Glycated Albumin Levels Research Articles

A multicenter all-inclusive prospective study on the relationship between glycemic control markers and maternal and neonatal outcomes in pregnant women

Objective Pregnant women afflicted with gestational diabetes mellitus (GDM) and diabetes mellitus (DM) are prone to both maternal and neonatal complications. Due to this, it is of importance to sustain a strict glycemic control during this time. Unfortunately, there is a lack of evidence-based medical research for the control criteria during pregnancy. Therefore, to develop better method of glycemic control for pregnant women, we conducted a multicenter all-inclusive prospective study to investigate the association between glycemic control markers and maternal and neonatal outcomes. Research design and methods: Four hundred fifty-two women were included in the study. Fasting blood glucose (FBG), HbA1c and glycated albumin (GA), and ferritin levels were measured at different gestational periods and compared to the pregnancy outcomes. Results The reference interval of GA and HbA1c was determined in Trimester I, II, III: 11.0–16.3%, 10.1–15.2%, and 9.5–14.6%, and 4.8–5.7%, 4.4–5.4%, and 4.7–5.8%, respectively. It was found that at the later stages of pregnancy, there was a reduction in ferritin levels and increase in HbA1c levels. Only in the GDM group, it was noticed that the frequency of total neonatal and maternal complications were significantly higher on comparison with the normal group (30.1 vs. 18.4%, p = .017 and 21.0% vs. 12.0%, p = .031, respectively). For the frequency of cesarean section and macrosomia in GDM group, GA > 15.69% group was significant higher compared to those of GA ≤ 15.69% group (p = .021 and p = .001, respectively). For HbA1c, no significant differences were observed. Conclusions A reference interval of HbA1c and GA was developed for Chinese pregnant women. We found that the GDM group had a higher frequency of neonatal and maternal complications. As only GA levels and not HbA1c, were associated with cesarean section and macrosomia in GDM, we hypothesize that GA could be an appropriate glycemic control marker for pregnant mothers.

Changes of Serum Adiponectin and Glycated Albumin Levels in Gestational Diabetes Mellitus Patients and Their Relationship with Insulin Resistance.

Background:We aimed to investigate the changes of serum adiponectin and glycated albumin (GA) levels in gestational diabetes mellitus patients and their relationship with insulin resistance.Methods:Overall, 137 pregnant women were enrolled from Jinan City People's Hospital, Laiwu District, China from Jan 2015 to Jun 2018. Among them, 71 pregnant women with gestational diabetes mellitus were examined as diabetes group, and 66 normal pregnant women as normal pregnant women group. In addition, 58 normal non-pregnant women of childbearing age who were examined in our hospital during the same period were selected as a control group. The serum adiponectin and GA levels of the three groups were compared, and the relationship between serum adiponectin, GA levels and insulin resistance was analyzed.Results:The serum adiponectin level of pregnant women in gestational diabetes mellitus (GDM) group was significantly lower than that of normal pregnant women and control group (P=0.031, P=0.027). The serum GA level of pregnant women in GDM group was significantly higher than that of normal pregnant women and control group (P<0.001). Pearson correlation analysis showed that GA was positively correlated with Fasting plasma glucose (FPG), Fasting insulin (FINS) and Insulin resistance index(HOMA-IR) levels (P<0.001), while adiponectin was negatively correlated with FPG FINS and HOMA-IR levels (P<0.001).Conclusion:Abnormal levels of serum GA and adiponectin are closely related to insulin resistance in patients with gestational diabetes mellitus. Detection of serum GA and adiponectin levels can diagnose gestational diabetes mellitus quickly and effectively.

Critical discrepancy in blood glucose control levels evaluated by glycated albumin and estimated hemoglobin A1c levels determined from a flash continuous glucose monitoring system in patients with type2 diabetes on hemodialysis.

We aimed to investigate if estimated hemoglobin A1c (eHbA1c) levels determined using a flash continuous glucose monitoring system could be an indicator of glycemic control status in hemodialysis patients with diabetes. Hemodialysis patients with type 2 diabetes were recruited. eHbA1c levels were measured using the FreeStyle Libre Flash Glucose Monitoring System®. A total of 18 hemodialysis patients with diabetes were included in the study. The eHbA1cGA – calculated based on glycated albumin level, and body mass index and serum hemoglobin concentration were also included in the formula – was higher than the eHbA1c in most patients. Furthermore, the eHbA1cGA – eHbA1c values were >2% in all patients with body mass index <18.5 kg/m2; the maximal value was 4.1%. This study shows that eHbA1c can be used as a reliable indicator for evaluating glycemic control and avoiding hypoglycemia in hemodialysis patients with diabetes, particularly those with decreased body mass index.

THE EFFICACY OF GLYCATED ALBUMIN IN DIAGNOSIS OF TYPE 2 DIABETES AMONG INDIAN CHILDREN AND YOUNG ADOLESCENTS.

Objective the main objective of our study to evaluate the diagnostic precision of Glycated Albumin (GA) in better screening of Type 2 Diabetes in children and young adolescents having asymptomatic glycosuria along with Fasting plasma glucose (FPG), 2 hours oral glucose tolerance test (OGTT) and Glycated hemoglobin (HbA1c). Materials & Methods 157 children aged between 9 to 15 years enrolled for this study and all went for 2 hours OGTT to confirm diabetes. Found on OGTT results we have divided all the subjects into three groups, the children and young adolescents having normal glucose tolerance placed in NGT group (n=95), with impaired glucose tolerance placed in IGT group (n=43) and third group DM had confirmed diabetes Mellitus (n=19). Serum samples were collected and analyzed for glucose (Fasting and OGTT) GA and HbA1c with lipid profile. All the three groups, FPG and 2 hrs. OGTT values compared to the GA, side-by-side to HbA1c for accuracy of its diagnostic precision. Results Based on GA values 84 (53.5%) subjects were with normal glucose tolerance, 47 (29.90 %) subjects were with impaired glucose tolerance and 26 (16.56 %) subjects are in Diabetic group. The Mean GA level is 18 % to FPG and 2 hrs. OGTT were 108.2 mg/dl and 175 mg/dl. The values of GA correlated well with 2 hrs. OGTT compared to FPGG values in DM group with confirmed Diabetes. The cut off value of GA in prediction of prediabetes along with HbA1c (6.15%) is 16 4% with sensitivity of 98.70%. Conclusion In the Indian children and young adolescents who are obese or having asymptomatic glycosuria, GA can be a additive with the value of 18 % in better screening of type 2 diabetes along with FPG, OGTT and HbA1c. Our study also proposes GA level of 16.4% as the excellent cut-off point to diagnose pre Diabetes.

1446-P: A1C and Glycated Albumin Combined Improves Detection of Abnormal Glucose Tolerance in Africans

In nonwhite populations the prevalence of abnormal glucose tolerance (Abnl-GT) is increasing in the nonobese. However, the prevalence of Abnl-GT in African-born blacks is unknown. As BMI correlates positively with A1C and negatively with glycated albumin (GA) and fructosamine (FA), BMI may influence the diagnostic sensitivity of nonfasting markers of glycemia. Working with Africans, our goals were to determine: a) by BMI category the prevalence of Abnl-GT; and b) the diagnostic value of nonfasting markers of glycemia, individually and combined. In 416 African-born blacks living in America (male: 66%; age: 39±10 (mean±SD), range 20 to 65y, BMI: 27.7±4.5, range 18.2-42.4 kg/m2) OGTT were performed. A1C, GA and FA levels were measured. A1C, GA and FA levels were repeated 11±7 days later in 136 participants. Abnl-GT was defined by glucose: 0h ≥100 and/or 2h ≥140 mg/dL. Thresholds for A1C, GA and FA were defined by the cut-off at the upper quartile for the population (5.7%, 14.2%, 234 µM/L, resp). Analytic tools were κ-statistic, Spearman correlations and the McNemar test. In short, Abnl-GT occurred in 36% (152/416). Of the individuals with Abnl-GT, 68% (104/152) were nonobese. Reproducibility of A1C and GA were excellent (both κ≥0.8) but only moderate for FA (κ=0.6). For this reason, results focus on A1C and GA. BMI positively correlated with A1C (r= 0.18) and negatively with GA (r=-0.18) (both P&amp;lt;0.01). The diagnostic sensitivities of A1C, GA and the combined tests were: 43%, 34% and 61%, resp (P&amp;lt;0.01 compared to A1C alone). By test, 66 people with Abnl-GT were detected by A1C or A1C and GA; whereas 25 people were detected by GA alone. People with Abnl-GT detected by GA only had lower BMI than those detected by A1C (26.8±2.4 vs. 30.4±4, P&amp;lt;0.01). Overall, two-thirds of African-born blacks with Abnl-GT are nonobese. As GA detects Abnl-GT in nonobese individuals not detected by A1C, using both tests could improve screening and lead to earlier intervention. Disclosure A.E. Sumner: None. A.F. Hobabagabo: None. E.M. Shoup: None. T. Hormenu: None. N.H. Osei-Tutu: None. C. DuBose: None. L. Mabundo: None. S.T. Chung: None. D.B. Sacks: Other Relationship; Self; Sebia, Trinity Biotech plc.

Effects of liraglutide and empagliflozin added to insulin therapy in patients with type 2 diabetes: A randomized controlled study

Aims/IntroductionLiraglutide and empagliflozin suppress cardiovascular events. However, reports on their long‐term combined use with insulin therapy or direct comparisons of these drugs are limited.Materials and MethodsThis open‐label, parallel‐group, randomized controlled trial compared the effects of liraglutide and empagliflozin combined with insulin therapy in type 2 diabetes patients. Adult type 2 diabetes outpatients undergoing stable insulin therapy with glycated hemoglobin levels of 7.0–9.5% were enrolled. Participants received 0.9 mg/day liraglutide or 10 mg/day empagliflozin for 24 weeks. The primary end‐point was the change in glycated hemoglobin levels from week 0 to 24. Body composition was assessed by dual‐energy X‐ray absorptiometry.ResultsA total of 64 insulin‐treated patients were randomized to receive liraglutide or empagliflozin. We analyzed 61 patients (30 liraglutide and 31 empagliflozin) who could be followed up. Liraglutide induced greater changes in glycated hemoglobin and glycated albumin than empagliflozin (glycated hemoglobin −1.24 ± 0.15% vs −0.35 ± 0.11%, P < 0.0001; glycated albumin −4.4 ± 0.6% vs −2.4 ± 0.5%, P < 0.01). Bodyweight (−1.3 ± 0.4 kg vs −1.5 ± 0.3 kg, P = 0.69) or body fat mass/lean tissue mass; urinary albumin excretion (median −5.3 mg/g‐creatinine [interquartile range −60.6, 9.9 mg/g‐creatinine] vs −12.9 mg/g‐creatinine [interquartile range −70.8, −2.0 mg/g‐creatinine], P = 0.23); and frequency of hypoglycemia did not differ significantly between the groups over a period of 24 weeks. There were no cases of study discontinuation owing to adverse effects.ConclusionsLiraglutide addition to ongoing insulin therapy more effectively reduced glycated hemoglobin and glycated albumin levels than empagliflozin in patients with inadequately controlled type 2 diabetes.

MON-661 Association of 25-Hydroxyvitamin D Serum Levels with Markers of Glycemic Control in Diabetic and Nondiabetic Patients on Maintenance Hemodialysis

Introduction: In type 2 diabetic patients (T2DM) with end-stage renal disease (ESRD) on hemodialysis (HD), an inverse relationship between 25(OH)D and glycated hemoglobin (HbA1c) have been reported. However, because of anemia and altered red cells turnover, glycated albumin (GA) has been proposed as a more reliable glycemic marker in these subjects. Therefore, we have examined whether an association exists between 25(OH)D and GA in HD diabetic and nondiabetic (ND) subjects. Material and methods: A total of 121 HD (M/F: 69/31%; age 69±15), of whom 43 (35.5%) had T2DM, were analyzed. Median Hb level was 10.2 g/dL (IQR, 9.35-10.9) and median albumin was 3.44 g/dL (IQR, 3.09-3.77). The median dialysis vintage was 29.3 months (IQR, 11.6-67.44). In all subjects, 25(OH)D, HbA1c, and GA were determined on the morning of the dialysis. Results: Median 25(OH)D concentration in the whole study population was 25.5 mcg/mL (IQR, 17.7-33.75), while median HbA1c level was 37 mmol/mol (IQR, 32-43) and GA was 16.5% (IQR, 14.3-20.2). The median serum concentration of 25(OH)D was lower in T2DM group compared to ND (19.0 vs. 27.3 mcg/mL; P=0.002). In the entire cohort, there was an inverse relationship between 25(OH)D and GA (r: -0.255; P=0.005), while there was no significant correlation between HbA1c and 25(OH)D (r:-0.158; p=0.086). The relationship between GA and 25(OH)D levels was confirmed among T2DM patients (r: -0.375; P=0.013) but not in ND (r: -0.036; P=0.751), while HbA1c didn’t significantly correlate with 25(OH)D neither in T2DM (r: -0.255; P=0.099) nor in ND (r: -0.002; P=0.986). Both in the whole cohort as well in T2DM, the independent association of GA and 25(OH)D persisted upon adjustment for age, sex, BMI, dialysis duration, and vitamin D supplementation. By these regression analyses, it was calculated that 10 mcg/mL decline in 25(OH)D was associated with a 2.4% increase in GA. When T2DM individuals were considered, this increase was 75% greater (4.2%). Conclusions: In HD patients, serum 25(OH)D is more strongly associated with GA than HbA1c in both diabetic and nondiabetic subjects. This might reflect the higher reliability of GA in assessing glucose control in this category of subjects. Furthermore, lower serum 25(OH)D concentration was associated with poorer glycemic control among T2DM subjects, but not in ND. Since 25(OH)D deficiency was more prevalent in T2DM than ND, these findings could emphasize the importance of adequate vitamin D repletion in this category of patients. Whether correction of vitamin D insufficiency might affect GA levels remains to be explored.

Glycated albumin is a better indicator for glucose levels than glycated hemoglobin in patients with diabetes mellitus on insulin therapy

BackgroundDiabetes mellitus (DM) is a metabolic disease with a large incidence in the world and constitutes a global health problem. By 2030 it is estimated that there will be around 439 million people suffering from DM. Diabetes mellitus is a metabolic disease caused by a lack or absence of the hormone insulin. In type 2 DM pharmacotherapy can be given one of which is insulin. To monitor therapy, random blood glucose, glycated hemoglobin (HbA1c) and glycated albumin (GA) levels can be examined. The objective of this study was to determine the relationship of glycated albumin and glycated hemoglobin (HbA1c) with random blood glucose in insulin-treated diabetics.MethodsA cross-sectional study was conducted involving 92 type 2 diabetic patients treated with insulin. The study used a questionnaire and blood samples. We measured the GA , HbA1C and random blood glucose levels. A multiple linear regression was used to analyze the data. ResultsMean HbA1c was 9.21 ± 2.15%, mean glycated albumin was 24.4 ± 8.65%, and mean blood glucose was 229.47 ± 98.7 mg/dL. Multiple linear regression tests showed that HbA1c (B= 5,544; â=0.121; p=0.420) and GA (B=5.899; â=0.517; p=0.001) was signigicantly corelated with random blood gucose, respectively, indicating that glycated albumin is significantly related to and has the greatest influence on glucose level.ConclusionGlycated albumin is correlated with and has greater influence on glucose level than does HbA1c. Glycated albumin could be a better marker for glycemic control than glycated hemoglobin in diabetic patients treated with insulin.

Visceral adiposity is associated with the discrepancy between glycated albumin and HbA1c in type 2 diabetes.

We investigated the association of visceral adiposity with glycated albumin (GA) as well as GA/hemoglobin A1c (HbA1c) in type 2 diabetes. One hundred twenty-three patients (68 males, 55 females) with type 2 diabetes were enrolled in this cross-sectional study. Visceral fat area (VFA) was determined using an abdominal dual bioelectrical impedance analysis (dual BIA) instrument. The relationship of VFA with GA and GA/HbA1c was analyzed. Simple regression analysis showed that BMI was inversely correlated with GA as well as GA/HbA1c, but not with HbA1c, while VFA had a significant correlation with GA and GA/HbA1c. Furthermore, multiple regression analysis revealed VFA as an independent contributor to GA/HbA1c. These results suggest that visceral adiposity is a primary factor associated with GA and HbA1c level discrepancy in patients with type 2 diabetes. GA is a useful indicator for glycemic control, while visceral obesity should also be taken into consideration in type 2 diabetes cases.

Influence of Sex Hormones on the Relationship Between Body Fat and Glycated Albumin Levels

BackgroundPrevious studies have reported that glycated albumin (GA) is affected by body fat distribution. Sex hormones are reported to play an important role in fat metabolism. AimThis study aimed to explore the influence of sex hormones on the relationship between body fat and GA in a community population. MethodsWe recruited 763 middle-aged and elderly subjects with normal glucose tolerance from communities. GA was determined using the enzyme method, and serum estradiol (E2), total testosterone, and sex hormone–binding globulin (SHBG) were detected using chemiluminescent microparticle immunoassays. OutcomeThere was a statistically significant association between SHBG and GA remained after adjusting for body fat in both men and women. ResultsThe average serum GA levels were 13.40 ± 1.10% in the 298 men and 465 postmenopausal women included in this study. GA presented a significant downward trend with increasing quartiles of total fat mass (FM), limb FM, and trunk FM in both men and women (all P for trend < .01). In men, total testosterone, free testosterone, and SHBG were positively correlated with GA (both P < .01), and the correlation between SHBG and GA remained after adjusting for body fat (P < .01). In women, E2, free testosterone, bioactive testosterone, and SHBG were correlated with GA (all P < .01); furthermore, the positive correlation between SHBG and GA and the inverse correlation between E2 and GA remained after adjusting for body fat (both P < .05). Multivariate linear regression analyses showed that in addition to trunk FM, SHBG was positively correlated with GA in both men and women (standardized β = 0.136, P = .035; standardized β = 0.101, P = .033); however, E2 was not independently correlated with GA in women. Clinical ImplicationsSHBG may contribute to the influence of body fat, especially trunk fat on GA levels. Strengths & ImplicationsThis study used an automated bioelectrical impedance analyzer to measure segmental body composition including limb FM and trunk FM and further investigated the role of segmental body fat in the correlation between SHBG and GA. Sex hormones may explain in part why body fat content and distribution can alter GA levels. ConclusionSHBG is positively correlated with serum GA levels, and this correlation is independent of total or segmental body fat.Xu Y, Ma X, Shen Y, et al. Influence of Sex Hormones on the Relationship Between Body Fat and Glycated Albumin Levels. J Sex Med 2020;17:903–910.

Elevated serum glycated albumin and glycated albumin:hemoglobin A1c ratio were associated with hippocampal atrophy in a general elderly population of Japanese: The Hisayama Study.

Aims/IntroductionTo investigate the association of alternative glycemic measures – namely, serum glycated albumin (GA), hemoglobin A1c (HbA1c) and the GA : HbA1c ratio – with global brain and hippocampal atrophy in a general elderly Japanese population.Materials and MethodsA total of 1,278 Japanese individuals aged ≥65 years in a community participated in brain magnetic resonance imaging scanning and screening examination of health status in 2012. We measured total brain volume (TBV), hippocampal volume (HV) and intracranial volume (ICV) using the data from the magnetic resonance imaging examination. The association of each glycemic measure with the ratios of TBV : ICV (an indicator of global brain atrophy) and HV : ICV (an indicator of hippocampal atrophy) was examined by analysis of covariance.ResultsThe mean values of the TBV : ICV and HV : ICV ratios decreased significantly with elevating serum GA levels and GA : HbA1c ratio levels (all P for trend < 0.05), but not with higher HbA1c levels, after adjusting for age, sex, low education, systolic blood pressure, antihypertensive medication, diabetes mellitus, serum total cholesterol, electrocardiogram abnormalities, body mass index, smoking habits, alcohol drinking habits and regular exercise. These significant associations were still observed in the sensitivity analysis after excluding individuals with mild cognitive impairment and dementia. In addition, increased serum GA levels and the GA : HbA1c ratio levels, but not HbA1c, were closely associated with lower mean values of the TBV : ICV and HV : ICV ratios, irrespective of the presence or absence of diabetes mellitus.ConclusionsThe present study suggests that higher serum GA and higher GA : HbA1c ratio are significantly associated with global brain and hippocampal atrophy.

Glycated hemoglobin and glycated albumin in patients with diabetes undergoing hemodiafiltration

BackgroundOnline hemodiafiltration (OHDF), which results in high albumin leakage, is now widely used in Japan for dialysis, since the national insurance system began reimbursing its costs in 2012. Glycated albumin (GA) levels are affected by albumin leakage into effluent dialysate fluid. Therefore, GA levels in patients requiring diabetes-related dialysis undergoing OHDF require monitoring. However, there have been no previous reports on glycemic control indicators of patients with diabetes undergoing OHDF. We aimed to develop a glycemic control index for patients requiring diabetes-related dialysis undergoing OHDF.MethodsThis study comprised 133 diabetic patients undergoing OHDF. We examined the correlation between GA and glycated hemoglobin (HbA1c) levels. We analyzed effluent dialysate fluid samples from 41 patients classified into 3 groups, namely, group A, non-protein-leaking OHDF (n = 20); group B, protein-leaking OHDF (n = 14); and group C, highly efficient protein-leaking OHDF (n = 7). We examined the association between GA and HbA1c levels in each group and among patients.ResultsA significant positive correlation was observed between GA and HbA1c levels (r = 0.562, p < 0.0001). There was no significant correlation between pre-dialysis blood glucose levels and HbA1c or GA levels as observed on regular blood tests performed under non-fasting conditions. Patients were classified into 2 groups based on their mean albumin levels (3.4 g/dL cutoff). The correlation between HbA1c and GA levels was found to be weaker in the 51 patients with mean albumin levels < 3.4 g/dL (r = 0.399, p = 0.0037) than in the 82 patients with mean albumin levels ≥ 3.4 g/dL (r = 0.674, p < 0.0001). When the hemodiafilter performance was assessed, no correlation was observed between HbA1c and GA levels in group C patients.ConclusionsGA levels may be underestimated in patients undergoing OHDF because of the effect of albumin leakage into the effluent dialysate fluid. If a stable hemoglobin value can be maintained during OHDF therapy, then GA and HbA1c levels should be used as a glycemic control index for patients requiring diabetes-related dialysis, considering the dialysis treatment method and protein permeability of the dialyzers and hemodiafilters.

Association of BMI and HDL Cholesterol in Relation to Glycated Albumin in Type 2 Diabetes Mellitus

Introduction: The main issue with the morbidity and mortality of type 2 diabetes is its associated health complications. In the last decade Glycated Albumin (GA) emerged as an extinguished marker for short-term glycaemic control. Aim: To Quadrate the association of Body Mass Index (BMI) along with HDL-cholesterol to GA in Type 2 diabetic cases. Materials and Methods: Total of 50 diabetic cases (Group 1) and 50 healthy non-diabetic control subjects (Group 2) recruited for the study between November 2017 to December 2018, which includes both males and females. Serum samples of both the groups were analysed to assess the lipid profile to GA levels along with BMI. Variations among groups was compared using student t-test by calculating r-values of the parametres and the pearson coefficient was calculated with significant p value at &lt;0.05. Results: The levels of High-Density Lipoprotein (HDL) cholesterol in group 1 when compared with group 2 were significantly lower. Both BMI and GA showed negative correlation with HDL-C levels in both the groups. (p values 0.051 and 0.331 respectively). To boot, there was a statistically undeviating reciprocity of Low Density Lipoprotein (LDL) cholesterol to GA levels, BMI to LDL-cholesterol and BMI to Triglycerides (TG). There was a statistically significant correlation between GA and BMI (r=0.240, p&lt;0.0001) and there was a statistically significant negative correlation between GA and HDL-cholesterol (r=-0.286, p&lt;0.051) in diabetic patients (group 1). The association between GA and LDL-cholesterol (r=0.271, p&lt;0.0001) was also been found statistically significant in group 1. Conclusion: The present study suggests that GA can be adapted as a reliable prospective biomarker that endures the potentiality in prognostication of serum lipid levels in diabetic patients and also BMI is the key formidable feature of dyslipidemia in type 2 diabetic cases.

Long-Term, Real-World Safety and Efficacy of Teneligliptin: A Post-Marketing Surveillance of More Than 10,000 Patients with Type2 Diabetes in Japan.

IntroductionTeneligliptin is a dipeptidyl peptidase 4 inhibitor that was approved for the treatment of type 2 diabetes mellitus (T2DM) in Japan in 2012. We performed a long-term post-marketing surveillance (RUBY) to obtain real-world evidence regarding the safety and efficacy of teneligliptin in Japan.MethodsThis 3-year follow-up RUBY surveillance registered patients with T2DM who started treatment with teneligliptin between May 2013 and February 2015 in Japan. Collected data included demographics, treatments, adverse drug reactions (ADRs) and laboratory variables. Data were evaluated in all patients and in patients divided according to baseline renal function across categories of estimated glomerular filtration rate (G1–G5) and dialysis. Safety was assessed as the incidence of ADRs and efficacy was assessed in terms of glycaemic control, for up to 3 years.ResultsOf 11,677 patients registered, 10,696 and 10,249 were evaluable for safety and efficacy analyses, respectively. The median duration of exposure was 1096 days. ADRs occurred in 412 patients (3.85%) and were serious in 117 patients (1.09%). The most frequent ADR class was gastrointestinal disorders (0.68%), which included constipation. There were no new ADRs warranting attention beyond those already described in teneligliptin’s package insert. ADRs and serious ADRs in renal function subgroups occurred in 3.24–7.14% and 0.65–5.36% in G1–G5, and 4.49% and 1.92% in patients on dialysis, respectively. Reduction in HbA1c was sustained for 3 years after starting teneligliptin (− 0.70% ± 1.36%, p < 0.001 at 3 years). The least-squares mean changes in HbA1c adjusted for baseline were − 0.76% to − 0.66% in G1–G5 at 3 years. Glycated albumin levels decreased in patients on dialysis (− 2.92% ± 4.78% at 3 years).ConclusionThere were no new safety or efficacy concerns about teneligliptin used in long-term, real-world, clinical settings in patients with T2DM with any stages of renal impairment.Trial registrationJapan Pharmaceutical Information Center clinical trials database identifier: Japic CTI-153047.Plain Language SummaryPlain language summary available for this article.Electronic supplementary materialThe online version of this article (10.1007/s12325-019-01189-w) contains supplementary material, which is available to authorized users.

Application of serum glycated albumin in pregnancy

Hyperglycemia during pregnancy is associated with many maternal and infant complications, hence strict blood glucose control during pregnancy is of great importance. Glycosylated hemoglobin Alc (HbA1c), glycated albumin (GA), self-monitoring of blood glucose (SMBG) and continuous glucose monitoring (CGM) are four main measures to assess sugar level during pregnancy. GA level is a reflection of blood sugar level in the past 2-3 weeks and is unlikely influenced by various factors, therefore holds great potential in better control of blood glucose to help improve maternal and fetal outcomes. Key words: Diabetes, gestational; Serum albumin; Glycated hemoglobin A; Blood glucose self-monitoring

Combination treatment of metformin and red fruit (Pandanus conoideus l.) extract increased pancreatic β cell density but had no effect toward fasting blood glucose and glycated albumin levels in diabetic male wistar rats (Rattus norvegicus)

Background: Diabetes mellitus (DM) is a degenerative disease associated with premature aging characterized by hyperglycemia. Hyperglycemia in people with DM causes oxidative stress and increases Glycated Albumin level, which is the initial precursor to the formation of AGEs. In turn, AGEs will lead to pancreatic β cell damage and apoptosis. Red fruit (Pandanus conoideus L) contains phytochemicals with antioxidant that has the potential to reduce diabetic complications. Therefore, this study aimed to evaluate the effect of metformin and red fruit extract combination toward blood glucose, glycated albumin and pancreatic β cells density in diabetic rats (Rattus norvegicus).&#x0D; Methods: A post-test only control group study was conducted using 36 male Wistar rats as subject. All subjects were induced for type-2 DM with Streptozotocin and Nicotinamide. The diabetic rats were then divided into 2 groups: the positive control group treated with metformin + placebo and the treatment group treated with metformin + red fruit extract. Pancreatic β cell, fasting blood glucose and glycated albumin assessments were performed after 21 days of treatment.&#x0D; Results: The results showed the mean number of pancreatic β cells in the treatment group was higher than the control group (116.11±33.14 vs 83.20±23.94 cells/visual field; p=0.002). But the mean fasting blood glucose in the treatment group was not significantly different compared to the control group (107.67±14.93 vs. 113.67±11.19 mg/dl; p=0.181). The same result also found in the gycated albumin level (Treatment vs control: 6.97±3.63 vs 6.42±4.01 ng/ml; p=0.666).&#x0D; Conclusion: It can be concluded that the administration of red fruit extract increased the density of pancreatic β cell but did not reduce fasting blood glucose and glycated albumin levels in diabetic Wistar rats.

Combination treatment of vildagliptin and bay leaf (Syzygium polyanthum) extract increased pancreatic beta cells number but have no effect toward glycated albumin levels in diabetic male Wistar rats (Rattus norvegicus)

Introduction: Diabetes mellitus is a complex and progressive disease which often lead to several debilitating complications that partly caused by by free radicals which can be overcome with antioxidants. Bay leaves contain essential oils, tannins, flavonoids and terpenoids which have considerable antioxidant properties. Therefore, this study aims to determine the effect combination treatment of vildagliptin and bay leaf (Syzygium polyanthum) extract toward pancreatic beta cells density and glycated albumin levels in diabetic male Wistar rats (Rattus norvegicus).&#x0D; Methods: An experimental posttest only control group study was conducted using 36 albino male rats, aged 2-3 months, weighing 180-200 grams. The rats were divided into 2 groups (n= 18) with control group treated with 1.8mg/200g body weight vildagliptin and 2cc placebo (aquabidest) while the treatment group received 1.8mg/200g BW vildagliptin and 250 mg/200g BW bay leaves extract. All treatment lasted for 21 days.&#x0D; Results: The results showed that pancreatic beta cell counts in the treatment group was significantly higher than the control group (109.07 ± 20.47 cells/field of view vs 90.87 ± 13.91 cells/field of view; p&lt;0.01). However, the levels of Glycated albumin between two groups were not significantly different (treatment vs control: 17.33 ± 4.51 vs 20.18 ± 4.57; p=0.068).&#x0D; Conclusion: This study suggested that combination treatment of vildagliptin and bay leaf extract increased pancreatic beta cells but did not reduce glycated albumin levels in diabetic male Wistar rats.

Xanthine Oxidase Inhibitor Febuxostat Exerts an Anti-Inflammatory Action and Protects against Diabetic Nephropathy Development in KK-Ay Obese Diabetic Mice.

Hyperuricemia has been recognized as a risk factor for insulin resistance as well as one of the factors leading to diabetic kidney disease (DKD). Since DKD is the most common cause of end-stage renal disease, we investigated whether febuxostat, a xanthine oxidase (XO) inhibitor, exerts a protective effect against the development of DKD. We used KK-Ay mice, an established obese diabetic rodent model. Eight-week-old KK-Ay mice were provided drinking water with or without febuxostat (15 μg/mL) for 12 weeks and then subjected to experimentation. Urine albumin secretion and degrees of glomerular injury judged by microscopic observations were markedly higher in KK-Ay than in control lean mice. These elevations were significantly normalized by febuxostat treatment. On the other hand, body weights and high serum glucose concentrations and glycated albumin levels of KK-Ay mice were not affected by febuxostat treatment, despite glucose tolerance and insulin tolerance tests having revealed febuxostat significantly improved insulin sensitivity and glucose tolerance. Interestingly, the IL-1β, IL-6, MCP-1, and ICAM-1 mRNA levels, which were increased in KK-Ay mouse kidneys as compared with normal controls, were suppressed by febuxostat administration. These data indicate a protective effect of XO inhibitors against the development of DKD, and the underlying mechanism likely involves inflammation suppression which is independent of hyperglycemia amelioration.

Individualized Correction of the Interference of Hemolysis on Glycated Albumin Determined by the Ketamine Oxidase Method.

To investigate the effect of hemolysis on glycated albumin (GA) levels, as determined by the ketamine oxidase method. GA levels and the hemolysis index were determined in nonhemolyzed serum and hemolyzed serum from corresponding patients. We developed an equation to correct the interference of hemolysis on GA, using multiple regression analysis. The degree of hemolysis was negatively correlated with GA levels (R2 = 0.9500). A correction equation for GA (corrected GA = 2.703 × OD of hemolysis + 1.044 × measured GA -0.906) can revert GA concentrations of hemolyzed specimens to values that were not significantly different from the GA concentration of corresponding nonhemolyzed specimens. The bias of GA concentrations before and after correction was statistically significantly different (P <.01). Our results indicate that the level of GA measured through the ketamine oxidase method is negatively affected by hemolysis. The individualized correction of GA results provides increased accuracy in hemolyzed specimens.

1599-P: Glycated Albumin Identifies Dysglycemia Not Detected by A1C: The Case for Combining Glycated Albumin and A1C in Africans

As the diabetes (DM) epidemic spreads in Africa, affected adults are younger and less obese than in high-income regions of the world. A1C, a nonfasting marker of glycemia, is used to diagnose dysglycemia, a summary term for prediabetes and DM. However, independent of glycemia, A1C increases with age and BMI. Conversely, hemoglobinopathies common in Africa such as sickle cell trait (SCT) can lead to artefactually low A1C levels. Because of the challenges surrounding A1C, attention is turning to glycated albumin (GA). Our goal was to determine in Africans the value of A1C and GA when a) performed individually and b) combined. OGTT was performed and A1C and GA levels were measured in 366 African-born blacks currently living in the Washington, DC area (male: 67%). Diagnosis of dysglycemia was based on fasting glucose≥100 mg/dL or 2h glucose≥140 mg/dL. The ability of A1C≥5.7% and GA≥14.2% to diagnose dysglycemia was evaluated. Both A1C≥5.7% and GA≥14.2% represent the upper quartile cut-off for their distribution in the population. To assess the value of performing both GA and A1C, people with dysglycemia were divided into 2 groups: 1) A1C-group detected by A1C only or A1C and GA; 2) GA-group identified by GA only and not detected by A1C. Dysglycemia occurred in 36% (135/366) of participants. SCT occurred in 17% (62/366) of the cohort and 20% (27/135) of people with dysglycemia. Sensitivities of A1C and GA were only 43% and 33%, resp. However, combining A1C and GA led to a sensitivity of 60% and this was better than either test alone (P&amp;lt;0.01). People identified by GA but not A1C were younger (age: 42±10 vs. 47±9y (mean±SD), P=0.05) and less obese (BMI: 26.7±2.5 vs. 30.3±4.5, P&amp;lt;0.01). A1C identified 52% (14/27) of the people with SCT and dysglycemia. GA identified an additional 22% (6/27) of people with SCT and dysglycemia not detected by A1C. Overall, combining GA with A1C leads to improved detection of dysglycemia in Africans from three groups: SCT, the nonobese and younger adults. Disclosure R. Mugeni: None. J.Y. Aduwo: None. S.M. Briker: None. M.F. Horlyck-Romanovsky: None. L. Mabundo: None. C. DuBose: None. A.E. Sumner: None.