals that the presence of Helicobacter pylori (H. pylori) bacteria is associated with elevated levels of glycosylated hemoglobin (HbA1c), an important biomarker for blood glucose levels and diabetes. The association was even stronger in obese individuals with a higher Body Mass Index (BMI). The results, which suggest the bacteria may play a role in the development of diabetes in adults, are available online in The Journal of Infectious Diseases.