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1.  The Effect of Prior Oophorectomy on Changes in Bone Mineral Density and Carotid Artery Intima-Media Thickness in Postmenopausal Women 
Fertility and sterility  2014;101(4):1117-1122.
Objective
To determine the effect of prior oophorectomy in healthy postmenopausal women on the rate of loss of bone mineral density (BMD) and rate of increase in carotid artery intima-media thickness (CIMT)
Design
Secondary analysis from a randomized controlled trial
Setting
University-based research clinic
Patient(s)
222 healthy postmenopausal women in the Greater Los Angeles Area
Intervention(s)
Baseline and annual screening of BMD and assessment of CIMT every 6 months for a total of 3 years
Main Outcome and Measure(s)
Changes in BMD and CIMT during postmenopausal years
Result(s)
Among women who were menopausal more than 10 years, the rate of CIMT progression was statistically significantly less in women with intact ovaries compared to prior oophorectomy. In women 5-10 years postmenopausal, there was a trend toward a slower loss of BMD in those who retained their ovaries and in women more than 10 years menopausal there was significantly less BMD loss in those who retained their ovaries.
Conclusion(s)
As time from menopausal transition increases, retained ovaries are associated with a slower rate of bone loss and a slower rate of thickening of the carotid artery wall compared to rates in menopausal women with oophorectomy.
doi:10.1016/j.fertnstert.2013.12.055
PMCID: PMC4215065  PMID: 24530156
menopause; oophorectomy; bone mineral density; intima-media thickness
2.  Associations of Urine Excretion of Isoflavonoids with Cognition in Postmenopausal Women in the Women’s Isoflavone Soy Health Clinical Trial 
Background/Objectives
Results from randomized trials of soy supplements on cognition in postmenopausal women are equivocal. We sought to determine associations of change in urine excretion of isoflavonoids on cognitive change.
Design
Post hoc analysis of isoflavonoid exposures (mean 2.7 years) during the randomized, placebo-controlled, double-blind Women’s Isoflavone Soy Health trial.
Setting
General community.
Participants
350 healthy postmenopausal women.
Intervention
25 g of isoflavone-rich soy protein (91 mg of aglycone weight isoflavones: 52 mg genistein, 36 mg daidzein, 3 mg glycitein) or milk protein-matched placebo, provided daily.
Measurements
Overnight urine excretion and fasting plasma levels of isoflavonoids, and cognitive function, measured at baseline and endpoint.
Results
300 women (mean age = 61 years, range 45-92 years) completed both cognitive assessments and did not use hormone replacement therapy during the trial. Mean on-trial change from baseline in urine excretion of isoflavonoids was not significantly associated with change in a composite score of global cognition (p=0.39). Secondary analyses indicated that change in urine excretion of isoflavonoids was inversely associated with change in a factor score representing general intelligence (p=0.02), but not with factor scores representing verbal or visual episodic memory. Mean differences in this general intelligence factor score among women in the first compared to highest quartile of isoflavonoid change are equivalent to an approximate 4.4 year age-associated decline. Analyses based on plasma isoflavonoid levels yielded similar but attenuated results.
Conclusion
Among healthy postmenopausal women, long-term changes in isoflavonoids are not associated with global cognition, supporting clinical trial results. Increasing isoflavonoid exposure from dietary supplements is, however, associated with decrements in general intelligence but not memory; this finding requires confirmation in future studies.
doi:10.1111/jgs.12752
PMCID: PMC4226524  PMID: 24617349
Cognition; isoflavones; menopause; soy; women’s health
3.  Serum Amyloid A Truncations in Type 2 Diabetes Mellitus 
PLoS ONE  2015;10(1):e0115320.
Serum Amyloid A (SAA) is an acute phase protein complex consisting of several abundant isoforms. The N- terminus of SAA is critical to its function in amyloid formation. SAA is frequently truncated, either missing an arginine or an arginine-serine dipeptide, resulting in isoforms that may influence the capacity to form amyloid. However, the relative abundance of truncated SAA in diabetes and chronic kidney disease is not known.
Methods
Using mass spectrometric immunoassay, the abundance of SAA truncations relative to the native variants was examined in plasma of 91 participants with type 2 diabetes and chronic kidney disease and 69 participants without diabetes.
Results
The ratio of SAA 1.1 (missing N-terminal arginine) to native SAA 1.1 was lower in diabetics compared to non-diabetics (p = 0.004), and in males compared to females (p<0.001). This ratio was negatively correlated with glycated hemoglobin (r = −0.32, p<0.001) and triglyceride concentrations (r = −0.37, p<0.001), and positively correlated with HDL cholesterol concentrations (r = 0.32, p<0.001).
Conclusion
The relative abundance of the N-terminal arginine truncation of SAA1.1 is significantly decreased in diabetes and negatively correlates with measures of glycemic and lipid control.
doi:10.1371/journal.pone.0115320
PMCID: PMC4301920  PMID: 25607823
4.  THE EFFECT OF ISOFLAVONE SOY PROTEIN SUPPLEMENTATION ON ENDOMETRIAL THICKNESS, HYPERPLASIA AND ENDOMETRIAL CANCER RISK IN POSTMENOPAUSAL WOMEN: A RANDOMIZED CONTROLLED TRIAL 
Menopause (New York, N.Y.)  2013;20(8):840-844.
Objective
To determine whether long-term isoflavone soy protein (ISP) supplementation affects endometrial thickness and rates of endometrial hyperplasia and cancer in postmenopausal women.
Methods
In this randomized, double-blind, placebo-controlled trial, 350 postmenopausal women 45–92 years of age were randomized to a total daily dose of 154 mg of ISP or a milk protein matched placebo for a 3-year period. Women with a surgically absent uterus were excluded from the analysis (final study population: n=224). The main outcome measures were the mean change in endometrial thickness on transvaginal ultrasound from baseline until up to 36 months of follow-up; the incidence of endometrial sampling, endometrial hyperplasia and endometrial cancer.
Results
A total of 666 visits among 224 participants were evaluated. Treatment groups did not significantly differ on the mean baseline or on-trial changes in endometrial thickness. Of the 103 placebo-treated participants, 7 (6.8%) underwent an endometrial biopsy; 6 (85.7%) of these biopsies were benign. One woman in the placebo group was diagnosed with complex endometrial hyperplasia with atypia and underwent a hysterectomy. The pathology result from this surgery was Stage IB endometrial cancer. Of the 121 participants in the soy group, 9 (7.4%) underwent an endometrial biopsy. The results were benign in all 9 cases (100%). Although the rate of hyperplasia / malignancy was higher in the placebo group (14.3% versus 0%), the difference was not statistically significant.
Conclusion
Three-year isoflavone soy protein (ISP) supplementation has no effect on endometrial thickness or rates of endometrial hyperplasia and cancer in postmenopausal women.
LEVEL OF EVIDENCE
I
doi:10.1097/GME.0b013e3182804353
PMCID: PMC3934100  PMID: 23422867
Isoflavones; menopause; endometrium; randomized controlled trial
6.  Interleukin 10 Responses Are Associated With Sustained CD4 T-Cell Counts in Treated HIV Infection 
The Journal of Infectious Diseases  2012;206(5):780-789.
Background.Inflammation persists in treated human immunodeficiency virus (HIV) infection and may contribute to an increased risk for non–AIDS-related pathologies. We investigated the correlation of cytokine responses with changes in CD4 T-cell levels and coinfection with hepatitis C virus (HCV) during highly active antiretroviral treatment (HAART).
Methods.A total of 383 participants in the Women's Interagency HIV Study (212 with HIV monoinfection, 56 with HCV monoinfection, and 115 with HIV/HCV coinfection) were studied. HIV-infected women had <1000 HIV RNA copies/mL, 99.7% had >200 CD4 T cells/μL; 98% were receiving HAART at baseline. Changes in CD4 T-cell count between baseline and 2–4 years later were calculated. Peripheral blood mononuclear cells (PBMCs) obtained at baseline were used to measure interleukin 1β (IL-1β), interleukin 6 (IL-6), interleukin 10 (IL-10), interleukin 12 (IL-12), and tumor necrosis factor α (TNF-α) responses to Toll-like receptor (TLR) 3 and TLR4 stimulation.
Results.Undetectable HIV RNA (<80 copies/mL) at baseline and secretion of IL-10 by PBMCs were positively associated with gains in CD4 T-cell counts at follow-up. Inflammatory cytokines (IL-1β, IL-6, IL-12, and TNF-α) were also produced in TLR-stimulated cultures, but only IL-10 was significantly associated with sustained increases in CD4 T-cell levels. This association was significant only in women with HIV monoinfection, indicating that HCV coinfection is an important factor limiting gains in CD4 T-cell counts, possibly by contributing to unbalanced persistent inflammation.
Conclusions.Secreted IL-10 from PBMCs may balance the inflammatory environment of HIV, resulting in CD4 T-cell stability.
doi:10.1093/infdis/jis380
PMCID: PMC3491747  PMID: 22693231
7.  Isoflavone Soy Protein Supplementation and Atherosclerosis Progression in Healthy Postmenopausal Women: A Randomized Controlled Trial 
Background and Purpose
Although epidemiological and experimental studies suggest that dietary intake of soy may be cardioprotective, use of isoflavone soy protein (ISP) supplementation as a primary preventive therapy remains unexplored. We determined whether ISP reduces subclinical atherosclerosis assessed as carotid artery intima-media thickness (CIMT) progression.
Methods
In a double-blind, placebo-controlled trial, 350 postmenopausal women 45–92 years of age without diabetes and cardiovascular disease (CVD) were randomized to 2 evenly divided daily doses of 25 g soy protein containing 91 mg aglycon isoflavone equivalents or placebo for 2.7-years.
Results
Overall, mean (95% confidence interval) CIMT progression rate was 4.77(3.39–6.16) μm/year in the ISP group and 5.68(4.30–7.06) μm/year in the placebo group. Although CIMT progression was reduced on average by 16% in the ISP group relative to the placebo group, this treatment effect was not statistically significant (p=0.36). Among the subgroup of women who were randomized within 5 years of menopause, ISP participants had on average a 68% lower CIMT progression rate than placebo participants 2.16(−1.10–5.43) vs. 6.79(3.56–10.01) μm/year, p=0.05). ISP supplementation had a null effect on women who were >5 years beyond menopause when randomized. There were no major adverse events from ISP supplementation.
Conclusion
ISP supplementation did not significantly reduce subclinical atherosclerosis progression in postmenopausal women. Subgroup analysis suggest that ISP supplementation may reduce subclinical atherosclerosis in healthy young (median age, 53 years) women at low-risk for CVD who were <5 years postmenopausal. These first trial results of their kind warrant further investigation.
doi:10.1161/STROKEAHA.111.620831
PMCID: PMC3202054  PMID: 21903957
Atherosclerosis; Cardiovascular disease; Intima-media thickness; Isoflavones; Menopause; Soy; Women
8.  The Impact of the AIDS Drug Assistance Program (ADAP) on Use of Highly Active Antiretroviral and Antihypertensive Therapy among HIV-Infected Women 
Objectives
To evaluate the association between enrollment into an AIDS Drug Assistance Program (ADAP) and use of highly active antiretroviral therapy (HAART) and antihypertensive therapy.
Methods
Cross-sectional analyses of data were performed on HAART-eligible women enrolled in the California (n=439), Illinois (n=168), and New York (n=487) Women’s Interagency HIV Study (WIHS) sites. A subset of HIV-infected women with hypertension (n=395) was also analyzed. Unadjusted and adjusted backward stepwise elimination logistic regression measured the association between demographic, behavioral, and health service factors and non-use of HAART or antihypertensive medication.
Results
In adjusted analysis of HAART non-use, women without ADAP were significantly more likely not to use HAART (odds ratio [OR] = 2.4, 95% confidence interval [CI] = 1.5–3.7) than women with ADAP. In adjusted analysis of antihypertensive medication non-use, women without ADAP had an increased but not significant odds of antihypertensive medication non-use (OR = 2.4, 95% CI = 0.93–6.0) than women with ADAP.
Conclusions
Government-funded programs for prescription drug coverage, such as ADAP, may play an important role in how HIV-positive women to access and use essential medications for chronic diseases.
doi:10.1097/QAI.0b013e31820a9d04
PMCID: PMC3042745  PMID: 21239994
AIDS; antiretroviral therapy; hypertension; women; healthcare disparity; prescription insurance
9.  Urine accurately reflects circulating isoflavonoids and ascertains compliance during soy intervention 
BACKGROUND
Isoflavonoids (IFLs) may protect against chronic diseases including cancer. IFL exposure is traditionally measured from plasma but the reliability of urine is uncertain. We assessed whether IFL excretion in overnight urine (OU) or spot urine (SU) reliably reflects IFLs in plasma (PL) and the usefulness of the three matrices to determine soy intake compliance.
METHODS
In a randomized, double-blind, placebo-controlled soy intervention trial with 350 postmenopausal women, IFLs (daidzein, genistein, glycitein, equol, O-desmethylangolensin, dihydrodaidzein, dihydrogenistein) were analyzed by LCMS in OU, SU, and PL collected at baseline and every 6 months over 2.5 years.
RESULTS
High between-subjects intraclass correlations between all three matrices (median 0.94) and high between-subjects Pearson correlations (median rOU-PL=0.80; median rSU-PL=0.80; median rOU-SU=0.92) allowed the development of equations to predict IFL values from any of the three matrices. Equations developed from a randomly selected 87% of all available data were valid as high correlations were found on the residual 13% of data between equation-generated and measured IFL values (median rOU-PL=0.86; median rSU-PL=0.78; median rOU-SU=0.84); median absolute IFL differences for OU-PL, SU-PL, and OU-SU were 8.8 nM, 10.3 nM and 0.28 nmol/mg, respectively. All three matrices showed highly significant IFL differences between the placebo and soy intervention group at study end (P<0.0001) and highly significant correlations between IFL values and counted soy doses in the intervention group.
CONCLUSIONS
OU and SU IFL excretion reflect circulating PL IFL levels in healthy postmenopausal women accurately.
IMPACT
Noninvasively-collected urine can be used to reliably determine systemic IFL exposure and soy intake compliance.
doi:10.1158/1055-9965.EPI-10-0116
PMCID: PMC2950801  PMID: 20615889
isoflavonoids; urine; plasma; compliance; soy; intervention; biomarker
10.  Retention and Attendance of Women Enrolled in a Large Prospective Study of HIV-1 in the United States 
Journal of Women's Health  2009;18(10):1627-1637.
Abstract
Objective
The objective was to assess study retention and attendance for two recruitment waves of participants in the Women's Interagency HIV Study (WIHS).
Methods
The WIHS, a prospective study at six clinical centers in the United States, has experienced two phases of participant recruitment. In phase one, women were screened and enrolled at the same time, and in phase two, women were screened and enrolled at separate visits. Compliance with study follow-up was evaluated by examining semiannual study retention and visit attendance.
Results
After 10 study visits, the retention rate in the original recruits (enrolled in 1994–1995) was 83% for the HIV-infected women and 69% for the HIV-uninfected women compared with 86% and 86%, respectively, in the new recruits (enrolled in 2001–2002). In logistic regression analysis of the HIV-infected women, factors associated with early (visits 2 and 3) nonattendance were temporary housing, moderate alcohol consumption, use of crack/cocaine/heroin, having a primary care provider, WIHS site of enrollment, lower CD4 cell count, and higher viral load. Among HIV-uninfected women, the factors associated with early nonattendance were recruitment into the original cohort, household income ≥$12,000 per year, temporary housing, unemployment, use of crack/cocaine/heroin, and WIHS site of enrollment. Factors associated with nonattendance at later visits (7–10) among HIV-infected participants were younger age, white race, not having a primary care provider, not having health insurance, WIHS site of enrollment, higher viral load, and nonattendance at a previous visit. In HIV-uninfected participants, younger age, white race, WIHS site of enrollment, and nonattendance at a previous visit were significantly associated with nonattendance at later visits.
Conclusions
Preventing early loss to follow-up resulted in better study retention early, but late loss to follow-up may require different retention strategies.
doi:10.1089/jwh.2008.1337
PMCID: PMC2825719  PMID: 19788344

Results 1-10 (10)