Autonomy of Patients With Type 2 Diabetes With an Insulin Pump Device: Is It Predictable?

Background:Insulin pump therapy may be offered to patients with type 2 diabetes that is not controlled by multiple daily injections. Patients with type 2 diabetes may suffer from unrecognized cognitive disabilities, which may compromise the use of a pump device.Methods:To predict patient autonomy, we evaluated 39 patients with type 2 diabetes from our database (n = 143) after continuous subcutaneous insulin infusion (CSII) initiation using (1) an autonomy questionnaire evaluating the patient’s cognitive and operative capacities for CSII utilization, (2) the Montreal Cognitive Assessment (MOCA) for the detection of mild cognitive disabilities, (3) the Hospital Anxiety and Depression Scale (HADS) for the detection of anxiety and depression, and (4) the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Patients were selected to constitute 3 groups matched for age, with different degrees of autonomy at discharge after the initial training program: complete (n = 13), partial (n = 13), or no autonomy (n = 13).Results:The satisfaction level with the pump device was high. At the last follow-up visit, only 23% of patients did not reach complete autonomy. The autonomy score correlated fairly with the MOCA score (R = 0.771, P < .001). A receiver operating characteristic (ROC) analysis showed that at a cut-off score of 24, the MOCA identified autonomous versus dependent patients at long-term follow-up (area under the ROC curve [AUC], 0.893; sensitivity, 81%; specificity, 81%). The HADS correlated negatively with the autonomy score, and the sociocultural level also influenced autonomy with pump utilization.Conclusion:Patients with type 2 diabetes with partial autonomy at discharge may progress to complete autonomy. The MOCA and HADS may help predict a patient’s ability to manage with a pump device.     

Does an Asthma Education Program Improve Quality of Life? A Two-Year Randomized Trial

Asthma education programs result in clinical improvement. However, most studies involved programs of up to 1 year of follow-up, and their efficacy in improving quality of life (QoL) is still controversial. The aim of this study was to evaluate the effectiveness of a program of patient education in asthmatics over 2 years. Thirty-seven asthmatic patients were randomly allocated to group A (usual treatment) and 32 to group B (usual treatment plus patient education program). The effectiveness of the education program was evaluated by comparing morbidity outcomes at baseline and 12 and 24 months afterwards. At baseline, no intergroup difference emerged in age, sex, smoking, asthma severity, atopy, FEV₁, symptom-free days, use of rescue salbutamol, and QoL. One year later, group B subjects had an improvement in the overall QoL (from 5.8 ± 0.8 to 6.1 ± 0.7, p< 0.005), and in “Activities” (from 5.3 ± 0.9 to 5.7 ± 0.8, p< 0.05) and “Environment” (from 6.4 ± 1.0 to 6.8 ± 0.4, p< 0.05) domains. Two years later the “Activities” domain score increased in group B (from 5.3 ± 0.9 to 5.7 ± 1.1, p< 0.05). QoL did not vary in group A. The education program was ineffective in all other parameters at both follow-up time-points. In group A, a significant increase in medication expenses and a significant decrease in rescue salbutamol use was found 1 and 2 years after baseline, respectively. In conclusion, this education program improved QoL for 1 year, but the improvement was not sustained in the 2nd year.     

Can a Short Period of Micronutrient Supplementation in Older Institutionalized People Improve Response to Influenza Vaccine? A Randomized,Controlled Trial

OBJECTIVES: To test the hypothesis that a micronutrient supplement can improve seroconversion after influenza immunization in older institutionalized people. DESIGN: : Randomized, double-blind, placebo-controlled study. SETTING: Nursing and residential homes in Liverpool, United Kingdom. PARTICIPANTS: One hundred sixty-four residents aged 60 and older from 31 homes were initially randomized; of these, 119 (72.6%) completed the study. INTERVENTION: Participants were randomized to receive a micronutrient supplement providing the reference nutrient intake for all vitamins and trace elements or identical placebo. Tablets were taken over an 8-week period during September and October 2000; influenza vaccine was administered 4 weeks after their commencement. MEASUREMENTS: The hemagglutination-inhibiting antibody response as defined by a fourfold or greater titer rise over 4 weeks and assessed separately for each of the three antigens contained in the 2000/2001 influenza vaccine (A/New Caledonia/20/99 (H1N1), A/Moscow/10/99 (H3N2), B/Beijing/184/93 (B)). RESULTS: Despite a significant increase in serum concentrations of vitamins A, C, D3, E, folate, and selenium in the supplemented group, there was no significant difference between groups (supplemented vs placebo, respectively) in the proportion of participants seroconverting to H1N1 (41% vs 49%, P=.374), H3N2 (49% vs 58%, P=.343), or B (41% vs 40%, P=.944). CONCLUSION: A micronutrient supplement providing the reference nutrient intake administered over 8 weeks had no beneficial effect on antibody response to influenza vaccine in older people living in long-term care.     

Does Type 2 Diabetes Genetic Testing and Counseling Reduce Modifiable Risk Factors? A Randomized Controlled Trial of Veterans

Objective

We examined the clinical utility of supplementing type 2 diabetes mellitus (DM) risk counseling with DM genetic test results and counseling.

Research Design and Methods

In this randomized controlled trial, non-diabetic overweight/obese veteran outpatients aged 21 to 65 years received DM risk estimates for lifetime risk, family history, and fasting plasma glucose, followed by either genetic test results (CR+G; N = 303) or control eye disease counseling (CR+EYE; N = 298). All participants received brief lifestyle counseling encouraging weight loss to reduce the risk of DM.

Results

The mean age was 54 years, 53% of participants were black, and 80% were men. There was no difference between arms in weight (estimated mean difference between CR+G vs. CR+EYE at 3 months = 0.2 kg, 95% CI: −0.3 to 0.7; at 6 months = 0.4 kg, 95 % CI: −0.3 to 1.1), insulin resistance, perceived risk, or physical activity at 3 or 6 months. Calorie and fat intake were lower in the CR+G arm at 3 months (p’s ≤ 0.05) but not at 6 months (p’s > 0.20).

Conclusions

Providing patients with genetic test results was not more effective in changing patient behavior to reduce the risk of DM compared to conventional risk counseling.Trial registration: ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01060540","term_id":"NCT01060540"}}NCT01060540 http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT01060540","term_id":"NCT01060540"}}NCT01060540

Electronic supplementary material

The online version of this article (doi:10.1007/s11606-015-3315-5) contains supplementary material, which is available to authorized users.KEY WORDS: Diabetes mellitus, Genetic counseling, Risk factors     

Are the ADA Hemoglobin A1c Criteria Relevant for the Diagnosis of Type 2 Diabetes in Youth?

Diagnostic criteria for diabetes in children have not been established with nearly the rigor as that employed in adults. Recently revised American Diabetes Association (ADA) criteria allowed utilization of hemoglobin A_1c (HbA1c) ≥6.5 % for diagnosis of diabetes. A recent series of pediatric studies appear to show that HbA1c has lower sensitivity than Fasting plasma glucose (FPG) or oral glucose tolerance test (OGTT). However, FPG and OGTT have themselves never been validated in children. Studies to validate diagnostic thresholds in children appear unlikely to take place. Thus, accepting the major ADA diagnostic criteria appears to be the best course of action for the pediatric community. One area in which correlation studies between HbA1c and FPG or OGTT might shed light is in the definition of criteria for intervention in ‘pre-diabetes,’ as the Diabetes Prevention Program Trial did not use HbA1c. However, such treatment, and the exact diagnostic thresholds at which it should be initiated in children, remains unproven.     

Lipoatrophy in Children With Type 1 Diabetes: An Increasing Incidence?

Objectives:

The objectives were to evaluate the current prevalence of lipoatrophy at insulin injection sites in young patients with type 1 diabetes.

Methods:

Standardized examination of insulin injection sites in all 678 patients with type 1 diabetes treated in 2013 in our outpatient clinic were conducted. In case of lipoatrophy photo documentation and standardized interview with parents and patients were performed.

Methods:

We identified a total of 16 patients (43.8% male) with lipoatrophy (overall prevalence 2.4%). The current mean age (±SD) of the affected patients was 14.4 ± 3.9 years, age and diabetes duration at onset of lipoatrophy were 11.5 ± 3.8 years and 5.4 ± 3.6 years, respectively. All patients were using analogs at the onset of lipoatrophy. In all, 14 of 16 patients (87.5%) were on insulin pump compared with 52% without lipoatrophy (P = .0018). The use of steel needle and Teflon catheter was equal between the pump patients. Concomitant autoimmune diseases were present in 37.5% of the patients (thyroiditis: n = 3, thyroiditis and celiac disease: n = 2, celiac disease: n = 1) compared with 15.0% in those without lipoatrophy (P = .0128).

Conclusions:

Lipoatrophy was present in young patients treated with modern insulins and pumps; however, the prevalence was relatively low as expected with the use of modern insulins. Our data may support the hypothesis that a constant mechanical element such as a subcutaneous catheter may trigger the development of lipoatrophy, particularly in those patients with more than 1 autoimmune disease.     

Can Innovative Technologies Overcome HbA1c Disparity for African-American Youth with Type 1 Diabetes?

Achieving normal or near-normal glycemic control as reflected by HbA1c levels in patients with type 1 diabetes (T1D) is important for preventing the development and progression of chronic complications. Despite delineation and dissemination of HbA1c management targets and advances in insulin pharmacology, insulin delivery systems, and glucose monitoring, the majority of children with T1D do not achieve HbA1c goals. In particular, African Americans are more likely not to reach HbA1c goals and have persistently higher HbA1c than Non-Hispanic Whites. Availability of pumps and other technology has not eliminated the disparity in HbA1c. Multiple factors play a role in the persisting racial disparity in HbA1c outcome. The carefully designed application and deployment of new technology to help the patient/family and facilitate the supportive role of the diabetes management team may be able to overcome racial disparity in glycemic outcome and improve patient quality of life.     

Can Lifestyle Interventions Do More Than Reduce Diabetes Risk? Treating Depression in Adults With Type 2 Diabetes With Exercise and Cognitive Behavioral Therapy

The epidemic of metabolic syndrome, prediabetes, and type 2 diabetes is global in scope and comprehensive in its impact on individuals, health care systems, and societies. One in four patients with diabetes will experience depression in their lifetime. Comorbid depression is associated with poorer outcomes, greater functional disability, and early mortality. Prior studies have demonstrated beneficial effects of exercise as an efficacious form of treatment for depression in the general population. Few studies have evaluated this strategy in patients with prediabetes or type 2 diabetes. Program ACTIVE (Appalachians Coming Together to Increase Vital Exercise) was designed to treat depression among adults with type 2 diabetes by pairing aerobic activity with individual cognitive behavioral therapy. This combination treatment approach has been shown to be feasible to implement in a rural environment and promising in terms of depression, diabetes, and cardiovascular outcomes. Data from this study suggest that exercise can be used to achieve multiple benefits for adults with type 2 diabetes. Future work to compare this approach to singular treatment strategies for adults at risk for type 2 diabetes is needed.     

Can Phone-Based Motivational Interviewing Improve Medication Adherence to Antiplatelet Medications After a Coronary Stent Among Racial Minorities? A Randomized Trial

BACKGROUNDMinorities have lower adherence to cardiovascular medications and have worst cardiovascular outcomes post coronary stent placementOBJECTIVEThe aim of this study is to compare the efficacy of phone-delivered Motivational Interviewing (MINT) to an educational video at improving adherence to antiplatelet medications among insured minorities.DESIGNThis was a randomized study.PARTICIPANTSWe identified minorities with a recently placed coronary stent from an administrative data set by using a previously validated algorithm.INTERVENTIONSMINT subjects received quarterly phone calls and the DVD group received a one-time mailed video.CONCLUSIONSAmong racial minorities, a phone-based motivational interview is effective at improving adherence to antiplatelet medications post coronary stent placement. Phone-based MINT seems to be a promising and cost-effective strategy to modify risk behaviors among minority populations at high cardiovascular risk.KEY WORDS: medication adherence, motivational interviewing, minorities, coronary stents, antiplatelet medications     

OPPORTUNITY?: A Randomized Clinical Trial of Growth Hormone on Outcome in Hemodialysis Patients

Background: The mortality rate of maintenance hemodialysis (MHD) patients remains high. Measures of protein-energy wasting, including hypoalbuminemia, are strongly associated with their high mortality. Growth hormone (GH) may improve lean body mass (LBM) and serum albumin levels, and health-related quality of life (HRQoL), which are significantly and positively associated with survival in MHD patients. The OPPORTUNITY™ Trial will examine whether GH reduces mortality and morbidity and improves overall health in hypoalbuminemic MHD patients.Hypothesis: The primary hypothesis is that daily recombinant human GH injections, compared with placebo, improve survival in hypoalbuminemic MHD patients. Secondary hypotheses are that GH improves morbidity and health, including number of hospitalized days, time to cardiovascular events, LBM, serum protein and inflammatory marker levels, exercise capacity, and HRQoL, and has a favorable safety profile.Design/Measurements: This is a prospective, double-blind, multicenter, randomized clinical trial involving 2500 MHD patients, up to 50% with diabetes mellitus, from 22 countries. Patients are randomized in a 1:1 ratio to receive daily injections of GH (20 μg/kg per day) or placebo for 104 weeks. Key inclusion criteria include clinically stable and well-dialyzed (Kt/V ≥1.2) adult MHD patients with serum albumin <4.0 g/dl. Exclusion criteria include active malignancy, active proliferative or severe nonproliferative diabetic retinopathy, uncontrolled hypertension, chronic use of high-dose glucocorticoids, or immunosuppressive agents and pregnancy.Conclusions: The OPPORTUNITY™ Trial is the first large-scale randomized clinical trial in adult MHD patients evaluating the response to GH of such clinical endpoints as mortality, morbidity, markers of body protein mass, inflammation, exercise capacity, and HRQoL.Adult end-stage renal disease (ESRD) patients undergoing maintenance hemodialysis (MHD) experience high mortality and morbidity with diminished quality of life (1,2). Death and hospitalization rates in MHD patients correlate strongly with indicators of low protein mass, as indicated by low serum albumin and decreased fat-free, edema-free body mass (i.e., lean body mass [LBM]), as well as chronic inflammation (3,4). This is an important association because protein-energy wasting (PEW) occurs in approximately 40% of MHD patients (5). The possibility that improved measures of PEW may lead to decreased mortality or morbidity was recently underscored by several cross-sectional and longitudinal evaluations of cohorts containing up to 58,000 MHD patients who were followed for up to 2 yr. These studies showed that both higher serum albumin and body weight and an increase in these measures are strongly associated with greater survival (6,7). However, there are no prospective, randomized, clinical trials (RCTs) that have confirmed or even assessed whether a pharmacologic intervention that improves indicators of PEW prolongs survival and/or reduces morbidity, including hospitalization, in MHD patients. Thus, major unmet medical needs and important questions exist concerning whether PEW causes mortality and morbidity in MHD patients and whether a treatment that reduces PEW will reduce their high mortality and morbidity.Growth hormone (GH) has extensive metabolic and, in particular, protein anabolic effects (8), a number of which have also been demonstrated in MHD or chronic peritoneal dialysis patients (9–23). Most of these studies were performed on small numbers of patients. A recent phase 2 RCT involving 139 MHD patients indicated that the GH-treated patients underwent improvement in LBM, serum transferrin, exercise capacity, and a tendency (P = 0.076) for serum albumin to rise (9). Based on these data, a decision was made to conduct a more definitive prospective RCT in hypoalbuminemic MHD patients.     

Topical Fluorometholone Treatment for Ocular Dryness in Patients With Sj?gren Syndrome: A Randomized Clinical Trial in China

The purpose of the study was to evaluate the efficacy of an ophthalmic solution containing 0.1% fluorometholone (FML) and 0.1% sodium hyaluronate (HA) for the treatment of ocular dryness in Sjögren syndrome (SS) patients.Forty SS patients were randomly assigned to the FML or cyclosporin A (CsA) treatment groups. The FML group was treated with 0.1% FML and 0.1% HA, and the CsA group was treated with 0.5% CsA and 0.1% HA. Primary outcomes were corneal fluorescein staining (CFS), the Ocular Surface Disease Index (OSDI) score, conjunctival goblet cell density, and the severity of conjunctival congestion. Patients were also evaluated based on tear film breakup time (TFBUT) and the Schirmer test.After 8 weeks of treatment, the mean CFS scores were significantly lower in both the groups, compared with the baseline values, and the CFS score of the FML group at week 2 was significantly lower than that of the CsA group (P = 0.042). The OSDI scores improved significantly in both the groups throughout the study, and the OSDI score in the FML group at week 4 was significantly lower than that of the CsA group (P = 0.042). After 8 weeks of therapy, the conjunctival goblet cell density was significantly higher in both the groups (P < 0.001 for both) compared with the baseline values. Conjunctival congestion was reduced in both the groups throughout the study, and the severity in the FML group was significantly less at week 4 compared with that in the CsA group (P = 0.035). The TFBUT in the FML group at week 8 was significantly longer than in the CsA group (P = 0.04).Treatment using topical 0.1% FML provided faster improvement in the symptoms of ocular dryness in SS patients compared with topical 0.5% CsA.     

Does Prevalence Matter to Physicians in Estimating Post-test Probability of Disease? A Randomized Trial

BACKGROUND  

The probability of a disease following a diagnostic test depends on the sensitivity and specificity of the test, but also on the prevalence of the disease in the population of interest (or pre-test probability). How physicians use this information is not well known.     

Does FDG PET-Assisted Management of Patients With Left Ventricular Dysfunction Improve Quality of Life? A Substudy of the PARR-2 Trial

Background

Patients with left ventricular dysfunction whose management is directed by F-18-fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging may have a quality of life (QOL) benefit over standard care.

Methods

Among 430 patients randomized in the PET and Recovery Following Revascularization (PARR)-2 trial to FDG PET-assisted management vs standard, QOL scores were obtained using the European Quality of Life-5 Dimensions (EQ-5D) in 427 patients at baseline (FDG PET n = 216; standard n = 211) and 355 patients at 12-month follow-up (FDG PET n = 184; standard n = 171). EQ-5D scores between FDG PET and standard arms were compared using mixed model repeated measures (MMRM). Subgroup analysis compared EQ-5D scores between patients in FDG PET who adhered to PET recommendations (Adherence) vs standard using MMRM. Interaction of revascularization with management was assessed using a general linear model.

Results

A trend toward higher EQ-5D scores in FDG PET was observed (P = 0.056). Subgroup analysis showed a significant difference favouring adherence (P = 0.04). Higher QOL at 6 months for FDG PET (P = 0.02) and Adherence (P = 0.02) were observed. For revascularization, an interaction with management (FDG PET vs standard) for QOL was observed (6 months: P = 0.01; 12 months: P = 0.1); Adherence (6 months: P = 0.01; 12 months: P = 0.1).

Conclusions

FDG PET-directed management improves QOL, at least in the short-term and with adherence to recommendations. This may relate to revascularization, and may indicate better treatment selection using FDG PET.     

Randomized Forced Titration to Different Doses of Technosphere? Insulin Demonstrates Reduction in Postprandial Glucose Excursions and Hemoglobin A1c in Patients with Type 2 Diabetes

Background

Individuals with type 2 diabetes mellitus have impairments in early insulin release, resulting in increased postprandial glucose excursions and suboptimal glycemic control. Studies with Technosphere® Insulin (TI) indicate that it has rapid systemic absorption and a short duration of glucose-lowering activity, making it well suited for controlling postprandial glucose levels.

Methods

The goal of this phase 2b, prospective, multicenter, double-blind, placebo-controlled study was to characterize the dose response of four different doses (equivalent to 3.6, 7.3, 10.9, and 14.6 U subcutaneous regular human insulin) of prandial TI or Technosphere powder alone administered before each of three meals daily, in combination with insulin glargine over an 11-week treatment period, in patients with type 2 diabetes and suboptimal glycemic control.

Results

The study enrolled 227 patients. In all dose groups, TI demonstrated statistically significant dose-dependent reductions in hemoglobin A1c (HbA1c) versus baseline (-0.4, -0.5, -0.5, and -0.6 for 3.6, 7.3, 10.9, and 14.6 U equivalents, respectively; p < 0.05 in all groups), as well as versus placebo or Technosphere powder alone (-0.40, -0.67, -0.70, and -0.78 for 3.6, 7.3, 10.9, and 14.6 U equivalents, respectively; p < 0.04 in all groups). It reduced the postprandial maximum glucose concentration within each treatment group (statistically significant in all but the TI 3.6 U-equivalent group) and reduced the postprandial area under the glucose curve (statistically significant for the TI 10.9 and 14.6 U-equivalent groups) versus placebo. There were no cases of severe hypoglycemia, while mild/moderate hypoglycemia was observed most frequently in the highest dosage groups, as expected. Rates of cough were low and comparable among all groups. No clinically relevant changes in pulmonary function tests, body weight, or high-resolution computerized axial tomography and magnetic resonance imaging were observed.

Conclusions

This study demonstrated that, over 11 weeks, TI plus basal insulin glargine is well tolerated and results in dose-dependent reductions in postprandial glucose and HbA1c levels.     

The Role of Mobile Applications in Improving Alcohol Health Literacy in Young Adults With Type 1 Diabetes: Help or Hindrance?

Background:Mobile health (mHealth) is an expanding field which includes the use of social media and mobile applications (apps). Apps are used in diabetes self-management but it is unclear whether these are being used to support safe drinking of alcohol by people with type 1 diabetes (T1DM). Alcohol health literacy is poor among young adults with T1DM despite specific associated risks.Methods:Systematic literature review followed by critical appraisal of commercially available apps. An eSurvey investigating access to mHealth technology, attitudes toward apps for diabetes management and their use to improve alcohol health literacy was completed by participants.Results:Of 315 articles identified in the literature search, 7 met the inclusion criteria. Ten diabetes apps were available, most of which lacked the educational features recommended by clinical guidelines. In all, 27 women and 8 men with T1DM, aged 19-31 years were surveyed. Of them, 32 had access to a smartphone/tablet; 29 used apps; 20 used/had used diabetes apps; 3 had used apps related to alcohol and diabetes; 11 had discussed apps with their health care team; 22 felt more communication with their health care team would increase awareness of alcohol-associated risks.Conclusions:Use of mobile apps is commonplace but the use of apps to support safe drinking in this population was rare. Most participants expressed a preference for direct communication with their health care teams about this subject. Further research is needed to determine the preferences of health care professionals and how they can best support young adults in safe drinking.     

Can Vitamin D Supplementation in Addition to Asthma Controllers Improve Clinical Outcomes in Patients With Asthma?: A Meta-Analysis

Effects of vitamin D on acute exacerbation, lung function, and fraction of exhaled nitric oxide (FeNO) in patients with asthma are controversial. We aim to further evaluate the roles of vitamin D supplementation in addition to asthma controllers in asthmatics.From 1946 to July 2015, we searched the PubMed, Embase, Medline, Cochrane Central Register of Controlled Trials, and ISI Web of Science using “Vitamin D,” “Vit D,” or “VitD” and “asthma,” and manually reviewed the references listed in the identified articles. Randomized controlled trials which reported rate of asthma exacerbations and adverse events, forced expiratory volume in 1 s (FEV₁, % of predicted value), FeNO, asthma control test (ACT), and serum 25-hydroxyvitamin D levels were eligible. We conducted the heterogeneities test and sensitivity analysis of the enrolled studies, and random-effects or fixed-effects model was applied to calculate risk ratio (RR) and mean difference for dichotomous and continuous data, respectively. Cochrane systematic review software Review Manager (RevMan) was used to test the hypothesis by Mann–Whitney U test, which were displayed in Forest plots.Seven trials with a total of 903 patients with asthma were pooled in our final studies. Except for asthma exacerbations (I2 = 81%, χ2 = 10.28, P = 0.006), we did not find statistical heterogeneity in outcome measures. The pooled RR of asthma exacerbation was 0.66 (95% confidence interval: 0.32–1.37), but without significant difference (z = 1.12, P = 0.26), neither was in FEV₁ (z = 0.30, P = 0.77), FeNO (z = 0.28, P = 0.78), or ACT (z = 0.92, P = 0.36), although serum 25-hydroxyvitamin D was significantly increased (z = 6.16, P < 0.001).Vitamin D supplementation in addition to asthma controllers cannot decrease asthma exacerbation and FeNO, nor improve lung function and asthma symptoms, although it can be safely applied to increase serum 25-hydroxyvitamin D levels.     

A Cluster Randomized Controlled Trial of an Adolescent HIV Prevention Program Among Bahamian Youth: Effect at 12?Months Post-Intervention

Behavioral interventions based on the Protection Motivation Theory (PMT) have been demonstrated to reduce HIV risk behavior among mid- and older adolescents in different settings across the globe but have not been evaluated among Caribbean nations and have received limited evaluation among pre-adolescents. To determine (1) the effectiveness among pre-adolescents in The Bahamas of a PMT-based HIV prevention program “Focus on Youth in the Caribbean” (FOYC) and (2) the role of the targeted PMT constructs in intervention effect. 1,360 sixth grade youth (10–11 years of age) from 15 urban schools in New Providence, The Bahamas were randomized by school to receive either FOYC or a control condition. Data collected at baseline, 6 and 12 months post intervention were analyzed. A five-step scheme was used to assess sexual behavior progression, ranging from “1” = “a virgin without intention to have sex” to “5” = “having sex without a condom”. Group-based trajectory analysis was utilized in assessing the program effect. Two sexual behavior progression patterns were detected: slow progressors and quick progressors. Receiving FOYC reduced the likelihood for adolescents to become quick progressors (adjusted OR = 0.77, 95% CI: 0.64–1.00). The observed effectiveness was especially impacted by a subset of the targeted PMT constructs. FOYC effectively delays sexual risk among Bahamian pre-adolescents. The group-based trajectory analysis provides an analytical approach for assessing interventions among adolescents with low rates and diverse progression patterns of sexual activity.     

Can We Predict the Site of Entry Tear by Computed Tomography in Patients With Acute Type A Aortic Dissection?

Background:

In patients with acute type A aortic dissection (AAD), localization of the primary entry tear to be excluded is of major importance for intervention.

Hypothesis:

There are reliable indirect computed tomography (CT) findings to predict the entry site.

Methods:

In 83 patients with type A AAD whose primary entry tears were identified surgically between 2003 and 2009, we retrospectively examined the diagnostic CT scans regarding pericardial effusion, the largest short‐axial diameter of the aorta, widths of true and false lumens, and false lumen thrombosis at 6 levels of thoracic aorta from the aortic root to the descending aorta.

Results:

The primary entry sites identified intraoperatively were proximal ascending in 21 patients, middle ascending in 21, distal ascending in 21, arch in 17, and descending or unknown in 16. The multivariate logistic analysis revealed that pericardial effusion (odds ratio [OR]: 2.2, 95% confidence interval [CI]: 1.2–3.4, P < 0.001) and dilated ascending aorta (OR: 1.6, 95% CI: 1.1–2.4, P = 0.012) were the significant CT findings to predict the entry tear in the ascending aorta. It also revealed that the significant CT finding to predict the entry tear distal to the aortic arch was nonthrombosed false lumen in the descending aorta (OR: 1.2, 95% CI: 1.1–2.1, P = 0.048).

Conclusions:

We can predict the primary entry site by the preoperative CT findings in patients with type A AAD, considering pericardial effusion, aortic diameter, widths of true and false lumens, and false lumen thrombosis at different anatomic levels. Clin. Cardiol. 2012 DOI: 10.1002/clc.21991 The authors have no funding, financial relationships, or conflicts of interest to disclose.     

Is the Risk and Nature of CVD the Same in Type 1 and Type 2 Diabetes?

The incidence of both type 1 and type 2 diabetes is increasing globally, most likely explained by environmental changes, such as changing exposures to foods, viruses, and toxins, and by increasing obesity. While cardiovascular disease (CVD) mortality has been declining recently, this global epidemic of diabetes threatens to stall this trend. CVD is the leading cause of death in both type 1 and type 2 diabetes, with at least a two- to fourfold increased risk in patients with diabetes. In this review, the risk factors for CVD are discussed in the context of type 1 and type 2 diabetes. While traditional risk factors such as dyslipidemia, hypertension, and obesity are greater in type 2 patients than in type 1 diabetes, they explain only about half of the increased CVD risk. The role for diabetes-specific risk factors, including hyperglycemia and kidney complications, is discussed in the context of new study findings.     

Serum Concentrations of Markers of TNFα and Fas-Mediated Pathways and Renal Function in Nonproteinuric Patients with Type 1 Diabetes

Background and objectives: The aim of our study was to examine serum markers of the TNF and Fas pathways for association with cystatin-C based estimated glomerular filtration rate (cC-GFR) in subjects with type 1 diabetes (T1DM) and no proteinuria.Design, setting, participants, & measurements: The study group (the 2nd Joslin Kidney Study) comprised patients with T1DM and normoalbuminuria (NA) (n = 363) or microalbuminuria (MA) (n = 304). Impaired renal function (cC-GFR <90 ml/min) was present in only 10% of patients with NA and 36% of those with MA. We measured markers of the tumor necrosis factor α (TNFα) pathway [TNFα, soluble TNF receptor 1 (sTNFR1), and 2 (sTNFR2)], its downstream effectors [soluble intercellular and soluble vascular adhesion molecules (sICAM-1 and sVCAM-1), interleukin 8 (IL8/CXCL8), monocytes chemoattractant protein-1 (MCP1), and IFNγ inducible protein-10 (IP10/CXCL10)], the Fas pathway [soluble Fas (sFas) and Fas ligand (sFasL)], CRP, and IL6.Results: Of these, TNFα, sTNFRs, sFas, sICAM-1, and sIP10 were associated with cC-GFR. However, only the TNF receptors and sFas were associated with cC-GFR in multivariate analysis. Variation in the concentration of the TNF receptors had a much stronger impact on GFR than clinical covariates such as age and albumin excretion.Conclusions: Elevated concentrations of serum markers of the TNFα and Fas-pathways are strongly associated with decreased renal function in nonproteinuric type 1 diabetic patients. These effects are independent of those of urinary albumin excretion. Follow-up studies are needed to characterize the role of these markers in early progressive renal function decline.The traditional model of the development of end-stage renal disease in type 1 diabetes mellitus (T1DM), in which microalbuminuria (MA) leads to proteinuria and then proteinuria is followed by renal function loss, has been challenged recently. Increase in urinary albumin excretion is an important determinant of diabetic nephropathy progression, but it does not entirely explain this phenomenon. For example, the loss of renal function commences earlier than previously recognized and precedes the onset of proteinuria (1). In our longitudinal study of T1DM (The First Joslin Study of Natural History of Microalbuminuria), renal function decline began with the onset of MA in about one-third of patients and progressed in a linear fashion from normal kidney function to renal insufficiency. Also, renal function decline occurred in a noticeable proportion of patients with T1DM and normal albumin excretion (1,2).Low-grade chronic inflammation is thought to be involved in the pathogenesis of diabetic nephropathy (3,4). Tumor necrosis factor alpha (TNFα/TNF) is a key mediator of inflammation and plays a role in apoptosis. In animal models, its effects on kidneys include reduced glomerular filtration rate (GFR) and increased albumin permeability (3). It mediates its signal via two distinct receptors, TNF receptor 1 (TNFR1/TNFRSF1A) and TNF receptor 2 (TNFR2/TNFRSF1B), which are membrane-bound and also present in soluble form in serum (5). TNFα mediates its inflammatory effects by induction of a broad spectrum of chemokines, including interleukin 8 (IL8/CXCL8); monocyte chemotactic protein-1 (MCP-1/CCL2); IFN-γ inducible protein-10 (IP-10/CXCL10); and adhesion molecules such as intercellular adhesion molecule-1 (ICAM-1) and vascular adhesion molecule-1 (VCAM-1) (6,7).The Fas pathway mediates apoptosis and may play a role in the progression of diabetic nephropathy (8–11). The binding of Fas ligand (FasL) to Fas, its membrane-bound receptor that is also present in serum in soluble form (sFasL, sFas), leads to an apoptotic response (12,13).Most studies on serum markers of TNFα-mediated inflammation and apoptosis in diabetic nephropathy have explored their association with MA and proteinuria rather than with GFR (14).The goal of this large cross-sectional study was to investigate whether serum concentrations of markers mediated by TNFα (sTNFR1, sTNFR2, sICAM-1, sVCAM-1, IL8, MCP-1, IP-10) or involved in Fas-related apoptosis (sFasL and sFas) are associated, independently from albuminuria, with variation in renal function in patients with T1DM who do not have proteinuria or advanced renal function impairment. This knowledge should facilitate the development of new diagnostic tools for identifying patients with early renal function decline and help the search for intervention protocols for high-risk patients that may be more effective if implemented 5 to 10 yr earlier in the disease course.In this study, the GFR was estimated by a cystatin C-based formula (cC-GFR), previously shown as an accurate way of evaluating renal function in patients with diabetes (15,16)