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Concept: Medicine

488

Background Long-term results from randomized, controlled trials that compare medical therapy with surgical therapy in patients with type 2 diabetes are limited. Methods We assessed outcomes 5 years after 150 patients who had type 2 diabetes and a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 27 to 43 were randomly assigned to receive intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The primary outcome was a glycated hemoglobin level of 6.0% or less with or without the use of diabetes medications. Results Of the 150 patients who underwent randomization, 1 patient died during the 5-year follow-up period; 134 of the remaining 149 patients (90%) completed 5 years of follow-up. At baseline, the mean (±SD) age of the 134 patients was 49±8 years, 66% were women, the mean glycated hemoglobin level was 9.2±1.5%, and the mean BMI was 37±3.5. At 5 years, the criterion for the primary end point was met by 2 of 38 patients (5%) who received medical therapy alone, as compared with 14 of 49 patients (29%) who underwent gastric bypass (unadjusted P=0.01, adjusted P=0.03, P=0.08 in the intention-to-treat analysis) and 11 of 47 patients (23%) who underwent sleeve gastrectomy (unadjusted P=0.03, adjusted P=0.07, P=0.17 in the intention-to-treat analysis). Patients who underwent surgical procedures had a greater mean percentage reduction from baseline in glycated hemoglobin level than did patients who received medical therapy alone (2.1% vs. 0.3%, P=0.003). At 5 years, changes from baseline observed in the gastric-bypass and sleeve-gastrectomy groups were superior to the changes seen in the medical-therapy group with respect to body weight (-23%, -19%, and -5% in the gastric-bypass, sleeve-gastrectomy, and medical-therapy groups, respectively), triglyceride level (-40%, -29%, and -8%), high-density lipoprotein cholesterol level (32%, 30%, and 7%), use of insulin (-35%, -34%, and -13%), and quality-of-life measures (general health score increases of 17, 16, and 0.3; scores on the RAND 36-Item Health Survey ranged from 0 to 100, with higher scores indicating better health) (P<0.05 for all comparisons). No major late surgical complications were reported except for one reoperation. Conclusions Five-year outcome data showed that, among patients with type 2 diabetes and a BMI of 27 to 43, bariatric surgery plus intensive medical therapy was more effective than intensive medical therapy alone in decreasing, or in some cases resolving, hyperglycemia. (Funded by Ethicon Endo-Surgery and others; STAMPEDE ClinicalTrials.gov number, NCT00432809 .).

Concepts: Medicine, Diabetes mellitus, Obesity, Surgery, Body mass index, Bariatric surgery, Gastric bypass surgery, Bariatrics

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Physical activity (PA) has an established favorable impact on cardiovascular disease (CVD) outcomes and quality of life. In this study, we aimed to estimate the economic effect of moderate-vigorous PA on medical expenditures and utilization from a nationally representative cohort with and without CVD.

Concepts: Medicine, Disease, Life, Cardiovascular disease, Economics, Non-infectious disease, Cost

468

Population-based studies have consistently shown that our diet has an influence on health. Therefore, the aim of our study was to analyze differences between different dietary habit groups in terms of health-related variables. The sample used for this cross-sectional study was taken from the Austrian Health Interview Survey AT-HIS 2006/07. In a first step, subjects were matched according to their age, sex, and socioeconomic status (SES). After matching, the total number of subjects included in the analysis was 1320 (N = 330 for each form of diet - vegetarian, carnivorous diet rich in fruits and vegetables, carnivorous diet less rich in meat, and carnivorous diet rich in meat). Analyses of variance were conducted controlling for lifestyle factors in the following domains: health (self-assessed health, impairment, number of chronic conditions, vascular risk), health care (medical treatment, vaccinations, preventive check-ups), and quality of life. In addition, differences concerning the presence of 18 chronic conditions were analyzed by means of Chi-square tests. Overall, 76.4% of all subjects were female. 40.0% of the individuals were younger than 30 years, 35.4% between 30 and 49 years, and 24.0% older than 50 years. 30.3% of the subjects had a low SES, 48.8% a middle one, and 20.9% had a high SES. Our results revealed that a vegetarian diet is related to a lower BMI and less frequent alcohol consumption. Moreover, our results showed that a vegetarian diet is associated with poorer health (higher incidences of cancer, allergies, and mental health disorders), a higher need for health care, and poorer quality of life. Therefore, public health programs are needed in order to reduce the health risk due to nutritional factors.

Concepts: Health care, Medicine, Public health, Health, Nutrition, Socioeconomic status, Diet, Carnivore

445

Electronic cigarettes (e-cigarettes) are generally recognized as a safer alternative to combusted tobacco products, but there are conflicting claims about the degree to which these products warrant concern for the health of the vapers (e-cigarette users). This paper reviews available data on chemistry of aerosols and liquids of electronic cigarettes and compares modeled exposure of vapers with occupational safety standards.

Concepts: Medicine, Smoking, Tobacco, Cigarette, Nicotine, Electronic cigarette, Propylene glycol, Cigarettes

439

Antiaging therapies show promise in model organism research. Translation to humans is needed to address the challenges of an aging global population. Interventions to slow human aging will need to be applied to still-young individuals. However, most human aging research examines older adults, many with chronic disease. As a result, little is known about aging in young humans. We studied aging in 954 young humans, the Dunedin Study birth cohort, tracking multiple biomarkers across three time points spanning their third and fourth decades of life. We developed and validated two methods by which aging can be measured in young adults, one cross-sectional and one longitudinal. Our longitudinal measure allows quantification of the pace of coordinated physiological deterioration across multiple organ systems (e.g., pulmonary, periodontal, cardiovascular, renal, hepatic, and immune function). We applied these methods to assess biological aging in young humans who had not yet developed age-related diseases. Young individuals of the same chronological age varied in their “biological aging” (declining integrity of multiple organ systems). Already, before midlife, individuals who were aging more rapidly were less physically able, showed cognitive decline and brain aging, self-reported worse health, and looked older. Measured biological aging in young adults can be used to identify causes of aging and evaluate rejuvenation therapies.

Concepts: Medicine, Death, Senescence, Biology, Population, Gerontology, Ageing, Aging

415

To describe the average primary care physician consultation length in economically developed and low-income/middle-income countries, and to examine the relationship between consultation length and organisational-level economic, and health outcomes.

Concepts: Medicine, Economics, Social sciences, Primary care physician

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We want to clarify, given recent concern about our policy, that the Journal is committed to data sharing in the setting of clinical trials. As stated in the Institute of Medicine report from the committee(1) on which I served and the recent editorial by the International Committee of Medical Journal Editors (ICMJE),(2) we believe there is a moral obligation to the people who volunteer to participate in these trials to ensure that their data are widely and responsibly used. Journal policy will therefore follow that outlined in the ICMJE editorial and the IOM report: when appropriate systems are in place, . . .

Concepts: Medicine, Avicenna, ClinicalTrials.gov

408

A new wave of portable biosensors allows frequent measurement of health-related physiology. We investigated the use of these devices to monitor human physiological changes during various activities and their role in managing health and diagnosing and analyzing disease. By recording over 250,000 daily measurements for up to 43 individuals, we found personalized circadian differences in physiological parameters, replicating previous physiological findings. Interestingly, we found striking changes in particular environments, such as airline flights (decreased peripheral capillary oxygen saturation [SpO2] and increased radiation exposure). These events are associated with physiological macro-phenotypes such as fatigue, providing a strong association between reduced pressure/oxygen and fatigue on high-altitude flights. Importantly, we combined biosensor information with frequent medical measurements and made two important observations: First, wearable devices were useful in identification of early signs of Lyme disease and inflammatory responses; we used this information to develop a personalized, activity-based normalization framework to identify abnormal physiological signals from longitudinal data for facile disease detection. Second, wearables distinguish physiological differences between insulin-sensitive and -resistant individuals. Overall, these results indicate that portable biosensors provide useful information for monitoring personal activities and physiology and are likely to play an important role in managing health and enabling affordable health care access to groups traditionally limited by socioeconomic class or remote geography.

Concepts: Health care, Medicine, Epidemiology, Cancer, Physiology, Sociology, Arthritis, Ibn al-Nafis

408

The usefulness of aspirin to defend against cardiovascular disease in both primary and secondary settings is well recognized by the medical profession. Multiple studies also have found that daily aspirin significantly reduces cancer incidence and mortality. Despite these proven health benefits, aspirin use remains low among populations targeted by cardiovascular prevention guidelines. This article seeks to determine the long-term economic and population-health impact of broader use of aspirin by older Americans at higher risk for cardiovascular disease.

Concepts: Medicine, Epidemiology, Disease, Death, Demography, United States, Economics, Aspirin