Biological variation of cardiovascular biochemical markers in patients with Type 2 Diabetes Mellitus.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a well-established risk factor for cardiovascular diseases. We aimed to identify the biological variation of ten cardiovascular biochemical markers in T2DM patients to aid in their interpretation. METHODS: Blood samples for evaluating ten biomarkers were collected biweekly from 23 T2DM patients (10 men, 13 women) for three months. The analytical variability and variations of within-subject (CVI) and between-subject (CVG) levels were calculated, as well as the analytical performance specifications, reference change value (RCV), and index of individuality (II). RESULTS: The levels of total cholesterol (CHOL), apolipoprotein A (apoA), homocysteine (HCY), high-sensitivity troponin T (hsTnT) and N-terminal pro-brain natriuretic peptide (NT-proBNP) differed between males and females (P < 0.05). The CVIs or CVGs of the biomakers were higher than those of healthy participants in Westgard online database, except for hsTnT. Triglyceride (TG), lipoprotein (a) [Lp(a)] and NT-proBNP had relatively high CVI, CVG and RCV, whereas CHOL, high-density lipoprotein cholesterol (HDL-C), apoA and HCY showed low variation. Moreover, the II of HDL-C, LP(a), apoA, HCY and hsTnT was <0.6 and other biochemical markers was between 0.6 and 1.4. CONCLUSION: The cardiovascular biochemical markers in T2DM patients showed higher CVI or CVG, except for hsTnT. ApoA had the lowest CVI and CVG values. Population-based reference intervals should be used with caution in clinical decision-making for T2DM patients.

Establishment of risk quality control charts based on risk management strategies.

BACKGROUND: Risk management strategies have been proposed for applications in clinical laboratories to reduce patient risks; however, effective and visual risk-monitoring tools are currently lacking in medical laboratories. In this study, we constructed a risk quality control (QC) chart based on risk management strategies. METHODS: We calculated the risk levels of QC materials based on Bayes' theorem by combining the total allowable error, QC results, and the maximum number of unacceptable errors in the laboratory. Then, we constructed a risk QC chart by presenting the Z values and corresponding risk levels of QC materials simultaneously. Finally, we evaluated the risk-monitoring capabilities of the risk QC charts by simulating different long-term errors in the laboratory. RESULTS: The risk levels of QC materials increased as the QC results moved further away from the set mean. Larger sigma values led to fewer risks obtained for the same QC results. The constructed risk QC charts intuitively showed specific risk levels and could warn lab staff out-of-control, without the need for QC rules to make judgments. The risk levels of erroneous results differed for items with different sigma performance. CONCLUSIONS: Risk-based QC charts allowed visualization of the QC results and specific risk levels simultaneously, providing more intuitive results than those obtained from traditional QC charts.

Clinical laboratory characteristics of patients with obstructive jaundice accompanied by dyslipidemia.

BACKGROUND: Abnormal lipid metabolism manifests as hypercholesterolemia in patients with obstructive jaundice due to lipoprotein X (LpX). Our aim was to explore the clinical laboratory characteristics of patients with obstructive jaundice accompanied by dyslipidemia in a large number of samples. METHODS: A total of 665 patients with obstructive jaundice were included and categorized into two groups (with/without dyslipidemia) based on the ratio of the sum of HDL-c and LDL-c to total cholesterol [(HDL-c + LDL-c)/TC] with a cut-off value of 0.695. Laboratory liver, kidney, and blood lipid parameters were determined. Cholesterol composition assessment was performed by ultracentrifugation and high-performance liquid chromatography (UC-HPLC), and serum protein profiles were analyzed by capillary electrophoresis. RESULTS: Liver function in patients with obstructive jaundice accompanied by dyslipidemia was more aggravated than that in patients with simple obstructive jaundice (P < 0.05). The (HDL-c + LDL-c)/TC ratio was negatively correlated with bilirubin levels (P < 0.05). In addition, the difference in ApoB/LDL-c ratios was statistically significant between the obstructive jaundice accompanied by dyslipidemia group and healthy control group (P < 0.05). The LDL-c concentration determined by the UC-HPLC method was more than five times that determined by the enzymatic method (P < 0.05). Bisalbuminemia was found in 43 of 60 patients with obstructive jaundice accompanied by hypercholesterolemia. CONCLUSIONS: In patients with obstructive jaundice, the decreased (HDL-c + LDL-c)/TC ratio may be a novel marker to identify dyslipidemia secondary to LpX. The decreased ratio was associated with poor liver function and indicated disease progression.

The association and discordance between glycated hemoglobin A1c and glycated albumin, assessed using a blend of multiple linear regression and random forest regression.

BACKGROUND: Due to a high prevalence of thalassemia in southwest China, the diagnostic value of glycated hemoglobin A1c (HbA1c) is limited in the local population. Glycated albumin (GA) must also be measured for glucose monitoring. We sought to explore the relationships between HbA1c and GA. METHODS: We analyzed 3,414 participants and allocated to four groups: GA > 14% and HbA1c > 5.7% (group 1), GA > 14% and HbA1c ≤ 5.7% (group 2), GA ≤ 14% and HbA1c > 5.7% (group 3), and GA ≤ 14% and HbA1c ≤ 5.7% (group 4). We used stepwise multivariable logistic regression analysis to study the inconsistency of HbA1c and GA. Furthermore, we explored their association using multiple linear regression (MLR), random forest regression (RFR), and 3 blended models. Finally, we performed sensitivity analyses by changing the thresholds of HbA1c (6.5%) and GA (12% or 16%). RESULTS: There were 934 participants in group 1, 86 in group 2, 964 in group 3, and 1,430 in group 4. Age, high-density lipoprotein-cholesterol concentration, and red blood cell count were associated with the discordance in HbA1c and GA values. We constructed an RFR model that included MLR predictions as independent variables and could explain 97.80% of the variance in HbA1c in the training set, and 91.65% in the cross-validation set. Our results remained robust in 3 sensitivity analyses. CONCLUSIONS: HbA1c and GA values are inconsistent in the population we studied. A model that blends MLR and RFR can be used to correct HbA1c values when conflicting HbA1c and GA values are encountered in patients.

The Association between Serum Uric Acid Levels and Insulin Resistance and Secretion in Prediabetes Mellitus: A Cross-Sectional Study.

BACKGROUND: We investigated the association between serum uric acid (SUA) levels and insulin secretion and resistance in prediabetes patients, which is currently unclear. METHODS: Our study population consisted of 11,523 representative patients from northwest China. It was divided into three groups based on the results of an oral glucose tolerance test: the non-diabetes group (n=3234), the impaired glucose regulation (IGR, prediabetes) group (n=2886), and the type-2 diabetes mellitus group (n=5403). SUA and 2-hour insulin (2h-Ins) levels were measured, and homeostasis model assessment of insulin resistance (HOMA-IR) scores were computed. The association between SUA level and insulin secretion and resistance was assessed via multivariate regression analysis. RESULTS: SUA and 2-hour insulin levels were highest in the IGR group in both men and women. After adjusting for multiple confounding risk factors, SUA levels significantly correlated with 2-hour insulin levels (odds ratio=1.700, 95% confidence interval=1.390, 2.080, P<0.001) and HOMA-IR scores (odds ratio=2.017, 95% confidence interval=1.671, 2.434, P<0.001) in the impaired glucose regulation (IGR) group. CONCLUSION: SUA was positively associated with hyperinsulinemia and insulin resistance in prediabetes patients in the retrospective study and is thus a potential risk factor for these conditions.

Practical application of the sigma-metric run size nomogram for multistage bracketed statistical quality control analysis of eight enzymes.

BACKGROUND: A sigma-metric run size nomogram is used to recommend quality control (QC) strategies to reduce patient risks. Herein, we aimed to evaluate the sigma performance of 8 enzymes and apply multistage bracketed statistical QC (SQC). METHODS: Sigma performance of alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), creatine kinase (CK), amylase (AMY), and lipase (LIP) were determined. Daily workload of each test was estimated and expected reporting QC intervals were designed. Per the nomogram, "start-up" and "monitor" QC rules were determined from sigma performance. SQC was finally applied, followed by quality improvement. RESULTS: Sigma metrics were as follows: 5.26 (ALT), 4.80(AST), 5.25(GGT), 3.36(ALP), 4.71(LDH), 15.45(CK), 10.77(AMY), and 3.70 (LIP). "Start-up" rules were MR N2, MR N4, MR N2, MR N4, MR N4, 1:2.5 s N1, 1:3 s N1, and MR N4, and "monitor" QC rules were 1:2.5 s N1, 1:3 s N2, 1:2.5 s N1, MR N4, 1:3 s N2, 1:3 s N1, 1:3 s N1, MR N2 for 8 enzymes, respectively. CONCLUSION: Multistage bracketed SQC is determined by sigma performance. Risk monitoring is significant during assaying to reduce patient risks and improve quality.

Evaluation of biological variation of glycated hemoglobin and glycated albumin in healthy Chinese subjects.

BACKGROUND: Glycated hemoglobin (HbA1c) and glycated serum albumin (GSA) are used to evaluate the mean blood glucose levels. To ensure safe clinical application of HbA1c and GSA, reliable biological variation (BV) data are required. The aim of this research was to define the BV of HbA1c and GSA employing stringent rules. METHODS: Blood samples were drawn from 19 healthy subjects (10 females, nine males) once per week for 5 weeks. All samples were analyzed using enzymatic method for GSA and HPLC for HbA1c. The data were assessed for outliers, normality and variance homogeneity, and coefficient of variation (by ANOVA) for BV. Sex-stratified BV including within-subject (CVI ) and between-subject (CVG ) was defined for HbA1c and GSA. RESULTS: The following estimates for BV values for CVI and CVG , respectively, were GSA: 1.23% and 4.67%, Alb: 0.75% and 3.18%, and HbA1c: 0.12% and 2.91%. The RCV of GSA was 3.61%, and HbA1c was 1.41%. And the II was 0.26 for GSA, and 0.07 for HbA1c, both of them less than 0.6. According to the 95% CI, the CVI of HbA1c was statistically different between females and males. And both the CVG of HbA1c and GSA were statistically different between females and males. CONCLUSION: All CVI and CVG estimates were lower than those reported in the online BV database. And there is a significant difference between males and females. Analytical performance specifications derived from BV of this research can be applied internationally.

[Phylogenetic study of drug resistance genes from clinical isolates of Helicobacter pylori].

To carry out phylogenetic analysis for drug-resistance genes from clinical isolates of Helicobacter pylori (Hp) among patients with gastric diseases from Tibet, China. METHODS: Hp strains were isolated and cultured from saliva and gastric mucosal tissues derived from patients with gastric diseases. Nine strains (including 5 isolated from oral tissues, 1 isolated from gastric tissues, and 3 representative strains of SS international standard strains used for animal models) were tested for common antibiotic resistance. Together with an ACTT 11637 international standard strain, these were subjected to re-sequencing to obtain drug-resistance genes. Such genes from various sources were compared with the resistance genes of Hp strains recorded by the NCBI website. Combined with results of drug-resistance experiments, correlation between molecular evolution and drug-resistance was analyzed. RESULTS: Testing of gastric mucosal tissues and salivary samples from 217 patients has found 89 Hp strains, which yielded a total infection rate of 41.01%. The resistance rates of 9 representative Hp strains for clarithromycin, amoxicillin, metronidazole, levofloxacin and tetracycline were 77.8%, 77.8%, 44.4%, 77.8%, and 77.8%, respectively. Compared with the reference strain, the similarity between clarithromycin-resistance genes was 99%, and that between amoxicillin- and metronidazole-resistance genes was 96%-97%. A2143G mutation was also found in clarithromycin-resistant genes of three Hp strains. CONCLUSION: The sensitivity of Hp to metronidazole is much higher in patients from Tibet region, and the sensitivity of Hp to clarithromycin, amoxicillin, levofloxacin and tetracycline is poor. Resistance mutations are consistent with drug resistance.

[Serum Uric Acid and Islet ß-cell Function in Patients with Pre-diabetes and Type 2 Diabetes Mellitus].

OBJECTIVE: To determine the correlation between serum uric acid (SUA) and insulin secretion function in patients with pre-diabetes and type-2 diabetes mellitus (T2DM). METHODS: A total of 4 112 adult people participated in this study. They were divided into three groups according to the results of oral glucose tolerance test (OGTT): 493 with normal glucose regulation (NGR),1 251 with impaired glucose regulation (IGR),and 2 368 with T2DM. Their levels of SUA,fasting insulin (FIns),2 h post-meal insulin (2 h-Ins),and insulin resistance index (HOMA-IR) were determined. Correlations between SUA and insulin secretion and HOMA-IR were estimated. RESULTS: IGR patients had higher levels of SUA and 2 h-Ins compared with those with NGR and T2DM ( P<0.000 1). T2DM patients had higher levels of FIns,glucosylated hemoglobin (HbA1c) and HOMA-IR compared with those with NGR and IGR ( P<0.000 1). In both male and female participants,the highest level of 2 h-Ins appeared in those with IGR,while T2DM had the highest level of HOMA-IA and HbA1c. FIns,2 h-Ins and HOMA-IR increased with SUA in both patients with IGR and T2DM. HbA1c decreased with SUA in T2DM patients. CONCLUSION: High serum SUA is correlated with islet ß-cell dysfunction. It may become an indicator of progression from pre-diabetes to T2DM.

The prevalence change of hyperlipidemia and hyperglycemia and the effectiveness of yearly physical examinations: an eight-year study in Southwest China.

BACKGROUND: The aim of this study was to investigate the prevalence changes of hyperlipidemia and hyperglycemia from 2009 to 2016 and the effectiveness of yearly physical examinations to hyperlipidemia and hyperglycemia prevention in Chengdu. METHODS: A total of 794 residents (499 males) who have undergone annual health check-ups for 8 consecutive years (from 2009 to 2016) in Chengdu, a city in southwest China were selected as the follow-up group, 7226 residents in 2009 and 75,068 residents in 2016 who underwent health examinations in the same hospital were chosen to be the contemporary control group. The concentration of fasting serum triglyceride(TG), total cholesterol(TC), low density lipoprotein cholesterol(LDL-C), high density lipoprotein cholesterol (HDL-C) and glucose were measured and compared among these groups. RESULTS: There was a clear rise in the prevalence of hypercholesterolemia and hyperglycemia from 2009 to 2016 (p < 0.05). The follow-up group didn't show difference in levels of serum lipids and glucose compared with the general population after an 8-years' consecutive physical examination (p > 0.05), the follow-up cohort in the 8th year exhibited significant increases in serum total cholesterol and glucose compared with the 1st year (p < 0.05). CONCLUSION: The prevalence of hypercholesterolemia and hyperglycemia were increased significantly from 2009 to 2016. Annual physical examination didn't show a positive effect in the prevention of hypercholesterolemia and hyperglycemia. Health education should be improved to ensure the fulfillment of the preventive objective of yearly physical examination.

[Interference of Exogenous Insulin on Insulin Detection Test by Electrochemiluminescence Immunoassay].

OBJECTIVE: To explore the interference of exogenous insulin therapy on insulin detection test by electrochemical luminescence immunoassay (ECLIA). METHODS: Insulin level was determined by ECLIA. According to the requirements of EP7-A2 of American Society for Clinical Laboratory Standards Institute Standards, paired difference experiment was conducted to evaluate the interference of 8 kinds of exogenous insulin on insulin detection, dose effect experiment was conducted to determine the relationship between exogenous insulin concentration and interference degree. RESULTS: When the interfering substance concentrations were ≤250 µU/mL, Gansulin NⓇ, Gansulin RⓇ, Humulin RⓇ,Novolin RⓇ and LantusⓇ all showed linear positive interference, while LevemirⓇ showed a linear negative interference in high concentrations insulin and non-interfering in low concentrations insulin, HumalogⓇ and Novo RapidⓇ showed non-interference in insulin detection. CONCLUSIONS: The use of different exogenous insulin may have different interference on insulin measurement, which need laboratorians and physicians notice to avoid misdiagnosis.

[The Preliminary Investigation of GLP-1 Receptor Agonist on Liver Steatosis in Obese Mice].

OBJECTIVES: To investigate the effects of glucagon-like peptide-1 (GLP-1) receptor agonist, exenatide, on liver function and steatosis in obese mice. METHODS: Male c57BL/6J mice (8 weeks old) were divided into high-fat-diet group (for obesity model construction) and chow diet group. 12 weeks later, mice of high-fat diet group were randomly divided into high-dose exenatide group [H group, intraperitoneal injection 0.02 µg/ (g·d) , high-fat-diet], low-dose exenatide group [L group, intraperitoneal injection 0.01 µg/ (g·d) , high-fat-diet], saline group (NS group, intraperitoneal injection of saline, high-fat-diet) , diet control group (D group, shifted to chow diet) and high-fat control group (M group, high-fat-diet) for 4-week treatments , respectively. The body mass and serum biochemical indicators of were detected. Liver tissues were stained with HE, and steatosis score was measured. RESULTS: After 4-week treatments, H group showed more body mass loss than L group and D group ( P<0.05). The serum alanine aminotransferase (ALT) level of NG group was higher than that of H, L, M, and NS groups ( P<0.05). Serum cholesterol and triglyceride declined to normal levels by diet intervention or drug treatment. High-dose exenatide treatment ran a risk of increasing serum uric acid level. The serum levels of aspartate aminotransferase (AST), glucose, homeostasis model assessment-insulin resistance (HOMA-IR), lipase, and amylase had no significant differences between groups (P>0.05). Hepatic steatosis score was reduced by diet intervention or drug treatment. CONCLUSIONS: High-dose exenatide treatment can effectively reduce body mass of obese mice, but it has little difference when compared with dietary intervention in improving blood fat and liver steatosis.

[The Targeted Regulating Role of Has-miR-577 and Has-miR-583 on Gene FGF-21 Detected by the Dual Luciferase Reporter System.]

OBJECTIVES: To determine the targeted regulating role of has-miR-577 and has-miR-583 on the expression of fibroblast growth factor 21 (FGF-21) based on a constructed luciferase reporter FGF-21 gene vector. METHODS: The site of has-miR-577 and has-miR-583 target genes FGF-21 were predicted by the bioinformatics analyzing tools online.FGF-21 gene fragments,combined with has-miR-577 or has-miR-583 sequences and mutant sequences,were designed and synthesized.The wild type (psiCHECK2-FGF-21) and mutant (psiCHECK2-FGF-21-mut) luciferase reporter gene carriers were constructed.The relevant plasmids [hsa-miR-577mimics,hsa-miR-583 mimics or miR negative control (miR-NC)] and luciferase reporter gene carrier (wild type or mutant ) were co-transfected into 293T cells.The luciferase reporter system was used to detect the luciferase activity.The effects of has-miR-577 and has-miR-583 on the expression of FGF-21 were observed. RESULTS: The double enzyme electrophoresis and sequencing results showed that the gene fragment size and sequences of the wild type (psiCHECK2-FGF-21) and mutant (psiCHECK2-FGF-21-mut) carriers met expectations of the experiment.The luciferase assays revealed that has-miR-577 and has-miR-583 significantly diminished luciferase activity from the reporter vector containing 3'UTR of FGF-21 (P<0.05),whereas no suppression of luciferase activity was found in the mutant (psiCHECK2-FGF-21-mut). CONCLUSIONS: FGF-21 gene can be targeted by has-miR-577 and has-miR-583.

[Association of Serum Uric Acid with 2-hour Postload Glucose in Predibetic Patients].

OBJECTIVE: To investigate whether serum uric acid (SUA) is associated with 2-hour postload glucose (2-h PG) in predibetic patients. METHODS: There were 3 588 subjects enrolled in this study from May 2014 to March 2015 in the department of physical examination center and outpatient clinic of West China Hospital of Sichuan University. All the subjects received a 75-g oral glucose tolerance test (OGTT) and measurements of serum uric acid (SUA), Creatinine, Cystatin (Cys-C), serum lipid and glycosylated hemoglobin (HbAlc). According to the results of glucose and HbAlc, the subjects were divided into three groups, including normal glucose regulation (NGT), impaired glucose regulation (IGR) and Type 2 Diabetes Mellitus (T2DM) group. The correlation between 2-h PG and serum uric acid in each group was analyzed. RESULTS: Based on the exam results, there were 556 cases of NGT, 1 019 cases of IGR, 2 013 cases of T2DM. There were statistically significant differences of glucose, serum insulin, triglycerides, high density lipoprotein, HbAlc, SUA, Creatinine, Cys-C levels among the three groups (P<0. 05). Multiple linear regression analysis showed that SUA level was positively correlated to 2-h PG level (P<0. 05) in NGT and IGR groups, but there was no correlation in T2DM group (P=0. 156). In the entire study population, levels of HbAlc and FPG were positive to 2-h PG correlated (P<0. 05). Positive correlation existed between FPG and 2-h PG in NGT group (P=0. 031). In IGR and T2DM group, HbAlc and 2-h PG were positively correlated (P<0. 05). HbAlc, FPG and SUA levels were independent risk factors for 2-h PG. CONCLUSION: In prediabetes, 2-h PG is associated with SUA and independent of FPG, HbAlc and other known risk factors. SUA may play a key role in the prediabetic condition as a risk indicator of T2DM.

Association of HLA-DP/DQ and STAT4 polymorphisms with HBV infection outcomes and a mini meta-analysis.

BACKGROUND: Though HLA-DP/DQ is regarded to associate with HBV susceptibility and HBV natural clearance, its role in hepatocellular carcinoma (HCC) development is obscure. And the role of STAT4 in HBV susceptibility and clearance as well as HCC development is still contentious. Therefore, we conducted this study, aiming to clarify these obscure relationships. METHODS: We recruited 1312 Chinese Han subjects including healthy controls, HBV carriers and HCC patients in the experiment stage. The meta-analysis included 3467 HCC patients and 5821 HBV carriers to appraise the association with HCC development. RESULTS: Consistent with previous studies, HLA-DP/DQ associated with HBV susceptibility and HBV natural clearance (p<0.05). However, the experiment showed that HLA-DP rs3077, rs9277535 and rs7453920 did not associate with HCC development (dominant model, rs3077, OR = 0.86, 95%CI = 0.62-1.18; rs9277535, OR = 0.94, 95%CI = 0.68-1.30; rs7453920, OR = 0.75, 95%CI = 0.44-1.27). Meta-analysis again consolidated this conclusion (allele model, rs3077, OR = 0.94, 95%CI = 0.87-1.02; rs9277535, OR = 1.04, 95%CI = 0.97-1.11; rs7453920, OR = 0.89, 95%CI = 0.76-1.02). As for STAT4 rs7574865, we did not find any significant association with HBV susceptibility (OR = 0.91, 95%CI = 0.66-1.26) or HBV natural clearance (OR = 1.13, 95%CI = 0.86-1.49). Moreover, current data failed to acquire positive connection of rs7574865 with HCC development (experiment, OR = 0.86, 95%CI = 0.62-1.19; meta-analysis, OR = 0.87, 95%CI = 0.74-1.03), which may be due to the small sample size. CONCLUSIONS: HLA-DP/DQ polymorphisms (rs3077, rs9277535, rs7453920) did not associate with HCC development, but did correlate with HBV susceptibility and HBV natural clearance. STAT4 rs7574865 seemed not to correlate with HBV susceptibility or natural clearance. And it seemed rather ambiguous in its role on HCC development at present.

[Study of glycated albumin cut-off point in diabetes mellitus and impaired glucose regulation].

OBJECTIVE: To investigate the cut-off point of glycated albumin (GA) in the detection of diabetes mellitus (DM) and impaired glucose regulation (IGR). METHODS: This study was conducted in 20-84 years-old adults who had risk factors of diabetes but no previously diagnosed diabetes. There were finally 392 individuals included and received the measurement of GA and HbA1c. Receiver operating characteristic curve (ROC) was plotted to determine the performance of GA. RESULTS: (1) Based on the diabetes diagnosis criteria of WHO (1999), the subjects were divided into DM group (n = 131), IGR group (n = 126), and normal glucose tolerance (NGT) group (n = 135). The GA level in the three groups tended to increase (P < 0.05). (2) Spearman correlation analysis demonstrated that GA was positively correlated with glycated haemoglobin A1c (HbA1c) (r = 0.942 1, P < 0.05), fasting plasma glucose (FPG) (r = 0.856 6, P < 0.05) and 2 h post-load plasma glucose (2-hPG) (r = 0.813 7, P < 0.05). (3) The mean levels of serum GA/HbA1c were 2.58 +/- 0.37, 2.44 +/- 0.37 and 2.17 +/- 0.25 for DM, IGR and NGT respectively. (4) The optimal cut-off points for detecting diabetes were 16.6% in GA [area under the carve (AUC) = 0.888], producing the sensitivity of 71.8% and the specificity of 87.4%. CONCLUSION: GA as a single screening test shows adequate to detect newly diagnosed DM, and the optimal GA cut-off point was 16.6% in this study.

Reference intervals and factors contributing to serum glycated albumin levels in West China.

BACKGROUND: In diabetic patients, non-enzymatically glycated albumin (GA), Amadori adducts, has been suggested as an ideal biomarker of short-term glycemic control. OBJECTIVE: To describe the reference intervals of serum GA and identify factors associated with serum GA, including age, gender, hemoglobin A1C (HbA1c) levels, fasting blood glucose (FPG) levels, total glycerin (TG) levels, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), systolic pressure (SBP) and diastolic pressure (DBP). METHODS: This study enrolled 1,296 healthy participants aged between 18 to 84 years of age attending physical tests in West China. Serum GA, blood glucose, blood lipid, and HbA1c levels were tested with commercially available reagents on automated clinical chemistry analyzers. RESULTS: In the West China population, the levels of serum GA concentrations were 11.6% (95% CI, 11.4 - 11.7) for overall population and 11.3% (95% CI, 11.1 - 11.4) and 11.9% (95% CI, 11.8 - 12.0) for males and females, respectively. In contrast, in a multiple model, gender (beta = 0.127), age (beta = 0.125), and HbAlc (beta = 0.177) were positively correlated with GA whilst body mass index (BMI) (beta = -0.197) and TG (beta = -0.153) were negatively correlated with GA. CONCLUSIONS: The reference intervals of GA were partitioned into five categories by age and gender; 8.7 - 13.7% for subjects aged 18 to 29 including both male and female, 8.1 - 13.7% for 30 to 49 years old males, 9.4 - 14.2% for 30 - 49 years old females, 9.1 - 14.9% for male and female subjects aged 50 - 59 and 9.6 - 15.7% for the male and female subjects over the age of 60 years.

[Changes of bone mineral density and bone metabolic marker in patients with subclinical hypothyroidism].

OBJECTIVE: To investigate the change of bone mineral density and bone metabolism biochemical markers in subclinical hypothyroidism. METHODS: This study included total 122 patients with subclinical hypothyroidism and 153 healthy age and gender matched people as control. All the patients and controls were subjected to the measurements of bone density by dual energy X-ray absorptiometry (DEXA), and serum free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH), Ca2+, PO4(3+), alkaline phosphatase (ALP) levels. All the data was analyzed statistically with the stratification of gender and menopause status. RESULTS: Compared to the control, the patients with subclinical hypothyroidism had significantly higher incidence of bone mass loss (P < 0.005) and lower level of Serum Ca2+ (P < 0.05) and higher levels of serum PO4(3+), T-value and Z-value (P < 0.05). Furthermore, premenopausal women had higher Z-value (P < 0.01) , but no significantly differences of T-value, serum PO4(3+) was found either in pre-menopause or post-menopause women when compared to the control. Multiple linear regression analysis showed gender (B = 0.543, P < 0.0001) was positive correlation with T value, female had lower T values. Moreover, T value was negative correlated to menopausal status (B = -0.274, P = 0.001), age (B = -0.161, P < 0.0001) and TSH (B = -0.108, P < 0.0001). CONCLUSION: Subclinical hypothyroism appears decreased serum calcium and low bone density.

[Risk stratification of diabetic chronic kidney disease using eGFR equations].

OBJECTIVE: To compare different eGFR equations for risk stratification of diabetic chronic kidney disease. METHODS: A total of 601 diabetic patients participated in the study. Data about the patient serum cystatin C (Cys-C), blood urea nitrogen (BUN), creatinine (Scr), uric acid (UA), glycosylated hemoglobin (HbAlc), and urinary albumin creatinine ratio (ACR) were extracted. Simplified MDRD formula were used for calculating glomerular filtration rate (eGFR) using eGFR-EPlcrea, eGFR-EPIcys and eGFR-EPIcrea-cys. The patients were divided into three groups according to their urine ACR. Comparisons were made between the groups of patients in Cys-C, BUN, UA, eGFR and Scr. RESULTS: There were significant differences (P < 0.05) in Cys-C, eGFR-MDRD, eGFR EPIcrea, eGFR-EPIcys, and eGFR-EPIcrea-cys among the groups of patients. The different equations for risk stratification produced different distributions of patients among the three groups. Significant differences appeared among the groups in the distribution of patients using eGFR-MDRD (P < 0.05), eGFR-EPIcrea (P = 0.000) and eGFR-EPIcys (P < 0.05) and indication for stratification. No significant differences were found in the distribution of patient among the three groups (P > 0.05) using GFR-MDRD, eGFR-EPIcrea and eGFR-EPIcrea-cys as an indication for stratification. In low risk patients, eGFR-MDRD was higher than other eGFR (P < 0.05). In medium and high-risk patients, eGFR-MDRD and eGFR-EPIcrea were higher than eGFR-EPIcys and eGFR-EPIcrea-cys. In very high-risk patients, the four eGFR did not show differences. CONCLUSION: The performance of different eGFR equations differs in risk stratification of diabetic chronic kidney disease. In low-risk patients, MDRD equation may overestimate GFR level.

First definition of reference intervals of liver function tests in China: a large-population-based multi-center study about healthy adults.

BACKGROUND: Reference intervals of Liver function tests are very important for the screening, diagnosis, treatment, and monitoring of liver diseases. We aim to establish common reference intervals of liver function tests specifically for the Chinese adult population. METHODS: A total of 3210 individuals (20-79 years) were enrolled in six representative geographical regions in China. Analytes of ALT, AST, GGT, ALP, total protein, albumin and total bilirubin were measured using three analytical systems mainly used in China. The newly established reference intervals were based on the results of traceability or multiple systems, and then validated in 21 large hospitals located nationwide qualified by the National External Quality Assessment (EQA) of China. RESULTS: We had been established reference intervals of the seven liver function tests for the Chinese adult population and found there were apparent variances of reference values for the variables for partitioning analysis such as gender(ALT, GGT, total bilirubin), age(ALP, albumin) and region(total protein). More than 86% of the 21 laboratories passed the validation in all subgroup of reference intervals and overall about 95.3% to 98.8% of the 1220 validation results fell within the range of the new reference interval for all liver function tests. In comparison with the currently recommended reference intervals in China, the single side observed proportions of out of range of reference values from our study for most of the tests deviated significantly from the nominal 2.5% such as total bilirubin (15.2%), ALP (0.2%), albumin (0.0%). Most of reference intervals in our study were obviously different from that of other races. CONCLUSION: These used reference intervals are no longer applicable for the current Chinese population. We have established common reference intervals of liver function tests that are defined specifically for Chinese population and can be universally used among EQA-approved laboratories located all over China.