Secondary analysis of a randomized trial testing community health educator interventions for diabetes prevention among refugees with depression: effects on nutrition, physical activity and sleep.

BACKGROUND: Refugees have high levels of psychological distress that hamper lifestyle change efforts. We previously reported that community health educator (CHE) diabetes prevention interventions decreased HbA1c and depressive symptoms among Cambodian-American refugees with depression; this paper reports health behavior outcomes of those interventions. METHODS: Participants were aged 35-75, Khmer speaking, at risk for diabetes, and met study criteria for likely depression by either a) antidepressant medication and/or b) prolonged elevated depressive symptoms. Participants were randomized to one of three CHE interventions: 1) lifestyle intervention called Eat, Walk, Sleep (EWS), 2) EWS plus medication therapy management with a pharmacist/CHE team (EWS + MTM), or, 3) social services (SS; control). Physical activity and sleep were measured with 7 days of actigraphy. Nutrition was measured as carbohydrates as reported in a culturally tailored food frequency questionnaire. Assessments were at baseline, end point (12 months), and follow-up (15 months). RESULTS: The n = 188 participants were 78% female, average age of 55 years, half had a household income < $20,000, and modal education was 7.0 years. Individuals in the two treatment groups that received the EWS intervention significantly increased their brown rice consumption (p < .001, Cohen's d = 0.76) and their moderate-to-vigorous activity (p = .039, d = 0.32). No intervention changed sleep duration, timing, efficiency or wake after sleep onset. Across groups, individuals who increased brown rice consumption, increased vigorous activity and decreased total sleep time variability showed decreased HbA1c, with small effect sizes. CONCLUSIONS: CHEs may improve nutrition and physical activity in refugees with depression but more intensive interventions may be required to impact sleep. Improvements in all three behaviors appear to be associated with HbA1c lowering TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02502929.

Evaluating the Translational Potential of Bacteriocins as an Alternative Treatment for Staphylococcus aureus Infections in Animals and Humans.

Antibiotic resistance remains a global threat to human and animal health. Staphylococcus aureus is an opportunistic pathogen that causes minor to life-threatening infections. The widespread use of antibiotics in the clinical, veterinary, and agricultural setting combined with the increasing prevalence of antibiotic-resistant S. aureus strains makes it abundantly clear that alternatives to antibiotics are urgently needed. Bacteriocins represent one potential alternative therapeutic. They are antimicrobial peptides that are produced by bacteria that are generally nontoxic and have a relatively narrow target spectrum, and they leave many commensals and most mammalian cells unperturbed. Multiple studies involving bacteriocins (e.g., nisin, epidermicin, mersacidin, and lysostaphin) have demonstrated their efficacy at eliminating or treating a wide variety of S. aureus infections in animal models. This review provides a comprehensive and updated evaluation of animal studies involving bacteriocins and highlights their translational potential. The strengths and limitations associated with bacteriocin treatments compared with traditional antibiotic therapies are evaluated, and the challenges that are involved with implementing novel therapeutics are discussed.

Community-based diabetes prevention randomized controlled trial in refugees with depression: effects on metabolic outcomes and depression.

Depression and antidepressant medications increase risk for type 2 diabetes. Cambodian-Americans have exceedingly high rates of both depression and diabetes. This paper reports outcomes of a diabetes prevention trial for Cambodian-Americans with depression. Primary outcomes were HbA1c, insulin resistance and depressive symptoms. Participants were aged 35-75, Khmer speaking, at risk for diabetes, and met study criteria for likely depression by either (a) antidepressant medication and/or (b) prolonged elevated depressive symptoms. Participants were randomized to one of three community health worker (CHW) interventions: (1) lifestyle intervention called Eat, Walk, Sleep (EWS), (2) EWS plus medication therapy management sessions with a pharmacist/CHW team to resolve drug therapy problems (EWS + MTM), or, (3) social services (SS; control). Assessments were at baseline, post-treatment (12 months), and follow-up (15 months). The n = 188 participants were 78% female, average age of 55 years, half had a household income < $20,000, and modal educational attainment was 7.0 years. Compared to the other arms, EWS + MTM showed a significant decrease in HbA1c and a trend for reduced inflammation and stress hormones. Depressive symptoms improved for EWS and EWS + MTM relative to SS. There was no change in insulin resistance. Cardiometabolic and mental health can be improved in tandem among immigrant and refugee groups.

Psychometric evaluation of the Persian version of the Heart Disease Fact Questionnaire (HDFQ) in people with diabetes in Iran.

BACKGROUND AND AIMS: Public health and clinic-based educational strategies are desperately needed to stem the tide of death from heart disease among people with diabetes in low and middle-income countries. This study translated the Heart Disease Fact Questionnaire into Persian and evaluated its reliability and validity for use in Iran. METHODS: Using rigorous translation methods, the 25-item scale was administered to Persian speakers with diabetes. The scale was evaluated for content validity, construct validity and reliability. RESULTS: Participants were 268 patients with diabetes with mean age of 63.19 ± 16.61 years. The mean HDFQ score was 17.31 ± 5.11 (in the low range). Higher scores were associated with younger age, younger age of diabetes onset, higher education, higher employment position, family history of diabetes and hypertension, shorter diabetes duration, and adherence to home exercise regimens. Kuder-Richardson's reliability coefficient was good, i.e., 0.82. Confirmatory factor analysis showed that the factor loadings of all questions, except question number 25, were favorable, i.e., >0.3. Model fit indices were favorable: Chi-square statistic to degree of freedom ratio (χ2/df) = 1.82, Comparative fit index = 0.96, Tucker-Lewis Index = 0.96 and root mean square error = 0.06. CONCLUSION: After removing item #25, the Persian heart disease fact questionnaire has good validity and reliability and can be used to inform and evaluate clinical and public health educational programs aimed at decreasing risk for heart disease among Persian speakers with diabetes.

Tobacco use patterns and clinical outcomes in the T1D exchange.

AIMS: This study examined associations between tobacco use and diabetes outcomes using the T1D Exchange Registry. METHODS: Adult participants (N = 933) completed standardized questionnaires including self-reported outcomes: past year serious hypoglycemic and diabetic ketoacidosis episodes, diabetes self-care, diabetes distress, and self-monitoring of blood glucose. Chart-extracted outcomes included HbA1c, nephrology and neuropathy diagnoses, and BMI. We examined the relation of tobacco use status (never, former, current) and frequency of use (daily versus less than daily) to these outcomes. RESULTS: The majority had never used tobacco (55%, n = 515); 27% (n = 252) were former users and 18% (n = 166) were current users (with 31% using daily). Tobacco status was associated with HbA1c, BMI, self-care, distress, and blood glucose monitoring frequency. Across most outcomes, current users evidenced worse values relative to never users, and former users were largely similar to never users. Daily use was associated with significantly worse outcomes on HbA1c, diabetes self-care, and distress scores relative to less than daily use. CONCLUSIONS: These cross-sectional comparisons suggest that current tobacco use is associated with worse status on important clinical diabetes indicators. Former users did not evidence these deleterious associations. Findings point to potential diabetes-specific motivators that could inform tobacco cessation interventions.

Risk factors for drug therapy problems among Cambodian Americans with complex needs: a cross-sectional, observational study.

BACKGROUND: Pharmaceutical drug therapy problems (DTPs) are a major public health problem. We examined patient-level risk factors for DTPs among Cambodian Americans. METHODS: Community health workers (CHWs) verbally administered surveys and completed a detailed medication review form with participants. A doctoral-level pharmacist reviewed the form with the patient and CHW to determine DTP number and type (appropriateness, effectiveness, safety, and adherence). RESULTS: Participants (n = 63) averaged 55 years old, 6 years of education, 52% were married, 87% spoke Khmer at home, with modal household income <$20,000 (41%). The percentage of participants with DTPs was: 45% appropriateness, 25% effectiveness, 64% safety, and 30% adherence, averaging 3.7 DTPs per patient. In multiple regressions, patient characteristics uniquely predicted each type of DTP. In a multiple regression controlling for number of medications, being married reduced total DTPs (IRR = 0.70) and being depressed increased total DTPs (IRR = 1.26). CONCLUSIONS: Vulnerable patients should be prioritized for pharmacist/CHW teams to identify DTPs.Trial registration: ClinicalTrials.gov identifier: NCT02502929.

Changes in negative affect and changes in heart rate variability among low-income latinos with type 2 diabetes in a randomized, controlled stress management trial.

BACKGROUND: Structural equation modeling examined the relationship between change in negative affect (NA) and change in heart rate variability (HRV) among 121 Latinos with type 2 diabetes. METHODS: This study leveraged data from the Community Health Workers Assisting Latinos Manage Stress and Diabetes (CALMSD) study which compared diabetes education vs diabetes education plus stress management. Participants completed surveys of NA at baseline and again 8-10 weeks later. They also wore 7­lead, 3-channel ambulatory ECG monitors for 24 h at both time points. The latent variable NA was modeled by observed scores on symptoms of depression, anxiety, diabetes distress, and wellbeing (reversed). The latent variable HRV was modeled by observed scores in the time domain (the standard deviation of the R-R interval [SDNN] and the root mean square of the successive differences [RMSSD]) and in the frequency domain, i.e., log-transformed ultra-low frequency, very-low frequency, low frequency, and high frequency. RESULTS: At baseline, there were strong, negative cross-sectional associations between NA and HRV. Baseline NA predicted change in HRV, whereas baseline HRV did not predict change in NA. Controlling for fasting glucose and treatment assignment did not meaningfully alter the findings. Stress management improved NA but not HRV. At followup, a greater reduction (improvement) in NA was associated with a larger increase (improvement) in HRV, with a small-to-medium negative association that approached statistical significance. CONCLUSIONS: Findings indicate a longitudinal relationship between NA and HRV, and suggest that improvement in one may be associated with improvement in the other.

Glucose management for rewards: A randomized trial to improve glucose monitoring and associated self-management behaviors in adolescents with type 1 diabetes.

BACKGROUND: This randomized, controlled trial evaluated a monetary-based reinforcement intervention for increasing self-monitoring of blood glucose (SMBG) among youth with poorly controlled type 1 diabetes. METHODS: After a 2-week baseline, 60 participants were randomized to enhanced usual care (EUC) or Reinforcers. The Reinforcers group earned monetary rewards for SMBG and associated behaviors such as uploading glucose meters. Reinforcers were withdrawn at 24 weeks. A follow-up evaluation occurred at 36 weeks. RESULTS: Participants in the reinforcers group increased the proportion of days they completed ≥4 SMBG from 14.6% at baseline to 64.4%, 47.5%, and 37.8% at 6, 12, and 24 weeks, respectively. In contrast, EUC participants declined from 22.7% at baseline to 17.5%, 10.5%, and 11.1% (Ps < .01 vs EUC at all time points). Group differences were attenuated but remained significant after withdrawal of reinforcers. Effect sizes for SMBG were very large during reinforcement and large after withdrawal of reinforcers. In the reinforcers group, mean A1c dropped from 9.5% ± 1.2% at baseline to 9.0% ± 1.3% at week 6 and 9.0% ± 1.4% at week 12. For EUC, A1c was 9.2% ± 0.2% at baseline and ranged from 9.2% ± 1.5% to 9.6% ± 1.6% throughout the study (P < .05 vs EUC). Group differences in A1c were no longer significant at weeks 24 and 36. Effect sizes for A1c were small during reinforcement and also after withdrawal of reinforcement. CONCLUSIONS: Monetary-based reinforcement of adolescents with type 1 diabetes caused durable increases in SMBG. Modification of the reinforcement structure may be needed to sustain improved metabolic control in this challenging age group.

Inflammation and Stress Biomarkers Mediate the Association between Household Food Insecurity and Insulin Resistance among Latinos with Type 2 Diabetes.

BACKGROUND: Household food insecurity (HFI) is a stressor that is associated with type 2 diabetes (T2D). However, little is known about HFI and the insulin resistance (IR) underlying T2D, and the mechanisms involved. OBJECTIVE: We examined the cross-sectional association between HFI and IR among low-income Latinos with T2D and tested whether inflammation and stress hormones mediated this association. METHODS: HFI was measured with the 6-item US Household Food Security Survey module. IR was calculated from fasting plasma blood glucose and serum insulin. Inflammation was indicated by high-sensitivity C-reactive protein (hsCRP), and stress hormones included urinary cortisol, metanephrine, and normetanephrine. To test for an indirect effect of HFI on homeostasis model assessment of IR, a parallel multiple mediation model was run with biological markers that significantly differed between food security status-entered as mediators in the model. We used 95% bias-corrected bootstrap CIs, with 10,000 bootstrap samples, to assess the significance of the indirect effects. RESULTS: The 121 participants with T2D were primarily Puerto Rican (85.8%), aged mean = 60.7 y, and 74% were female. Eighty-two (68%) were classified as food insecure. Compared with food-secure individuals, food-insecure individuals had a significantly higher IR [mean difference (Δ) = 7.21, P = 0.001], insulin (Δ = 9.7, P = 0.019), glucose (Δ = 41, P < 0.001), hsCRP (Δ = 0.8, P = 0.008), cortisol (Δ = 21, P = 0.045), and total cholesterol (Δ = 29, P = 0.004). Groups did not differ on other lipids, metanephrine, normetanephrine, or A1c. The mediation model showed a significant direct effect of HFI on hsCRP (P = 0.020) and on cortisol (P = 0.011). There was a direct effect of cortisol (P = 0.013), hsCRP (P = 0.044), and HFI on IR (P = 0.015). The total combined indirect effect of HFI through cortisol and hsCRP indicated partial mediation. CONCLUSIONS: Among Latinos with T2D, HFI is associated with IR partially through inflammation and stress hormones. Interventions to ameliorate HFI and mitigate its effects on inflammation, stress, and IR are warranted. This trial was registered at clinicaltrials.gov as NCT01578096.

Substance Use Disorders among Patients with Type 2 Diabetes: a Dangerous but Understudied Combination.

PURPOSE OF REVIEW: This paper reviews research on substance use and disorders (SUDs) among adults with diabetes. It describes epidemiological data on SUDs in persons with type 2 diabetes, overviews effects of substance use on diabetes outcomes, and discusses treatments for SUDs in patients with diabetes. RECENT FINDINGS: Rates of current smoking range from 10 to 26% and alcohol use disorders are 0-5%. Rates of illicit SUDs are 3-4%, but there are no population-based studies using nationally representative samples. Smoking increases the risk for long-term diabetes complications and premature death. Alcohol and illicit drug use can also impact long-term diabetes complications by impairing glucose homeostasis and adversely influencing self-management behaviors. There is mixed evidence about psychosocial smoking cessation interventions in adults with diabetes and little on alcohol and illicit SUD interventions. Limited data exist on pharmacotherapies for SUDs in this population, but a recent study suggests that varenicline is safe and effective for treating smoking in patients with diabetes. Substance use is an understudied problem in type 2 diabetes, and addressing substance use holds potential for improving outcomes. Additional large population-based epidemiological studies in those with type 2 diabetes are needed, particularly for alcohol and illicit SUDs. Longitudinal studies should be conducted to better understand the time course of diabetes onset and outcomes in relation to SUDs. Randomized controlled trials are needed to assess safety and efficacy of promising psychosocial and pharmacological interventions.

Diabetes-Specific Food Insecurity Is Associated with Impaired Heart Rate Variability Independent of Glycemic Control: Exploratory Findings among Latinos with Type 2 Diabetes.

Background: Food insecurity (FI), diabetes prevalence, and poor diabetes outcomes all disproportionately affect Latinos in the United States. Heart rate variability (HRV) reflects autonomic tone, is associated with glycemic control, and predicts mortality in type 2 diabetes. It is unknown whether FI is related to HRV and, if so, whether glycemic control accounts for this association. Objective: This exploratory cross-sectional study examined FI and HRV among US Latinos with type 2 diabetes. Methods: Participants reported demographic characteristics, socioeconomic status, and FI, including the 6-item USDA food security module and a 1-item measure of diabetes-specific food security. Participants wore an ambulatory electrocardiogram monitor for 24 h. In the time domain, HRV was assessed with the SD of the R-R interval (SDNN). In the frequency domain, the power spectrum was integrated over 3 frequency bands-very low frequency (VLF), low frequency (LF), and high frequency (HF)-and then natural log transformed. Unadjusted ANOVA and ANCOVA adjusted for age, sex, glycated hemoglobin (HbA1c), and indicators of socioeconomic status compared food security groups on HRV. Results: Participants' mean ± SD age was 59.7 ± 10.9 y, and 73% were women. Of the 94 participants, 63 reported FI according to the USDA food security module and 46 reported FI according to the diabetes-specific measure. Mean ± SD HbA1c was 8.6% ± 1.7% and was marginally higher among those reporting diabetes-specific FI than those reporting diabetes-specific food security. Participants who reported diabetes-specific FI had lower SDNN, VLF, LF, and HF HRV with effect sizes in the small-to-medium range. Differences remained significant even after controlling for age, sex, socioeconomic hardship, and HbA1c. The 6-item USDA food security module was not associated with HRV. Conclusions: Diabetes-specific FI may be a unique risk factor for poor health outcomes among US Latinos. Efforts to address FI could benefit diabetes outcomes.

Medication Adherence and Operating Room Efficiency for a Surgical Subspecialty.

The implementation of a 5-step reminder process and pharmacist consultation/visit improved medication adherence and reduced operative delays.

Testing for rewards: a pilot study to improve type 1 diabetes management in adolescents.

OBJECTIVE: To evaluate the effectiveness of monetary reinforcement to increase the frequency of self-monitoring blood glucose (SMBG). RESEARCH DESIGN AND METHODS: Ten adolescents with poorly controlled diabetes enrolled in a 12-week program in which they earned monetary reinforcers based on SMBG frequency ($0.10 per test, with bonuses for ≥4 tests per day, and $251.40 maximum). RESULTS: SMBG increased from 1.8 ± 1.0 to 4.9 ± 1.0 tests per day (P < 0.001) with 90% completing four or more tests per day. Mean A1C fell from 9.3 ± 0.9% to 8.4 ± 1.5% (P = 0.05). Adolescents and parents reported high satisfaction with procedures. CONCLUSIONS: Reinforcing adolescents for SMBG may increase testing and improve A1C.

Stress, depression and medication nonadherence in diabetes: test of the exacerbating and buffering effects of family support.

Stressors and depressive symptoms have been associated with medication nonadherence among adults with type 2 diabetes (T2DM). We tested whether these associations were exacerbated by obstructive family behaviors or buffered by supportive family behaviors in a sample of 192 adults with T2DM and low socioeconomic status using unadjusted and adjusted regression models. We found support for the exacerbating hypothesis. Stressors and nonadherence were only associated at higher levels of obstructive family behaviors (interaction AOR = 1.12, p = .002). Similarly, depressive symptoms and nonadherence were only associated at higher levels of obstructive family behaviors (interaction AOR = 3.31, p = .002). When participants reported few obstructive family behaviors, neither stressors nor depressive symptoms were associated with nonadherence. We did not find support for the buffering hypothesis; stressors and depressive symptoms were associated with nonadherence regardless of supportive family behaviors. Nonadherent patients experiencing stressors and/or major depressive symptoms may benefit from interventions that reduce obstructive family behaviors.

Self-reported discrimination, diabetes distress, and continuous blood glucose in women with type 2 diabetes.

We investigated whether self-reported racial discrimination was associated with continuous glucose levels and variability in individuals with diabetes, and whether diabetes distress mediated these associations. Seventy-four Black and White women with type 2 diabetes completed the Experience of Discrimination scale, a measure of lifetime racial discrimination, and the Problem Areas in Diabetes, a measure of diabetes distress. Participants wore a continuous glucose monitor for 24 h after 8 h of fasting, a standard meal, and a 4-h run in period. Higher discrimination predicted higher continuous mean glucose and higher standard deviation of glucose. For both mean and standard deviation of glucose, a race × discrimination interaction indicated a stronger relationship between discrimination and glucose for Whites than for Blacks. Diabetes distress mediated the discrimination-mean glucose relationship. Whites who report discrimination may be uniquely sensitive to distress. These preliminary findings suggest that racial discrimination adversely affects glucose control in women with diabetes, and does so indirectly through diabetes distress. Diabetes distress may be an important therapeutic target to reduce the ill effects of racial discrimination in persons with diabetes.

Stressors may compromise medication adherence among adults with diabetes and low socioeconomic status.

Studies examining the impact of stressors on diabetes self-care have focused on a single stressor or have been largely qualitative. Therefore, we assessed the stressors experienced by a high-risk population with type 2 diabetes, and tested whether having more stressors was associated with less adherence to multiple self-care behaviors. Participants were recruited from a Federally Qualified Health Center and 192 completed a stressors checklist. Experiencing more stressors was associated with less adherence to diet recommendations and medications among participants who were trying to be adherent, but was not associated with adherence to other self-care behaviors. Because having more stressors was also associated with more depressive symptoms, we further adjusted for depressive symptoms. Stressors remained associated with less adherence to medications, but not to diet recommendations. For adults engaged in adherence, experiencing an accumulation of stressors presents barriers to adherence that are distinct from associated depressive symptoms.

Racial and ethnic disparities in diabetes complications in the northeastern United States: the role of socioeconomic status.

The role of socioeconomic status (SES) in explaining racial/ ethnic disparities in diabetes remains unclear. We investigated disparities in self-reported diabetes complications and the role of macro (eg, income, education) and micro (eg, owning a home or having a checking account) SES indicators in explaining these differences. The sample included individuals with a diagnosis of diabetes (N=795) who were aged, on average, 55 years, and 55.6% non-Hispanic white, 25.0% African American, and 19.4% Hispanic. Approximately 8% reported nephropathy, 35% reported retinopathy, and 16% reported cardiovascular disease. There were significant disparities in the rates of complications among non-Hispanic white, African American, and Hispanic participants, with Hispanic participants having the highest rates of nephropathy, retinopathy, and cardiovascular disease. Macro SES indicators (eg, income) mediated racial differences (ie, non-Hispanic whites vs African Americans) in self-reported retinopathy, a combination of macro and more micro SES indicators (eg, education, income, and ownirg a home or having a checking account) mediated racial/ethnic differences (ie, non-Hispanic white vs Hispanic participants) in self-reported cardiovascular disease, and only micro SES indicators (eg, owning a home or having a checking account) mediated differences between lower-income SES racial/ethnic minority groups (ie, African American vs Hispanic participants) in self-reported retinopathy and cardiovascular disease. Findings underscore that indicators of SES must be sensitive to the outcome of interest and the racial/ethnic groups being compared.

Self-reported racial discrimination and endothelial reactivity to acute stress in women.

This study investigated the effect of self-reported racial discrimination on endothelial responses to acute laboratory mental stress among post-menopausal women. One-hundred thirteen women (n = 94 self-identified as White and n = 19 self-identified as racial/ethnic minority), 43% with type 2 diabetes, reported lifetime experiences of racial/ethnic discrimination. Repeated assessments of flow-mediated dilation were performed at baseline, immediately after 5 min of mental arithmetic and at 20-min recovery. Both White and racial/ethnic minority women reported lifetime discrimination, with rates significantly higher among minorities. Self-reported lifetime discrimination was associated with attenuated flow-mediated dilation at recovery. Confounding variables, including clinical characteristics, mood, personality traits, other life stressors and general distress, did not better account for the effect of racial discrimination. Neither race/ethnicity nor diabetes status moderated the effect. The perceived stressfulness of the mental arithmetic was not associated with the endothelial response. In conclusion, self-reported lifetime discrimination is associated with attenuated endothelial recovery from acute mental stress. Elucidating the effects of discrimination and the biological mechanisms through which it affects the vasculature may suggest interventions to improve health.

Racial discrimination and metabolic control in women with type 2 diabetes.

PURPOSE: We investigated whether self-reported racial discrimination was associated with insulin resistance (IR) and glycosylated hemoglobin (A1c) in women with type 2 diabetes in the United States, after controlling for covariates. METHODS: Seventy-seven Black and White women with type 2 diabetes completed the Experiences of Discrimination Scale, which assesses self-reported lifetime frequency of racially motivated discrimination. Participants provided fasting blood samples for assessment of glucose and insulin for determination of IR and A1c. Covariates included age, education, waist circumference, diabetes distress, and stressful life events. RESULTS: In unadjusted regression analysis discrimination was significantly associated with IR. There was a trend for a race by discrimination interaction, with a weaker effect for Blacks than Whites. Follow up analysis showed that discrimination was significantly associated with IR in both Blacks and Whites, even after adjustment, as was waist circumference. In unadjusted regression analysis, discrimination was significantly associated with A1c. There was a significant race by discrimination interaction. Follow up analysis showed that discrimination was not significantly associated with A1c among Blacks, but was among Whites, even after adjustment, as was diabetes distress and insulin use. CONCLUSIONS: Racial discrimination is associated with insulin resistance in Black and White women with diabetes, and with A1c in White women with diabetes.