Eugene Komaroff

A randomized comparison of a commercially available portion-controlled weight-loss intervention with a diabetes self-management education program

Objective:This study examined the efficacy of a commercially available, portion-controlled diet (PCD) on body weight and HbA1c over 6 months in obese patients with type 2 diabetes.Research Design and Methods:One-hundred participants with a mean±s.d. age of 55.6±10.6 year, body weight of 102.9±18.4 kg and HbA1c of 7.7±1.3% were randomly assigned to a 9-session group lifestyle intervention that included a PCD or to a 9-session group program of diabetes self-management education (DSME). Participants in the two groups were prescribed the same goals for energy intake (1250–1550 kcal per day) and physical activity (200 min per week).Results:While both groups produced significant improvements in weight and HbA1c after 6 months of treatment, PCD participants lost 7.3 kg [95% confidence interval (CI): −5.8 to −8.8 kg], compared with 2.2 kg (95% CI: −0.7 to −3.7 kg) in the DSME group (P<0.0001). Significantly more PCD than DSME participants lost ⩾5% of initial weight (54.0% vs 14.0%, P<0.0001) and ⩾10% (26.0% vs 6.0%, P<0.0001). HbA1c declined by 0.7% (95% CI: −0.4 to −1.0%) in the PCD group, compared with 0.4% (95% CI: −0.1 to −0.7%) in DSME (P<0.026). Across both groups, larger weight losses were associated with greater reductions in HbA1c (r=0.52, P<0.0001).Conclusions:These findings demonstrate that a commercially available portion-controlled meal plan can induce clinically meaningful improvements in weight and glycemic control in obese individuals with type 2 diabetes. These data have implications for the management of obesity in primary care, as now provided by the Centers for Medicare and Medicaid Services.

Elevated circulating tissue factor procoagulant activity, factor VII, and plasminogen activator inhibitor-1 in childhood obesity: evidence of a procoagulant state.

Childhood obesity is rapidly increasing in prevalence. We compared circulating membrane‐bound tissue factor (FIII, F3) procoagulant activity (TF‐PCA) and plasma markers of coagulation, fibrinolysis and endothelial dysfunction in 21 obese (10·1 ± 1·5 years, mean ± standard deviation) and 22 healthy weight children (9·9 ± 1·6 years), classified by Body Mass Index (BMI). TF‐PCA and factor VII coagulant activity (FVII:C), plasminogen activator inhibitor (PAI‐1, SERPINE1) and soluble vascular cell adhesion molecule 1 (sVCAM1) were higher in obese children. BMI correlated positively with TF‐PCA, FVII:C, and PAI‐1. Childhood obesity is associated with a procoagulant state and endothelial dysfunction. Studies are needed to assess whether weight reduction reverses these abnormalities.

Double-Lung Transplantation Can Be Safely Performed Using Donors With Heavy Smoking History

BACKGROUND Lung transplantation using grafts from donors with a history of heavy smoking (>20 pack-years) is thought to confer worse prognosis. We attempt to determine if adult, double-lung transplantation can be safely performed with lungs from heavy-smoking donors (HSD). METHODS The United Network for Organ Sharing (UNOS) database was examined for adult, double-lung transplants from 2005 to 2011. RESULTS Of 5,900 double-lung transplants, 766 (13.0%) were from HSDs. The two groups were similar in recipient age (49.8 vs 50.5 years, p = 0.15), male sex (56.9% vs 56.5%, p = 0.87), and lung allocation score (45.8 vs 44.9, p = 0.18). Recipients of lungs from HSDs had lower forced expiratory volume in 1 second (FEV1; 34.3 vs 36.1% predicted, p = 0.04), longer ischemic time (5.75 vs 5.58 hours, p = 0.01), less human leukocyte antigen mismatch (4.51 vs 4.62, p = 0.01), and lower class I plasma reactive antigens (2.64 vs 3.69%, p = 0.001). HSDs were older (40.9 vs 32.6 years, p < 0.001) and less likely male (51.7 vs 59.7%, p < 0.001). Recipients of lungs from HSDs had longer median length of stay (18.0 vs 17.0 days, p < 0.001). Freedom from bronchiolitis obliterans syndrome (p = 0.09), decrement in FEV1 (p = 0.12), peak FEV1 (79.8% vs 79.0%, p = 0.51), and median survival (2,043 vs 1,928 days, p = 0.69) were not different. On multivariate analysis, HSD lungs were not associated with death (hazard ratio, 1.003; 95% confidence interval, 0.867 to 1.161, p = 0.96). Death was associated with donor age, ischemic time, race mismatch, mechanical ventilation, and extracorporeal membranous oxygenation before transplantation. CONCLUSIONS Double-lung transplantation can be safely performed with lungs from donors with a heavy smoking history.

Continuous flow left ventricular assist device technology has influenced wait times and affected donor allocation in cardiac transplantation

OBJECTIVE Bridge to transplantation patients with continuous flow left ventricular assist devices (cfLVADs) are assigned United Network for Organ Sharing status 1A or 1B priority while awaiting orthotopic heart transplantation. We investigated the influence of cfLVAD on the waitlist times and organ allocation. METHODS The United Network for Organ Sharing database was examined from 2005 to 2012 for patients with cfLVAD and pulsatile flow LVAD (pLVAD). These 2 cohorts were compared with patients who did not receive LVAD. RESULTS Of 16,476 total orthotopic heart transplantations, 3270 (19.8%) were performed on patients with an LVAD as a bridge to transplantation. The cfLVAD group had the longest total waitlist time (259.6 days) compared with the pLVAD (134.6 days) and non-LVAD (121.7 days) groups (P < .001). The cfLVAD group spent more time in status 1A (44.7 days) than did the pLVAD (32.1 days) and non-LVAD (16.4 days) cohorts (P < .001). The median waitlist survival was better for the cfLVAD group (1234.0 days) than in the pLVAD (441.0 days) and non-LVAD (471.0 days) groups (P < .001). The cfLVAD recipients were older, had a greater body mass index, and more often had diabetes than did pLVAD and non-LVAD patients. The cfLVAD cohort received hearts from older, more often male donors, with a greater body mass index. Post-transplant survival was not significantly different among the 3 groups on Kaplan-Meier analysis (P = .12). CONCLUSIONS Despite being older, less favorable recipients, the cfLVAD patients spent more time in status 1A and had greater waitlist survival. This might allow cfLVAD patients to receive preferred donor hearts, which might allow for better post-transplant survival.

Smoking cue reactivity across massed extinction trials: Negative affect and gender effects.

Designing and implementing cue exposure procedures to treat nicotine dependence remains a challenge. This study tested the hypothesis that gender and negative affect (NA) influence changes in smoking urge over time using data from a pilot project testing the feasibility of massed extinction procedures. Forty-three smokers and ex-smokers completed the behavioral laboratory procedures. All participants were over 17 years old, smoked at least 10 cigarettes daily over the last year (or the year prior to quitting) and had expired CO below 10 ppm at the beginning of the ~4-hour session. After informed consent, participants completed 45 min of baseline assessments, and then completed a series of 12 identical, 5-minute exposure trials with inter-trial breaks. Smoking cues included visual, tactile, and olfactory cues with a lit cigarette, in addition to smoking-related motor behaviors without smoking. After each trial, participants reported urge and negative affect (NA). Logistic growth curve models supported the hypothesis that across trials, participants would demonstrate an initial linear increase followed by a decrease in smoking urge (quadratic effect). Data supported hypothesized gender, NA, and gender×NA effects. Significant linear increases in urge were observed among high and low NA males, but not among females in either NA subgroup. A differential quadratic effect showed a significant decrease in urge for the low NA subgroup, but a non-significant decrease in urge in the high NA group. This is the first study to demonstrate gender differences and the effects of NA on the extinction process using a smoking cue exposure paradigm. Results could guide future cue reactivity research and exposure interventions for nicotine dependence.

Impact of extracorporeal membrane oxygenation or mechanical ventilation as bridge to combined heart-lung transplantation on short-term and long-term survival.

Background Extracorporeal membrane oxygenation (ECMO) and mechanical ventilation (MV) can be used as a bridge to heart-lung transplantation (HLT). The goal of this study was to determine if pretransplantation ECMO or MV affects survival in HLT. Methods The United Network for Organ Sharing database was reviewed for all adult patients receiving HLT from 1995 to 2011. The primary outcome measured was risk-adjusted all cause mortality. Results There were 542 adult patients received HLT during the study period. Of these, 15 (2.8%) required ECMO and 22 (4.1%) required MV as a bridge to transplantation. The groups were evenly matched with regards to recipient age, recipient gender, ischemic time, donor age, and donor gender. The ECMO cohort had worse survival than the control group at 30 days (20.0% vs. 83.5%) and 5 years (20.0% vs. 47.4%; P<0.001). When compared with control, patients requiring MV had worse survival at 1 month (77.3% vs. 83.5%) and 5 years (26.5% vs. 47.4%; P<0.001). The use of ECMO (hazard ratio [HR]=3.820, 95% confidence interval [CI]=1.600–9.116; P=0.003) or MV (HR=2.011, 95% CI=1.069–3.784; P=0.030) as a bridge to transplantation was independently associated with mortality on multivariate analysis. Recipient female gender was associated with survival (HR=0.754, 95% CI=0.570–0.998; P=0.048). Conclusions HLT recipients bridged by MV or ECMO have increased short-term and long-term mortality. Further studies are needed to optimize survival in these high-risk patients.

Developing measures of community-relevant outcomes for violence prevention programs: A community-based participatory research approach to measurement

Community-Based Participatory Research is a research paradigm that encourages community participation in designing and implementing evaluation research, though the actual outcome measures usually reflect the “external” academic researchers’ view of program effect and the policy-makers’ needs for decision-making. This paper describes a replicable process by which existing standardized psychometric scales commonly used in youth-related intervention programs were modified to measure indicators of program success defined by community partners. This study utilizes a secondary analysis of data gathered in the context of a community-based youth violence prevention program. Data were retooled into new measures developed using items from the Alabama Parenting Questionnaire, the Hare Area Specific Self-Esteem Scale, and the Youth Asset Survey. These measures evaluated two community-defined outcome indicators, “More Parental Involvement” and “Showing Kids Love.” Results showed that existing scale items can be re-organized to create measures of community-defined outcomes that are psychometrically reliable and valid. Results also show that the community definitions of parent or parenting caregivers exemplified by the two indicators are similar to how these constructs have been defined in previous research, but they are not synonymous. There are nuanced differences that are important and worthy of better understanding, in part through better measurement.

Cardiac transplantation can be safely performed using selected diabetic donors

OBJECTIVE Cardiac transplantation (OHT) using diabetic donors (DDs) is thought to adversely influence survival. We attempt to determine if adult OHT can be safely performed using selected DDs. METHODS The United Network for Organ Sharing (UNOS) database was examined for adult OHT from 2000 to 2010. RESULTS Of the 20,348 patients undergoing OHT, 496 (2.4%) were with DDs. DDs were older (39.6 vs 31.3 years; P < .001), more likely female (41.5% vs 28.3%; P < .001), and had a higher body mass index (BMI) (29.9 vs 26.4; P < .001). Recipients of DD hearts were older (53.4 vs 51.8; P = .004) and more likely to have diabetes (18.9% vs 14.9%; P = .024). The 2 groups were evenly matched with regard to recipient male gender (78.0% vs 76.1%; P = .312), ischemic time (3.3 vs 3.2 hours; P = .191), human leukocyte antigen mismatches (4.7 vs 4.6; P = .483), and requirement of extracorporeal membrane oxygenation (ECMO) as a bridge to transplant (0.8% vs 0.5%; P = .382). Median survival was similar (3799 vs 3798 days; P = .172). On multivariate analysis, DD was not associated with mortality (hazard ratio [HR], 1.155; 95% confidence interval [CI], 0.943-1.415; P = .164). As previously demonstrated, donor age, decreasing donor BMI, ischemic time, recipient creatinine, recipient black race, recipient diabetes, race mismatch, and mechanical ventilation or ECMO as a bridge to transplant were associated with mortality. On multivariate analysis of subgroups, neither insulin-dependent diabetes (1.173; 95% CI, 0.884-1.444; P = .268) nor duration of diabetes for more than 5 years (HR, 1.239; 95% CI, 0.914-1.016; P = .167) was associated with mortality. CONCLUSIONS OHT can be safely performed using selected DDs. Consensus criteria for acceptable cardiac donors can likely be revised to include selected DDs.

Single-lung transplantation can be performed with acceptable outcomes using selected donors with heavy smoking history.

BACKGROUND We attempt to determine if adult, single-lung transplantation could be performed with acceptable results in heavy-smoking donors (HSDs; > 20 pack-years). METHODS The United Network of Organ Sharing database was examined for adult single-lung transplantation from 2005 to 2011. RESULTS Of the 3,704 single-lung transplantations, 498 (13.4%) were from HSDs. The 2 groups were similar in recipient age (60.6 vs. 60.7 years, p = 0.20), male gender (61.3% vs. 59.8%, p = 0.54), ischemic time (4.1 vs. 4.2 hours, p = 0.11), and pre-transplant forced expiratory volume in 1 second (FEV1; 41.1% vs. 40.0% predicted). Recipients of HSDs had lower lung allocation score (39.7 vs. 38.0, p = 0.02), less human leukocyte antigen mismatches (4.6 vs. 4.5, p = 0.01), and higher class I panel reactive antibody (2.9% vs. 3.8%, p < 0.001). HSDs were older (33.0 vs. 41.3 years, p < 0.001) and less likely male (62.5 vs. 56.0%, p = 0.01). Recipients with HSDs had longer length of stay (20.5 vs. 23.0 days, p < 0.001) and lower peak FEV1 after single-lung transplantation (80.1% vs. 73.4%, p < 0.001). Freedom from bronchiolitis obliterans syndrome (p = 0.64), post-single-lung transplantation decrement in FEV1 (p = 0.07), and median survival (1,516 vs. 1,488 days, p = 0.10) were similar. Multivariable analysis found receiving lungs from actively smoking HSDs was associated with mortality (hazard ratio [HR], 1.23, 95% confidence interval [CI], 1.05-1.45; p = 0.01). Use of HSDs who were not actively smoking was not associated with mortality (HR, 0.84; 95% CI, 0.59-1.19; p = 0.33). Mortality was associated with recipient age, longer ischemic time, race mismatch, class I panel reactive antibody > 10%, mechanical ventilation, and extracorporeal membrane oxygenation as a bridge to transplantation. CONCLUSIONS Although single-lung transplantation with actively smoking HSDs results in worse results, outcomes are acceptable and should continue to be considered.

Effects of weight loss on foot structure and function in obese adults: A pilot randomized controlled trial

OBJECTIVE To investigate the effects of weight reduction on foot structure, gait, and dynamic plantar loading in obese adults. DESIGN In a 3-month randomized-controlled trial, participants were randomized to receive either a weight loss intervention based on portion-controlled meals or a delayed-treatment control. PARTICIPANTS 41 adults (32 F, 9 M) with a mean ± SD age of 56.2 ± 4.7 years and a BMI of 35.9 ± 4.2 kg/m(2). MEASUREMENTS Arch Height Index (AHI), Malleolar Valgus Index (MVI), spatial and temporal gait parameters, plantar peak pressure (PP) and weight were measured at baseline, 3, and 6 months. RESULTS The intervention group experienced significantly greater weight loss than did the control group (5.9 ± 4.0 kg versus 1.9 ± 3.2 kg, p = 0.001) after 3 months. There were no differences between the groups in anatomical foot structure or gait. However, the treatment group showed a significantly reduced PP than the control group beneath the lateral arch and the metatarsals 4 (all p values < .05) at 3 months. The change in PP correlated significantly with the change in weight at the metatarsal 2 (r = 0.57, p = 0.0219), metatarsal 3 (r = 0.56, p = 0.0064) and the medial arch (r = 0.26, p < 0.0001) at 6 months. CONCLUSION This was the first RCT designed to assess the effects of weight loss on foot structure, gait, and plantar loading in obese adults. Even a modest weight loss significantly reduced the dynamic plantar loading in obese adults. However, weight loss appeared to have no effects on foot structure and gait.