Absence of antibody responses to SARS-CoV-2 N protein in COVID-19 vaccine breakthrough cases.

Understanding the risk factors for breakthrough coronavirus disease 2019 (COVID-19) (BC19) is critical to inform policy. Herein, we assessed Delta (Lineage B.1.617.2) variant-specific effectiveness of the BNT162b2 (Pfizer) vaccine and characterized Delta-driven BC19 cases (fully vaccinated individuals who get infected) with known-time-since-vaccination. In this longitudinal prospective study (January 21-October 30, 2021), 90 naïve and 15 convalescent individuals were enrolled at the initiation of vaccination. Samples from 27 unvaccinated individuals with previous laboratory-confirmed COVID-19 diagnosis were collected at a single time point. Longitudinal serology profile (antibodies against severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] S and N proteins) and live-virus-based neutralization capacities were assessed while controlling for age. Sex, age, history of reactions to the COVID-19 vaccine, and viral neutralization capacities were identified as significant risk factors for breakthrough COVID-19. At 8 months postvaccination, male sex, individuals ⩾65 years of age, and individuals who experienced noticeable side effects with the COVID-19 vaccine were at 5.47 (p-value = 0.0102), 4.33 (p-value = 0.0236), and 4.95 (p-value = 0.0159) fold greater risk of BC19 as compared to their peers, respectively. Importantly, every five-fold increase in viral neutralization capacities (by live-virus-based assays) was significantly associated with ~4-fold reduction in the risk occurrence of breakthrough COVID-19 (p-value = 0.045). Vaccine boosting remarkably increased these viral neutralization capacities by 16.22-fold (p- value = 0.0005), supporting the importance of the BNT162b2 booster in efforts to control the incursion of future variants into the population at large. Strikingly, BC19 cases exhibited a delayed/absent antibody response to the N protein, suggesting limited exposure to the virus. Since antibodies against N protein are widely used to evaluate the extent of virus spread in communities, our finding has important implications on the utility of existing serological diagnostic and surveillance for COVID-19.

Liraglutide 3 mg on weight, body composition, and hormonal and metabolic parameters in women with obesity and polycystic ovary syndrome: a randomized placebo-controlled-phase 3 study.

OBJECTIVE: To study the efficacy and safety of the GLP-1 analog liraglutide 3 mg (LIRA 3 mg) vs. placebo (PL) for reduction of body weight (BW) and hyperandrogenism in women with obesity and polycystic ovary syndrome (PCOS). DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Hospital-based outpatient endocrine and metabolic center. PATIENT(S): Women diagnosed with PCOS (NIH criteria) were randomly assigned to LIRA 3 mg (n = 55) or PL (n = 27) once daily for 32 weeks with lifestyle intervention. INTERVENTION(S): Study visits at baseline and 32 weeks included BW and body composition by dual-energy x-ray absorptiometry. Oral glucose tolerance tests were done with sex steroids, free androgen index (FAI), and lipids measured in the fasting sample. MAIN OUTCOME MEASURE(S): The primary end points were changes in BW and FAI. Safety was assessed in all patients who received at least one dose of the study drug. RESULT(S): Change in BW from baseline to week 32 was -5.7% (±0.75) with LIRA 3 mg vs. -1.4% (±1.09) with PL. At week 32, more participants on LIRA 3 mg than on PL achieved at least 5% weight reductions (25 of 44 vs. 5 of 23). Free androgen index significantly reduced with LIRA 3 mg compared with the PL where the mean FAI slightly increased. Gastrointestinal events, which were mostly mild to moderate, were reported in 58.2% of the LIRA 3 mg-subjects and 18.5% of PL subjects. CONCLUSION(S): LIRA 3 mg once daily appears superior to PL in reducing BW and androgenicity and improving cardiometabolic parameters in women with PCOS and obesity. CLINICAL TRIAL REGISTRATION NUMBER: NCT03480022.

Exenatide, Dapagliflozin, or Phentermine/Topiramate Differentially Affect Metabolic Profiles in Polycystic Ovary Syndrome.

CONTEXT: Glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors reduce weight and improve insulin sensitivity via different mechanisms. OBJECTIVE: The efficacy of once-weekly exenatide (EQW) and dapagliflozin (DAPA) alone and coadministered (EQW/DAPA), DAPA/extended-release (ER) metformin (DAPA/MET), and phentermine topiramate extended release (PHEN/TPM) on metabolic parameters, body composition, and sex hormones were examined in obese women with PCOS. METHODS: Nondiabetic women (n = 119; aged 18-45 years) with a body mass index (BMI) greater than 30 and less than 45 and polycystic ovary syndrome (National Institutes of Health criteria) were randomly assigned in a single-blinded fashion to EQW (2 mg weekly); DAPA (10 mg daily), EQW/DAPA (2 mg weekly/10 mg daily), DAPA (10 mg)/MET (2000 mg XR daily), or PHEN (7.5 mg)/TPM (46 mg ER daily) treatment for 24 weeks. Study visits at baseline and 24 weeks included weight, blood pressure (BP), waist (WC) measures, and body composition evaluated by dual-energy x-ray absorptiometry (DXA). Oral glucose tolerance tests were conducted to assess glycemia and mean blood glucose (MBG), and compute insulin sensitivity (SI) and secretion (IS) measures. Sex steroids, free androgen index (FAI), and lipid profiles were measured in the fasting sample. RESULTS: EQW/DAPA and PHEN/TPM resulted in the most loss of weight and total body fat by DXA, and WC. Despite equivalent reductions in BMI and WC with PHEN/TPM, only EQW/DAPA and EQW resulted in significant improvements in MBG, SI, and IS. Reductions in fasting glucose, testosterone, FAI, and BP were seen with all drugs. CONCLUSION: Dual therapy with EQW/DAPA was superior to either alone, DAPA/MET and PHEN/TPM in terms of clinical and metabolic benefits in this patient population.

A randomized trial of dapagliflozin and metformin, alone and combined, in overweight women after gestational diabetes mellitus.

BACKGROUND: Women with a history of gestational diabetes mellitus are at a substantially increased risk of gestational diabetes mellitus recurrence and type 2 diabetes. Weight gain, particularly increased central adiposity after delivery, is strongly associated with deterioration of pancreatic beta cell compensation for insulin resistance. Weight management after gestational diabetes mellitus could have a significant benefit in these women who are at a high risk of developing type 2 diabetes. OBJECTIVE: This study aimed to evaluate the treatment efficacy of dapagliflozin and metformin, alone and in combination, on body weight and anthropometric, cardiovascular, and metabolic parameters in overweight women with a recent history of gestational diabetes mellitus. STUDY DESIGN: This was a prospective, single-blind, randomized, outpatient clinical trial with 3 parallel treatment groups. Overweight or obese (body mass index>25) females (n=66; ≥18-45 years) with gestational diabetes mellitus in pregnancy in the past 12 months were randomized in a single-blind manner to dapagliflozin, metformin, or dapagliflozin-metformin for 24 weeks. Body weight, height, body mass index, waist circumference, waist-to-height ratio, and blood pressure were determined at baseline and trial completion. Oral glucose tolerance tests were performed at baseline and 24 weeks to assess glycemia and mean blood glucose and calculate insulin sensitivity and secretion measures. Plasma lipid fractions, thyroid-stimulating hormone, and liver enzymes were also assessed in the fasting sample at the beginning and completion of the study trial. RESULTS: The study was completed by 49 participants (74%). Significant reduction of weight, waist circumference, and waist-to-height ratio and improved glycemia and insulin sensitivity index derived from oral glucose tolerance test were found with dapagliflozin-metformin vs metformin monotherapy. Both dapagliflozin and dapagliflozin-metformin therapy were superior to metformin in increasing high-density lipoprotein levels, reducing triglyceride concentrations, lowering the triglyceride-to-high-density lipoprotein cholesterol ratio, and improving glucose excursion after an oral glucose tolerance test. The early insulin response to a glucose challenge significantly improved with only dapagliflozin-metformin compared with single-drug treatments. CONCLUSION: This is the first report comparing the efficacy of a sodium-glucose cotransporter 2 inhibitor alone and in combination with metformin in this patient population. We found that combination dapagliflozin-metformin treatment over a 24-week period had a greater positive effect on body weight, waist circumference, and glycemic, cardiovascular, and metabolic parameters than metformin monotherapy in overweight or obese at-risk women with a recent history of gestational diabetes mellitus.

Postpartum treatment with liraglutide in combination with metformin versus metformin monotherapy to improve metabolic status and reduce body weight in overweight/obese women with recent gestational diabetes: A double-blind, randomized, placebo-controlled study.

BACKGROUND: Gestational diabetes (GDM) imparts a high risk of developing diabetes postpartum. Insulin resistance appears to be the major contributor. Liraglutide, a glucagon-like peptide-1 analogue, improves peripheral glucose disposal and reduces body weight. We evaluated whether liraglutide in combination with metformin (MET-LIRA) is more effective than metformin monotherapy (MET-P) in improving insulin action and reducing body weight in overweight prior GDM (pGDM) women. METHODS: Women (n = 153; body mass index (BMI) ≥25 kg/m2; 18-45 y; GDM within 12 months) with metabolic abnormalities were randomized to MET-LIRA (MET-2000 mg, LIRA 1.8 mg SC QD) or MET-P (MET-2000 mg, Placebo QD). Study visits at baseline, 36-40, 56-60 and 80-84 weeks included body weight (BW), BMI, waist circumference and waist-to-height ratio measures. Oral glucose tolerance tests (OGTTs) were performed to assess glycemia, mean blood glucose (MBG), lipids, and compute insulin sensitivity and secretion measures. FINDINGS: Seventy-two (47%) participants completed the study. MET-LIRA therapy was significantly better in improving MBG and insulin sensitivity indices [SIOGTT MET-LIRA from 4.6 (3.2) to 5.9 (2.9) vs. MET-P 5.5 (3.0) to 5.4 (3.2)] and reducing BW and central adiposity [BMI MET-LIRA from 37.2 (8.3) to 33.8 (5.2) vs MET-P 33.8(5.2) to 32.8(6)]. MET-LIRA therapy but not MET-P decreased triglycerides (TRG) and TRG/high density lipoprotein cholesterol (HDL-C) ratios. INTERPRETATION: MET-LIRA treatment demonstrated superior efficacy in correcting the metabolic status of pGDM women over 84 weeks of therapy. The addition of liraglutide to metformin therapy resulted in a more dramatic decrease in BW and central adiposity than metformin alone. FUNDATION: Supported by an unrestricted investigator initiated grant from Novo Nordisk, Inc. awarded to K.E.H. MEETING PRESENTATION: The results from preliminary analyses of this study were presented at 76th meeting of the American Diabetes Association, June 10-14, 2016 New Orleans, LA, and 77th meeting of the American Diabetes Association, June 9-12, 2017San Diego, CA.

SHORT-TERM SITAGLIPTIN-METFORMIN THERAPY IS MORE EFFECTIVE THAN METFORMIN OR PLACEBO IN PRIOR GESTATIONAL DIABETIC WOMEN WITH IMPAIRED GLUCOSE REGULATION.

OBJECTIVE: Our pilot study examined the effectiveness of sitagliptin-metformin (SITA-MET), metformin (MET), and placebo (P) therapy on fasting and post-glucose challenge glucose levels in postpartum women with prior gestational diabetes mellitus (GDM) and impaired glucose regulation. METHODS: Prediabetic women (N = 36, age 18 to 42 years) with recent GDM were randomized to P (one pill twice a day), MET (1,000 mg twice a day), or SITA-MET (50 mg SITA, 1,000 mg MET twice a day) for 16 weeks in a single-blind fashion. An individualized diet and exercise plan were provided to all participants. At baseline and 16 weeks, oral glucose tolerance tests were performed to assess glycemia, mean blood glucose (MBG), and calculate insulin sensitivity (IS) and secretion (SI) indexes. Lipid profile, thyroid-stimulating hormone level, and pregnancy test were performed in the baseline sample. RESULTS: Thirty-three (92%) participants completed the study. At study end, 15 participants had normal glycemia (SITA-MET vs. MET, P; P = .035). MBG, IS, IS-SI index, and waist to height ratio were significantly improved with SITA-MET compared with MET and P treatment. SITAMET therapy was more effective in lowering body mass index and waist circumference compared to P treatment. CONCLUSION: Our pilot study is the first to evaluate the use of a dipeptidyl peptidase 4 inhibitor combined with MET in glucose-impaired women with a history of GDM. In this investigation, combination SITA-MET was found to be superior to MET and P in improving glycemia and metabolic measures in this prediabetic population. ABBREVIATIONS: BID = twice a day; BMI = body mass index; BP = blood pressure; BW = body weight; CHOL = cholesterol; DI = disposition index; DM = diabetes mellitus; DPP-4i = dipeptidyl peptidase 4 inhibitor; FBG = fasting blood glucose; GDM = gestational diabetes mellitus; GLP-1 = glucagon-like peptide 1; HDL-C = high-density-lipoprotein cholesterol; HOMA-IR = homeostasis model assessment of insulin resistance; IGI = insulinogenic index; IGR = impaired glucose regulation; IGT = impaired glucose tolerance; IR = insulin resistance; IS = insulin sensitivity; LDL-C = low-density-lipoprotein cholesterol; MBG = mean blood glucose; MET = metformin; OGTT = oral glucose tolerance test; P = placebo; SI = insulin secretion; SIOGTT = Matsuda's insulin sensitivity index; TRG = triglycerides; WC = waist circumference; WHR = waist to hip ratio; WHtR = waist to height ratio.

Dietary Intake and Omega-3 DHA Status in Pregnant Women Who Are Overweight.

OBJECTIVE: To estimate dietary intake of pregnant women who are overweight, assess their omega-3 docosahexaenoic acid (DHA) status, and compare results between Black and White women. DESIGN: Cross-sectional study with a longitudinal component (dietary assessment). SETTING: Outpatient clinics at Woman's Hospital, Baton Rouge, Louisiana and telephone calls. PARTICIPANTS: Pregnant women (N = 21) who were overweight (body mass index = 25.0-29.9 kg/m2). METHODS: Repeated 24-hour dietary recalls using the University of Minnesota Nutrition Data System for Research were conducted to determine nutrient intakes. Red blood cell fatty acids were analyzed with gas chromatography to determine omega-3 DHA status. Descriptive statistics, one- and two-sample t tests, Fisher's exact tests, chi-square test, and analysis of covariance were used to analyze data. RESULTS: On average, participants consumed 72 ± 63 mg omega-3 DHA/day. Age, race, and socioeconomic status did not affect the probability of achieving recommended omega-3 DHA dietary intake (p > .05). Black women had lower omega-3 DHA status (7.98 ± 0.94 weight percentage) than White women (9.29 ± 1.68 weight percentage; p ≤ .05). CONCLUSION: Analysis of our data suggests a need for nutrition education regarding the benefits of omega-3 DHA consumption during pregnancy for women of childbearing age. The current finding warrants further exploration.

Effectiveness of SmartMoms, a Novel eHealth Intervention for Management of Gestational Weight Gain: Randomized Controlled Pilot Trial.

BACKGROUND: Two-thirds of pregnant women exceed gestational weight gain (GWG) recommendations. Because excess GWG is associated with adverse outcomes for mother and child, development of scalable and cost-effective approaches to deliver intensive lifestyle programs during pregnancy is urgent. OBJECTIVE: The aim of this study was to decrease the proportion of women who exceed the Institute of Medicine (IOM) 2009 GWG guidelines. METHODS: In a parallel-arm randomized controlled trial, 54 pregnant women (age 18-40 years) who were overweight (n=25) or obese (n=29) were enrolled to test whether an intensive lifestyle intervention (called SmartMoms) decreased the proportion of women with excess GWG, defined as exceeding the 2009 IOM guidelines, compared to no intervention (usual care group). The SmartMoms intervention was delivered through mobile phone (remote group) or in a traditional in-person, clinic-based setting (in-person group), and included a personalized dietary intake prescription, self-monitoring weight against a personalized weight graph, activity tracking with a pedometer, receipt of health information, and continuous personalized feedback from counselors. RESULTS: A significantly smaller proportion of women exceeded the IOM 2009 GWG guidelines in the SmartMoms intervention groups (in-person: 56%, 10/18; remote: 58%, 11/19) compared to usual care (85%, 11/13; P=.02). The remote intervention was a lower cost to participants (mean US $97, SD $6 vs mean US $347, SD $40 per participant; P<.001) and clinics (US $215 vs US $419 per participant) and with increased intervention adherence (76.5% vs 60.8%; P=.049). CONCLUSIONS: An intensive lifestyle intervention for GWG can be effectively delivered via a mobile phone, which is both cost-effective and scalable. TRIAL REGISTRATION: Clinicaltrials.gov NCT01610752; https://clinicaltrials.gov/ct2/show/NCT01610752 (Archived by WebCite at http://www.webcitation.org/6sarNB4iW).

Short-term therapy with combination dipeptidyl peptidase-4 inhibitor saxagliptin/metformin extended release (XR) is superior to saxagliptin or metformin XR monotherapy in prediabetic women with polycystic ovary syndrome: a single-blind, randomized, pilot study.

OBJECTIVE: To evaluate efficacy with the dipeptidyl peptidase-4 inhibitor saxagliptin (SAXA), metformin extended release (MET), and combination (SAXA-MET) in patients with polycystic ovary syndrome (PCOS) and impaired glucose regulation. DESIGN: Prospective, randomized, single-blind drug study. SETTING: Outpatient clinic. PATIENT(S): Patients (n = 38) with PCOS (aged 18-42 years) and prediabetic hyperglycemia determined by a 75-gram oral glucose tolerance test. INTERVENTION(S): Patients were randomized to SAXA-MET (5 mg/2,000 mg), SAXA (5 mg), or MET (2,000 mg) for 16 weeks. MAIN OUTCOME MEASURE(S): Fasting and mean blood glucose, insulin sensitivity, insulin secretion, and insulin secretion-sensitivity index (IS-SI) by oral glucose tolerance tests. Free androgen index and lipid levels, average menstrual interval, and anthropometric measurements (body mass index, waist circumference, and waist/height ratio). RESULT(S): The study was completed by 34 patients. Nineteen patients had normal glucose tolerance: 3 of 12 (25%) on MET; 6 of 11 (55%) on SAXA; and 10 of 11 (91%) on SAXA-MET (SAXA-MET statistically superior to MET) at study completion. Body mass index, waist circumference, waist/height ratio, free androgen index, insulin sensitivity, IS-SI, and menses improved in all groups; however, IS-SI and menstrual regularity were significantly better with SAXA-MET vs. MET treatment. Triglyceride, triglyceride/high-density lipoprotein cholesterol ratio and mean blood glucose significantly declined in the SAXA-MET and SAXA groups only. CONCLUSION(S): This pilot work provides the first evidence regarding the effects of a dipeptidyl peptidase-4 inhibitor alone and in combination with MET in this patient population. Treatment with SAXA-MET was superior to either drug alone in terms of clinical and metabolic benefits in prediabetic patients with PCOS. CLINICAL TRIAL REGISTRATION NUMBER: NCT02022007.

Prepregnancy obesity and periodontitis among pregnant females with and without gestational diabetes mellitus.

BACKGROUND: This study explored whether there is an association between prepregnancy obesity and periodontitis among pregnant females. METHODS: A retrospective cohort study was conducted by using data from a previous case-control study at Woman's Hospital, Baton Rouge, Louisiana. One hundred fifty-nine pregnant females were recruited at their prenatal care visits. Periodontal status was assessed through dental examinations performed at an average of 31 weeks gestation. Periodontitis was defined as the presence of one or more sites exhibiting probing depth ≥4 mm or clinical attachment level ≥4 mm. A Poisson regression with robust error variance was used to estimate risk ratio (RR) and 95% confidence interval (CI). RESULTS: Prepregnancy obesity was statistically significantly associated with periodontitis during pregnancy, with obese females at 1.7 times higher risk compared with under/normal-weight females (RR = 1.7, 95% CI = 1.2 to 2.3, P <0.01). There is no difference in the association between maternal obesity and periodontitis between females with gestational diabetes mellitus (GDM) and females without GDM. CONCLUSION: There is a positive association between prepregnancy obesity and periodontitis among pregnant females.

Change of periodontal disease status during and after pregnancy.

BACKGROUND: This study explored whether there is any change of periodontal disease status during and after pregnancy. We also examined whether the change is different between females with a history of gestational diabetes mellitus (GDM) and females without GDM during pregnancy. METHODS: A follow-up study was conducted at Woman's Hospital, Baton Rouge, Louisiana. Thirty-nine females who were previously enrolled in a case-control study during pregnancy were followed an average of 22 months postpartum. Periodontal status was assessed through dental examinations performed both during and after pregnancy. Clinical periodontal parameters included bleeding on probing (BOP), mean probing depth (PD), and mean clinical attachment level (CAL). Periodontitis was defined as the presence of ≥1 sites exhibiting PD ≥4 mm or CAL ≥4 mm. We used generalized estimating equation analysis to examine the change of periodontal status. RESULTS: Mean number and percentage of sites with BOP decreased from 10.7 ± 11.6 (mean ± SD) and 6.5% ± 7.0% during pregnancy to 7.1 ± 8.8 and 4.3% ± 5.3% at 22 months postpartum (P <0.05), respectively. Mean levels of PD and CAL decreased from 1.8 ± 0.4 mm and 1.9 ± 0.3 mm to 1.6 ± 0.3 mm and 1.6 ± 0.3 mm (P <0.01), respectively. The prevalence of periodontitis decreased from 66.7% to 33.3% (P <0.01, adjusted risk ratio = 2.1, 95% confidence interval = 1.3 to 3.4). There was no difference in the change of periodontal status between females with GDM and females without GDM during pregnancy. CONCLUSIONS: Pregnancy may be associated with an increased risk of periodontal disease. The association is not different between females with GDM and females without GDM during pregnancy.

Periodontal disease as a potential risk factor for the development of diabetes in women with a prior history of gestational diabetes mellitus.

OBJECTIVE: To examine if periodontal disease is associated with later development of impaired glucose metabolism in women with a recent history of gestational diabetes (GDM). METHODS: Women with (n = 19) and without (n = 20) a history of GDM were prospectively followed at 22 months postpartum. All subjects underwent: a) a 75-gram oral glucose tolerance test (OGTT); and b) an oral examination for measuring periodontal disease. Insulin sensitivity and pancreatic ß-cell secretory capacity derived from fasting (HOMA-IR) and glucose-stimulated measures (SI(OGTT) and IGI/HOMA-IR) were determined. Periodontitis was defined as the presence of any site with a probing depth ≥ 4 mm or a clinical attachment loss ≥ 4 mm. RESULTS: Compared to women without a history of GDM, prior GDM women had significantly higher fasting glucose and insulin concentrations, increased insulin resistance and decreased ß-cell function. Although not statistically significant, prior GDM women had a higher prevalence of periodontal disease (42.1%) than women without a history of GDM (25.0%). Women with periodontal disease showed greater insulin resistance and lower ß-cell function. Women with both prior GDM and periodontal disease had the most impaired glucose metabolism; the insulin secretion-sensitivity index was significantly lower in women with both prior GDM and periodontal disease (208.20 ± 2.60) than in women without prior GDM and periodontal disease (742.93 ± 1.78) (P < 0.05). CONCLUSIONS: Women with prior GDM show reduced insulin sensitivity and inadequate ß-cell secretory function at 22 months postpartum. Periodontal disease may contribute to their impaired glucose metabolism and future risk of developing diabetes.

Aerobic exercise in women with polycystic ovary syndrome improves ovarian morphology independent of changes in body composition.

In a prospective study, eight women with polycystic ovary syndrome completed 16 weeks of individualized aerobic exercise training. Independent of changes in body weight and adiposity there was a statistically significant increase in aerobic fitness and insulin sensitivity and a statistically significant decrease in the total number of follicles measured by magnetic resonance imaging.

Hurricane Katrina experience and the risk of post-traumatic stress disorder and depression among pregnant women.

OBJECTIVE: Little is known about the effects of disaster exposure and intensity on the development of mental disorders among pregnant women. The aim of this study was to examine the effect of exposure to Hurricane Katrina on mental health in pregnant women. DESIGN: Prospective cohort epidemiological study. SETTING: Tertiary hospitals in New Orleans and Baton Rouge, U.S.A. PARTICIPANTS: Women who were pregnant during Hurricane Katrina or became pregnant immediately after the hurricane. MAIN OUTCOME MEASURES: Post-traumatic stress disorder (PTSD) and depression. RESULTS: The frequency of PTSD was higher in women with high hurricane exposure (13.8 percent) than women without high hurricane exposure (1.3 percent), with an adjusted odds ratio (aOR) of 16.8 (95% confidence interval: 2.6-106.6) after adjustment for maternal race, age, education, smoking and alcohol use, family income, parity, and other confounders. The frequency of depression was higher in women with high hurricane exposure (32.3 percent) than women without high hurricane exposure (12.3 percent), with an aOR of 3.3 (1.6-7.1). Moreover, the risk of PTSD and depression increased with an increasing number of severe experiences of the hurricane. CONCLUSIONS: Pregnant women who had severe hurricane experiences were at a significantly increased risk for PTSD and depression. This information should be useful for screening pregnant women who are at higher risk of developing mental disorders after a disaster.

Loss of resources and hurricane experience as predictors of postpartum depression among women in southern Louisiana.

BACKGROUND: After a natural disaster, mental disorders often become a long-term public health concern. Previous studies under smaller-scale natural disaster conditions suggest loss of psychosocial resources is associated with psychological distress. METHODS: We examined the occurrence of depression 6 and 12 months postpartum among 208 women residing in New Orleans and Baton Rouge, Louisiana, who were pregnant during or immediately after Hurricane Katrina's landfall. Based on the Conservation of Resources (COR) theory, we explored the contribution of both tangible/financial and nontangible (psychosocial) loss of resources (LOR) on the outcome of depression, measured using the Edinburgh Postnatal Depression Scale (EPDS). We also investigated the influence on depression of individuals' hurricane experience through a Hurricane Experience Score (HES) that includes such factors as witnessing death, contact with flood waters, and injury to self or family members. RESULTS: Both tangible and nontangible LOR were associated with depression cross-sectionally and prospectively. Severe hurricane exposure (high HES) was also associated with depression. Regression analysis showed LOR-associated depression was explained almost entirely by nontangible rather than tangible factors. Consistent with COR theory, however, nontangible LOR explained some of the association between severe hurricane exposure and depression in our models. A similar result was seen prospectively for depression at 12 months, even controlling for depression symptoms at 6 months. CONCLUSIONS: These results suggest the need for preventive measures aimed at preserving psychosocial resources to reduce the long-term effects of disasters.

Resilience after hurricane Katrina among pregnant and postpartum women.

BACKGROUND: Although disaster causes distress, many disaster victims do not develop long-term psychopathology. Others report benefits after traumatic experiences (posttraumatic growth). The objective of this study was to examine demographic and hurricane-related predictors of resilience and posttraumatic growth. METHODS: We interviewed 222 pregnant southern Louisiana women and 292 postpartum women completed interviews at delivery and 8 weeks later. Resilience was measured by scores lower than a nonaffected population, using the Edinburgh Depression Scale and the Post-Traumatic Stress Checklist. Posttraumatic growth was measured by questions about perceived benefits of the storm. Women were asked about their experience of the hurricane, addressing danger, illness/injury, and damage. Chi-square tests and log-Poisson models were used to calculate associations and relative risks for demographics, hurricane experience, and mental health resilience and perceived benefit. FINDINGS: Thirty-five percent of pregnant and 34% of the postpartum women were resilient from depression, whereas 56% and 49% were resilient from posttraumatic stress disorder. Resilience was most likely among White women, older women, and women who had a partner. A greater experience of the storm, particularly injury/illness or danger, was associated with lower resilience. Experiencing damage because of the storm was associated with increased report of some perceived benefits. CONCLUSION: Many pregnant and postpartum women are resilient from the mental health consequences of disaster, and perceive benefits after a traumatic experience. Certain aspects of experiencing disaster reduce resilience, but may increase perceived benefit.

Hurricane Katrina-related maternal stress, maternal mental health, and early infant temperament.

To investigate temperament in infants whose mothers were exposed to Hurricane Katrina and its aftermath, and to determine if high hurricane exposure is associated with difficult infant temperament. A prospective cohort study of women giving birth in New Orleans and Baton Rouge, LA (n = 288) in 2006-2007 was conducted. Questionnaires and interviews assessed the mother's experiences during the hurricane, living conditions, and psychological symptoms, 2 months and 12 months postpartum. Infant temperament characteristics were reported by the mother using the activity, adaptability, approach, intensity, and mood scales of the Early Infant and Toddler Temperament Questionnaires, and "difficult temperament" was defined as scoring in the top quartile for three or more of the scales. Logistic regression was used to examine the association between hurricane experience, mental health, and infant temperament. Serious experiences of the hurricane did not strongly increase the risk of difficult infant temperament (association with three or more serious experiences of the hurricane: adjusted odds ratio (aOR) 1.50, 95% confidence interval (CI) 0.63-3.58 at 2 months; 0.58, 0.15-2.28 at 12 months). Maternal mental health was associated with report of difficult infant temperament, with women more likely to report having a difficult infant temperament at 1 year if they had screened positive for PTSD (aOR 1.82, 95% confidence interval (CI) 0.61-5.41), depression, (aOR 3.16, 95% CI 1.22-8.20) or hostility (aOR 2.17, 95% CI 0.81-5.82) at 2 months. Large associations between maternal stress due to a natural disaster and infant temperament were not seen, but maternal mental health was associated with reporting difficult temperament. Further research is needed to determine the effects of maternal exposure to disasters on child temperament, but in order to help babies born in the aftermath of disaster, the focus may need to be on the mother's mental health.

Periodontal disease is associated with gestational diabetes mellitus: a case-control study.

BACKGROUND: Few studies have specifically examined the relationship between periodontal disease and gestational diabetes mellitus (GDM). The objective of this study was to examine whether maternal periodontal disease is associated with GDM. METHODS: A case-control study was conducted of 53 pregnant women with GDM and 106 pregnant women without GDM at Woman's Hospital, Baton Rouge, Louisiana. The periodontal examinations were performed by a calibrated dentist who was masked to the diabetic status of the pregnant women. Periodontitis was defined as the presence of any site with a probing depth (PD) >or=4 mm or a clinical attachment loss (AL) >or=4 mm. The severity of periodontal disease was measured in quartiles of PD and clinical AL. Univariable analysis and multivariable logistic regression were used to examine the relationships between periodontal disease and GDM. RESULTS: The percentage of periodontitis was 77.4% in women with GDM and 57.5% in women without GDM, with an odds ratio (OR) of 2.5 and a 95% confidence interval (CI) of 1.2 to 5.3. After adjusting for confounding variables of maternal age, parity, race, marital status, education, family income, smoking, alcohol consumption, systemic antibiotics during pregnancy, family history of diabetes, income, dental insurance coverage, and body mass index, the adjusted OR (95% CI) was 2.6 (1.1 to 6.1). The adjusted ORs (95% CIs) of GDM comparing the highest-to-lowest quartiles of PD and clinical AL were 3.8 (1.0 to 14.0) and 4.5 (1.2 to 16.9). CONCLUSION: This study supports the hypothesis of an association between periodontal disease and GDM.

Postpartum mental health after Hurricane Katrina: a cohort study.

BACKGROUND: Natural disaster is often a cause of psychopathology, and women are vulnerable to post-traumatic stress disorder (PTSD) and depression. Depression is also common after a woman gives birth. However, no research has addressed postpartum women's mental health after natural disaster. METHODS: Interviews were conducted in 2006-2007 with women who had been pregnant during or shortly after Hurricane Katrina. 292 New Orleans and Baton Rouge women were interviewed at delivery and 2 months postpartum. Depression was assessed using the Edinburgh Depression Scale and PTSD using the Post-Traumatic Stress Checklist. Women were asked about their experience of the hurricane with questions addressing threat, illness, loss, and damage. Chi-square tests and log-binomial/Poisson models were used to calculate associations and relative risks (RR). RESULTS: Black women and women with less education were more likely to have had a serious experience of the hurricane. 18% of the sample met the criteria for depression and 13% for PTSD at two months postpartum. Feeling that one's life was in danger was associated with depression and PTSD, as were injury to a family member and severe impact on property. Overall, two or more severe experiences of the storm was associated with an increased risk for both depression (relative risk (RR) 1.77, 95% confidence interval (CI) 1.08-2.89) and PTSD (RR 3.68, 95% CI 1.80-7.52). CONCLUSION: Postpartum women who experience natural disaster severely are at increased risk for mental health problems, but overall rates of depression and PTSD do not seem to be higher than in studies of the general population.

Improved glycemic control and reduction of cardiometabolic risk factors in subjects with type 2 diabetes and metabolic syndrome treated with exenatide in a clinical practice setting.

BACKGROUND: Type 2 diabetes mellitus (T2DM) with the presence of metabolic syndrome (MetS) carries increased risk for cardiovascular disease. Adjunctive exenatide treatment in patients with T2DM is associated with improvements in glycemic control coupled with progressive weight reduction. We evaluated exenatide use on glycosylated hemoglobin A1c (HbA(1c)) and cardiometabolic risk factors in patients with T2DM and MetS in a single clinical practice setting. METHODS: A retrospective analysis of clinical data extracted from the records of 176 adult patients with T2DM and MetS (106 women, 70 men) who received exenatide along with existing therapeutic regimes from 2005 to 2007 was performed. HbA(1c), lipid profiles, blood pressure, and anthropometric measures were evaluated at baseline and after 16 (+/-4) weeks of exenatide therapy. RESULTS: Mean HbA(1c) was significantly reduced from baseline in 16 weeks (P < 0.001), with 68% of patients achieving HbA(1c) <7%. Total, high-density lipoprotein-, and low-density lipoprotein-cholesterol levels decreased significantly. This decline was not attributable to changes in lipid-lowering agents. Significant reductions were also noted in body mass index, mean body weight, and abdominal girth (AG) with the addition of exenatide. Additional analyses showed 76% of subjects lost weight. Lessening of AG was much more pronounced in female compared with male subjects with diabetes (P < 0.032). No consistent changes in blood pressure were observed. CONCLUSIONS: We found that addition of exenatide to an existing treatment regimen in patients with T2DM and MetS resulted in significant reductions in HbA(1c) along with decline in lipids, AG, and body weight. This indicates improvement in these patients' metabolic profiles.