Perinatal Outcomes of Two Screening Strategies for Gestational Diabetes Mellitus: A Randomized Controlled Trial.

OBJECTIVE: To evaluate differences in short-term perinatal outcomes between the two prominent screening strategies for gestational diabetes mellitus, the International Association of Diabetes and Pregnancy Study Groups (IADPSG) and Carpenter-Coustan. METHODS: In this single-site, blinded, randomized, comparative effectiveness trial, participants received a nonfasting 50-g oral glucose tolerance test and, if less than 200 mg/dL (less than 11.1 mmol/L), were randomized to further screening with either IADPSG or Carpenter-Coustan criteria. Gestational diabetes treatment occurred per routine clinical care. The primary outcome was incidence of large-for-gestational-age (LGA) neonates. Prespecified secondary outcomes included small-for-gestational-age (SGA) neonates, cesarean birth, and neonatal and maternal composites of adverse perinatal outcomes. Assuming a 15% incidence of LGA neonates in the Carpenter-Coustan group, 782 participants provided more than 80% power to detect a 7% absolute risk reduction with the use of IADPSG; planned recruitment was 920 for anticipated attrition. RESULTS: From June 2015 to February 2019, 1,016 participants were enrolled and 921 were randomized to IADPSG (n=461) or Carpenter-Coustan (n=460) groups. Gestational diabetes incidence (14.4% vs 4.5%, P<.001) and diabetes medication use (9.3% vs 2.4%; P<.001) were more common in the IADPSG group; there were no differences in LGA neonates, either overall (risk reduction 0.90, 97.5% CI 0.53-1.52) or among women without gestational diabetes (risk reduction 0.85, 97.5% CI 0.49-1.48). Those screened with IADPSG had higher rates of neonatal morbidity but fewer study-related adverse events. Rates of SGA neonates, cesarean birth, and maternal morbidity composite did not differ significantly between study groups. CONCLUSIONS: The IADPSG screening criteria resulted in more women diagnosed and treated for gestational diabetes than Carpenter-Coustan without reducing the incidence of LGA birth weight or maternal or neonatal morbidity. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02309138.

Treatment of Gestational Diabetes Mellitus and Offspring Early Childhood Growth.

BACKGROUND: Gestational diabetes mellitus (GDM) is associated with fetal overgrowth, and certain treatments are associated with an increased risk of macrosomia. However, there are limited data about the long-term effect of GDM treatment on childhood growth. METHODS: Cohort study of 816 women with GDM and their offspring delivered between 2009 and 2012. Childhood height and weight through age 3 were collected from the medical record and z-scores and body mass index (BMI) were calculated. We assessed the association between GDM treatment and childhood growth using linear mixed modeling. RESULTS: Treatment was divided into medical nutritional therapy (MNT) (n = 293), glyburide (n = 421), and insulin (n = 102). At delivery, birthweight, z-score, and BMI were higher in the offspring of women treated with either glyburide or insulin compared to MNT. However, weight, z-score, and BMI were similar among all offspring at 6 months and 1, 2, and 3 years of age. After controlling for covariates, there were differences in the weight z-score (P = 0.01) over the 3-year period by treatment group, but no differences in weight (P = 0.06) or change in BMI (P = 0.28). Pairwise comparisons indicated that insulin was associated with more weight gain compared with MNT (0.69 kg; 95% CI, 0.10-1.28; P = 0.02) and glyburide was associated with a trend toward lower weight z-score compared with MNT (-0.24; 95% CI, -0.47 to 0.003; P = 0.05). CONCLUSION: Despite growth differences detected at birth, we observed no meaningful differences in childhood growth from 6 months to 3 years among treatment groups, including in the offspring of women with GDM treated with glyburide.

Brief Report: Dipyridamole Decreases Gut Mucosal Regulatory T-Cell Frequencies Among People With HIV on Antiretroviral Therapy.

BACKGROUND: We had previously conducted a double-blind, randomized placebo-controlled, partial cross-over trial showing that 12 weeks of dipyridamole decreased CD8 T-cell activation among treated HIV(+) individuals by increasing extracellular adenosine levels. METHODS: In this substudy, rectosigmoid biopsies were obtained from 18 participants (9 per arm), to determine whether 12 weeks of dipyridamole affects mucosal immune cells. Participants randomized to placebo were then switched to dipyridamole for 12 weeks while the treatment arm continued dipyridamole for another 12 weeks. We evaluated T-cell frequencies and plasma markers of microbial translocation and intestinal epithelial integrity. Linear regression models on log-transformed outcomes were used for the primary 12-week analysis. RESULTS: Participants receiving dipyridamole had a median 70.2% decrease from baseline in regulatory T cells (P = 0.007) and an 11.3% increase in CD8 T cells (P = 0.05). There was a nonsignificant 10.80% decrease in plasma intestinal fatty acid binding protein levels in the dipyridamole arm compared with a 9.51% increase in the placebo arm. There were no significant differences in plasma levels of ß-D-glucan. In pooled analyses, there continued to be a significant decrease in regulatory T cells (-44%; P = 0.004). There was also a trend for decreased CD4 and CD8 T-cell activation. CONCLUSION: Increasing extracellular adenosine levels using dipyridamole in virally suppressed HIV (+) individuals on antiretroviral therapy can affect regulation of gut mucosal immunity.

Lifestyle Habits Associated with Weight Regain After Intentional Loss in Primary Care Patients Participating in a Randomized Trial.

BACKGROUND: Though long-term weight loss maintenance is the treatment goal for obesity, weight regain is typical and few studies have evaluated lifestyle habits associated with weight regain. OBJECTIVE: To identify dietary and physical activity habits associated with 6- and 24-month weight regain among participants in a weight loss maintenance clinical trial. DESIGN: Secondary analysis of randomized clinical trial data. PARTICIPANTS: Adult primary care patients with recent, intentional weight loss of at least 5%. MAIN MEASURES: Lifestyle habits included consumption of low-fat foods, fish, desserts, sugary beverages, fruits, and vegetables and eating at restaurants from the Connor Diet Habit Survey; moderate-vigorous physical activity by self-report; steps recorded by a pedometer; and sedentary behavior by self-report. The outcome variable was weight change at 6 and 24 months. Linear regression models estimated adjusted associations between changes in weight and changes in dietary and physical activity habits. KEY RESULTS: Overall, participants (mean (SD): 53.4 (12.2) years old; 26% male; 88% white) maintained weight loss at 6 months (n = 178, mean (SD): - 0.02 (5.70)% change) but began to regain weight by 24 months (n = 157, mean (SD): 4.22 (9.15)% increase). When considered all together, more eating at restaurants, reduced fish consumption, and less physical activity were most consistently associated with weight regain in fully adjusted models at both 6 and 24 months of follow-up. In addition, more sedentary behavior was associated with weight regain at 6 months while reduced consumption of low-fat foods, and more desserts and sugary beverages were associated with weight regain at 24 months. CONCLUSIONS: Consuming less fish, fewer steps per day, and more frequent restaurant eating were most consistently associated with weight regain in primary care patients. Primary care providers may consider addressing specific lifestyle behaviors when counseling patients after successful weight loss. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01946191.

Inflammatory Bowel Disease and Thrombosis: A National Inpatient Sample Study.

Introduction Thrombosis is more common in inflammatory bowel disease (IBD) patients than the general population, but disease-specific correlates of thrombosis remain unclear. Methods We performed a retrospective analysis of discharge data from the National Inpatient Sample between 2009 and 2014, using International Disease Classification codes to identify IBD and non-IBD patients with or without thrombosis. We used NIS-provided discharge-level weights to reflect prevalence estimates. Categoric variables were analyzed by Rao-Scott Chi-square test, continuous variables by weighted simple linear regression, and covariates associated with thrombosis by weighted multivariable logistic regression. Results Thrombosis prevalence in IBD was significantly greater than in non-IBD, 7.52 versus 4.54%, p < 0.0001. IBD patients with thrombosis were older and more likely to be Caucasian than IBD without thrombosis, each p < 0.001. Thrombosis occurred most commonly in the mesenteric vein. Thrombotic risk factors in IBD include surgery, ports, malignancy, dehydration, malnutrition, and steroids at 53.7, 13.2, 13.1, 12.4, 8.9, and 8.2%, respectively. Those with thrombosis had greater severity of illness, 1.42 versus 0.96; length of stay, 7.7 versus 5.5 days; and mortality, 3.8 versus 1.5%; all p < 0.0001. Adjusting for age and comorbidity, odds ratios for predictors of thrombosis included ports, steroids, malnutrition, and malignancy at 1.73, 1.61, 1.34, and 1.13, respectively, while Asian race, 0.61, was protective, each p < 0.001. Conclusion Thrombosis prevalence is 1.7-fold greater in IBD than non-IBD patients. Adjusting for age and comorbidity, the odds ratio for thrombosis in IBD was 73% higher with ports, 61% higher with steroids, 34% with malnutrition, and 13% with malignancy. Whether long-term anticoagulation would benefit the latter is unknown.

A Randomized, Placebo-Controlled, Pilot Clinical Trial of Dipyridamole to Decrease Human Immunodeficiency Virus-Associated Chronic Inflammation.

BACKGROUND: Adenosine is a potent immunoregulatory nucleoside produced during inflammatory states to limit tissue damage. We hypothesized that dipyridamole, which inhibits cellular adenosine uptake, could raise the extracellular adenosine concentration and dampen chronic inflammation associated with human immunodeficiency virus (HIV) type 1. METHODS: Virally suppressed participants receiving antiretroviral therapy were randomized 1:1 for 12 weeks of dipyridamole (100 mg 4 times a day) versus placebo capsules. All participants took open-label dipyridamole during weeks 12-24. Study end points included changes in markers of systemic inflammation (soluble CD163 and CD14, and interleukin 6) and levels of T-cell immune activation (HLA-DR+CD38+). RESULTS: Of 40 participants who were randomized, 17 dipyridamole and 18 placebo recipients had baseline and week 12 data available for analyses. There were no significant changes in soluble markers, apart from a trend toward decreased levels of soluble CD163 levels (P = .09). There was a modest decrease in CD8+ T-cell activation (-17.53% change for dipyridamole vs +13.31% for placebo; P = .03), but the significance was lost in the pooled analyses (P = .058). Dipyridamole also reduced CD4+ T-cell activation (-11.11% change; P = .006) in the pooled analyses. In post hoc analysis, detectable plasma dipyridamole levels were associated with higher levels of inosine, an adenosine surrogate, and of cyclic adenosine monophosphate. CONCLUSION: Dipyridamole increased extracellular adenosine levels and decreased T-cell activation significantly among persons with HIV-1 infection receiving virally suppressive therapy.

Perinatal Outcomes Associated with Early Diabetes Testing in Pregnancies Complicated by Obesity.

OBJECTIVE: This study aimed to determine whether early diabetes testing is associated with differences in perinatal outcomes among pregnant women with obesity (body mass index ≥30 kg/m2). STUDY DESIGN: We conducted a retrospective cohort study of singleton pregnancies from 2012 to 2014 at a large academic medical center which examined the association of diabetes testing (HBA1c, 50 g glucose challenge test, or 100 g oral glucose tolerance test) before 24 weeks with perinatal outcomes using propensity score modeling and logistic regression. RESULTS: Among women with obesity, 790 out of 2,698 (29.3%) underwent early diabetes testing. Propensity score modeling demonstrated that early testing was associated with higher rates of diabetes diagnosis (odds ratio [OR]: 1.62, 95% confidence interval [CI]: 1.10-2.37, p = 0.01) and a trend toward small for gestational age birth weight (OR: 1.38, 95% CI: 1.00-1.90, p = 0.05) and neonatal composite morbidity (OR: 1.25, 95% CI: 1.00-1.57, p = 0.05) compared with routine testing. Women with inadequate weight gain were more likely a small for gestational age (SGA) infant if they underwent early testing compared with those with routine testing alone (19.8 vs. 11.6%, p = 0.01). CONCLUSION: Early testing targets higher risk women and yields a higher diabetes diagnosis rate, but inadequate weight gain in these women may increase risk SGA birth weight and neonatal morbidity. Randomized clinical trials are urgently needed to assess whether early diabetes testing improves outcomes in women with obesity.

Effect of Electronic Health Record-Based Coaching on Weight Maintenance: A Randomized Trial.

Background: Weight regain after intentional loss is common. Most evidence-based weight management programs focus on short-term loss rather than long-term maintenance. Objective: To evaluate the benefit of coaching in an electronic health record (EHR)-based weight maintenance intervention. Design: Randomized controlled trial. (ClinicalTrials.gov: NCT01946191). Setting: Practices affiliated with an academic medical center. Participants: Adult outpatients with body mass index (BMI) of 25 kg/m2 or higher, intentional weight loss of at least 5% in the previous 2 years, and no bariatric procedures in the previous 5 years. Intervention: Participants were randomly assigned to EHR tools (tracking group) versus EHR tools plus coaching (coaching group). The EHR tools included weight, diet, and physical activity tracking flow sheets; standardized surveys; and reminders. The coaching group received 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts. Measurements: The primary outcome was weight change at 24 months. Secondary outcomes included 5% weight loss maintenance and changes in BMI, waist circumference, number of steps per day, health-related quality of life, physical function, blood pressure, and satisfaction. Results: Among 194 randomly assigned participants (mean age, 53.4 years [SD, 12.2]; 143 [74%] women; 171 [88%] white), 157 (81%) completed the trial. Mean baseline weight and BMI were 85.8 kg (SD, 19.1) and 30.4 kg/m2 (SD, 5.9). At 24 months, mean weight regain (± SE) was 2.1 ± 0.62 kg and 4.9 ± 0.63 kg in the coaching and tracking groups, respectively. The between-group difference in weight change at 24 months was significant (-2.86 kg [95% CI, -4.60 to -1.11 kg]) in the linear mixed model. At 24 months, 65% of participants in the coaching group and 50% in the tracking group maintained weight loss of at least 5%. Limitation: Single-site trial, which limits generalizability. Conclusion: Among adults with intentional weight loss of at least 5%, use of EHR tools plus coaching resulted in less weight regain than EHR tools alone. Primary Funding Source: Agency for Healthcare Research and Quality and National Institutes of Health.

Creating an academic research organization to efficiently design, conduct, coordinate, and analyze clinical trials: The Center for Clinical Trials & Data Coordination.

When properly executed, the randomized controlled trial is one of the best vehicles for assessing the effectiveness of one or more interventions. However, numerous challenges may emerge in the areas of study startup, recruitment, data quality, cost, and reporting of results. The use of well-run coordinating centers could help prevent these issues, but very little exists in the literature describing their creation or the guiding principles behind their inception. The Center for Clinical Trials & Data Coordination (CCDC) was established in 2015 through institutional funds with the intent of 1) providing relevant expertise in clinical trial design, conduct, coordination, and analysis; 2) advancing the careers of clinical investigators and CCDC-affiliated faculty; and 3) obtaining large data coordinating center (DCC) grants. We describe the organizational structure of the CCDC as well as the homegrown clinical trial management system integrating nine crucial elements: electronic data capture, eligibility and randomization, drug and external data tracking, safety reporting, outcome adjudication, data and safety monitoring, statistical analysis and reporting, data sharing, and regulatory compliance. Lastly, we share numerous lessons that can be taken from our experience. Specifically, we focus on 1) funding for DCCs, 2) the importance of DCCs to clinical researchers, 3) the expertise of DCC personnel, and 4) continually striving to improve. In conclusion, the CCDC strives to provide high-quality support for the design, conduct, coordination, and analyses of clinical trials, and we hope this paper will serve as a blueprint for future clinical trialists involved in DCCs.

Von Willebrand disease and gastrointestinal bleeding: A national inpatient sample study.

INTRODUCTION: Gastrointestinal tract bleeding (GIB) is a serious complication of von Willebrand Disease (VWD), but little is known regarding prevalence and risk factors. We, therefore, evaluated correlates of GIB among VWD using a large national database. METHODS: We conducted a retrospective analysis of adult discharges from the National Inpatient Sample (NIS) between 2009 and 2014. International Disease Classification codes were used to identify those with and without VWD with and without GIB. Prevalence estimates were weighted using NIS-provided discharge-level weights to reflect national estimates. Categorical variables were compared by Rao-Scott chi-square test, continuous variables by weighted simple linear regression, and independent factors associated with GIB in VWD were determined by weighted multivariable logistic regression. RESULTS: GIB is more prevalent in VWD, 3.70%, than those without VWD, 1.49%, p < .0001, and is more common in those who are younger, male, or Black than in VWD without GIB, each p < .001. Comorbidities of GIB in VWD include surgery, hypertension, hyperlipidemia, and smoking, each more common than in VWD without GIB, p < .0001. VWD with GIB also have higher length of stay and inpatient mortality, p < .0001. In a multivariable model, variables significantly associated with GIB in VWD were angiodysplasia, diverticulitis, hepatitis C, black race, male gender, and smoking, each p < .001. CONCLUSIONS: GIB is more common in VWD who are young, black, or male, and the most significant predictors of GIB include angiodysplasia, diverticulitis, hepatitis C, and smoking. After a first GIB, such individuals should consider factor prophylaxis to prevent GIB recurrence and associated morbidity.

Incidence and risk factors for hepatocellular cancer in individuals with haemophilia: A National Inpatient Sample Study.

INTRODUCTION: Among haemophilic (H) men, hepatitis C virus (HCV) is the leading cause of liver disease and mortality, but demographics and risks of hepatocellular carcinoma (HCC) in H are not well known. METHODS: Adult discharges in H and non-haemophilic (NH) men, with and without HCC were identified in the National Inpatient Sample (NIS) between 1998 and 2014, using ICD-9 codes. Analyses included NIS-provided discharge-level weights to reflect national estimates. Categorical variables were assessed by Rao-Scott chi-square and continuous variables by weighted simple linear regression. HCC predictors were determined by weighted multivariable logistic regression. RESULTS: Of 18 098 H, 144 (0.79%) had HCC between 1998 and 2014. Adjusted rates of HCC increased 3.0-fold in H vs 1.7-fold in NH (P = 0.484). Among HCV+, HCC rates adjusted for HIV, increased 2.2-fold in H vs 1.7-fold in NH (P = 0.740), while among HIV+, HCC increased 1.4-fold in H vs 0.2-fold in NH (P = 0.448). Among those with HCC, H were older than NH (P < 0.001), Caucasian (P = 0.006), platelet transfusion recipients (P < 0.001), with greater comorbidity (P < 0.001) and mortality (P < 0.006). H with HCC also had greater rates of HCV and HIV (each P < 0.001), lower rates of alcoholism and hyperlipidemia (each P < 0.001), and similar rates of HBV (P = 0.866), smoking (P = 0.507) and obesity (P = 0.502). In multivariable logistic regression, HCV was a strong predictor for HCC in haemophilia, (OR: 15.42, 95% CI: 8.75-27.16). DISCUSSION: Haemophilic men have increasing rates of HCC, similar to men without haemophilia. HCV is the major predictor of HCC in haemophilia. Future trends in HCC will depend on the impact of newer HCV antiviral therapy.

Comparison of longitudinal Aß in nondemented elderly and Down syndrome.

Down syndrome (DS) predisposes individuals to early Alzheimer's disease (AD). Using Pittsburgh Compound B ([11C]PiB), a pattern of striatal amyloid beta (Aß) that is elevated relative to neocortical binding has been reported, similar to that of nondemented autosomal dominant AD mutation carriers. However, it is not known whether changes in striatal and neocortical [11C]PiB retention differ over time in a nondemented DS population when compared to changes in a nondemented elderly (NDE) population. The purpose of this work was to assess longitudinal changes in trajectories of Aß in a nondemented DS compared to an NDE cohort. The regional trajectories for anterior ventral striatum (AVS), frontal cortex, and precuneus [11C]PiB retention were explored over time using linear mixed effects models with fixed effects of time, cohort, and time-by-cohort interactions and subject as random effects. Significant differences between DS and NDE cohort trajectories for all 3 region of interests were observed (p < 0.05), with the DS cohort showing a faster accumulation in the AVS and slower accumulation in the frontal cortex and precuneus compared to the NDE cohort. These data add to the previously reported distinct pattern of early striatal deposition not commonly seen in sporadic AD by demonstrating that individuals with DS may also accumulate Aß at a rate faster in the AVS when compared to NDE subjects.

Response to Medical Nutritional Therapy and Need for Pharmacological Therapy in Women with Gestational Diabetes.

OBJECTIVE: We assessed if the initial response to medical nutritional therapy (MNT) can help predict the need for pharmacological therapy in women with gestational diabetes mellitus (GDM). STUDY DESIGN: We identified 1,174 women with GDM who underwent standardized dietary counseling and reported glucose values from the first week of MNT. We compared women who required pharmacological therapy with those who did not use bivariate statistics, and used multivariable logistic regression modeling to assess for factors predicting the need for pharmacological therapy. RESULTS: We identified 819 women (69.8%) who needed pharmacological therapy. They had higher prepregnancy body mass index, higher rates of GDM diagnosis before 24 weeks, and higher oral glucose tolerance test values. After adjustment for covariates, age (odds ratio [OR]: 1.04; 95% confidence interval [CI]: 1.01-1.08), obesity (OR: 2.49; 95% CI: 1.70-3.66), and ≥33% of abnormal glucose values from the first week of MNT (OR: 13.84; 95% CI: 9.4-20.20) were associated with the need for pharmacological therapy. Area under the curve of the regression model was 0.83, with a sensitivity of 72.2%, a specificity of 86.8%, and a positive predictive value of 92.5%. CONCLUSION: Glucose values from the first week of MNT were the strongest predictor of needing pharmacological therapy. Further studies are needed to define metabolic predictors of response to MNT in women with GDM.

Comparison of Birth Outcomes by Gestational Diabetes Screening Criteria.

Objectives This study is to examine the association between different diagnostic criteria for gestational diabetes mellitus (GDM) and adverse birth outcomes. Study Design A retrospective cohort study of 5,937 women with a singleton pregnancy was conducted, who completed GDM screening between 24 to 32 weeks gestational age. Four nonoverlapping groups of women defined as: 1) Normal: glucose challenge test (GCT) <130 mg/dL, 2) elevated GCT + normal oral glucose tolerance test (OGTT): abnormal 1 hour GCT + normal 3 hour OGTT, 3) GDM/International Association of Diabetes in Pregnancy Study Group (IADPSG): abnormal 3 hour OGTT by the IADPSG criteria, and 4) GDM/Carpenter-Coustan (CC): diagnosis per CC criteria. We used logistic regression to examine the association between GDM group classification and main outcome of macrosomia and secondary birth outcomes. Results Prevalences were GDM/CC 4.6%, GDM/IADPSG 3.0, and 7.6% overall. GDM/IADPSG group was associated with increased macrosomia (adj OR [odd ratio] 1.87; 95% CI [confidence interval]: 1.08-3.25; p = 0.02), while GDM/CC group was associated with increased preterm birth (adj OR 1.75; 95% CI: 1.05-2.80; p = 0.03). Conclusion Little difference in birth outcomes was found between the two criteria, GDM/CC and GDM/IADPSG. Randomized controlled trials are needed to clarify the risks and benefits of these screening paradigms before their incorporation into clinical practice.

Prevalence and correlates of thrombosis in adults with immune thrombocytopenia: An NIS study.

BACKGROUND: Immune thrombocytopenia (ITP) is increasingly recognized as a thrombophilic disorder. However, no further investigation of risk factors has been conducted to date. This study evaluated classic and disease-specific correlates of thrombosis among ITP patients. We hypothesized the disease-specific thrombosis risk profile differed between ITP and non-ITP patients. METHODS: A retrospective analysis of adult discharge data from the National Inpatient Sample between 2009 and 2014 was performed. International Disease Classification codes were used to identify ITP and non-ITP patients with or without thrombosis. Estimates of prevalence were weighted using NIS-provided discharge-level weights to reflect national estimates. Rao-Scott Chi-square test was used to analyze categoric variables; weighted simple linear regression for continuous variables; and a weighted multivariable logistic regression to determine covariates associated with thrombosis. RESULTS: Thrombotic risk factors are increased in ITP patients, including postoperative state, malignancy, central venous lines, systemic lupus erythematosus, advanced age, obesity, and hypertension. Factors associated with thrombosis identified in multivariable logistic regression included antiphospholipid syndrome, systemic lupus erythematosus, central venous lines, obesity, and hypertension, which were similar to non-ITP patients. CONCLUSIONS: Our results show a higher prevalence of thrombosis in ITP than in non-ITP patients, and despite their lower platelet counts, correlates of thrombosis are similar between ITP and non-ITP patients. The most significant correlates include antiphospholipid syndrome, central venous lines, surgery, hypertension, age, and obesity.

Longitudinal Assessment of Left Ventricular Mass in Autosomal Dominant Polycystic Kidney Disease.

INTRODUCTION: The high burden of cardiovascular morbidity and mortality in autosomal dominant polycystic kidney disease (ADPKD) is related to development of hypertension and left ventricular hypertrophy. Blood pressure reduction has been shown to reduce left ventricular mass in ADPKD; however, moderators and predictors of response to lower blood pressure are unknown. METHODS: This was a post hoc cohort analysis of HALT PKD study A, a randomized placebo controlled trial examining the effect of low blood pressure and single versus dual renin-angiotensin blockade in early ADPKD. Participants were hypertensive ADPKD patients 15 to 49 years of age with estimated glomerular filtration rate (eGFR) > 60 ml/min per 1.73 m2 across 7 centers in the United States. Predictors included age, sex, baseline eGFR, systolic blood pressure, total kidney volume, serum potassium, and urine sodium, potassium, albumin, and aldosterone. Outcome was left ventricular mass index (LVMI) measured using 1.5-T magnetic resonance imaging at months 0, 24, 48, and 60. RESULTS: Reduction in LVMI was associated with higher baseline systolic blood pressure and larger kidney volume regardless of blood pressure control group assignment (P < 0.001 for both). Male sex and baseline eGFR were associated with a positive annual slope in LVMI (P < 0.001 and P = 0.07, respectively). CONCLUSION: Characteristics associated with higher risk of progression in ADPKD, including higher systolic blood pressure, larger kidney volume, and lower eGFR are associated with improvement in LVMI with intensive blood pressure control, whereas male sex is associated with a smaller slope of reduction in LVMI.

Pregnancy outcomes in women with an early diagnosis of gestational diabetes mellitus.

AIM: To examine pregnancy outcomes in women with gestational diabetes mellitus (GDM) based on the timing of diagnosis. METHOD: We compared demographics, blood sugars and outcomes between women diagnosed before (n = 167) or after 24 weeks' gestation (n = 1202) in a single hospital between 2009 and 2012. Because early screening is risk-based we used propensity score modelling and conditional logistic regression to account for systematic differences. RESULTS: Women diagnosed with GDM before 24 weeks were more likely to be obese and they were less likely to have excess gestational weight gain (35 vs. 45%, p = 0.04). Early diagnosis was associated with more frequent therapy including glyburide (65 vs. 56%, p < 0.001) and insulin (19 vs 6%, p < 0.001). After propensity score modelling and accounting for covariates, early diagnosis was associated with an increased risk for macrosomia (OR 2, 95% 1-4.15, p = 0.0498). Early diagnosis was not associated with other adverse outcomes. In a subgroup analysis comparing women treated with glyburide prior to 24 weeks compared to those diagnosed after 24 weeks, early diagnosis in women treated with glyburide was associated with an increased risk for macrosomia (OR 2.3, 95% CI 1.1-5.4, P = 0.04). CONCLUSION: Women diagnosed with GDM before 24 weeks have unique features, are at risk for adverse outcomes, and require targeted approaches to therapy.

Prevalence and Risk Factors Associated With Hypertension in von Willebrand Disease.

BACKGROUND: von Willebrand factor (VWF) is a biomarker for endothelial damage. Increased VWF levels are observed in hypertension (HTN) and disorders of endothelial dysfunction, for example, atherosclerotic heart disease (ASHD) and diabetes. Whether low VWF protects against HTN is unknown. METHODS: To determine prevalence and risk factors for HTN in patients with von Willebrand disease (VWD), we conducted a cross-sectional analysis of discharge data from the National Inpatient Sample, 2009 to 2011. Group comparisons were performed by Rao-Scott χ2 test. Odds of HTN and HTN outcomes in VWD were estimated by weighted multivariable logistic regression. RESULTS: The prevalence of hypertension in patients with VWD (N = 7556), 37.35%, was significantly lower than that in non-VWD patients (N = 19 918 970), 49.40%, P < .0001. Hypertension risk factors (hyperlipidemia, diabetes, smoking, hepatitis C, and HIV) and HTN outcomes (ASHD, myocardial infarction [MI], ischemic stroke, and renal failure) were less common in patients with VWD than in non-VWD patients, all P ≤ .0001. Patients with VWD were younger, 49.67 versus 57.30 years, Caucasian, 82.23% versus 68.35%, and female, 75.44% versus 59.61%, P < .0001. Patients with HTN were older, 67.55 versus 47.29 years, male, 45.99% versus 34.90%, and had more HTN risk factors and HTN outcomes than those without HTN, all P < .0001, including male and female subgroups, each P < .0001. The unadjusted odds of HTN in patients with VWD (odds ratio [OR] = 0.611, P < .0001) and of HTN outcomes in patients with VWD (ASHD, OR = 0.509; MI, OR = 0.422; ischemic stroke, OR = 0.521; renal failure, OR = 0.420, all P < .0001) became insignificant after adjustment for HTN risk factors plus demographics (age/race/gender), OR = 1.035, P = .260. CONCLUSION: The risk of HTN is reduced in patients with VWD, but not after adjustment for HTN risk factors plus demographics, as patients with VWD not having HTN are also typically young, Caucasian, and female.

Diet and Physical Activity Behaviors in Primary Care Patients with Recent Intentional Weight Loss.

PURPOSE: Lifestyle habits of primary care patients with recent, intentional weight loss are unclear and need to be better understood to aid in translational health promotion efforts. We aimed to characterize diet and exercise habits in primary care patients with recent, intentional weight loss, comparing those with greater (≥10%) vs. lesser (5 to <10%) weight loss. METHODS: This was a cross-sectional analysis of baseline data from a randomized trial comparing weight loss maintenance interventions. The study included primary care patients, 18-75 years old, with ≥5% intentional weight loss via lifestyle change in the past 2 years. Participants (74% female, 87% white) had mean age 53 (12) years, body mass index 30.4 (5.9) kg/m2, and recent weight loss of 11 (8)%. Dietary habits were measured by the Diet Habits Survey. Physical activity and sedentary behavior were measured by self-report and objectively by pedometer. RESULTS: On average, participants reported high fruits and vegetables intake (5 servings/day), and low intake of fried foods (1 serving/week), desserts (1 serving/week) and sugar-sweetened beverages (0 servings/week). Those with greater vs. lesser weight loss had higher intake of fruits and vegetables (p=0.037) and low fat foods or recipes (p=0.019). Average self-reported moderate-vigorous physical activity was 319 (281) minutes/week, with significant differences between greater (374 (328) minutes/week) vs. lesser (276 (230) minutes/week) weight loss groups (p=0.017). By pedometer, 30% had ≥7,500 steps/day; the proportion was higher in greater (43%) vs. lesser (19%) weight loss groups (p=0.005). CONCLUSIONS: For weight loss, clinical patients typically employ simple strategies such as 5+ fruits and vegetables per day, fried foods and desserts ≤1 per week, elimination of sugary drinks, choosing low fat foods/recipes, and physical activity 45-60 min/day.

Promoting weight maintenance with electronic health record tools in a primary care setting: Baseline results from the MAINTAIN-pc trial.

Maintaining weight loss is a significant challenge in combating obesity. The goal of Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) is to evaluate the use of tools delivered through an electronic health record (EHR) and patient portal, with or without health coach support, to help primary care patients maintain weight loss. EHR tools include flowsheets, standardized surveys, and secure patient messaging. Inclusion criteria were age 18-75years, voluntary 5% weight loss in the past 2years with prior BMI≥25kg/m2, and no bariatric procedures in past 5years. Participants were randomized 1:1 to tailored online coaching with EHR tracking tools (CC) or EHR tracking tools alone (TO). We screened 721 individuals between October 2013 and February 2015; 194 participants enrolled (98 CC; 96 TO). The most common reasons for not enrolling included lack of interest (56%), not meeting age or weight loss criteria (17%), and no verified prior weight loss (10%). At baseline, participants were 53.4 (SD 12.2) years old, 74% female, and 88% White; 95% reported moderate physical activity. Average weight and BMI at baseline were 189.1 (SD 42.1) lbs and 30.4 (5.9) kg/m2, respectively. Pre-weight loss BMI was 34.4 (SD 6.5) kg/m2. Participants lost an average of 11.3% (SD 6.6) of their body weight before enrolling. Demographic and clinical characteristics did not differ by randomized group. The study successfully identified and recruited primary care patients with recent voluntary weight loss for participation in a weight maintenance program that uses EHR-based tools.