The REVEAL Study: Ranibizumab Monotherapy or Combined with Laser versus Laser Monotherapy in Asian Patients with Diabetic Macular Edema.

OBJECTIVE: The primary study hypothesis was that ranibizumab 0.5 mg monotherapy or combined with laser is superior to laser monotherapy based on mean average change in best-corrected visual acuity (BCVA) over 12 months in Asian patients with visual impairment resulting from diabetic macular edema (DME). DESIGN: A 12-month, randomized, double-masked, multicenter, laser-controlled, phase III study. PARTICIPANTS: Three hundred ninety-six patients aged ≥18 years, with type 1 or 2 diabetes mellitus, BCVA of 78-39 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, and visual impairment resulting from DME. METHODS: Patients were randomized to ranibizumab + sham laser (n = 133), ranibizumab + active laser (n = 132), or sham injection + active laser (n = 131). Ranibizumab/sham injections were administered on day 1 and continued monthly. As of month 3, monthly injections were continued if stable vision was not reached. Treatment was reinitiated if BCVA decreased because of DME progression. Active/sham laser was administered on day 1 and thereafter according to ETDRS guidelines. MAIN OUTCOME MEASURES: Average change in BCVA from baseline to months 1 through 12, central retinal subfield thickness (CRST), and safety over 12 months. RESULTS: Ranibizumab monotherapy or combined with laser was superior to laser in improving mean average change in BCVA from baseline to months 1 through 12 (+5.9 and +5.7 vs +1.4 letters). At month 12, greater proportion of patients gained ≥15 letters with ranibizumab and ranibizumab + laser compared with laser (18.8% and 17.8% vs 7.8%). Mean CRST reduced significantly from baseline to month 12 with ranibizumab (-134.6 µm) and ranibizumab + laser (-171.8 µm) versus laser (-57.2 µm). Patients received a mean of 7.8 and 7.0 ranibizumab injections in the ranibizumab and ranibizumab + laser arms, respectively, and 1.5-1.9 active laser across treatment arms over 12 months. Conjunctival hemorrhage was the most common ocular, whereas nasopharyngitis and hypertension were the most common nonocular adverse events. Ranibizumab was not associated with any cases of cerebrovascular hemorrhage and cerebrovascular ischemia. No death related to study treatment was reported. CONCLUSIONS: Ranibizumab monotherapy or combined with laser showed superior BCVA improvements over laser treatment alone in Asian patients with visual impairment resulting from DME. No new ocular or nonocular safety findings were observed and treatment was well tolerated over 12 months.

Papillary thyroid carcinoma in black thyroids.

BACKGROUND: Black thyroid is a rare condition. It has been considered to be pathognomonic of chronic minocycline ingestion for more than 30 years, although it can also occur in patients with hemochromatosis, ochronosis, mucoviscidosis, and hemorrhage. A possible association of black thyroid with thyroid cancer has been considered, but no direct causal relationship has been established. Hence, the purpose of this article was to identify the malignant potential of such glands. METHODS: A retrospective medical chart review was performed on 433 patients who underwent thyroid surgery at Tulane University Medical Center from 2001 to 2008. Patients were grouped based on pathology: (1) benign, (2) papillary carcinoma, and (3) non-papillary thyroid carcinoma. RESULTS: At surgery, 63 patients (15%) with black thyroid gland were found to have thyroid nodules. Among these nodules, 22 (35%) were benign, 21 (33%) contained papillary thyroid cancer, and 20 (32%) had a non-papillary thyroid malignancy. Nodules in black thyroids were associated with higher risk of malignancy than nodules in non-black thyroids (p = .0001). Further analysis of the papillary thyroid carcinoma group showed no statistical difference in regard to tumor size or evidence of multifocality of disease. CONCLUSION: The finding of a black thyroid gland is unusual and disconcerting. To our knowledge, this is the first study aimed at documenting the malignant potential of black thyroid glands. This report documents that the risk of malignancy is higher in black thyroid compared to non-black thyroid glands. Furthermore, among those with papillary thyroid cancer, the presence of the pigment did not correlate with malignancy, multifocality, or tumor size.

Update of cancer and non-cancer mortality in the Missouri poultry cohort.

BACKGROUND: workers in poultry slaughtering and processing plants have one of the highest human exposures to transmissible agents that cause cancer and other diseases in chickens and turkeys, and also have other occupational carcinogenic exposures. The general population is also exposed to these transmissible agents. METHODS: we investigated mortality in workers who belong to a poultry union in Missouri, and estimated standardized mortality ratios. RESULTS: significantly increased mortality was observed for some leukemias, benign neoplasms, thyroid diseases, bacterial infections, and schizophrenic disorders. The risk of breast cancer and several non-cancer conditions was significantly depressed. CONCLUSION: the findings add to the growing evidence suggesting that workers occupationally exposed to transmissible agents and carcinogens in the poultry industry, are at increased risk of dying from certain chronic diseases, including cancer.

Urinary catalytic iron in obesity.

INTRODUCTION: Obesity precedes the development of many cardiovascular disease risk factors, including type 2 diabetes mellitus (DM), hypertension, and chronic kidney disease. Catalytic iron, which has been associated with these chronic diseases, may be one of the links between obesity and these multifactorial diverse disorders. OBJECTIVE: We investigated whether urinary catalytic iron is increased in obese individuals without DM and overt kidney disease. STUDY DESIGN: We measured urinary catalytic iron using established methods in 200 randomly selected individuals without DM [100 who were obese (body mass index ≥30 kg/m(2)) and 100 who were nonobese (body mass index ≤27)]. Participants were selected from an outpatient clinic and community setting and were part of an ongoing cross-sectional study of obesity in individuals between the ages of 18 and 70 years. RESULTS: There was a significant difference in mean (95% CI) urinary catalytic iron excretion between the obese participants and the nonobese participants, 463 (343-582) nmol/mg [52.3 (38.8-65.8) nmol/µmol] vs 197 (141-253) nmol/mg [22.3 (15.9-28.6) nmol/µmol]; P < 0.001. The significant predictors of increased urinary catalytic iron were obesity (P = 0.001) and waist-to-hip ratio (P = 0.03). CONCLUSIONS: Our study results demonstrate that obesity and waist-to-hip ratio are associated with increased urinary catalytic iron, which may be a useful marker of oxidative stress. Additional studies are needed to determine the role of catalytic iron in increased cardiovascular disease and chronic kidney disease associated with obesity.

Long-term outcome of highly sensitized African American patients transplanted with deceased donor kidneys.

Undertaking transplantation in highly sensitized African American (AA) patients as transplant recipients represents a unique challenge. We retrospectively compared the outcomes of AA with non-African American (NAA) patients who had panel reactive antibody >80% and received deceased donor (DD) kidneys by virtual crossmatch. Immunosuppressive regimen included basiliximab induction and tacrolimus, mycophenolate acid and steroids maintenance. Among 835 consecutive transplants from 1998 to 2007, 142 (17%) were sensitized patients including 89 (16.6%) AA and 53 (17.7%) NAA patients. The AA group had similar 5-year incidence of acute rejection as NAA group (21.4% vs. 26.4%, P = 0.25). Kaplan-Meier estimated graft survival at 1, 3 and 5 years were 91%, 85% and 82% in AA group, and 94%, 79% and 71% in NAA group (P = 0.08). The death-censored graft survival at 1, 3, and 5 years were 93%, 86% and 84% in AA group, and 96%, 83% and 78% in NAA group (P = 0.11). The 1, 3, and 5 years patient survivals were 93%, 88% and 85% in AA group, and 96%, 96% and 94% in NAA group (P = 0.17). Highly sensitized AA patients could be transplanted with DD kidneys at a similar rate as NAA patients, and they may not have a higher incidence of rejection or an inferior graft survival than NAA patients.

The Relationship between Mold Exposure and Allergic Response in Post-Katrina New Orleans.

Objectives. The study's objective was to examine the relation between mold/dampness exposure and mold sensitization among residents of Greater New Orleans following Hurricane Katrina. Methods. Patients were recruited from the Allergy Clinic of a major medical facility. Any patient receiving a skin prick test for one of 24 molds between December 1, 2005 and December 31, 2008 was eligible for the study. Exposure was assessed using standardized questionnaires. Positive mold reactivity was defined as a wheal diameter >3 mm to any mold genera. Results. Approximately 57% of participants tested positive to any indoor allergen, 10% to any mold. Over half of respondents had significant home damage, 34% reported dampness/mold in their home, half engaged in renovation, and one-third lived in a home undergoing renovation. Despite extensive exposure, and multiple measures of exposure, we found no relationship between mold/dampness exposure and sensitivity to mold allergens. Conclusions. These results along with results of earlier research indicate no excess risk of adverse respiratory effects for residents living in New Orleans after the devastation of Hurricane Katrina.

Time to recovery in diabetes and comorbidities following Hurricane Katrina.

BACKGROUND: The impact of a natural disaster on self-care and health care delivery has been well documented. The objective of the study was to document the recovery pattern from the impact of a natural disaster such as Hurricane Katrina on clinical and biochemical measures of diabetes and its comorbidities. METHODS: Patients were selected from Tulane University Hospital and Clinic, Southeast Louisiana Veterans Health Care System, and the Medical Center of Louisiana at New Orleans. Adults with diabetes and A(1c) measurement 6 months before (pre-K) Hurricane Katrina (February 28, 2005-August 27, 2005) and 6 to 16 months after (post-K) Katrina (March 1, 2006-December 31, 2006) were identified within the 3 facilities. Follow-up data (January 1, 2007-December 31, 2007) were 1 year after the first post-K visit. The outcome measures were hemoglobin A(1c) (HbA(1c)), systolic and diastolic blood pressure (BP), and lipids (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL], triglycerides). RESULTS: Averaged across the 3 facilities, the parameters significantly different in the follow-up period compared with pre- and post-K were HbA(1c) (P = .04), HDL, and systolic and diastolic BP (P < .0001). Parameters with significantly different patterns of change in the 3 facilities over time were HbA(1c), HDL, systolic and diastolic BP (P < .0001), and low-density lipoprotein (P < .01). CONCLUSIONS: Our results suggest that a variety of clinical and biochemical parameters related to diabetes and its comorbidities affected by natural disaster have varied the rate of recovery to predisaster levels.

Consequences of delayed pump infusion line change in patients with type 1 diabetes mellitus treated with continuous subcutaneous insulin infusion.

OBJECTIVE: To systematically investigate the effect of lack of adherence to the recommended change in insulin pump infusion line use beyond 48 h and determine whether the type of insulin made a difference. RESEARCH DESIGN AND METHODS: This was a double-blind, randomized, crossover trial with 20 patients with diabetes mellitus I using insulins aspart and lispro without a line change for up to 100 h. Using retrospective continuous glucose monitoring, we analyzed the average glucose over the day. Changes in serum 1,5-anhydroglucitol, carboxymethyllysine, and free 15-F(2t) isoprostane were also studied. RESULTS: From Day 2 to Day 5 of the pump line use, the daily average glucose level increased from 122.7 to 163.9 mg/dl (P<.05), fasting glucose from 120.3 to 154.5 mg/dl (P<.05), postprandial glucose from 114.6 to 172.1 mg/dl (P<.05), and the daily maximum glucose from 207.7 to 242.8 dl (P<.05 for the trend). Time period that the glucose was >180 mg/dl increased from 14.5% to 38.3% (P<.05). Loss of control occurred despite increase in total daily insulin dose from 48.5+/-11.8 to 55.3+/-17.9 U (P=.05). There was no difference in loss of control between insulin types, and biomarkers measured did not change significantly. CONCLUSIONS: The insulin pump infusion should be changed every 48 h in patients using continuous subcutaneous insulin infusion (CSII), to avoid loss of glycemic control. In the short-term, this loss of glycemic control has no impact on oxidative stress and glycation.

Laparoscopic procurement of single versus multiple artery kidney allografts: is long-term graft survival affected?

BACKGROUND: Living donor kidneys with multiple arteries (MA) are increasingly procured laparoscopically for transplant. METHODS: We compare long-term graft function and survival of kidneys with single arteries (SA) and MA over a 10-year period. RESULTS: There were a total of 218 grafts with SA and 60 grafts with MA. The MA group had longer operative and ischemic times than SA group. There was a small increase in ureteral complication (8.3% vs. 2.3% P=0.06) and a significantly higher incidence of rejection (23.3% vs. 10.1%, P=0.01) in MA group than in SA group. Graft function was lower in MA group than SA group. The 5-year graft survival by Kaplan Meier analysis was better in SA group than in MA group (P=0.023). The estimated graft survivals at 1, 3, and 5 year were 94.4%, 90.6%, and 86% for SA group and 89.6%, 83.2%, and 71.8% for MA group. There was a higher percentage of graft loss from chronic allograft nephropathy in MA group than in SA group (16.7% vs. 5.5%, P=0.01). The presence of MA (vs. SA) was an independent risk for acute rejection (OR 3.60, 95% CI 1.59-8.14, P=0.002) and for graft loss (HR 2.31, 95% CI 1.05-5.09, P=0.038). CONCLUSION: Laparoscopic procurement of living donor kidneys with SA may be associated with a lower risk of rejection, better function, and superior long-term survival when compared with kidneys with MA.

Long-term outcome of adults who undergo transplantation with single pediatric kidneys: how young is too young?

BACKGROUND AND OBJECTIVES: The optimal donor age for transplanting a single pediatric kidney in an adult recipient remains unknown. En block kidney transplantation is usually performed when the donor age is <5 yr. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We compared the outcomes of adult patients who underwent transplantation with single pediatric kidneys from donors who were younger than 5 yr (group 1, n = 40) and from donors who were aged 5 to 10 yr of age (group 2, n = 39) in our center. RESULTS: The donor kidney sizes were significantly smaller in group 1 than in group 2 (P < 0.001), and group 1 required more ureteral stents than group 2 (73 versus 38%). The surgical complications, delayed graft function, and development of proteinuria were similar in both groups. Group 1 had slightly higher rejection episodes than group 2 (25 versus 18%; P = 0.67), and graft function was comparable in both groups. There were no statistical differences between the two groups in patient (P = 0.73) or death-censored graft (P = 0.68) survivals over 5 yr. CONCLUSIONS: Single pediatric kidney transplants from donors who are younger than 5 yr can be used with acceptable complications and long-term outcomes as those from older donors.

Impact of a natural disaster on diabetes: exacerbation of disparities and long-term consequences.

OBJECTIVE: To examine the impact of Hurricane Katrina on the health of individuals with diabetes. RESEARCH DESIGN AND METHODS: This was an observational study in 1,795 adults with an A1C measurement 6 months before and 6-16 months after Hurricane Katrina in three health care systems: private (Tulane University Hospital and Clinic [TUHC]), state (Medical Center of Louisiana at New Orleans [MCLNO]), and Veterans Affairs (VA). Glycemic control (A1C), blood pressure, and lipids before the hurricane were compared with the patients' first measurement thereafter. The CORE Diabetes Model was used to project life expectancy and health economic impact. RESULTS: Mean predisaster A1C levels differed between MCLNO and VA patients (mean 7.7 vs. 7.3%, P < 0.001) and increased significantly among MCLNO patients to 8.3% (P < 0.001) but not among VA and TUHC patients. Mean systolic blood pressure increased in all three systems (130-137.6 mmHg for TUHC and 130.7-143.7 for VA, P < 0.001; 132-136 for MCLNO, P = 0.008). Mean LDL cholesterol increased in the VA (97.1-104.3 mg/dl) and TUHC patients (103.4-115.5; P < 0.001). Hurricane Katrina increased modeled direct, indirect, and total health care costs and also reduced life expectancy as well as quality-adjusted life expectancy, with the economic impact being quite substantial because of the large population size affected. We estimate a lifetime cost of USD $504 million for the adult population affected, with the largest economic impact seen among MCLNO patients. CONCLUSIONS: A major disaster had a significant effect on diabetes management and exacerbated existing disparities. These effects may have a lasting impact on both health and economic implications.

Hypertension subtype and risk of cardiovascular disease in Chinese adults.

BACKGROUND: We examined the relationship between hypertension subtype and cardiovascular disease incidence and mortality in Chinese adults. METHODS AND RESULTS: We conducted a prospective cohort study in a nationally representative sample of 169 871 Chinese men and women aged >or=40 years. Data on systolic (SBP) and diastolic blood pressure (DBP) and other variables were obtained at a baseline examination in 1991 with the use of standard protocols. Follow-up evaluation was conducted in 1999-2000, with a response rate of 93.4%. Hypertension subtypes were defined as combined systolic and diastolic hypertension (SBP >or=140 and DBP >or=90 mm Hg), isolated systolic hypertension (SBP >or=140 and DBP <90 mm Hg), isolated diastolic hypertension (SBP <140 and DBP >or=90 mm Hg), and 2 categories of treated hypertension (SBP <140 and DBP <90 mm Hg or SBP >or=140 and/or DBP >or=90 mm Hg). After participants with missing BP values were excluded, 169 577 adults were included in the analyses. Compared with normotensives, relative risks (95% CIs) of cardiovascular disease incidence and mortality were 2.73 (2.60 to 2.86) and 2.53 (2.39 to 2.68) for combined systolic and diastolic hypertension, 1.78 (1.69 to 1.87) and 1.68 (1.58 to 1.78) for isolated systolic hypertension, 1.59 (1.43 to 1.76) and 1.45 (1.27 to 1.65) for isolated diastolic hypertension, 2.01 (1.64 to 2.48) and 1.61 (1.28 to 2.03) for treated hypertension with SBP <140 and DBP <90 mm Hg, and 3.37 (3.07 to 3.69) and 2.88 (2.60 to 3.19) for treated hypertension with SBP >or=140 and/or DBP >or=90 mm Hg, respectively, after adjustment for important covariables. CONCLUSIONS: Our results indicate that all hypertension subtypes are associated with significantly increased risk of cardiovascular disease in Chinese adults. Primary prevention of hypertension should be a public health priority in the Chinese population.

Body mass index and risk of ESRD in China.

BACKGROUND: The relationship between body mass index (BMI) and risk of end-stage renal disease (ESRD) in Asians has not been well established. STUDY DESIGN: Prospective cohort study. SETTING & PARTICIPANTS: 143,802 men and women 40 years and older in China. PREDICTOR: Body weight, height, and covariables were obtained at a baseline examination in 1991 by following a standardized protocol. BMI was calculated as weight in kilograms divided by the square of height in meters. OUTCOMES: Time to onset of ESRD, ascertained in 1999 to 2000 from medical records, death certificates, and interviews with participants or their proxies. RESULTS: During 1,112,667 person-years of follow-up, 350 participants initiated renal replacement therapy or died of renal failure. After adjustment for age, sex, geographic region (north versus south China), urbanization (urban versus rural residence), education, physical activity, cigarette smoking, and alcohol consumption, a J-shaped association between BMI and all-cause ESRD was observed. Compared with those with normal body weight (BMI, 18.5 to 24.9 kg/m(2)), multivariate-adjusted relative risks for all-cause ESRD for underweight (BMI < 18.5 kg/m(2)), overweight (BMI, 25.0 to 29.9 kg/m(2)), and obese subjects (BMI >or= 30 kg/m(2)) were 1.39 (95% confidence interval [CI], 1.02 to 1.91), 1.21 (95% CI, 0.92 to 1.59), and 2.14 (95% CI, 1.39 to 3.29), respectively. The J-shaped association existed even after additional adjustment for systolic blood pressure and history of diabetes and cardiovascular disease. LIMITATIONS: Although patients with ESRD at baseline were excluded, information for chronic kidney disease at the baseline examination was not available. CONCLUSION: Strategies aimed at preventing the development of ESRD should incorporate measures to maintain a normal body weight.

Determining standards for laparoscopic proficiency using virtual reality.

Laparoscopic training using virtual reality has proven effective, but rates of skill acquisition vary widely. We hypothesize that training to predetermined expert levels may more efficiently establish proficiency. Our purpose was to determine expert levels for performance-based training. Four surgeons established as laparoscopic experts performed 11 repetitions of 12 tasks. One surgeon (EXP-1) had extensive Minimally Invasive Surgical Trainer-Virtual Reality (MIST VR) exposure and formal laparoscopic fellowship training. Trimmed mean scores for each were determined as expert levels. A composite score (EXP-C) was defined as the average of all four expert levels. Thirty-seven surgery residents without prior MIST VR exposure and two research residents with extensive MIST VR exposure completed three repetitions of each task to determine baseline performance. Scores for EXP-1 and EXP-C were plotted against the best score of each participant. On average, the EXP-C level was reached or exceeded by 7 of the 37 (19%) residents. In contrast, the EXP-1 level was reached or exceeded by 1 of 37 (3%) residents and both research residents on all tasks. These data suggest the EXP-C level may be too lenient, whereas the EXP-1 level is more challenging and should result in adequate skill acquisition. Such standards should be further developed and integrated into surgical education.

Increasing trends in elderly persons' use of nonvitamin, nonmineral dietary supplements and concurrent use of medications.

OBJECTIVE: Use of nonvitamin, nonmineral dietary supplements among an elderly cohort was surveyed to determine which were the most frequently used, and to report potential medication/supplement interactions observed. DESIGN: A retrospective review of the use of 22 supplements and prescription/over-the-counter medications was collected annually from 1994 to 1999. SUBJECTS/SETTING: Supplement and medication records for an average of 359 male (36%) and female (64%) participants aged 60 to 99 years were reviewed annually. Ethnic distribution was 91% non-Hispanic white, 7% Hispanic, 1% Asian, and 1% African American. STATISTICAL ANALYSES PERFORMED: Descriptive statistics generated included mean, standard deviation, and frequency by percentage. To compare supplement user and nonsupplement user percentages across age groups, the chi 2 test was used. Linear regression was performed to test for longitudinal usage trends of each individual supplement. RESULTS: By 1999, glucosamine emerged as the most frequently used nonvitamin, nonmineral supplement followed by ginkgo biloba, chondroitin, and garlic. For women, there was a significant linear trend ( P < .05) over time for these 12 supplements: black cohosh, borage, evening primrose, flaxseed oil, chondroitin, dehydroepiandrosterone, garlic, ginkgo biloba, glucosamine, grapeseed extract, hawthorn, and St John's wort. For men, three supplements (alpha lipoic acid, ginkgo biloba, and grape-seed extract) showed a significant linear trend ( P <.05). Potential interactions between supplements and medications were seen for 10 of the 22 supplements surveyed, with a total of 142 potential interactions observed over the 6-year period. CONCLUSIONS: Examining nonvitamin, nonmineral supplement use in combination with prescription/over-the-counter medications in elderly persons is important to identify the potential risks of interactions.

Laparoscopic virtual reality training: are 30 repetitions enough?

BACKGROUND: Current literature suggests that novices reach a plateau after two to seven trials when training on the MIST VR laparoscopic virtual reality system. We hypothesize that significant benefit may be gained through additional training. MATERIALS AND METHODS: Second-year medical students (n = 12) voluntarily enrolled under an IRB-approved protocol for MIST VR training. All subjects completed pre- and posttraining questionnaires and performed 30 repetitions of 12 tasks. Performance data were automatically recorded for each trial. Learning curves for each task were generated by fitting spline curves to the mean overall scores for each repetition. Scores were assessed for plateaus by repeated measures, slope, and best score. RESULTS: On average, subjects completed training in 7.1 h. (range, 5.9-9.2). Two to seven performance plateaus were identified for each of the 12 MIST VR tasks. Initial plateaus were found for all tasks by the 8th repetition; however, ultimate plateaus were not reached until 21-29 repetitions. Overall best score was reached between 20 and 30 repetitions and occurred beyond the ultimate plateau for 9 tasks. CONCLUSIONS: These data indicate that a lengthy learning curve exists for novices and may be seen throughout 30 repetitions and possibly beyond. Performance plateaus may not reliably determine training endpoints. We conclude that a significant and variable amount of training may be required to achieve maximal benefit. Neither a predetermined training duration nor an arbitrary number of repetitions may be adequate to ensure laparoscopic proficiency following simulator training. Standards which define performance-based endpoints should be established.

Serum Sex Hormones, IGF-1, and IGFBP3 Exert a Sexually Dimorphic Effect on Lean Body Mass in Aging.

BACKGROUND: Endogenous and exogenous sex hormones affect changes in body composition during aging via independent and dependent effects on the growth hormone/insulin-like growth factor-1 (GH/IGF-1) axis and associated binding proteins (BP). METHODS: Fasting serum IGF-1, IGFBP3, testosterone, estrone, and sex hormone binding globulin were analyzed in 48 women on hormone replacement (HRT) (unopposed oral estrogen, HRT+, 74.0 +/- 6 years), 135 women not on HRT (HRT-, 77.3 +/- 7 years), and 128 healthy men (men, ). Total lean body mass (LBM) and total fat were measured by dual energy X-ray absorptiometry. RESULTS: Total LBM decreased with age in all groups (p = .05). LBM was greater, and IGF-1, IGFBP3, and testosterone were lower in HRT+ versus HRT- women (p = .02, p = .01, p = .04, and, respectively). LBM in men was positively related to IGF-1 (p = .02) and testosterone (p < .01), whereas LBM was associated with IGFBP3 (p = .04) and total fat (p < .001) in female HRT+ and total fat (p < .01) in HRT- women. IGF-1 decreased with age in men and HRT- women (p < .01) but did not decrease in HRT+ women. Total fat significantly decreased across age (p < .05). Controlling for age and HRT, the rate of decrease in fat was slower in men versus women (p = .02). IGFBP3 decreased in all groups across age (p < .01), and the ratio of IGF-1 to IGFBP3 decreased faster in men compared to HRT+ and HRT- women (p = .02). CONCLUSIONS: Our data indicate divergent influences of sex steroids, IGF-1, and IGFBP3 on age-related changes in LBM in healthy elderly men and women.

Serum homocysteine concentrations and their relation to serum folate and vitamin B12 concentrations and coronary artery disease prevalence in an urban, bi-ethnic community.

OBJECTIVE: To compare fasting serum total homocysteine (tHcy) concentrations in a randomly selected sample of elderly (> or = 65 years of age) Hispanic and non-Hispanic White (NHW) men and women, to examine associations of tHcy with folate and vitamin B12, and then to correlate these with the prevalence of coronary heart disease (CHD) in these 4 ethnic/ gender groups. DESIGN AND PARTICIPANTS: Equal numbers of Hispanic and NHW men and women were randomly selected from the Healthcare Financing Administration (Medicare) registrant list for Bernalillo County (Albuquerque), New Mexico, and asked to volunteer for a paid home interview, to be followed by a paid, comprehensive interview/examination covering health and health-related issues. INTERVENTIONS AND MAIN OUTCOME MEASURES: Serum concentrations of tHcy, folate, and vitamin B12 were determined and correlated with the prevalence of CHD, after adjusting for other CHD risk factors (age, diabetes, hypertension, smoking, dyslipidemia, adiposity). RESULTS: Men and Hispanics had higher serum tHcy concentrations compared to women and non-Hispanic Whites (NHWs), respectively. After adjusting for lower concentrations of serum folate and vitamin B12 in Hispanics, the differences between Hispanics and NHWs were no longer significant. There was a direct association between serum tHcy concentrations and the prevalence of CHD after adjusting for other known risk factors that was most significant in Hispanic women. CONCLUSIONS: The higher serum tHcy concentrations observed in Hispanics compared to NHWs can be explained by lower levels of serum folate and vitamin B12. A direct association between serum tHcy concentrations and prevalence of CHD was observed primarily in women, and was most significant in Hispanic women.

Analysis of censored and incomplete survival data using flowgraph models.

Multi-state stochastic models are widely used to model stages of disease progression in survival analysis. This paper develops flowgraph models for data analysis in survival analysis. We illustrate these methods using data from a study of diabetic retinopathy consisting of 277 subjects with insulin-dependent (type I) diabetes mellitus (IDDM). These data were collected at the Eye-Kidney Clinic of the Barbara Davis Center for Childhood Diabetes at the University of Colorado Health Sciences Center.