Publications by authors named "Ronald Goldberg"

218 Publications

Predictive utilities of lipid traits, lipoprotein subfractions and other risk factors for incident diabetes: a machine learning approach in the Diabetes Prevention Program.

BMJ Open Diabetes Res Care 2021 Mar;9(1)

Biostatistics Center and Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Rockville, Maryland, USA

Introduction: Although various lipid and non-lipid analytes measured by nuclear magnetic resonance (NMR) spectroscopy have been associated with type 2 diabetes, a structured comparison of the ability of NMR-derived biomarkers and standard lipids to predict individual diabetes risk has not been undertaken in larger studies nor among individuals at high risk of diabetes.

Research Design And Methods: Cumulative discriminative utilities of various groups of biomarkers including NMR lipoproteins, related non-lipid biomarkers, standard lipids, and demographic and glycemic traits were compared for short-term (3.2 years) and long-term (15 years) diabetes development in the Diabetes Prevention Program, a multiethnic, placebo-controlled, randomized controlled trial of individuals with pre-diabetes in the USA (N=2590). Logistic regression, Cox proportional hazards model and six different hyperparameter-tuned machine learning algorithms were compared. The Matthews Correlation Coefficient (MCC) was used as the primary measure of discriminative utility.

Results: Models with baseline NMR analytes and their changes did not improve the discriminative utility of simpler models including standard lipids or demographic and glycemic traits. Across all algorithms, models with baseline 2-hour glucose performed the best (max MCC=0.36). Sophisticated machine learning algorithms performed similarly to logistic regression in this study.

Conclusions: NMR lipoproteins and related non-lipid biomarkers were associated but did not augment discrimination of diabetes risk beyond traditional diabetes risk factors except for 2-hour glucose. Machine learning algorithms provided no meaningful improvement for discrimination compared with logistic regression, which suggests a lack of influential latent interactions among the analytes assessed in this study.

Trial Registration Number: Diabetes Prevention Program: NCT00004992; Diabetes Prevention Program Outcomes Study: NCT00038727.
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http://dx.doi.org/10.1136/bmjdrc-2020-001953DOI Listing
March 2021

Hepatic Fat in Participants With and Without Incident Diabetes in the Diabetes Prevention Program Outcome Study.

J Clin Endocrinol Metab 2021 Mar 11. Epub 2021 Mar 11.

J. W. Ruby Memorial Hospital, 1 Medical Center Dr, Morgantown, WV, USA.

Purpose: To characterize hepatic fat content and fatty liver prevalence, their determinants, and effect of interventions to prevent diabetes using computerized tomography in a cohort with prediabetes, in those developing diabetes versus not.

Methods: We measured liver fat as liver attenuation (LA) in Hounsfield units in 1876 participants at ~14 years following randomization into the Diabetes Prevention Program, which tested the effects of lifestyle or metformin interventions versus standard care to prevent diabetes. LA was compared among intervention groups and in those with versus without diabetes, and associations with baseline and follow-up measurements of anthropometric and metabolic covariates were assessed.

Results: There were no differences in liver fat between treatment groups at 14 years of follow-up. Participants with diabetes had lower LA (mean ± SD: 46±16 vs. 51±14HU; p<0.001) and a greater prevalence of fatty liver (LA<40HU) (34% vs 17%; p<0.001). Severity of metabolic abnormalities at the time of LA evaluation were associated with lower LA categories in a graded manner and more strongly in those with diabetes. Averaged annual fasting insulin (an index of insulin resistance [OR, 95% CI 1.76, 1.41-2.20]) waist circumference (1.63, 1.17-2.26), and triglyceride (1.42, 1.13-1.78), but not glucose, were independently associated with LA<40HU prevalence.

Conclusions: Fatty liver is common in the early phases of diabetes development. The association of LA with insulin resistance, waist circumference and triglyceride levels emphasizes the importance of these markers for hepatic steatosis in this population and that assessment of hepatic fat in early diabetes development is warranted.
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http://dx.doi.org/10.1210/clinem/dgab160DOI Listing
March 2021

Augmented Reality-Assisted Video Laryngoscopy and Simulated Neonatal Intubations: A Pilot Study.

Pediatrics 2021 Mar;147(3)

Department of Pediatrics,

Background: For novice providers, achieving competency in neonatal intubation is becoming increasingly difficult, possibly because of fewer intubation opportunities. In the present study, we compared intubation outcomes on manikins using direct laryngoscopy (DL), indirect video laryngoscopy (IVL) using a modified disposable blade, and augmented reality-assisted video laryngoscopy (ARVL), a novel technique using smart glasses to project a magnified video of the airway into the intubator's visual field.

Methods: Neonatal intensive care nurses ( = 45) with minimal simulated intubation experience were randomly assigned ( = 15) to the following 3 groups: DL, IVL, and ARVL. All participants completed 5 intubation attempts on a manikin using their assigned modalities and received verbal coaching by a supervisor, who viewed the video while assisting the IVL and ARVL groups. The outcome and time of each attempt were recorded.

Results: The DL group successfully intubated on 32% of attempts compared to 72% in the IVL group and 71% in the ARVL group ( < .001). The DL group intubated the esophagus on 27% of attempts, whereas there were no esophageal intubations in either the IVL or ARVL groups ( < .001). The median (interquartile range) time to intubate in the DL group was 35.6 (22.9-58.0) seconds, compared to 21.6 (13.9-31.9) seconds in the IVL group and 20.7 (13.2-36.5) seconds in the ARVL group ( < .001).

Conclusions: Simulated intubation success of neonatal intensive care nurses was significantly improved by using either IVL or ARVL compared to DL. Future prospective studies are needed to explore the potential benefits of this technology when used in real patients.
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http://dx.doi.org/10.1542/peds.2020-005009DOI Listing
March 2021

The use of supplemental hydrocortisone in the management of persistent pulmonary hypertension of the newborn.

J Perinatol 2021 Feb 15. Epub 2021 Feb 15.

Department of Pediatrics, Duke University, Durham, NC, USA.

Objective: Characterize association between hydrocortisone receipt and hospital outcomes of infants with persistent pulmonary hypertension of the newborn (PPHN).

Study Design: Cohort study of infants ≥34 weeks with PPHN who received inhaled nitric oxide at <7 days of age (2010-2016). We generated propensity scores, and performed inverse probability-weighted regression to estimate hydrocortisone effect on outcomes: death, chronic lung disease (CLD), oxygen at discharge.

Results: Of 2743 infants, 30% received hydrocortisone, which was associated with exposure to mechanical ventilation, sedatives, paralytics, or vasopressors (p < 0.001). There was no difference in death, CLD, or oxygen at discharge. In infants with meconium aspiration syndrome, hydrocortisone was associated with decreased oxygen at discharge (odds ratio 0.56; 95% confidence interval 0.21, 0.91).

Conclusions: There was no association between hydrocortisone receipt and death, CLD, or oxygen at discharge in our cohort. Prospective studies are needed to evaluate the effectiveness of hydrocortisone in infants with PPHN.
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http://dx.doi.org/10.1038/s41372-021-00943-9DOI Listing
February 2021

The National Lipid Association scientific statement on coronary artery calcium scoring to guide preventive strategies for ASCVD risk reduction.

J Clin Lipidol 2021 Jan-Feb;15(1):33-60. Epub 2020 Dec 11.

Department of Medicine, Emory University.

An Expert Panel of the National Lipid Association reviewed the evidence related to the use of coronary artery calcium (CAC) scoring in clinical practice for adults seen for primary prevention of atherosclerotic cardiovascular disease. Recommendations for optimal use of this test in adults of various races/ethnicities, ages and multiple domains of primary prevention, including those with a 10-year ASCVD risk <20%, those with diabetes or the metabolic syndrome, and those with severe hypercholesterolemia were provided. Recommendations were also made on optimal timing for repeat calcium scoring after an initial test, use of CAC scoring in those taking statins, and its role in informing the clinician patient discussion on the benefit of aspirin and anti-hypertensive drug therapy. Finally, a vision is provided for the future of coronary calcium scoring.
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http://dx.doi.org/10.1016/j.jacl.2020.12.005DOI Listing
December 2020

Osteopontin and LDLR Are Upregulated in Hearts of Sudden Cardiac Death Victims With Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus.

Front Cardiovasc Med 2020 30;7:610282. Epub 2020 Nov 30.

Division of Cardiology, Department of Medicine, University of Miami Leonard M. Miller School of Medicine, Miami, FL, United States.

Diabetes mellitus (DM) is associated with increased risk of sudden cardiac death (SCD), particularly in patients with heart failure with preserved ejection fraction (HFpEF). However, there are no known biomarkers in the population with DM and HFpEF to predict SCD risk. This study was designed to test the hypothesis that osteopontin (OPN) and some proteins previously correlated with OPN, low-density lipoprotein receptor (LDLR), dynamin 2 (DNM2), fibronectin-1 (FN1), and 2-oxoglutarate dehydrogenase-like (OGDHL), are potential risk markers for SCD, and may reflect modifiable molecular pathways in patients with DM and HFpEF. Heart tissues were obtained at autopsy from 9 SCD victims with DM and HFpEF and 10 age and gender-matched accidental death control subjects from a Finnish SCD registry and analyzed for the expression of OPN and correlated proteins, including LDLR, DNM2, FN1, and OGDHL by immunohistochemistry. We observed a significant upregulation in the expression of OPN, LDLR, and FN1, and a marked downregulation of DNM2 in heart tissues of SCD victims with DM and HFpEF as compared to control subjects ( < 0.01). The dysregulated protein expression of OPN, LDLR, FN1, and DNM2 in patients with DM and HFpEF who experienced SCD provides novel potential modifiable molecular pathways that may be implicated in the pathogenesis of SCD in these patients. Since secreted OPN and soluble LDLR can be measured in plasma, these results support the value of further prospective studies to assess the predictive value of these plasma biomarkers and to determine whether tuning expression levels of OPN and LDLR alters SCD risk in patients with DM and HFpEF.
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http://dx.doi.org/10.3389/fcvm.2020.610282DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7734052PMC
November 2020

A Comprehensive Update on the Chylomicronemia Syndrome.

Front Endocrinol (Lausanne) 2020 23;11:593931. Epub 2020 Oct 23.

Department of Medicine, University of Washington, Seattle, WA, United States.

The chylomicronemia syndrome is characterized by severe hypertriglyceridemia and fasting chylomicronemia and predisposes affected individuals to acute pancreatitis. When due to very rare monogenic mutations in the genes encoding the enzyme, lipoprotein lipase, or its regulators, APOC2, APOA5, GPIHBP1, and LMF1, it is referred to as the familial chylomicronemia syndrome. Much more frequently, the chylomicronemia syndrome results from a cluster of minor genetic variants causing polygenic hypertriglyceridemia, which is exacerbated by conditions or medications which increase triglyceride levels beyond the saturation point of triglyceride removal systems. This situation is termed the multifactorial chylomicronemia syndrome. These aggravating factors include common conditions such as uncontrolled diabetes, overweight and obesity, alcohol excess, chronic kidney disease and pregnancy and several medications, including diuretics, non-selective beta blockers, estrogenic compounds, corticosteroids, protease inhibitors, immunosuppressives, antipsychotics, antidepressants, retinoids, L-asparaginase, and propofol. A third uncommon cause of the chylomicronemia syndrome is familial forms of partial lipodystrophy. Development of pancreatitis is the most feared complication of the chylomicronemia syndrome, but the risk of cardiovascular disease as well as non-alcoholic steatohepatitis is also increased. Treatment consists of dietary fat restriction and weight reduction combined with the use of triglyceride lowering medications such as fibrates, omega 3 fatty acids and niacin. Effective management of aggravating factors such as improving diabetes control, discontinuing alcohol and replacing or reducing the dose of medications that raise triglyceride levels is essential. Importantly, many if not most cases of the chylomicronemia syndrome can be prevented by effective identification of polygenic hypertriglyceridemia in people with conditions that increase its likelihood or before starting medications that may increase triglyceride levels. Several new pharmacotherapeutic agents are being tested that are likely to considerably improve treatment of hypertriglyceridemia in people at risk.
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http://dx.doi.org/10.3389/fendo.2020.593931DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7644836PMC
October 2020

A Provider's Guide to Vascular Disease, Dyslipidemia, and Glycemic Dysregulation in Chronic Spinal Cord Injury.

Top Spinal Cord Inj Rehabil 2020 ;26(3):203-208

Department of Physical Medicine & Rehabilitation, Leonard M. Miller School of Medicine of University of Miami, Miami, Florida.

Individuals with chronic spinal cord injury (SCI) are predisposed to accelerated atherogenesis, dyslipidemia, and glycemic dysregulation, although not enough is known about the etiologies or clinical consequences of these secondary effects of paralysis. While guidelines for the detection and treatment of cardiometabolic disease in SCI have recently been published, there has been a historical paucity of data-driven approaches to these conditions. This article will describe what is and not known about the cardiovascular disease and glycemic dysregulation that frequently attend SCI. It will conclude with a review of both guideline-driven and informal recommendations addressing the clinical care of people living with SCI.
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http://dx.doi.org/10.46292/sci2603-203DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7640912PMC
March 2021

Limitations of Conventional Magnetic Resonance Imaging as a Predictor of Death or Disability Following Neonatal Hypoxic-Ischemic Encephalopathy in the Late Hypothermia Trial.

J Pediatr 2021 Mar 13;230:106-111.e6. Epub 2020 Nov 13.

Eunice Kennedy Shriver National Institute of Child Health and Human Development, Pregnancy and Perinatology Branch, Bethesda, MD; George Mason University, Fairfax, VA.

Objective: To investigate if magnetic resonance imaging (MRI) is an accurate predictor for death or moderate-severe disability at 18-22 months of age among infants with neonatal encephalopathy in a trial of cooling initiated at 6-24 hours.

Study Design: Subgroup analysis of infants ≥36 weeks of gestation with moderate-severe neonatal encephalopathy randomized at 6-24 postnatal hours to hypothermia or usual care in a multicenter trial of late hypothermia. MRI scans were performed per each center's practice and interpreted by 2 central readers using the Eunice Kennedy Shriver National Institute of Child Health and Human Development injury score (6 levels, normal to hemispheric devastation). Neurodevelopmental outcomes were assessed at 18-22 months of age.

Results: Of 168 enrollees, 128 had an interpretable MRI and were seen in follow-up (n = 119) or died (n = 9). MRI findings were predominantly acute injury and did not differ by cooling treatment. At 18-22 months, death or severe disability occurred in 20.3%. No infant had moderate disability. Agreement between central readers was moderate (weighted kappa 0.56, 95% CI 0.45-0.67). The adjusted odds of death or severe disability increased 3.7-fold (95% CI 1.8-7.9) for each increment of injury score. The area under the curve for severe MRI patterns to predict death or severe disability was 0.77 and the positive and negative predictive values were 36% and 100%, respectively.

Conclusions: MRI injury scores were associated with neurodevelopmental outcome at 18-22 months among infants in the Late Hypothermia Trial. However, the results suggest caution when using qualitative interpretations of MRI images to provide prognostic information to families following perinatal hypoxia-ischemia.

Trial Registration: Clinicaltrials.gov: NCT00614744.
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http://dx.doi.org/10.1016/j.jpeds.2020.11.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7914162PMC
March 2021

Clinical Approach to Assessment and Amelioration of Atherosclerotic Vascular Disease in Diabetes.

Front Cardiovasc Med 2020 6;7:582826. Epub 2020 Oct 6.

Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL, United States.

Atherosclerotic cardiovascular disease is increased on average 2-3-fold in people with diabetes as compared to their non-diabetic counterparts and is the major cause of the increased morbidity and mortality in this disease. There is however heterogeneity in cardiovascular risk between individuals based on demographic, cardiometabolic and clinical risk factors in the setting of hyperglycemia, insulin resistance and obesity that needs to be taken into consideration in planning preventive interventions. Randomized clinical trials of agents or procedures used for amelioration of augmented CVD risk in diabetes have been pivotal in providing evidenced-based treatments. Improvement in hyperglycemia in both type 1 and type 2 diabetes is considered to be central in the prevention of microvascular and macrovascular complications although selected antihyperglycemic agents have demonstrated beneficial as well as possible deleterious off-target effects. Lowering low density lipoprotein cholesterol, treating hypertension and stopping smoking each play important roles in preventing cardiovascular disease in diabetes as they do in the general population and low dose aspirin is overall beneficial in high risk individuals. Hypertriglyceridemia may represent another important marker for augmented cardiovascular risk in diabetes and newer agents targeting dyslipidemia appear promising. The fall in cardiovascular events over the past two decades offers hope that modern intervention strategies as well as novel approaches such as those targeting inflammation may contribute to a continued reduction of cardiovascular disease in people with diabetes.
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http://dx.doi.org/10.3389/fcvm.2020.582826DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7573064PMC
October 2020

Defining Abdominal Obesity as a Risk Factor for Coronary Heart Disease in the U.S.: Results From the Hispanic Community Health Study/Study of Latinos (HCHS/SOL).

Diabetes Care 2020 08 19;43(8):1774-1780. Epub 2020 Jun 19.

Behavioral Medicine Research Center, University of Miami, Coral Gables, FL.

Objective: Various organizations have highlighted the need to examine whether abdominal obesity cut points are appropriate for identification of cardiovascular risk among ethnic minority adults, particularly Hispanic/Latino adults living in Western societies. This study aimed ) to establish optimal definitions for abdominal obesity among Hispanics/Latinos and ) to determine the level of agreement between the presence of metabolic syndrome diagnosed by the current Joint Interim Statement (JIS) definition and an updated definition with optimal abdominal obesity cut points.

Research Design And Methods: The sample included 16,289 adults who self-identified as Hispanic/Latino ages 18-74 years enrolled in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). Receiver operating characteristic curves were used to derive sensitivity and specificity values. The largest sum of sensitivity plus specificity was used to determine appropriate cut points.

Results: Among U.S. Hispanic/Latino adults, waist circumference cut points of >102 cm in men (in line with current JIS criteria) and >97 cm (9 points higher than JIS criteria) in women provide optimal discrimination for cardiovascular risk as judged by the presence of coronary heart disease. When using these cut points to create an updated metabolic syndrome definition among women, we found disagreement between our updated definition and the current JIS criteria. The prevalence of the metabolic syndrome was overestimated by ∼5 percentage points among women based on JIS criteria in comparison with our definition.

Conclusions: Our results suggest that the current recommendations for waist circumference cut points may not be appropriate for U.S. Hispanic/Latino women.
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http://dx.doi.org/10.2337/dc19-1855DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7372049PMC
August 2020

The 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guidelines on the Management of Blood Cholesterol in Diabetes.

Diabetes Care 2020 08;43(8):1673-1678

University of Texas Southwestern Medical Center, Dallas, TX.

The American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines recently published its 2018 recommendations on management of LDL cholesterol (LDL-C) in people with diabetes. For primary prevention, moderate-intensity statin therapy is recommended for those aged 40-75 years, with a preference for high-intensity statin treatment for older subjects and for those with higher estimated risk or risk-enhancing factors following a patient-clinician discussion. Statin therapy may be reasonable in adults <40 years or >75 years of age where there is less evidence for benefit. For people with diabetes and established atherosclerotic cardiovascular disease, high-intensity statin therapy is recommended. The majority of these subjects have very high risk, and an LDL-C goal of <70 mg/dL is recommended. If this target is not achieved, ezetimibe and/or a proprotein convertase subtilisin/kexin type 9 inhibitor may be added.
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http://dx.doi.org/10.2337/dci19-0036DOI Listing
August 2020

Racial/Ethnic Disparities Among Extremely Preterm Infants in the United States From 2002 to 2016.

JAMA Netw Open 2020 06 1;3(6):e206757. Epub 2020 Jun 1.

Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.

Importance: Racial/ethnic disparities in quality of care among extremely preterm infants are associated with adverse outcomes.

Objective: To assess whether racial/ethnic disparities in major outcomes and key care practices were changing over time among extremely preterm infants.

Design, Setting, And Participants: This observational cohort study used prospectively collected data from 25 US academic medical centers. Participants included 20 092 infants of 22 to 27 weeks' gestation with a birth weight of 401 to 1500 g born at centers participating in the National Institute of Child Health and Human Development Neonatal Research Network from 2002 to 2016. Of these infants, 9316 born from 2006 to 2014 were eligible for follow-up at 18 to 26 months' postmenstrual age (excluding 5871 infants born before 2006, 2594 infants born after 2014, and 2311 ineligible infants including 64 with birth weight >1000 g and 2247 infants with gestational age >26 6/7 weeks), of whom 745 (8.0%) did not have known follow-up outcomes at 18 to 26 months.

Main Outcomes And Measures: Rates of mortality, major morbidities, and care practice use over time were evaluated using models adjusted for baseline characteristics, center, and birth year. Data analyses were conducted from 2018 to 2019.

Results: In total, 20 092 infants with a mean (SD) gestational age of 25.1 (1.5) weeks met the inclusion criteria and were available for the primary outcome: 8331 (41.5%) black infants, 3701 (18.4%) Hispanic infants, and 8060 (40.1%) white infants. Hospital mortality decreased over time in all groups. The rate of improvement in hospital mortality over time did not differ among black and Hispanic infants compared with white infants (black infants went from 35% to 24%, Hispanic infants went from 32% to 27%, and white infants went from 30% to 22%; P = .59 for race × year interaction). The rates of late-onset sepsis among black infants (went from 37% to 24%) and Hispanic infants (went from 45% to 23%) were initially higher than for white infants (went from 36% to 25%) but decreased more rapidly and converged during the most recent years (P = .02 for race × year interaction). Changes in rates of other major morbidities did not differ by race/ethnicity. Death before follow-up decreased over time (from 2006 to 2014: black infants, 14%; Hispanic infants, 39%, white infants, 15%), but moderate-severe neurodevelopmental impairment increased over time in all racial/ethnic groups (increase from 2006 to 2014: black infants, 70%; Hispanic infants, 123%; white infants, 130%). Rates of antenatal corticosteroid exposure (black infants went from 72% to 90%, Hispanic infants went from 73% to 83%, and white infants went from 86% to 90%; P = .01 for race × year interaction) and of cesarean delivery (black infants went from 45% to 59%, Hispanic infants went from 49% to 59%, and white infants went from 62% to 63%; P = .03 for race × year interaction) were initially lower among black and Hispanic infants compared with white infants, but these differences decreased over time.

Conclusions And Relevance: Among extremely preterm infants, improvements in adjusted rates of mortality and most major morbidities did not differ by race/ethnicity, but rates of neurodevelopmental impairment increased in all groups. There were narrowing racial/ethnic disparities in important care practices, including the use of antenatal corticosteroids and cesarean delivery.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.6757DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7287569PMC
June 2020

Survival, Morbidities, and Developmental Outcomes among Low Birth Weight Infants with Congenital Heart Defects.

Am J Perinatol 2020 Jun 2. Epub 2020 Jun 2.

Department of Pediatrics, Duke University Medical Center, Durham, North Carolina.

Objective:  Prematurity and low birth weight (LBW) are risk factors for increased morbidity and mortality in infants with congenital heart defects (CHDs). We sought to describe survival, inhospital morbidities, and 2-year neurodevelopmental follow-up in LBW infants with CHD.

Study Design:  We included infants with birth weight (BW) <2,500 g diagnosed with CHD (except isolated patent ductus arteriosus) admitted January 2013 to March 2016 to a single level-IV academic neonatal intensive care unit. We reported CHD prevalence by BW and gestational age; selected in-hospital morbidities and mortality by infant BW, CHD type, and surgical intervention; and developmental outcomes by Bayley's scales of infant and toddler development, third edition (BSID-III) scores at age 2 years.

Results:  Among 420 infants with CHD, 28 (7%) underwent cardiac surgery. Median (25th and 75th percentiles) gestational age was 30 (range: 27-33) weeks and BW was 1,258 (range: 870-1,853) g. There were 134 of 420 (32%) extremely LBW (<1,000 g) infants, 82 of 420 (20%) were small for gestational age, and 51 of 420 (12%) multiples. Most common diagnosis: atrial septal defect (260/420, 62%), followed by congenital anomaly of the pulmonary valve (75/420, 18%). Most common surgical procedure: pulmonary artery banding (5/28, 18%), followed by the tetralogy of Fallot corrective repair (4/28, 14%). Survival to discharge was 88% overall and lower among extremely LBW (<1,000 g, 81%) infants and infants undergoing surgery (79%). Comorbidities were common (35%); retinopathy of prematurity and bronchopulmonary dysplasia were most prevalent. BSID-III scores were available on 148 of 176 (84%); any scores <85 were noted in 73 of 148 (49%), with language being most commonly affected.

Conclusion:  Among LBW infants with congenital heart disease, hospital mortality varied by BW and cardiac diagnosis.

Key Points: · In low birth weight infants with congenital heart disease, survival varied by birth weight and cardiac diagnosis.. · Overall survival was higher than previously reported.. · There were fewer morbidities than previously reported.. · Bayley's scale-III scores at 2 years of age were <85 for nearly half..
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http://dx.doi.org/10.1055/s-0040-1712964DOI Listing
June 2020

Exercise based assessment of cardiac autonomic function in type 1 versus type 2 diabetes mellitus.

Cardiol J 2020 May 7. Epub 2020 May 7.

University of Miami Miller School of Medicine, Division of Endocrinology, 1120 NW 14th Street., 33136 Miami, United States.

Background: Cardiac autonomic neuropathy (CAN) is a complication of diabetes mellitus (DM) that is associated with increased mortality. Exercise-based assessment of autonomic function has identified diminished parasympathetic reactivation after exercise in type 2 DM. It is postulated herein, that this would be more prominent among those with type 1 DM.

Methods: Sixteen subjects with type 1 DM (age 32.9 ± 10.1 years), 18 subjects with type 2 DM (55.4 ± 8.0 years) and 30 controls (44.0 ± 11.6 years) underwent exercise-based assessment of autonomic function. Two 16-min submaximal bicycle tests were performed followed by 45 min of recovery. On the 2nd test, atropine (0.04 mg/kg) was administered near end-exercise so that all of the recovery occurred under parasympathetic blockade. Plasma epinephrine and norepinephrine levels were measured at rest, during exercise, and during recovery.

Results: There were no differences in resting or end-exercise heart rates in the three groups. Parasympathetic effect on RR-intervals during recovery (p < 0.03) and heart rate recovery (p = 0.02) were blunted in type 2 DM. Type 1 DM had higher baseline epinephrine and norepinephrine levels (p < 0.03), and exhibited persistent sympathoexcitation during recovery.

Conclusions: Despite a longer duration of DM in the study patients with type 1 versus type 2 DM, diminished parasympathetic reactivation was not noted in type 1 DM. Instead, elevation in resting plasma catecholamines was noted compared to type 2 DM and controls. The variable pathophysiology for exercise-induced autonomic abnormalities in type 1 versus type 2 DM may impact prognosis.
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http://dx.doi.org/10.5603/CJ.a2020.0064DOI Listing
May 2020

Infertility, Gravidity, and Risk Of Diabetes among High-Risk Women in the Diabetes Prevention Program Outcomes Study.

J Clin Endocrinol Metab 2020 03;105(3)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Phoenix, Arizona.

Objective: The extent to which infertility and pregnancy independently increase risk of diabetes and subclinical atherosclerosis is not known.

Research Design And Methods: We conducted a secondary analysis of Diabetes Prevention Program (DPP) and the DPP Outcomes Study over a 15-year period. We included women who answered questions about gravidity and infertility at baseline (n = 2085). Infertility was defined as > 1 year of unsuccessful attempts to conceive; thus, women could have histories of infertility as well as pregnancy. Risk of diabetes associated with gravidity and infertility was calculated using Cox proportional hazards models adjusting for age, race/ethnicity, treatment arm, body mass index, and pregnancy during the study. Among women who underwent assessment of coronary artery calcification (CAC) (n = 1337), odds of CAC were calculated using logistic regression models with similar covariates.

Results: Among premenopausal women (n = 1075), women with histories of pregnancy and infertility (n = 147; hazard ratio [HR] 1.80; 95% confidence interval [CI] 1.30, 2.49) and women with histories of pregnancy without infertility (n = 736; HR 1.49; 95% CI 1.15, 1.93) had greater diabetes risk than nulligravid women without infertility (n = 173). Premenopausal nulligravid women with histories of infertility had a non-significant elevation in risk, although the number of these women was small (n = 19; HR 1.63; 95% CI 0.88, 3.03). Associations were not observed among postmenopausal women (n = 1010). No associations were observed between infertility or pregnancy with CAC.

Conclusions: Pregnancy, particularly combined with a history of infertility, confers increased risk of diabetes but not CAC among glucose-intolerant premenopausal women.
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http://dx.doi.org/10.1210/clinem/dgaa013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7007766PMC
March 2020

A Polygenic Lipodystrophy Genetic Risk Score Characterizes Risk Independent of BMI in the Diabetes Prevention Program.

J Endocr Soc 2019 Sep 24;3(9):1663-1677. Epub 2019 Jun 24.

Diabetes Research Center, Diabetes Unit, Massachusetts General Hospital, Boston, Massachusetts.

Context: There is substantial heterogeneity in insulin sensitivity, and genetics may suggest possible mechanisms by which common variants influence this trait.

Objectives: We aimed to evaluate an 11-variant polygenic lipodystrophy genetic risk score (GRS) for association with anthropometric, glycemic and metabolic traits in the Diabetes Prevention Program (DPP). In secondary analyses, we tested the association of the GRS with cardiovascular risk factors in the DPP.

Design: In 2713 DPP participants, we evaluated a validated GRS of 11 common variants associated with fasting insulin-based measures of insulin sensitivity discovered through genome-wide association studies that cluster with a metabolic profile of lipodystrophy, conferring high metabolic risk despite low body mass index (BMI).

Results: At baseline, a higher polygenic lipodystrophy GRS was associated with lower weight, BMI, and waist circumference measurements, but with worse insulin sensitivity index (ISI) values. Despite starting at a lower weight and BMI, a higher GRS was associated with less weight and BMI reduction at one year and less improvement in ISI after adjusting for baseline values but was not associated with diabetes incidence. A higher GRS was also associated with more atherogenic low-density lipoprotein peak-particle-density at baseline but was not associated with coronary artery calcium scores in the Diabetes Prevention Program Outcomes Study.

Conclusions: In the DPP, a higher polygenic lipodystrophy GRS for insulin resistance with lower BMI was associated with diminished improvement in insulin sensitivity and potential higher cardiovascular disease risk. This GRS helps characterize insulin resistance in a cohort of individuals at high risk for diabetes, independent of adiposity.
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http://dx.doi.org/10.1210/js.2019-00069DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6694040PMC
September 2019

Gastrostomy Tube Feeding in Extremely Low Birthweight Infants: Frequency, Associated Comorbidities, and Long-term Outcomes.

J Pediatr 2019 11 16;214:41-46.e5. Epub 2019 Aug 16.

Department of Pediatrics, Duke University, Durham, NC.

Objective: To assess the frequency of gastrostomy tube (GT) placement in extremely low birth weight (ELBW) infants, associated comorbidities, and long-term outcomes.

Study Design: Analysis of ELBW infants from 25 centers enrolled in the National Institute of Child Health and Human Development Neonatal Research Network's Generic Database and Follow-up Registry from 2006 to 2012. Frequency of GT placement before 18-22 months, demographic and medical factors associated with GT placement, and associated long-term outcomes at 18-22 months of corrected age were described. Associations between GT placement and neonatal morbidities and long-term outcomes were assessed with logistic regression after adjustment for center and common co-variables.

Results: Of the 4549 ELBW infants included in these analyses, 333 (7.3%) underwent GT placement; 76% had the GT placed postdischarge. Of infants with GTs, 11% had birth weights small for gestational age, 77% had bronchopulmonary dysplasia, and 29% severe intraventricular hemorrhage or periventricular leukomalacia. At follow-up, 56% of infants with a GT had weight <10th percentile, 61% had neurodevelopmental impairment (NDI), and 55% had chronic breathing problems. After adjustment, small for gestational age, bronchopulmonary dysplasia, intraventricular hemorrhage/periventricular leukomalacia, poor growth, and NDI were associated with GT placement. Thirty-two percent of infants with GTs placed were taking full oral feeds at follow-up.

Conclusions: GT placement is common in ELBW infants, particularly among those with severe neonatal morbidities. GT placement in this population was associated with poor growth, NDI, and chronic respiratory and feeding problems at follow-up. The frequency of GT placement postneonatal discharge indicates the need for close nutritional follow-up of ELBW infants.

Trial Registration: ClinicalTrials.gov: NCT00063063.
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http://dx.doi.org/10.1016/j.jpeds.2019.06.066DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6815700PMC
November 2019

Regression From Prediabetes to Normal Glucose Regulation and Prevalence of Microvascular Disease in the Diabetes Prevention Program Outcomes Study (DPPOS).

Diabetes Care 2019 09 18;42(9):1809-1815. Epub 2019 Jul 18.

Johns Hopkins University, Baltimore, MD.

Objective: Regression from prediabetes to normal glucose regulation (NGR) was associated with reduced incidence of diabetes by 56% over 10 years in participants in the Diabetes Prevention Program Outcomes Study (DPPOS). In an observational analysis, we examined whether regression to NGR also reduced risk for microvascular disease (MVD).

Research Design And Methods: Generalized estimating equations were used to examine the prevalence of aggregate MVD at DPPOS year 11 in people who regressed to NGR at least once (vs. never) during the Diabetes Prevention Program (DPP). Logistic regression assessed the relationship of NGR with retinopathy, nephropathy, and neuropathy, individually. Generalized additive models fit smoothing splines to describe the relationship between average A1C during follow-up and MVD (and its subtypes) at the end of follow-up.

Results: Regression to NGR was associated with lower prevalence of aggregate MVD in models adjusted for age, sex, race/ethnicity, baseline A1C, and treatment arm (odds ratio [OR] 0.78, 95% CI 0.65-0.78, = 0.011). However, this association was lost in models that included average A1C during follow-up (OR 0.95, 95% CI 0.78-1.16, = 0.63) or diabetes status at the end of follow-up (OR 0.92, 95% CI 0.75-1.12, = 0.40). Similar results were observed in examination of the association between regression to NGR and prevalence of nephropathy and retinopathy, individually. Risk for aggregate MVD, nephropathy, and retinopathy increased across the A1C range.

Conclusions: Regression to NGR is associated with a lower prevalence of aggregate MVD, nephropathy, and retinopathy, primarily due to lower glycemic exposure over time. Differential risk for the MVD subtypes begins in the prediabetes A1C range.
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http://dx.doi.org/10.2337/dc19-0244DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6702603PMC
September 2019

Inadequate oral feeding as a barrier to discharge in moderately preterm infants.

J Perinatol 2019 09 11;39(9):1219-1228. Epub 2019 Jul 11.

Department of Pediatrics, Duke University, Durham, NC, 27708, USA.

Objectives: The objectives describe the frequency that inadequate oral feeding (IOF) is the reason why moderately preterm (MPT) infants remain hospitalized and its association with neonatal morbidities.

Study Design: Prospective study using the NICHD Neonatal Research Network MPT Registry. Multivariable logistic regression was used to describe associations between IOF and continued hospitalization at 36 weeks postmenstrual age (PMA).

Result: A total of 6017 MPT infants from 18 centers were included. Three-thousand three-seventy-six (56%) remained hospitalized at 36 weeks PMA, of whom 1262 (37%) remained hospitalized due to IOF. IOF was associated with RDS (OR 2.02, 1.66-2.46), PDA (OR 1.86, 1.37-2.52), sepsis (OR 2.36, 95% 1.48-3.78), NEC (OR 16.14, 7.27-35.90), and BPD (OR 3.65, 2.56-5.21) compared to infants discharged and was associated with medical NEC (OR 2.06, 1.19-3.56) and BPD (OR 0.46, 0.34-0.61) compared to infants remaining hospitalized for an alternative reason.

Conclusion: IOF is the most common barrier to discharge in MPT infants, especially among those with neonatal morbidities.
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http://dx.doi.org/10.1038/s41372-019-0422-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7246972PMC
September 2019

Does diabetes prevention translate into reduced long-term vascular complications of diabetes?

Diabetologia 2019 08 4;62(8):1319-1328. Epub 2019 Jul 4.

Washington University School of Medicine, St Louis, MO, USA.

The global epidemic of type 2 diabetes has prompted numerous studies and public health efforts to reduce its development. A variety of interventions, including lifestyle modifications and pharmacological agents directed at ameliorating the major risk factors for type 2 diabetes, are of proven efficacy in reducing the development of type 2 diabetes in people with impaired glucose tolerance. While prevention of the hyperglycaemia characteristic of diabetes is arguably an important, clinically relevant outcome, a more compelling outcome with greater clinical significance is the prevention or reduction of the relatively diabetes-specific microvascular and less-specific cardiovascular disease (CVD) complications associated with diabetes. These complications cause the majority of morbidity and excess mortality associated with diabetes. Any reduction in diabetes should, logically, also reduce the occurrence of its long-term complications; however, most diabetes prevention trials have not been of sufficient duration to allow such an evaluation. The limited long-term data, largely from the Da Qing Diabetes Prevention Study (DQDPS) and the Diabetes Prevention Program (DPP) and their respective follow-up studies (DQDPOS and DPPOS), suggest a reduction in microvascular complications and amelioration of CVD risk factors. Only the DQDPOS and Study to Prevent Non-Insulin-Dependent Diabetes Mellitus (STOP-NIDDM) studies have shown a reduction in CVD events and only DQDPOS has demonstrated a decrease in CVD and overall mortality. While these limited data are promising, whether diabetes prevention directly reduces complication-related morbidity and mortality remains unclear. Longer follow-up of prevention studies is needed to supplement the limited current clinical trial data, to help differentiate the effects of diabetes prevention itself from the means used to reduce diabetes development and to understand the balance among benefits, risks and costs of prevention.
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http://dx.doi.org/10.1007/s00125-019-4928-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6818092PMC
August 2019

Disrupted Maturation of the Microbiota and Metabolome among Extremely Preterm Infants with Postnatal Growth Failure.

Sci Rep 2019 06 3;9(1):8167. Epub 2019 Jun 3.

Division of Neonatology, Department of Pediatrics, Duke University, Durham, NC, 27710, USA.

Growth failure during infancy is a major global problem that has adverse effects on long-term health and neurodevelopment. Preterm infants are disproportionately affected by growth failure and its effects. Herein we found that extremely preterm infants with postnatal growth failure have disrupted maturation of the intestinal microbiota, characterized by persistently low diversity, dominance of pathogenic bacteria within the Enterobacteriaceae family, and a paucity of strictly anaerobic taxa including Veillonella relative to infants with appropriate postnatal growth. Metabolomic profiling of infants with growth failure demonstrated elevated serum acylcarnitines, fatty acids, and other byproducts of lipolysis and fatty acid oxidation. Machine learning algorithms for normal maturation of the microbiota and metabolome among infants with appropriate growth revealed a pattern of delayed maturation of the microbiota and metabolome among infants with growth failure. Collectively, we identified novel microbial and metabolic features of growth failure in preterm infants and potentially modifiable targets for intervention.
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http://dx.doi.org/10.1038/s41598-019-44547-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6546715PMC
June 2019

2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

Circulation 2019 06 10;139(25):e1082-e1143. Epub 2018 Nov 10.

ACC/AHA Representative. †AACVPR Representative. ‡ACC/AHA Task Force on Clinical Practice Guidelines Liaison. §Prevention Subcommittee Liaison. ‖PCNA Representative. ¶AAPA Representative. **AGS Representative. ††ADA Representative. ‡‡PM Representative. §§ACPM Representative. ‖‖NLA Representative. ¶¶APhA Representative. ***ASPC Representative. †††ABC Representative.

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http://dx.doi.org/10.1161/CIR.0000000000000625DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7403606PMC
June 2019

2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

Circulation 2019 06 10;139(25):e1046-e1081. Epub 2018 Nov 10.

ACC/AHA Representative. †AACVPR Representative. ‡ACC/AHA Task Force on Clinical Practice Guidelines Liaison. §Prevention Subcommittee Liaison. ‖PCNA Representative. ¶AAPA Representative. **AGS Representative. ††ADA Representative. ‡‡PM Representative. §§ACPM Representative. ‖‖NLA Representative. ¶¶APhA Representative. ***ASPC Representative. †††ABC Representative.

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http://dx.doi.org/10.1161/CIR.0000000000000624DOI Listing
June 2019

Genetic variants associated with patent ductus arteriosus in extremely preterm infants.

J Perinatol 2019 03 5;39(3):401-408. Epub 2018 Dec 5.

Department of Pediatrics, University of Iowa, Iowa City, IA, USA.

Objective: Patent ductus arteriosus (PDA) is a commonly observed condition in preterm infants. Prior studies have suggested a role for genetics in determining spontaneous ductal closure. Using samples from a large neonatal cohort we tested the hypothesis that common genetic variations are associated with PDA in extremely preterm infants.

Study Design: Preterm infants (n = 1013) enrolled at NICHD Neonatal Research Network sites were phenotyped for PDA. DNA was genotyped for 1634 single nucleotide polymorphisms (SNPs) from candidate genes. Analyses were adjusted for ancestral eigenvalues and significant epidemiologic variables.

Results: SNPs in several genes were associated with the clinical diagnosis of PDA and with surgical ligation in extremely preterm neonates diagnosed with PDA (p < 0.01). None of the associations were significant after correction for multiple comparisons.

Conclusion: We identified several common genetic variants associated with PDA. These findings may inform further studies on genetic risk factors for PDA in preterm infants.
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http://dx.doi.org/10.1038/s41372-018-0285-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6391165PMC
March 2019

Non-traditional biomarkers and incident diabetes in the Diabetes Prevention Program: comparative effects of lifestyle and metformin interventions.

Diabetologia 2019 01 17;62(1):58-69. Epub 2018 Oct 17.

Department of Epidemiology and Biostatistics, Biostatistics Center and Milken Institute School of Public Health, George Washington University, Rockville, MD, USA.

Aims/hypothesis: We compared the associations of circulating biomarkers of inflammation, endothelial and adipocyte dysfunction and coagulation with incident diabetes in the placebo, lifestyle and metformin intervention arms of the Diabetes Prevention Program, a randomised clinical trial, to determine whether reported associations in general populations are reproduced in individuals with impaired glucose tolerance, and whether these associations are independent of traditional diabetes risk factors. We further investigated whether biomarker-incident diabetes associations are influenced by interventions that alter pathophysiology, biomarker concentrations and rates of incident diabetes.

Methods: The Diabetes Prevention Program randomised 3234 individuals with impaired glucose tolerance into placebo, metformin (850 mg twice daily) and intensive lifestyle groups and showed that metformin and lifestyle reduced incident diabetes by 31% and 58%, respectively compared with placebo over an average follow-up period of 3.2 years. For this study, we measured adiponectin, leptin, tissue plasminogen activator (as a surrogate for plasminogen activator inhibitor 1), high-sensitivity C-reactive protein, IL-6, monocyte chemotactic protein 1, fibrinogen, E-selectin and intercellular adhesion molecule 1 at baseline and at 1 year by specific immunoassays. Traditional diabetes risk factors were defined as family history, HDL-cholesterol, triacylglycerol, BMI, fasting and 2 h glucose, HbA, systolic blood pressure, inverse of fasting insulin and insulinogenic index. Cox proportional hazard models were used to assess the effects of each biomarker on the development of diabetes assessed semi-annually and the effects of covariates on these.

Results: E-selectin, (HR 1.19 [95% CI 1.06, 1.34]), adiponectin (0.84 [0.71, 0.99]) and tissue plasminogen activator (1.13 [1.03, 1.24]) were associated with incident diabetes in the placebo group, independent of diabetes risk factors. Only the association between adiponectin and diabetes was maintained in the lifestyle (0.69 [0.52, 0.92]) and metformin groups (0.79 [0.66, 0.94]). E-selectin was not related to diabetes development in either lifestyle or metformin groups. A novel association appeared for change in IL-6 in the metformin group (1.09 [1.021, 1.173]) and for baseline leptin in the lifestyle groups (1.31 [1.06, 1.63]).

Conclusions/interpretation: These findings clarify associations between an extensive group of biomarkers and incident diabetes in a multi-ethnic cohort with impaired glucose tolerance, the effects of diabetes risk factors on these, and demonstrate differential modification of associations by interventions. They strengthen evidence linking adiponectin to diabetes development, and argue against a central role for endothelial dysfunction. The findings have implications for the pathophysiology of diabetes development and its prevention.
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http://dx.doi.org/10.1007/s00125-018-4748-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6456055PMC
January 2019

Variability in sediment-water carbonate chemistry and bivalve abundance after bivalve settlement in Long Island Sound, Milford, Connecticut.

Mar Pollut Bull 2018 Oct 11;135:165-175. Epub 2018 Jul 11.

NOAA Fisheries, Milford Laboratory, 212 Rogers Avenue, Milford, CT 06460, United States of America.

Cues that drive bivalve settlement and abundance in sediments are not well understood, but recent reports suggest that sediment carbonate chemistry may influence bivalve abundance. In 2013, we conducted field experiments to assess the relationship between porewater sediment carbonate chemistry (pH, alkalinity (A), dissolved inorganic carbon (DIC)), grain size, and bivalve abundance throughout the July-September settlement period at two sites in Long Island Sound (LIS), CT. Two dominate bivalves species were present during the study period Mya arenaria and Nucula spp. Akaike's linear information criterion models, indicated 29% of the total community abundance was predicted by grain size, salinity, and pH. When using 2 weeks of data during the period of peak bivalve settlement, pH and phosphate concentrations accounted 44% of total bivalve community composition and 71% of Nucula spp. abundance with pH, phosphate, and silica. These results suggest that sediment carbonate chemistry may influence bivalve abundance in LIS.
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http://dx.doi.org/10.1016/j.marpolbul.2018.07.025DOI Listing
October 2018