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News and Trends—January 2016

| January 1, 2016

News from the American Association of Clinical Endocrinologists
About the AACE. The AACE represents more than 7,000 endocrinologists in the United States and abroad. AACE is the largest association of clinical endocrinologists in the world. The majority of AACE members are certified in endocrinology, diabetes and metabolism and concentrate on the treatment of patients with endocrine and metabolic disorders including diabetes, thyroid disorders, osteoporosis, growth hormone deficiency, cholesterol disorders, hypertension and obesity. Visit  http://www.aace.com to learn more.

AACE/American College of Endocrinology Release 2016 Comprehensive Type 2 Diabetes Management Algorithm to Support Physicians In Developing a Comprehensive Care Plan
JACKSONVILLE, Florida—The American Association of Clinical Endocrinologists (AACE), in conjunction with the American College of Endocrinology (ACE), today announced the publication of its 2016 update of the AACE/ACE Comprehensive Diabetes Management Algorithm and Executive Summary as a clinical guide for physicians managing the care of patients with type 2 diabetes (T2D).

The 2016 algorithm considers new therapies, disease management approaches and key clinical data, resulting in a new section on lifestyle therapy optimization; a complications-centric model for approaches to the treatment of the overweight/obese patient, including an analysis of currently available obesity drugs; further stratification of therapy choices based on the patient’s initial A1C level; and a detailed examination of all anti-hyperglycemic, anti-hypertensive and lipid-lowering medications approved through December 2015 by the U.S. Food and Drug Administration (FDA).

The algorithm prioritizes safety in any anti-diabetic therapy in order to minimize, or avoid altogether, hypoglycemia and its serious consequences.
In promoting the development of individualized patient management plans, the algorithm offers comprehensive clinical guidance for establishing/maintaining optimal A1C and glycemic control targets, minimizing weight gain and its associated complications, and managing T2D comorbidities such as insulin resistance, macro- and microvascular complications, hypertension, cardiovascular disease and lipid disorders.
“Although the algorithm is comprehensive in nature, its presentation as an illustrated, action-driven treatment pathway should assist decision-making for physicians who are regularly challenged with managing the many facets of this disease in the most effective and safe manner,” noted Alan J. Garber, MD, PhD, FACE, chair of the AACE/ACE Comprehensive Diabetes Management Algorithm Task Force.

“This latest iteration of our algorithm provides physicians with a valuable and necessary point-of-care tool to assess the full range of critical factors that accompany diabetes and can assist in providing patient care in a concise manner,” added AACE president George Grunberger, MD, FACE.
The algorithm and accompanying executive summary are published online at https://www.aace.com/publications/algorithm and in the Volume 22, Issue 1, January 2016 issue of the association’s monthly, peer-reviewed scientific journal Endocrine Practice, http://journals.aace.com/loi/endp.

AACE Continues to Lead Efforts to Improve the Lives of Patients with Diabetes by Hosting Consortium of Experts to Address Continuous Glucose Monitoring Issues.
JACKSONVILLE, Florida—The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) is conducting the AACE/ACE  Consensus Conference on Continuous Glucose Monitoring (CGM), on Saturday, February 20, 2016 at the Hyatt Regency Capitol Hill in Washington, D.C.

The Consensus Conference is being organized to identify the evidence supporting the development of clinical recommendations for the management of patients with diabetes using CGM technology.
There is a growing body of clinical evidence that demonstrates the effectiveness of CGM in the management of diabetes and improved outcomes. Advances in CGM technology support expanded use in patient diabetes management.

This conference will assemble a group of leaders representing a spectrum of stakeholders in the diabetes technology arena including medical, scientific, and professional societies; patient and lay organizations; government; large employers; medical device industry representatives and payers, to consider gaps in knowledge and practice with use of CGM in clinical care. During the Conference, the following will be addressed:
•    Identification of patient populations who may benefit from personal and/or professional CGM use
•    Standardization of CGM reporting to facilitate consistent interpretation in clinical practice;
•    Definition of a protocol for effective analysis of CGM data for clinical utilization
•    Impact of using CGM to reduce healthcare costs associated with diabetes (e.g. severe hypoglycemic events)
•    Mechanisms to remove barriers for successful use of professional and personal CGM by patients and healthcare professionals for improved diabetes management
•    Use of CGM in the evolving healthcare environment, (e.g. PCMH, alternative payment).

At the conclusion of the Conference, a designated writing committee consisting of AACE member experts will prepare a Consensus Statement that will be published in Endocrine Practice.
For more information, visit www.aace.com.

2015 OPTIFAST® “INSPIRE” Award Celebrates Healthcare Professional
Healthcare Practitioner from Texas Celebrated for Unwavering Commitment to Patients
FLORHAM PARK, New Jersey—Nestlé Health Science recognized Christelle Leiker, Certified Nurse Practitioner, for her unwavering commitment to promoting the health and well-being of her patients. Christelle practices at the Texas Center for Obesity and General Surgery, where she runs the nonsurgical weight management program.

The OPTIFAST® “INSPIRE” award recognizes outstanding healthcare professionals for their dedication to helping patients achieve long-term weight loss and maintain a healthy, active lifestyle. These individuals devote themselves to the long-term success of their patients, taking the time to understand their unique needs and provide one-on-one support. The recipients of this award inspire patients throughout their weight loss journey by providing personalized guidance on how to best integrate the OPTIFAST Program into their everyday lives, ultimately assisting with long-term success.

Originally from South Africa, Christelle began her career more than two decades ago as a Registered Nurse when she moved to the United States. During her 16-year tenure as a Registered Nurse, Christelle developed a passion for helping people make healthy and sustainable lifestyle choices. She went on to earn a Master’s Degree in Nursing and became a licensed Family Nurse Practitioner, a specialty that allows her to manage the care of patients of all ages.

Today, Christelle sees between 15 and 30 patients a day, each of whom she offers a personalized one-on-one approach to weight management. When asked why she recommends the OPTIFAST Program to her patients, she says, “I’m a complete believer. When I see the opportunity for a patient to go on the OPTIFAST Program, I encourage it.”

To learn more about the INSPIRE award and the OPTIFAST Program, please visit www.OPTIFAST.com.

About OPTIFAST®. The OPTIFAST Program was developed in 1974 to fill the growing need to address obesity in a healthy, effective way. As diseases related to obesity became more prevalent, and more people began seeking a solution, the OPTIFAST Program was introduced as a sensible option for lifestyle transformation. The program combines support and counseling, lifestyle education, and medical monitoring with meal replacements to help people lose weight, which can in turn reduce weight-related health risks. Medical supervision is a key component of the program. The OPTIFAST Program is offered by Nestlé Health Science and is available in key markets worldwide. For more information, to see patient stories and to find a clinic, visit www.optifast.com.

About Nestlé Health Science. Nestlé Health Science, a wholly-owned subsidiary of Nestlé, is a health-science company engaged in advancing the role of nutritional therapy to change the course of health for consumers, patients and its partners in healthcare. Nestlé Health Science’s portfolio of nutrition solutions, supported variously by proprietary diagnostics and devices, targets a number of health areas, such as inborn errors of metabolism, pediatric and acute care, obesity care, healthy aging as well as gastrointestinal and brain health. Through investing in innovation and leveraging leading edge science, Nestlé Health Science brings forward innovative nutritional therapies with proven clinical, health economic value and quality of life benefits. Nestlé Health Science employs around 3,000 people worldwide and is headquartered in Epalinges (near Lausanne), Switzerland. For more information, please visit www.nestlehealthscience.us.
*The typical OPTIFAST patient loses over 50 pounds in 18-24 weeks. For many dieters, weight loss is temporary.

American Board of Obesity Medicine Review Course Added to Lineup for Obesity Medicine Association Spring Conference
Registration is now open for Obesity Medicine 2016, the spring conference of the Obesity Medicine Association (OMA), to be held April 6–10, 2016 in San Francisco, California. Attendees can earn up to 30 CME credits on the topic of obesity. OMA will also offer its Review Course for the American Board of Obesity Medicine exam at Obesity Medicine 2016. OMA’s review course had typically been offered only once each year in the fall.
“We saw ABOM’s exam application numbers rising, and we wanted to accommodate the need for high-quality exam preparation content for those physicians,” said Laurie Traetow, executive director of OMA.

Obesity Medicine 2016 provides education about the clinical application of obesity medicine that is unique for the obesity medicine practitioner. Health care professionals who attend can expect to take away practical information that can be used either in their clinics or as preparation for the ABOM certification exam.

More information about the courses offered at Obesity Medicine 2016 is available online at ObesityMedicineConference.org.

Obesity Action Coalition Welcomes Amber Huett-Garcia, MPA, as New Board Chairwoman for 2016
Tampa, FLORIDA—The OAC is pleased to welcome Amber Huett-Garcia, MPA, as Chairwoman of the Obesity Action Coalition (OAC). As a longtime supporter and advocate for the OAC, and a recipient of the 2014 OAC Chairman’s Award, Ms. Huett-Garcia has assisted greatly with the growth of the Coalition.

Ms. Huett-Garcia is a six-year post-op bariatric surgery patient who joined the OAC in 2009 after she read an infuriating news article about obesity. This article later inspired her to take action in support of the OAC’s mission.
“Who fights for people affected by the disease of obesity? I got that answer by finding the Obesity Action Coalition,” Ms. Huett-Garcia said. “The experience of millions of Americans is not just valid and important, but it’s also being ignored. It can’t continue, and the OAC has made it very loud and clear that it won’t let that happen.”

Shortly after becoming a member of the OAC, Ms. Huett-Garcia joined the Advocacy Committee, as well as several other committees, and was later invited to participate in the National Board of Directors. She is also a former Your Weight Matters National Convention Committee Chair. Outside of the OAC, Ms. Huett-Garcia currently serves as the Director of Development and Public Affairs with Teach for America in Memphis, Tennessee.

“It is such a great privilege to be a voice for our membership and individuals everywhere who are affected by obesity,” Ms. Huett-Garcia said. “Also, I believe we’re more powerful together and I’ve seen what a group of folks can do when they’re passionate and committed. We’ve got the power to create change at dramatic levels, and I can’t wait to work alongside the OAC Board, staff, and members to get things done.”

The remaining OAC National Board of Directors are as follows: Ted Kyle, RPh, MBA, Immediate-past Chairman; Georgeann Mallory, RD, Treasurer; Michelle Vicari, Secretary; Tammy Beaumont, BSN, RN, CBN; Sarah Bramblette, MSHL; Pam Davis, RN, BSN, CBN; Jaime Fivecoat, MBA; Robert Kushner, MD; Holly F. Lofton, MD; Tracy Martinez, RN, BSN, CBN; Walter Medlin, MD, FACS; Lloyd Stegemann, MD, FASMBS and Melinda J. Watman, BSN, MSN, CNM, MBA.

For more information on the OAC National Board of Directors, please visit the OAC Web site at www.ObesityAction.org.

About the OAC. The Obesity Action Coalition (OAC), a more-than 50,000 member-strong National non-profit organization, is dedicated to improving the lives of individuals affected by the disease of obesity through education, advocacy and support.

Low Vitamin D May Raise Bariatric Surgery Complication Risk
Baltimore, Maryland—Low vitamin D levels in bariatric surgery patients may raise the risk for adverse surgical outcomes, new US research suggests.
The findings were published online in Obesity Science & Practice by Leigh A Peterson, PhD, of the Johns Hopkins Center for Bariatric Surgery, Baltimore, Maryland, and colleagues.

Using nationwide inpatient data, investigators found that bariatric surgeries conducted in winter and those performed in the northern half of the country—both proxies for lower vitamin D status—were associated with higher rates of surgical complications, including dehiscence and wound infection, and longer hospital length of stay.

They note that screening patients for vitamin D status is included as part of a preoperative checklist for bariatric surgery in clinical practice guidelines cosponsored by the American Association of Clinical Endocrinologists, Obesity Society, and American Society for Metabolic & Bariatric Surgery.
Prior research by Dr. Peterson and colleagues showed that 92.9 percent of bariatric surgery candidates had insufficient levels of vitamin D (< 30 ng/mL) and 71.4 percent were vitamin D deficient (< 20 ng/mL).
Peterson cautioned that it’s not yet clear exactly what dose of vitamin D is required to produce ideal blood concentrations (which are also unknown) for optimal outcomes in bariatric surgery.

To read the full article, visit http://onlinelibrary.wiley.com/doi/10.1002/osp4.15/full.

Low-income Communities More Likely to Face Childhood Obesity
ANN ARBOR, Michigan (/PRNewswire-USNewswire)—Using a model created from data on 111,799 Massachusetts students, the University of Michigan Health System showed that as poverty rises, so does the rate of obesity among children in 68 of its public school districts.

Although obesity rates were higher among African-American and Hispanic kids, the relationship disappeared when factoring in family income, according to the study published in the journal Childhood Obesity.
Authors concluded that fewer resources like recreational programs and parks and access to full service grocery stores appear to have a greater impact on the nation’s childhood obesity rate than race.

“The findings reveal differences in the inequalities in the physical and social environment in which children are raised,” says senior author Kim A. Eagle, MD, a cardiologist and director at the University of Michigan Frankel Cardiovascular Center. “It illustrates that race and ethnicity in communities may not have a significant connection to obesity status once the community’s income is considered.”

In low-income communities where places to play and supermarkets may be scarce, it can promote consumption of low nutrition and fast food and little to no physical activity, authors say.

Among the school districts for every 1 percent increase in low-income status there was a 1.17 percent increase in rates of overweight/obese students.
Eagle and colleagues from the Michigan Clinical Outcomes Research and Reporting Program used data collected from mandated student body mass index screenings that began in Massachusetts schools in 2011.

To correlate community rates of childhood obesity with lower-income status, the percentage of students who were overweight or obese was compared with the percentage of students in each district who was eligible for free and reduced price lunch, transitional aid or food stamps.

The resulting model presented a strong argument that low-income children and adolescents are more likely to be obese than their higher income peers.
“The battle to curb childhood obesity is critically tied to understanding its causes and focusing on the modifiable factors that can lead to positive health changes for each and every child,” Eagle says.

Obesity rates among adults and children in the United States have steadily risen in the past few decades. About 18.4 percent of 12-19-year-olds are overweight or obese and childhood obesity often continues into adulthood.
There’s a 70 percent chance that an overweight adolescent will remain overweight or obese as an adult, and in the short run, obesity can lead to cardiovascular risk factors such as high blood pressure, high cholesterol, and abnormal glucose tolerance or diabetes.

Grass roots efforts are changing the tide in children’s health status. Project Healthy Schools, which was founded by Eagle 10 years ago in collaboration with public and private partners, teaches sixth grade students the importance of making healthy food choices and reducing time spent watching TV and video games.

Following the program students had lower levels of cholesterol and other blood fats.

“Ultimately, bottom-up neighborhood, school, and community engagement and education, and top-down legislative actions that will support healthier choices for adults and children, are needed to battle this health crisis,” Eagle says.

Article citation: Rogers R, Eagle TF, Sheetz A, et al. The relationship between childhood obesity, low socioeconomic status, and race/ethnicity: Lessons from Massachusetts. Child Obes. 2015;11(6):691–695.
PMID: 26562758

ConsumerMedical Enters into Agreement with Cleveland Clinic to Offer Remote Expert Opinion Services
PEMBROKE, Massachusetts (PRNewswire)—ConsumerMedical, a medical decision support and expert opinion company, announced that it will offer its members remote expert opinion services through an agreement with Cleveland Clinic, a world-class medical facility and one of America’s top five hospitals, as named by U.S. News & World Report. Through the agreement, ConsumerMedical members will have access to Cleveland Clinic’s MyConsult® program and network of highly trained, world-renowned physician specialists for second opinion services. The new service complements ConsumerMedical’s existing suite of treatment decision support services, which cover more than 1 million members at mid- to large-size employers.

Physicians in the MyConsult program review participants’ medical records and provide comprehensive, personalized reports, answer questions and offer treatment options as well as future care recommendations. Notably, physicians in the MyConsult network routinely perform online second opinion consultations as part of their day-to-day responsibilities with Cleveland Clinic, and may consult with any of their 3,000+ colleagues on second opinion cases, particularly when complex situations are presented. Physicians are available to consult in over 1,200 diagnoses, covering specialties including cardiology, orthopaedics, oncology, infertility, rheumatology, gastroenterology and bariatric surgery, urology and nephrology.

“Cleveland Clinic is pleased to offer the MyConsult service through ConsumerMedical,” says Jonathan Schaffer, MD, MBA, Managing Director, Cleveland Clinic Distance Health. “MyConsult enables patients across the country to access Cleveland Clinic expertise without leaving the comfort of home. When your health—and perhaps even your life—is at stake, we want to make sure you are making the most informed healthcare decision.”

The Cleveland Clinic program enhances ConsumerMedical’s current expert opinion services. Expert opinion is integrated within our broader Guided Patient Support solution to ensure participants receive more than a second opinion; they receive the information, support and guidance needed to make truly informed decisions about their care. ConsumerMedical facilitates the entire remote expert opinion process, including collecting necessary medical records.

To learn more, visit www.consumermedical.com/.

Renova Therapeutics Expands Robust Gene Therapy Intellectual Property Portfolio for Cardiovascular and Metabolic Disease Treatments  
SAN DIEGO, California (PRNewswire-USNewswire)—Renova™ Therapeutics, a biopharmaceutical company developing gene therapy treatments for congestive heart failure and other chronic diseases, has obtained an exclusive worldwide license to several patents from the nonprofit Research Development Foundation (RDF). This group of patents adds to Renova Therapeutics’ extensive intellectual property portfolio in the cardiovascular and metabolic disease space, paving the way for its paracrine gene therapy product pipeline.

RDF and Renova Therapeutics have entered into a worldwide exclusive license agreement for RDF’s portfolio of urocortin and stresscopin genes, as well as select peptides and proteins. The company intends to explore use of this family of genes to create treatments for sufferers of cardiovascular and metabolic diseases, including one of the world’s most common, fatal and expensive chronic diseases—type 2 diabetes. The incidence of type 2 diabetes is staggering and growing rapidly, with 27.6 million people in the United States and approximately 370 million people around the world1 living with this debilitating disease.

“This agreement with RDF enables us to expand our pioneering research in gene therapy for CHF, type 2 diabetes and other metabolic diseases,” says Jack W. Reich, PhD., CEO and Co-Founder of Renova Therapeutics. “We have reason to believe that these genes, using our paracrine gene therapy approach, will have a profoundly positive effect on patient healthcare in years to come.”

Renova Therapeutics’ paracrine gene therapy treatments are based on a novel systemic approach that introduces therapeutic genes capable of directing the body’s cells to work more normally. This single-IV-injection approach is a foundation for future products that have the potential to bring about permanent improvements in congestive heart failure and type 2 diabetes patients.

The company’s paracrine gene therapy approach was developed by Dr. H. Kirk Hammond, Professor of Medicine, University of California, San Diego, a cardiologist at the San Diego Veterans’ Affairs Healthcare System, and co-founder of Renova Therapeutics. This approach involves sustained activity following systemic delivery of the therapeutic gene to the blood and distribution to other organs, where it can exert beneficial effects on target organs from a distance.

Paracrine gene therapy has been shown to dramatically improve animal models of type 2 diabetes and other chronic diseases, including fatty liver disease and obesity. In proof-of-concept studies, after type 2 diabetes was established in animal models, a single dose of the paracrine gene therapy normalized these animals. In similar protocols in which animals were dosed initially prior to being fed a high-fat diet, treated animals did not develop type 2 diabetes in their lifetime—signaling a potential for a preventative therapy.
Reference: 1. http://www.idf.org/diabetesatlas

Visit www.renovatherapeutics.com to learn more.

Category: News and Trends, Past Articles

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