Impact of incident diabetes on atherosclerotic cardiovascular disease according to statin use history among postmenopausal women.

To compare impact of incident diabetes on atherosclerotic cardiovascular disease (ASCVD) risk among postmenopausal women according to statin use. Prospective data from 120,499 postmenopausal women without prevalent diabetes or cardiovascular disease at baseline from the Women's Health Initiative were used. Incident diabetes was self-reported annually and defined as treatment with pills or injectable medication for diabetes. Current statin use was determined at enrollment and years 1, 3, 6, 9 and 13.5 in the three clinical trial arms, and at baseline, year 3, and 13.5 for the observational study. The primary outcome was incident ASCVD events, self-reported annually and adjudicated by blinded local and central physicians. Incident diabetes and statin use status were fitted as time-varying covariates in Cox regression models to assess ASCVD risk during an average follow-up of 13.6 years. For those not on statins at the time of diabetes diagnosis, there was a 42 % increased risk of ASCVD [hazard ratio (HR) 1.42, 95 % CI 1.28-1.58] among women with incident diabetes versus those without diabetes. Among women on statins, there was a 39 % increased risk of ASCVD (HR 1.39, 95 % CI 1.12-1.74) in women with incident diabetes versus those without diabetes. The increased ASCVD risk due to diabetes was similar between women before or after initiating statins (P = 0.89). Whether diabetes was diagnosed before or after statin use did not alter the increased risk of ASCVD associated with diabetes. Mitigating the increased incidence of diabetes in statin users could increase the ASCVD benefit-to-risk ratio of statins.

Single-component versus multicomponent dietary goals for the metabolic syndrome: a randomized trial.

BACKGROUND: Few studies have compared diets to determine whether a program focused on 1 dietary change results in collateral effects on other untargeted healthy diet components. OBJECTIVE: To evaluate a diet focused on increased fiber consumption versus the multicomponent American Heart Association (AHA) dietary guidelines. DESIGN: Randomized, controlled trial from June 2009 to January 2014. (ClinicalTrials.gov: NCT00911885). SETTING: Worcester, Massachusetts. PARTICIPANTS: 240 adults with the metabolic syndrome. INTERVENTION: Participants engaged in individual and group sessions. MEASUREMENTS: Primary outcome was weight change at 12 months. RESULTS: At 12 months, mean change in weight was -2.1 kg (95% CI, -2.9 to -1.3 kg) in the high-fiber diet group versus -2.7 kg (CI, -3.5 to -2.0 kg) in the AHA diet group. The mean between-group difference was 0.6 kg (CI, -0.5 to 1.7 kg). During the trial, 12 (9.9%) and 15 (12.6%) participants dropped out of the high-fiber and AHA diet groups, respectively (P = 0.55). Eight participants developed diabetes (hemoglobin A1c level ≥6.5%) during the trial: 7 in the high-fiber diet group and 1 in the AHA diet group (P = 0.066). LIMITATIONS: Generalizability is unknown. Maintenance of weight loss after cessation of group sessions at 12 months was not assessed. Definitive conclusions cannot be made about dietary equivalence because the study was powered for superiority. CONCLUSION: The more complex AHA diet may result in up to 1.7 kg more weight loss; however, a simplified approach to weight reduction emphasizing only increased fiber intake may be a reasonable alternative for persons with difficulty adhering to more complicated diet regimens. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute.

Challenges in sodium intake reduction and meal consumption patterns among participants with metabolic syndrome in a dietary trial.

BACKGROUND: Dietary guidelines suggest limiting daily sodium intake to <2,300 mg for the general population, and <1,500 mg/d for those with certain cardiovascular risk factors. Despite these recommendations, few Americans are able to achieve this goal. Identifying challenges in meeting these guidelines is integral for successful compliance. This analysis examined patterns and amount of daily sodium intake among participants with metabolic syndrome enrolled in a one-year dietary intervention study. METHODS: Two hundred forty participants with metabolic syndrome enrolled in a dietary intervention trial to lose weight and improve dietary quality. Three 24-hour dietary recalls were collected at each visit which provided meal patterns and nutrient data, including sodium intake. A secondary data analysis was conducted to examine sodium consumption patterns at baseline and at one-year study visits. Sodium consumption patterns over time were examined using linear mixed models. RESULTS: The percentage of meals reported eaten in the home at both baseline and one-year follow-up was approximately 69%. Follow-up for the one-year dietary intervention revealed that the participants who consumed sodium greater than 2,300 mg/d declined from 75% (at baseline) to 59%, and those that consumed higher than 1,500 mg/d declined from 96% (at baseline) to 85%. Average sodium intake decreased from 2,994 mg at baseline to 2,558 mg at one-year (P < 0.001), and the sodium potassium ratio also decreased from 1.211 to 1.047 (P < 0.001). Sodium intake per meal varied significantly by meal type, location, and weekday, with higher intake at dinner, in restaurants, and on weekends. At-home lunch and dinner sodium intake decreased (P < 0.05), while dinner sodium intake at restaurant/fast food chains increased from baseline to one-year (P < 0.05). CONCLUSION: Sodium intake for the majority of participants exceeded the recommended dietary guidelines. Findings support actions that encourage low-sodium food preparation at home and encourage public health policies that decrease sodium in restaurants and prepared foods.

Relations of depressive symptoms and antidepressant use to body mass index and selected biomarkers for diabetes and cardiovascular disease.

OBJECTIVES: We investigated whether depressive symptoms and antidepressant use are associated with biomarkers for glucose dysregulation and inflammation, body mass index (BMI), and waist circumference. METHODS: Postmenopausal women were recruited into the Women's Health Initiative from 1993 to 1998, and data were collected at regular intervals through 2005. We used multiple linear regression models to examine whether depressive symptoms and antidepressant use are associated with BMI, waist circumference, and biomarkers. RESULTS: Analysis of data from 71, 809 women who completed all relevant baseline and year 3 assessments showed that both elevated depressive symptoms and antidepressant use were significantly associated with higher BMI and waist circumference. Among 1950 women, elevated depressive symptoms were significantly associated with increased insulin levels and measures of insulin resistance. Analyses of baseline data from 2242 women showed that both elevated depressive symptoms and antidepressant use were associated with higher C-reactive protein levels. CONCLUSIONS: Monitoring body habitus and other biomarkers among women with elevated depression symptoms or taking antidepressant medication may be prudent to prevent diabetes and cardiovascular disease.

Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative.

BACKGROUND: This study investigates whether the incidence of new-onset diabetes mellitus (DM) is associated with statin use among postmenopausal women participating in the Women's Health Initiative (WHI). METHODS: The WHI recruited 161,808 postmenopausal women aged 50 to 79 years at 40 clinical centers across the United States from 1993 to 1998 with ongoing follow-up. The current analysis includes data through 2005. Statin use was captured at enrollment and year 3. Incident DM status was determined annually from enrollment. Cox proportional hazards models were used to estimate the risk of DM by statin use, with adjustments for propensity score and other potential confounding factors. Subgroup analyses by race/ethnicity, obesity status, and age group were conducted to uncover effect modification. RESULTS: This investigation included 153,840 women without DM and no missing data at baseline. At baseline, 7.04% reported taking statin medication. There were 10,242 incident cases of self-reported DM over 1,004,466 person-years of follow-up. Statin use at baseline was associated with an increased risk of DM (hazard ratio [HR], 1.71; 95% CI, 1.61-1.83). This association remained after adjusting for other potential confounders (multivariate-adjusted HR, 1.48; 95% CI, 1.38-1.59) and was observed for all types of statin medications. Subset analyses evaluating the association of self-reported DM with longitudinal measures of statin use in 125,575 women confirmed these findings. CONCLUSIONS: Statin medication use in postmenopausal women is associated with an increased risk for DM. This may be a medication class effect. Further study by statin type and dose may reveal varying risk levels for new-onset DM in this population.

Elevated depressive symptoms, antidepressant use, and diabetes in a large multiethnic national sample of postmenopausal women.

OBJECTIVE: To examine elevated depressive symptoms and antidepressant use in relation to diabetes incidence in the Women's Health Initiative. RESEARCH DESIGN AND METHODS: A total of 161,808 postmenopausal women were followed for over an average of 7.6 years. Hazard ratios (HRs) estimating the effects of elevated depressive symptoms and antidepressant use on newly diagnosed incident diabetes were obtained using Cox proportional hazards models adjusted for known diabetes risk factors. RESULTS: Multivariable-adjusted HRs indicated an increased risk of incident diabetes with elevated baseline depressive symptoms (HR 1.13 [95% CI 1.07-1.20]) and antidepressant use (1.18 [1.10-1.28]). These associations persisted through year 3 data, in which respective adjusted HRs were 1.23 (1.09-1.39) and 1.31 (1.14-1.50). CONCLUSIONS: Postmenopausal women with elevated depressive symptoms who also use antidepressants have a greater risk of developing incident diabetes. In addition, longstanding elevated depressive symptoms and recent antidepressant medication use increase the risk of incident diabetes.

The dietary quality of persons with heart failure in NHANES 1999-2006.

BACKGROUND: Dietary quality may impact heart failure outcomes. However, the current status of the dietary quality of persons with heart failure has not been previously reported. OBJECTIVE: To describe sodium intake, patient factors associated with sodium intake and overall dietary quality in a national sample of persons with heart failure. DESIGN: Analysis of repeated cross-sectional probability sample surveys using data from National Health and Nutrition Examination Surveys (NHANES) of 1999-2000, 2001-2002, 2003-2004 and 2005-2006. PARTICIPANTS: The study sample consisted of 574 persons with self-reported heart failure (mean age = 70 years; 52% women). MEASUREMENTS: Diet of each survey participant was assessed using single 24 hour recall. Dietary nutrients of interest included sodium, the mainstay of heart failure dietary recommendations, and additionally potassium, calcium, magnesium, fish oils, saturated fat and fiber. Specific dietary goals were based on established guidelines. RESULTS: Mean sodium intake was 2,719 mg, with 34% consuming less than 2,000 mg per day. Patient factors associated with greater sodium intake included male gender, lower education, lower income and no reported diagnosis of hypertension. Mean potassium intake was 2,367 mg/day, with no differences by type of diuretic used or renal disease status. Adherence rates to established guidelines for other nutrients were 13% for calcium, 10% for magnesium, 2% for fish oils, 13% for saturated fat and 4% for fiber. CONCLUSIONS: Dietary quality of persons with self-reported heart failure was poor. Public health approaches and clinical dietary interventions are needed for persons with this increasingly prevalent clinical syndrome.

A simple dietary message to improve dietary quality: Results from a pilot investigation.

OBJECTIVE: The present study compared the feasibility of two simple messages (a high-fiber diet or a low saturated fat diet) to a combination message (high fiber/low saturated fat) on their potential to affect dietary quality and metabolic health. METHODS: Thirty-six subjects were randomized to one of three intervention conditions and received individual dietary counseling sessions. Study assessments occurred at baseline, 3 mo, and 6 mo. RESULTS: The sample was 84% female and 94% Caucasian. Mean body mass index was 31kg/m(2). At the 6-mo assessment phase, we retained all 12 patients in the high-fiber diet condition, 10 of 12 in the low saturated fat condition, and 9 of 12 in the combination condition. Participants reported that the dietary fiber intervention was easier to maintain compared with the other two intervention conditions (83% for high dietary fiber versus 60% for low saturated fat versus 33% for the combination, P=0.008). Overall dietary quality improved in all three conditions during the study (P=0.01). In addition to increasing fiber, the high-fiber condition decreased their saturated fat intake, even though a reduction in saturated fat was not a part of that intervention condition. Participants in all three conditions lost an average of 9 lb from baseline weight (P<0.001). CONCLUSION: A simple dietary message is feasible and can improve overall dietary quality. Results support the need for a larger randomized controlled trial that is powered to detect the efficacy of a simplified dietary recommendation for dietary quality and metabolic health.

A randomized clinical trial comparing low-glycemic index versus ADA dietary education among individuals with type 2 diabetes.

OBJECTIVE: We compared the effects of a low glycemic index (GI) diet with the American Diabetes Association (ADA) diet on glycosylated hemoglobin (HbA1c) among individuals with type 2 diabetes. METHODS: Forty individuals with poorly controlled type 2 diabetes were randomized to a low-GI or an ADA diet. The intervention, consisting of eight educational sessions (monthly for the first 6 mo and then at months 8 and 10), focused on a low-GI or an ADA diet. Data on demographics, diet, physical activity, psychosocial factors, and diabetes medication use were assessed at baseline and 6 and 12 mo. Generalized linear mixed models were used to compare the two groups on HbA1c, diabetic medication use, blood lipids, weight, diet, and physical activity. RESULTS: Participants (53% female, mean age 53.5 y) were predominantly white with a mean body mass index of 35.8 kg/m(2). Although both interventions achieved similar reductions in mean HbA1c at 6 mo and 12 mo, the low-GI diet group was less likely to add or increase dosage of diabetic medications (odds ratio 0.26, P = 0.01). Improvements in high-density lipoprotein cholesterol, triacylglycerols, and weight loss were similar between groups. CONCLUSION: Compared with the ADA diet, the low-GI diet achieved equivalent control of HbA1c using less diabetic medication. Despite its limited size, this trial suggests that a low-GI diet is a viable alternative to the ADA diet. Findings should be evaluated in a larger randomized controlled trial.

Low-carbohydrate and high-fat intake among adult patients with poorly controlled type 2 diabetes mellitus.

OBJECTIVE: This study examined baseline dietary intake, body weight, and physiologic status in patients enrolled in a dietary intervention for type 2 diabetes mellitus (T2DM). METHODS: Dietary, physiologic, and demographic information were collected at baseline from 40 adult patients with poorly controlled T2DM (glycosylated hemoglobin >7%) who participated in a clinical trial at an academic medical center in Worcester, Massachusetts, USA. RESULTS: The average age at enrollment was 53.5 y (SD 8.4), average body mass index was 35.48 kg/m(2) (SD 7.0), and glycosylated hemoglobin was 8.3% (SD 1.2). Participants were predominantly white, married, and employed full time. Forty-eight percent were men. Seventy-eight percent had hyperlipidemia, and 68% had hypertension. Reported baseline daily average energy intake was 1778 kcal (SD 814), daily carbohydrate was 159 g (SD 71.5), and dietary fiber was 11.4 g (SD 5.2). The dietary composition was 35% carbohydrate, 45% fat (15% saturated fat), and 20% protein. The American Diabetes Association (ADA) guidelines recommends 45-65% of energy from carbohydrate, 20-35% from fat (<7% saturated), and 20% from protein. CONCLUSION: These patients reported a low-carbohydrate, low-fiber, high-fat (especially saturated) diet, although they stated they are not following any of the popular low-carbohydrate diets. Patients with T2DM may find the current trend toward reducing weight through low-carbohydrate diets attractive for control of blood glucose, despite ADA recommendations. This dietary pattern may represent a popular trend that extends beyond our particular study and, if so, has serious cardiovascular implications in this vulnerable population of T2DM patients.

Methodology for adding glycemic index and glycemic load values to 24-hour dietary recall database.

OBJECTIVES: We describe a method of adding the glycemic index (GI) and glycemic load (GL) values to the nutrient database of the 24-hour dietary recall interview (24HR), a widely used dietary assessment. We also calculated daily GI and GL values from the 24HR. METHODS: Subjects were 641 healthy adults from central Massachusetts who completed 9067 24HRs. The 24HR-derived food data were matched to the International Table of Glycemic Index and Glycemic Load Values. The GI values for specific foods not in the table were estimated against similar foods according to physical and chemical factors that determine GI. Mixed foods were disaggregated into individual ingredients. RESULTS: Of 1261 carbohydrate-containing foods in the database, GI values of 602 foods were obtained from a direct match (47.7%), accounting for 22.36% of dietary carbohydrate. GI values from 656 foods (52.1%) were estimated, contributing to 77.64% of dietary carbohydrate. The GI values from three unknown foods (0.2%) could not be assigned. The average daily GI was 84 (SD 5.1, white bread as referent) and the average GL was 196 (SD 63). CONCLUSION: Using this methodology for adding GI and GL values to nutrient databases, it is possible to assess associations between GI and/or GL and body weight and chronic disease outcomes (diabetes, cancer, heart disease). This method can be used in clinical and survey research settings where 24HRs are a practical means for assessing diet. The implications for using this methodology compel a broader evaluation of diet with disease outcomes.