Metformin and carotid intima-media thickness in never-smokers with type 1 diabetes: The REMOVAL trial.

AIM: To determine whether metformin's effects on carotid artery intima-media thickness (cIMT) in type 1 diabetes differ according to smoking status. METHODS: Regression model effect estimates for the effect of metformin versus placebo (double-blind) on carotid IMT were calculated as a subgroup analysis of the REMOVAL trial. RESULTS: In 428 randomized participants (227 never-smokers, 201 ever-smokers), averaged mean carotid IMT progression (per year) was reduced by metformin versus placebo in never-smokers (-0.012 mm, 95% CI -0.021 to -0.002; p = .0137) but not in ever-smokers (0.003 mm, 95% CI -0.008 to 0.014; p = .5767); and similarly in non-current smokers (-0.008 mm, 95% CI -0.015 to -0.00001; p = .0497) but not in current smokers (0.013 mm, 95% CI -0.007 to 0.032; p = .1887). Three-way interaction terms (treatment*time*smoking status) were significant for never versus ever smoking (p = .0373, prespecified) and non-current versus current smoking (p = .0496, exploratory). Averaged maximal carotid IMT progression (per year) was reduced by metformin versus placebo in never-smokers (-0.020 mm, 95% CI -0.034 to -0.006; p = .0067) but not in ever-smokers (-0.006 mm, 95% CI -0.020 to 0.008; p = .4067), although this analysis was not supported by a significant three-way interaction term. CONCLUSIONS: This subgroup analysis of the REMOVAL trial provides additional support for a potentially wider role of adjunct metformin therapy in cardiovascular risk management in type 1 diabetes, particularly for individuals who have never smoked cigarettes.

Metformin in adults with type 1 diabetes: Design and methods of REducing with MetfOrmin Vascular Adverse Lesions (REMOVAL): An international multicentre trial.

AIMS: Cardiovascular (CV) disease is a major cause of reduced life expectancy in type 1 diabetes (T1D). Intensive insulin therapy prevents CV complications but is constrained by hypoglycaemia and weight gain. Adjunct metformin reduces insulin dose requirement and stabilizes weight but there are no data on its cardiovascular effects. We have therefore initiated an international double-blind, randomized, placebo-controlled trial (REMOVAL: REducing with MetfOrmin Vascular Adverse Lesions in type 1 diabetes) to examine whether metformin reduces progression of atherosclerosis in adults with T1D. Individuals ≥40 years of age with T1D for ≥5 years are eligible if they have ≥3 of 10 specified CV risk factors. The enrolment target is 500 participants in 17 international centres. MATERIALS AND METHODS: After 12 weeks of single-blind placebo-controlled run-in, participants with ≥ 70% adherence are randomized to metformin or matching placebo for 3 years with insulin titrated towards HbA1c 7.0% (53 mmol/mol). The primary endpoint is progression of averaged mean far wall common carotid intima-media thickness (cIMT) measured by ultrasonography at baseline, 12, 24 and 36 months. This design provides 90% power to detect a mean difference of 0.0167 mm in cIMT progression between treatment arms (α = 0.05), assuming that up to 20% withdraw or discontinue treatment. Other endpoints include HbA1c, weight, LDL cholesterol, insulin requirement, progression of retinopathy, endothelial function and frequency of hypoglycaemia. CONCLUSION: REMOVAL is the largest clinical trial of adjunct metformin therapy in T1D to date and will provide clinically meaningful information on its potential to impact CV disease and other complications.

Lack of Measles Transmission to Susceptible Contacts from a Health Care Worker with Probable Secondary Vaccine Failure - Maricopa County, Arizona, 2015.

On January 23, 2015, the Maricopa County Department of Public Health (MCDPH) was notified of a suspected measles case in a nurse, a woman aged 48 years. On January 11, the nurse had contact with a patient with laboratory-confirmed measles associated with the Disneyland theme park-related outbreak in California. On January 21, she developed a fever (103°F [39.4°C]), on January 23 she experienced cough and coryza, and on January 24, she developed a rash. The patient was instructed to isolate herself at home. On January 26, serum, a nasopharyngeal swab, and a urine specimen were collected. The following day, measles infection was diagnosed by real time reverse transcription polymerase chain reaction testing of the nasopharyngeal swab and urine specimen and by detection of measles-specific immunoglobulin (Ig)M and IgG in serum by enzyme-linked immunosorbent assay. Because of her symptoms and laboratory results, the patient was considered to be infectious.

Developing a competency framework for U.S. state food and feed testing laboratory personnel.

A competency-based training curriculum framework for U.S. state food and feed testing laboratories personnel is being developed by the International Food Protection Training Institute (IFPTI) and three partners. The framework will help laboratories catalog existing training courses/modules, identify training gaps, inform training curricula, and create career-spanning professional development learning paths, ensuring consistent performance expectations and increasing confidence in shared test results. Ultimately, the framework will aid laboratories in meeting the requirements of ISO/IEC 17025 (2005) international accreditation and the U.S. Food Safety Modernization Act (U.S. Public Law 111-353). In collaboration with the Association of Food and Drug Officials, the Association of Public Health Laboratories, and the Association of American Feed Control Officials, IFPTI is carrying out the project in two phases. In 2013, an expert panel of seven subject matter experts developed competency and curriculum frameworks for five professional levels (entry, mid-level, expert, supervisor/manager, and senior administration) across four competency domains (technical, communication, programmatic, and leadership) including approximately 80 competencies. In 2014 the expert panel will elicit feedback from peers and finalize the framework.

Outbreak of campylobacteriosis associated with consumption of raw peas.

BACKGROUND: Campylobacter jejuni is a leading cause of acute gastroenteritis worldwide, and most cases are identified as sporadic events rather than as parts of recognized outbreaks. We report findings from a substantial 2008 campylobacteriosis outbreak with general implications for fresh produce safety. METHODS: We conducted a matched case-control study to determine the source of the outbreak and enhanced surveillance to identify additional cases. Clinical and environmental specimens were tested for Campylobacter, and isolates were subtyped by pulsed-field gel electrophoresis (PFGE). RESULTS: By routine surveillance, we identified 63 cases of laboratory-confirmed infection. Only raw peas, consumed by 30 (67%) of 45 case-patients and by 15 (17%) of 90 control participants, were associated with illness (adjusted odds ratio: 8.2; P<.001). An additional 69 patients (26 laboratory-confirmed) who reported eating raw peas within 10 days of illness onset were identified through enhanced surveillance. In all, 5 cases were hospitalized, and Guillain-Barré syndrome developed in 1 case; none died. The implicated pea farm was located near a Sandhill crane (Grus canadensis) stopover and breeding site. Of 36 environmental samples collected, 16 were positive for C. jejuni-14 crane-feces samples and 2 pea samples. We identified 25 unique combined SmaI-KpnI PFGE patterns among clinical isolates; 4 of these combined PFGE patterns identified in 15 of 55 human isolates were indistinguishable from PFGE patterns identified in environmental samples. CONCLUSIONS: This investigation established a rare laboratory-confirmed link between a campylobacterosis outbreak and an environmental source and identified wild birds as an underrecognized source of produce contamination.

Tinnitus and its risk factors in the Beaver Dam offspring study.

OBJECTIVE: To assess the prevalence of tinnitus along with factors potentially associated with having tinnitus. DESIGN: Data were from the Beaver Dam Offspring Study, an epidemiological cohort study of aging. STUDY SAMPLE: After a personal interview and audiometric examination, participants (n = 3267, ages 21-84 years) were classified as having tinnitus if in the past year they reported having tinnitus of at least moderate severity or that caused difficulty in falling asleep. RESULTS: The prevalence of tinnitus was 10.6%. In a multivariable logistic regression model adjusting for age and sex, the following factors were associated with having tinnitus: hearing impairment (Odds Ratio (OR) = 3.20), currently having a loud job (OR = 1.90), history of head injury (OR = 1.84), depressive symptoms (OR = 1.82), history of ear infection (men, OR = 1.75), history of target shooting (OR = 1.56), arthritis (OR = 1.46), and use of NSAID medications (OR = 1.33). For women, ever drinking alcohol in the past year was associated with a decreased risk of having tinnitus (OR = 0.56). CONCLUSIONS: These results suggest that tinnitus is a common symptom in this cohort and may be associated with some modifiable risk factors.

The ten-year incidence of tinnitus among older adults.

As part of a population-based study in Beaver Dam, Wisconsin, we estimated the 10-year cumulative incidence of tinnitus and its risk factors. Participants (n = 2922, aged 48-92 years) not reporting tinnitus at baseline (1993-1995) were followed for up to ten years. In addition to audiometric testing and anthropometric measures, data on tinnitus, health, and other history were obtained via questionnaire. Potential risk factors were assessed with discrete-time proportional hazards models. The 10-year cumulative incidence of tinnitus was 12.7%. The risk of developing tinnitus was significantly associated with: history of arthritis (hazard ratio (HR = 1.37), history of head injury (HR = 1.76), history of ever smoking (HR = 1.40), and among women, hearing loss (HR = 2.59). Alcohol consumption (HR = 0.63 for > or = 141 grams/week vs. <15 grams/week), age (among women, HR = 0.90 for each five-year increase in age), and among men, obesity (HR = 0.55), were associated with decreased risk. The risk of developing tinnitus was high for older adults, and associated with modifiable health and behavioral factors.

Assessing food safety training needs of environmental health specialists in the U.S.: focus group summary.

As part of a U.S. Department of Agriculture Cooperative State Research, Education, and Extension Service grant, six focus group sessions on the topic of food safety education and training were held June 24, 2008, at NEHA's Annual Educational Conference & Exhibition in Tucson, Arizona. A total of 30 participants attended one of the six 50-minute sessions. Participants were NEHA conference attendees and nearly all stated they had a food safety training and education role in their job. A series of questions related to food safety at retail and food service levels was asked. This report summarizes some of the opinions provided by focus group participants.

The Post-illumination Pupil Response (PIPR) Is Associated With Cognitive Function in an Epidemiologic Cohort Study.

We conducted a cross-sectional study on 403 participants in the 10-year follow-up examination of the Beaver Dam Offspring Study. The participants included 172 male and 231 female, with age ranging from 33 to 81 years (mean ± SD, 60.7 ± 9.3). The post-illumination pupil response (PIPR) was recorded using binocular infrared pupillometer (Neur-Optics, Inc., Irvine, CA). Cognitive testing consisted of Trail Making Test (TMT) Parts A and B, Rey Auditory Verbal Learning Test (AVLT), Digit Symbol Substitution Test (DSST), and Verbal Fluency Test (VFT) (F, A, and S). Principal component analysis (PCA) was used to calculate an overall cognitive function score. There was a significant reduction in the mean baseline pupil diameter by 0.21 mm for every 5-year increase in age (95% CI: -0.25, -0.17). There was also a significant increase in the PCA cognitive score by 0.20 (linear regression, 95% CI: 0.08, 0.32) for every 0.1 unit increase in the PIPR. The association remained significant after adjusting for age, sex, education, medications, systemic and ocular disease, and short form-12 physical and mental component score. The results of this study demonstrated a modest association between the PIPR and cognitive function, warranting longitudinal studies to evaluate the role of the PIPR in predicting cognitive function in the middle-aged and older adults.

Projection of diabetic retinopathy and other major eye diseases among people with diabetes mellitus: United States, 2005-2050.

OBJECTIVES: To estimate the number of people with diabetic retinopathy (DR), vision-threatening DR (VTDR), glaucoma, and cataracts among Americans 40 years or older with diagnosed diabetes mellitus for the years 2005-2050. METHODS: Using published prevalence data of DR, VTDR, glaucoma, and cataracts and data from the National Health Interview Survey and the US Census Bureau, we projected the number of Americans with diabetes with these eye conditions. RESULTS: The number of Americans 40 years or older with DR and VTDR will triple in 2050, from 5.5 million in 2005 to 16.0 million for DR and from 1.2 million in 2005 to 3.4 million for VTDR. Increases among those 65 years or older will be more pronounced (2.5 million to 9.9 million for DR and 0.5 million to 1.9 million for VTDR). The number of cataract cases among whites and blacks 40 years or older with diabetes will likely increase 235% by 2050, and the number of glaucoma cases among Hispanics with diabetes 65 years or older will increase 12-fold. CONCLUSION: Future increases in the number of Americans with diabetes will likely lead to significant increases in the number with DR, glaucoma, and cataracts. Our projections may help policy makers anticipate future demands for health care resources and possibly guide the development of targeted interventions. CLINICAL RELEVANCE: Efforts to prevent diabetes and to optimally manage diabetes and its complications are needed.

Relations of serum ascorbic acid and alpha-tocopherol to diabetic retinopathy in the Third National Health and Nutrition Examination Survey.

The protective relation of ascorbic acid and alpha-tocopherol to the development of diabetic retinopathy has not been thoroughly evaluated in epidemiologic studies. The association of prevalent diabetic retinopathy with serum ascorbic acid and alpha-tocopherol was studied among participants with type 2 diabetes (>or=40 years) (n = 998) in the Third National Health and Nutrition Examination Survey (1988-1994); 20% of the sample (n = 199) had prevalent retinopathy. The overall odds ratio for retinopathy among participants in quartile 4 compared with quartile 1 for serum ascorbic acid was 1.3 (95% confidence interval: 0.8, 2.3), with a p for trend = 0.60 after adjustment for the confounders of smoking, race, waist/hip ratio, hypertension, and duration of diabetes. The overall odds ratio for retinopathy among participants in quartile 4 compared with quartile 1 for serum alpha-tocopherol was 2.7 (95% confidence interval: 1.6, 4.6), with a p for trend = 0.14 after adjustment for confounders. After removal of supplement users of vitamin C (n = 307) or vitamin E (n = 298), the odds ratio changed direction or was attenuated: adjusted odds ratios for retinopathy among participants in quartile 4 compared with quartile 1 for serum ascorbic acid and alpha-tocopherol = 0.7 (95% confidence interval: 0.3, 1.4) and 1.6 (95% confidence interval: 0.9, 2.9), respectively. In summary, no significant associations were observed between serum levels of major dietary antioxidants and retinopathy. Recent use of supplements for treatment of complications of diabetes may explain the direct associations.