Session Briefs

Keynote Lecture 1:
Weight and the Health of the Population

Katherine M. Flegal, PhD

In the United States and elsewhere in the world, the body weights of both children and adults have increased over the past several decades.  The distribution of body weight has become more skewed with marked increases at the higher levels.  The reasons for these increases are not completely clear, and it appears at present that these increases in weight may be leveling off. 

The impact of these changes in weight on population health also are not completely clear.  At the same time that weight has increased, cardiovascular disease mortality rates have fallen and life expectancy has increased.  Levels of several cardiovascular risk factors have improved and the prevalence of hypertension has decreased, but the prevalence of diabetes has increased.  Factors other than weight may be more important determinants of some of these health outcomes, and the associations of weight with mortality may vary considerably by cause of death.  The relation of body weight to mortality and morbidity is complex and the health effects of population changes in body weight are not always predictable. 

Keynote Lecture 2:
Diabetes and the Metabolic Syndrome and Their Impact on Cardiovascular Disease

Barbara V. Howard, PhD

Prevalence rates of diabetes and cardiovascular disease (CVD) are increasing throughout the world. Diabetes is preceded by insulin resistance, which is manifest clinically as a constellation of risk factors referred to as the metabolic syndrome (MS).  Diabetes is a strong independent risk factor for CVD; since rates of diabetes are rising it is becoming an increasingly important determinant of CVD, with diabetic patients accounting for half of all hospital admissions for CVD in some regions.  Reasons for the increase in CVD in diabetic individuals include higher occurrence of CVD risk factors such as hypertension and dyslipidemia as well as diabetes-specific metabolic changes that confer CVD risk such as renal disease, inflammation and cardiac dysfunction.  Individuals with MS generally have abdominal obesity, higher triglycerides or lower HDL, hypertension, and altered gylcemia, and MS occurs more frequently in populations with higher rates of diabetes.  MS is a strong predictor of diabetes, and it is also a risk factor for CVD in itself and because it leads to diabetes.  There are multiple therapeutic agents available to treat diabetes and the risk factors associated with MS, and many have been shown to reduce the risk for CVD.  Both diabetes and CVD risk factors can be controlled and prevented by lifestyle changes such as weight reduction and increasing physical activity, and it is only through the latter strategies that the worldwide epidemics of diabetes and CVD will be reversed. 

Writing Workshop 1A:
So You Want to Be an Author: How to Write and Read an Article 

Catherine DeAngelis, MD, MPH

Biomedical publication is the primary method for disseminating medical research findings and new clinical discoveries, and is perhaps the important method for communicating medical information among academicians, practicing physicians, and other health care professionals. This workshop will provide practical information and insights about the scientific publication process, including guidelines for manuscript preparation, selection of a target journal, the peer review and editorial decision-making processes, and interactions with biomedical journals.

Writing Workshop 1B:
So You Want to Be an Author: How to Write and Read an Article (expert consultation)

Phil Fontanarosa, MD, MBA

Biomedical publication is the primary method for disseminating medical research findings and new clinical discoveries, and is perhaps the important method for communicating medical information among academicians, practicing physicians, and other health care professionals. This session will allow participants to ask questions about their research or any publication-related issues. Participants are encouraged to bring their papers for the discussion; however this is NOT a paper critique session.

SIG Seminar 1:
The ‘Economics’ of Diabetes

Barbara V. Howard, PhD

Because of its increasing prevalence, diabetes is having a major impact on health care costs.  In the USA, the direct costs for diabetic patients are four times greater than for patients without diabetes (US$85 billion/yr.); indirect costs—i.e. , those that include loss of wages, productivity, and premature mortality—are estimated at US$138 billion/yr.   In the EU countries, annual costs per patient per year have averaged almost €3000.  Of the direct costs, about 1/3 represents ambulatory care and the remainder are hospitalization costs. Drugs are a major source of costs, which include costs for hypoglycemic agents as well as cardiovascular, anti-infective, and gastrointestinal drugs.   As complications develop, costs for care increase, with the most expensive complication being end-stage renal disease followed by cardiovascular disease and eye problems.

A number of analyses have examined the cost effectiveness of both therapeutic and preventive strategies.  The incremental costs of intensive treatment can be computed, and the projected benefits are computed in terms of quality adjusted life years (QUALY) gained.  In the USA, it is estimated that the cost effectiveness for treating diabetes is US$20K/QUALY gained.  The UKPDS and DCCT trials estimated the cost effectiveness of preventing CVD and diabetes, respectively; these data can be translated into costs for planning prevention programs in a variety of populations and health care settings.  Work must continue to define cost-effective strategies for prevention of both diabetes, and treatment of diabetes to enhance quality of life and prevent complications. 

SIG Seminar 2:
Practical Considerations in Setting Public Health Guidelines

Xavier Pi-Sunyer, MD, MPH

Guidelines are promulgated to improve health care in a population.  In clinical medicine, they will be treatment and prevention guidelines.  In public health, they will be guidelines for policy to improve population health.  Guidelines need to be evidence-based in order to gain acceptance by health professionals and policy makers.  Developing guidelines can be difficult because evidence for making recommendations is often incomplete.  But it is important to set goals so that public health departments have coherent plans for strategic action.  Guidelines however need to be continually evaluated.  It is necessary to monitor results at the physicians’ offices, clinics, and the population at large as they are being used.  Comments for improvement from those who are using the guidelines should be welcomed. Continual assessment is necessary.  Guidelines need to be changed as more definitive evidence becomes available. 

SIG Seminar 3:
What Does It Take to Run a Clinical Trial in a Hospital Setting?—Resources, Process, and Values

Christopher D. Saudek, MD

Since the 1960s, in the USA there has been a federal grant program called “General Clinical Research Centers” (GCRC), now going by another name.  The National Institutes of Health funding is to universities, the mission being to provide an optimal setting for in-patient and out-patient clinical research.

The GCRCs support the research of many investigators, in many fields of clinical research.  Both investigator-initiated and industry-initiated studies can use the facilities.  In-patients can be admitted for research purposes, and out-patients can be seen in clinic space by a trained research staff.

Considerable resources are needed to support the implementation of research studies, especially those requiring hospitalization.  Trained study coordinators, research nurses, and frequently research labs or imaging resources are necessary.  But before a study ever gets started, we believe that it must be reviewed by qualified, independent peers in two distinct areas: protection of human subjects, and scientific merit.  Human subjects review is done by the Institutional Review Board, in a formal process that has been increasingly tightened, increasingly scrutinized.  Scientific merit is harder to quantify and assure.  Our approach has been to have faculty peers formally review each proposed protocol for significance, feasibility study design, and analytic plan.  In scientific review, rather than simply accept or reject, the faculty committee works with investigators in an iterative process, to improve their study protocol.  The object is to have, before the study starts, optimal human subjects and scientific validity.

SIG Seminar 4:
Maximizing the utility of large national cohort databases

Katherine M. Flegal, PhD

In the United States, repeated cross-sectional representative national survey data are available beginning in 1960.  These surveys cover a wide range of health topics and include questionnaire, examination, and laboratory data.  Although these samples are designed for the purpose of producing national estimates of specific conditions, their utility has extended well beyond that objective.  These data can be used to construct national reference data, such as growth charts for U.S. children.  In addition, numerous epidemiologic topics can be addressed using these data.  Successive surveys can be used to track trends in the US population.  With the addition of mortality data, the associations of risk factors with mortality outcomes can be addressed.  Advances in software and in estimation methods for complex survey data have allowed for improved statistical estimation procedures.   A key factor in maximizing the utility of such data bases is allowing the data to be made publicly available so that a wide variety of researchers from all over the world can make use of the data.

Keynote Lecture 3:
Assessing Glycemia in Diabetes

Christopher D. Saudek, MD

Assessment of glycemia is essential in managing diabetes and is not always easy.  Symptoms of hyperglycemia (polydypsia, polyuria, weight loss, fatigue) and testing urine glucose are crude methods and very insensitive. Random blood glucose (BG) and fasting BG are only somewhat more representative, since BG is a continuously varying parameter.  Self-monitoring of blood glucose (SMBG) and periodic measurement of Hemoglobin A1c (HbA1c) are the preferred methods to assess glycemia.

SMBG allows patients to know their BG anytime, anywhere.  Patients are empowered by the ability to relate symptoms of high or low to an actual BG number; they are able to discern patterns throughout the day; they can see the effects of their own self-care (nutrition, exercise, stress, illness).  Recommended timing and frequency of SMBG, as well as options for downloading SMBG results, will be discussed.

HbA1c reflects glycemia over the previous 3-4 months, providing information that is quite different from SMBG.  There are confounding issues, particularly altered erythrocyte lifespan, but a recent international study confirmed the tight correlation between average BG and HbA1c.  A new HbA1c “anchor” method, changes in how results are reported, the venerable question of “how low should you go?”, whether BG variability matters, and potential use of HbA1c in screening and diagnosis, all will be discussed.

Keynote Lecture 4:
An Integrative Approach to Childhood Obesity

David Ludwig, MD, PhD

Excessive body weight has become the most common chronic medical condition of childhood, with prevalence rates of 1 in 3 among the general population and an astounding 1 in 2 among some minority groups. Obesity in children increases the risk of many immediate and in some cases life-threatening complications, including type 2 diabetes, fatty liver, and sleep apnea.

Despite recent widespread attention to the problem, the treatment of childhood obesity remains largely ineffectual. A likely explanation for this situation is that conventional approaches tend to focus on just one determinant of body weight, whereas the cause of obesity is multi-dimensional in nature. The most powerful behavioral modification methods will likely fail, if they promote a dietary plan that exacerbates hunger and adversely affects metabolism.  Conversely, the best possible diet will produce little practical benefit, if people lack the motivation to follow it. Moreover, the effectiveness of all diet and behavioral change programs are undermined by what has increasingly become a “toxic environment.”

Ultimately, successful long-term treatment of childhood obesity will require an integrative approach, focusing on three key factors: 1) Biology – including a low glycemic load diet and an activity plan that works with, rather than against, the underlying physiological mechanisms governing body weight. 2) Behavior – providing parents with age-appropriate tools to guide their children toward healthful lifestyle habits, without causing conflict. 3) Environment – for now, the family remains the last bastion of protection for children in a world seemingly designed to make them fat.  However, families can come together, uniting with health care providers, teachers and others, to create a social environment that truly values the wellbeing of our children.

Keynote Lecture 5:
Identifying Individuals at Risk of Diabetes and Its Complications in Asia

Tai E-Shyong, MB, ChB

It has been suggested that the phenotype associated with type 2 diabetes mellitus in Asia may differ from that observed in other populations.  Our studies in Singapore suggest that the major risk factors for diabetes mellitus in Asian populations are similar to those in developed countries.  Obesity is a prominent feature.  However, it does appear that Asians develop diabetes at lower levels of obesity than Western populations.  One reason is that the relationship between anthropometric measures and fat mass differs between ethnic groups.  Thus, despite the lower body mass index, the degree of adiposity associated with diabetes is similar in our populations compared other populations.  It is also possible that Asians suffer metabolic sequelae at lower levels of adiposity.  However, there is little evidence to support of this.  Ethnicity also has an impact on susceptibility to diabetes mellitus.

Despite undergoing rapid urbanization over a very similar period, Chinese Malays and Asian Indians living in Singapore exhibit marked differences in susceptibility to type 2 diabetes mellitus.  Emerging data suggests that the phenotypes associated with type 2 diabetes mellitus also differs between ethnic groups.  Finally, it is becoming evident that the different ethnic groups may also exhibit differences in the patterns of complications associated with type 2 diabetes mellitus such as coronary artery disease and nephropathy.  The pathophysiologic bases for these ethnic differences remain unclear.  An understanding of these differences may help us understand the pathogenesis of type 2 diabetes mellitus and its complications.

Keynote Lecture 6:
Surgical Approaches to Obesity, Diabetes, and the Metabolic Syndrome

David Flum, MD, MPH

The twin, worldwide epidemics of obesity and diabetes will be the most dominant feature in population healthcare and healthcare costs.  Classic approaches to obesity routinely fail to effect long-term weight loss, and standard approaches to diabetes relegate it to a chronic disease with little hope for a "cure."  While surgery offers both significant / sustained weight loss and dramatic improvements of most patients' diabetes, the appropriate role of surgery in the treatment of obesity and obesity-related conditions can only be appreciated through a comprehensive evaluation of its safety, effectiveness and long-term impact on survival.  From a health system perspective, the health economic implications of bariatric surgery and surgical approaches to obesity are complex given the long-term competing costs of non-surgical care.  A framework is proposed to guide healthcare systems trying to tackle this complex problem.

Keynote Lecture 7:
Early Retinal Vascular Changes as Biomarkers of Diabetes and Its Complications

Wong Tien Yin, FRCSE, FRANZCO, PhD

The retina can be viewed directly and offers us the unique opportunity to study blood vessels in the human body in a non-invasive manner. Using new cameras and computer imaging techniques, subtle changes to the retinal blood vessels can now be measured precisely. In the last 5-10 years, studies conducted in large numbers of people with and without diabetes have shown that early damage seen in the retinal blood vessels (e.g., isolated retinopathy signs, changes in vascular caliber) is an indicator of the risk of diabetes and its complications, including cardiovascular disease and kidney failure. There is also emerging evidence to suggest that early retinal complications may share common genetic linkages with systemic vascular diseases. The literature therefore supports the theory that early retinal vascular damage reflects widespread microcirculatory disease not only in the eye but also vital organs elsewhere in the body, and that a retinal photographic scan may allow physicians to quantify vascular risk and predict diabetes complications years before they develop and independent of traditional methods.

Keynote Lecture 8:
Current Insulin Strategies for Type 2 Diabetes

Irl B. Hirsch, MD

One of the primary defects in type 2 diabetes is a progressive loss of β-cell function over time. This obviously results in an increased need for insulin therapy to control glycemia over time. It is ironic that insulin therapy in the United States is low compared to other countries.  While the plethora of new agents to treat type 2 diabetes may be part of the reason for this, the more important reason is the lack of understanding and intimidation many clinicians have regarding insulin therapy.

Insulin strategies do not need to be complicated. There are only three functional insulin components: basal, prandial, and correction-dose insulin. Furthermore, there are only two types of insulin regimens: non-physiologic, usually consisting of only basal insulin, and physiologic, consisting of both basal and prandial insulin. When starting insulin for a patient with type 2 diabetes, the best way to know if a non-physiologic or physiologic regimen is required is by knowing the baseline A1C level. In general, when the A1C is above 8.5 or 9%, it is unlikely basal insulin by itself will get the patient to target.

While the long-acting insulin analogues (insulin glargine and detemir) are clearly basal insulins, and the rapid-acting analogues (lispro, aspart and glulisine) are used for prandial replacement, the two human insulins still in use (NPH and regular insulin) actually have components of both basal and prandial insulins. Except for insulin pump therapy in type 1 diabetes, the main advantage of using the analogues is the consistent reporting of less hypoglycemia with the analogues.

There is no consensus on which of the oral agents should be continued once insulin therapy is started. With the use of basal insulin alone, my bias is to continue sulfonylureas and metformin, while with both basal insulin and meal-time insulin I discontinue the sulfonylurea. Due to the added risk of fluid retention and weight gain with thiazolidinediones used with insulin therapy, I suggest stopping these agents completely when any insulin is initiated.

The most common mistake made with insulin therapy is using basal insulin to replace prandial needs. This occurs when it is not appreciated that bedtime glucose levels are quite high, yet the bedtime basal insulin is used to titrate the fasting blood glucose to normal. By appreciating the high bedtime glucose and preventing that with dinner-time insulin, this problem can be prevented altogether.

Keys for success with prandial insulin include enough home blood glucose monitoring to understand how much is needed to both correct the hyperglycemia and learn how much insulin is required for a given type of food or meal. The timing of the insulin in relation to the beginning of the meal is also critical. Even the rapid-acting analogues require 10-15 minutes of “lag time,” or time between insulin injection and food intake.

Pre-mixed insulin is an option for patients requiring meal-time insulin. In general, these insulins work best with only modest insulin deficiency. The main problem with these insulins is lack of flexibility when a different amount of carbohydrate intake is anticipated or for correction dose when the blood glucose is above target.

Writing Workshop 2A:
So You Want to Be an Author: How to Write and Read an Article (expert consultation)

Catherine DeAngelis, MD, MPH

Biomedical publication is the primary method for disseminating medical research findings and new clinical discoveries, and is perhaps the important method for communicating medical information among academicians, practicing physicians, and other health care professionals. This session will allow participants to ask questions about their research or any publication-related issues. Participants are encouraged to bring their papers for the discussion; however this is NOT a paper critique session.

Writing Workshop 2B:
So You Want to Be an Author: How to Write and Read an Article

Phil Fontanarosa, MD, MBA

Biomedical publication is the primary method for disseminating medical research findings and new clinical discoveries, and is perhaps the important method for communicating medical information among academicians, practicing physicians, and other health care professionals. This workshop will provide practical information and insights about the scientific publication process, including guidelines for manuscript preparation, selection of a target journal, the peer review and editorial decision-making processes, and interactions with biomedical journals.  

SIG Seminar 5:
Why Diabetes Goes Away after Bariatric Surgery 

David Flum, MD, MPH

For most diabetics who have bariatric surgery, all measures of diabetes are either improved or effectively reversed before they leave the hospital after their operation.  The effect of diabetes reversal occurring before weight loss has taken place has challenged our understanding of diabetes.  In fact, the study of surgical approaches to obesity and its impact on diabetes has opened up a golden era in the study of gut hormones that many believe will be as important as the discovery of insulin.  This session will explore the competing theories about why diabetes goes away after gastrointestinal surgery and present the available evidence for each theory.  The underlying mechanism of effect has direct implications on the development of drug-based therapy and other less invasive approaches to achieve these outcomes without surgery.   

SIG Seminar 6:
Strategies to Reduce Diabetes Complications

Irl B. Hirsch, MD

The primary prevention for microvascular and neuropathic complications is aggressive treatment of blood glucose. In type 1 diabetes, it appears the critical time is in the first 10 to 15 years after diagnosis. It is unclear what the impact of meticulous control has after longer duration of disease. While this is also true for type 2 diabetes, it is unfortunate that by the time asymptomatic patients are diagnosed, microvascular and neuropathic complications may already be present. Aggressive glucose control does not seem to have as much impact once the complications are advanced.

To date, the only data to convincingly show meticulous glucose control has an impact on macrovascular disease has been shown in type 1 diabetes with the follow-up of the Diabetes Control and Complications Trial. Only 6.5 years of improved control early in the course of diabetes resulted in a 57% reduction of macrovascular events 18 years after the study started. The data are much less clear for type 2 diabetes, although the STENO-2 study did show that control of glucose, blood pressure, and LDL-cholesterol resulted in an improvement of cardiovascular events. It is safe to say that hyperglycemia by itself is not as strong of a risk factor for a cardiovascular event compared to blood pressure or cholesterol reduction.

After considering control of hyperglycemia, the following summarizes what strategies can prevent or treat the various complications:

1. Retinopathy. Clearly, hypertension control reduces progression of retinopathy, and the data suggests that ACE inhibitors may have more protection than other agents. The most important service a primary care provider can do is ensure all patients have a formal dilated eye exam by someone expert in diabetic retinopathy.
2. Nephropathy. Both ACE inhibitors and ARBs appear to have additional benefit compared to other agents to slow the progression of nephropathy. BP goal is < 120/75. The combination of ACE inhibitors with ARBs or aldosterone antagonists also appears to be beneficial. Low-protein diets may be helpful but are difficult to implement for many.
3. Painful symmetrical polyneuropathy. A variety of different agents are used, and it is difficult to predict which patient will respond to which drug.
4. Cardiovascular disease. Blood pressure control to 130/80, and ACE inhibitors may afford more protection than other hypertensive agents. It is recommended that most adults over the age of 40 years be placed on a statin with the goal LDL-C to be less than 100 mg/dL. For those with known vascular disease LDL-C should be optimally reduced to less than 70 mg/dL. Unless there is a contraindication, adults over the age of 40 years should receive 81-325 mg/day of aspirin.

SIG Seminar 7:
Tackling Childhood Obesity–Issues in Designing an Intervention Program

David Ludwig, MD, PhD

Using an interactive format, we will discuss the theoretical issues and practical challenges involved in setting up a pediatric obesity treatment program. 

SIG Seminar 8:
Establishing a Successful Business Model for Chronic Care

Norman Chan, FRCP, MD

Chronic diseases consume a large proportion of health care resources worldwide. Take type 2 diabetes as an example, the prevalence of this condition has increased sharply in Asia over recent years. This has placed significant strain on the health care system in most countries across Asia. Setting up a good business model for diabetes care will help prevention of diabetes complications in a sustained manner over the long term. The many barriers in quality diabetes care delivery lie far beyond the solutions of clinical competency and good intention of physicians. The magnitude and multi-faceted nature of the disease warrants restructuring of the care organization to redefine health care provider roles and responsibilities in a diabetes care team to ensure the most cost-effective use of finite resources. The silent nature and complications of diabetes compel health care providers to better understand their patients' values and perceived barriers in changing lifestyles and adhering to long-term therapy. Furthermore, marked differences exist in culture, beliefs, and mentality across different countries in Asia, which hampers delivery of evidence-based medicine for chronic diseases. High-quality data are needed to convince policy makers or health care payers regarding long-term benefits in preventive care.

Keynote Lecture 9:
Management of Type 2 Diabetes in Asia: Translating Research into Clinical Practice

Norman Chan, FRCP, MD

Prevalence of diabetes and its complications continue to increase worldwide and especially in Asia, in spite of a wealth of evidence confirming the beneficial effects of pharmacological treatment on reducing cardiovascular and renal events in diabetic patients and lifestyle modification in preventing the onset of diabetes in high risk subjects,. There are many barriers in the delivery of quality diabetes care, the solution of which lies far beyond the clinical competency and good intention of physicians. Given the size of the problem and multi-faceted nature of the disease, restructuring of the care organization is needed to better define roles and responsibilities of different health care providers in a diabetes care team to avoid gaps and overlaps and to ensure the most cost-effective use of finite resources. Due to the silent nature of diabetes and its complications, health care providers also need to better understand their patients’ values and perceived barriers in changing lifestyles and adhering to long-term therapy. Finally, high-quality data are needed to convince the policy makers or health care payers (such as insurance companies or corporations or patients themselves) regarding the long-term benefits of investing in preventive care.

In the Steno Type 2 Diabetes Study, patients treated to target using a multidisciplinary team have 50-70% risk reduction in the development of micro and macrovascular complications. After the completion of the DCCT, there was progressive increase in HbA1c in type 1 diabetic patients previously treated intensively, highlighting the importance of continuous surveillance and reinforcement in patients with chronic diseases. In a 2-year randomized study, patients receiving multiple medications, 50% of them having diabetes, periodic telephone call by a pharmacist was associated with improved compliance and better survival. Similarly, type 2 diabetic patients managed in clinical trials had better survival and reduced incidence of cardiovascular and renal outcomes compared to those receiving usual care.

To turn these results into reality, local champions are needed to develop clinical protocols, which are relevant and feasible to their health care settings and cultures, and to initiate dialogues to gain support from other health care professionals and stakeholders, including policy makers to implement these protocols. These include not only reorganization of existing health care systems with appropriate financing but also introduction of coordinated publicity program to raise societal awareness and targeted screening. To achieve these combined goals of early diagnosis, risk stratification, treatment to target and patient empowerment, participation from policy makers, health care organizations, insurance companies and industry are needed. In Hong Kong, limited success is being observed in how a prototype developed in a regional hospital has gradually influenced care processes in other hospital and community settings. Innovative care models involving academia and private health care company and possibly insurance companies may also provide an alternative solution to the current impasse situation in chronic disease management.

Keynote Lecture 10:
The Relation of Fat Distribution to Metabolic and Cardiovascular Risk

Xavier Pi-Sunyer, MD, MPH