HbA1c Concentration Research Articles

Trajectories of Health-Related Quality of Life and HbA1c Values of Children and Adolescents With Diabetes Mellitus Type 1 Over 6 Months: A Longitudinal Observational Study.

Introduction: To achieve optimized blood glucose concentrations (assessed by HbA1c) and high health-related quality of life (HRQL), children and adolescents with diabetes mellitus type 1 (T1DM) must follow strict disease management strategies. This study aims to investigate HRQL of children and adolescents with T1DM and its association with HbA1c values over the course of 6 months.Methods: Patients aged 7–17 years (n = 203) with T1DM provided HRQL data on a monthly basis. HRQL was measured using the Kids-CAT, a computer-adaptive test (CAT) comprising five generic HRQL domains. HbA1c concentrations were assessed at baseline, at 3 and 6 months. We explored the trajectory of HRQL at the domain level using linear mixed effects models. Further, we investigated the association between HRQL and HbA1c concentrations over time using path analysis models.Results: Children and adolescents with T1DM reported high scores across all HRQL domains over time. However, those with an HbA1c concentrations of >9.0% reported significantly lower scores in physical well-being and parent relations compared with those with an HbA1c concentration of <7.5%. Path analysis models revealed a minimal temporal relationship between HbA1c and HRQL, with a small negative impact of HbA1c on physical well-being, psychological well-being and parent relations.Conclusion: Although observed HRQL of young patients with T1DM was comparable to age-related German-speaking reference population over the course of 6 months, those with an HbA1c concentration >9.0% reported lower scores in selected HRQL domains. Thus, special attention should be drawn to HRQL of children and adolescents with higher HbA1c concentrations. The minimal relationship between HbA1c and HRQL indicates that the two therapy goals, i.e., achievement and maintenance of glycemic targets and high HRQL, should be considered and evaluated independently in clinical routine.Trial Registration: DRKS00006326 (German Clinical Trial Register), date of registration: August 1st, 2014.

Correlation Between Serum Asprosin Level And Oxidative Stress In Iraqi Patients With Type Ii Diabetes Mellitus

Background: Asprosin, a new protein hormone identifies by USA researcher team in 2016, secreted by the white adipose tissue. Asprosin induce releasing of hepatic glucose, its pathologically increased in insulin resistant, obesity and diabetic mellitus. Method: Cross sectional study were carried out to evaluate the concentration of serum asprosin, glucose, Total antioxidant capacity-TAC, malondialdehyde –MDA, Glutathione-S-transferase-GST and HbA1c for 121 sample of patients with type II diabetes mellitus (age between 25-45) collected from Specialized Center for Diabetes and Endocrinology / Baghdad-Alrasapha from 1/10/2019 to 20/12/2019. The groups of samples were divided into three groups, 1st group G1 include twenty four patients(12male and 12female) newly diagnose with type II diabetic mellitus without any treatment(new onset), 2nd group G2 include sixty nine(36male and 33female) patients with type II diabetic mellitus taken a treatment(old diagnostic cases) and twenty eight sample(12male and 16 female) for healthy individuals as control group-C. Results:The results showed that the concentration of asprosin, glucose, HbA1c and MDA were significantly higher P≤0.05 in G2 as compared with control group, with no significant change P≤0.05 to the concentration of asprosin , glucose and MDA in G1 as compared with control group, while at the same group the concentration of HbA1c and GST significantly higher P≤0.05 comparing with C, The concentration of TAC significantly decreased P≤0.05 in G1 and G2 as comparing with control group. Conclusion: The concentration of asprosin was increase in type II diabetic mellitus, this result associated with the complication of the disease.

Relationship between ACR and other determinants of microalbuminuria in T2DM patients

Introduction: The occurrence of microalbuminuria in type 2 diabetes mellitus (T2DM) patients is regarded as an early clinical sign of incipient kidney damage. Microalbuminuria is often evaluated as urinary albumin to urinary creatinine ratio (ACR). Aim: To assess determinants of microalbuminuria in T2DM patients without prior diagnosis of nephropathy using ACR cut-off values. Materials and Methods: ACR was measured in a total of 90 T2DM patients, during two months in three non-consecutive days, and routine biochemical analyses were performed, including glycated hemoglobin (HbA1c), serum uric acid (SUA), and atherogenic index of plasma (AIP). The cut-off values of ACR were ≤ 2.5 mg/mmol in males, and ≤ 3.5 mg/mmol in females. Duration of T2DM, history of hypertension, HbA1c, estimated glomerular filtration rate (eGFR), AIP, and SUA were investigated for association with microalbuminuria. Results: According to ACR patients were considered as non-albuminuric (n= 57) and microalbuminuric (n = 33). Compared to non-albuminuric group, microalbuminuric group had increased urinary creatinine, urinary albumin, HbA1c, triglycerides and SUA, whilst decreased HDL-cholesterol levels. Although eGFR was generally reduced, the correlation between LogACR and eGFR was not significant (p &gt; 0.05). However, the correlation between LogACR and LogHbA1c was significant. The multiple logistic regression analysis revealed HbA1c (t = 3.42; p = 0.012) and SUA (t = 2.44; p = 0.040) as independent predictors of microalbuminuria in T2DM patients. Conclusion: At ACR cut-off values, concentrations of HbA1c and SUA were independent predictors of microalbuminuria in T2DM patients not yet diagnosed with nephropathy.

Relationships between severity of steatosis with glycemic control and carotid intima-media thickness among diabetic patients with ischemic heart disease.

Background:Nonalcoholic fatty liver disease (NAFLD) has become one of the major diseases plaguing worldwide. Several studies reported its association with ischemic heart disease (IHD). This study aims to determine the relationships between severity of steatosis with glycemic control and carotid intima-media thickness (CIMT) among a high-risk population of type 2 diabetes mellitus (T2DM) with proven IHD.Materials and Methods:This was a cross-sectional study involving patients aged between 18 and 65 years diagnosed with T2DM with IHD (n = 150). Ultrasonography of the abdomen to determine NAFLD severity category and CIMT measurements was performed by two independent radiologists. NAFLD was graded according to the severity of steatosis (NAFLD-3, NAFLD-2, NAFLD-1, and NAFLD-0). Comparison between different stages of NAFLD (NAFLD-3, NAFLD-2, NAFLD-1, and NAFLD-0) was analyzed using Chi-square and analysis of variance tests for categorical and continuous variables, respectively.Results:The prevalence of NAFLD was 71% (n = 107). NAFLD-1 was detected in 39% of the patients, 32% had NAFLD-2, no patients with NAFLD-3, and 29% had non-NAFLD. There were no patients with NAFLD-2 having higher systolic and diastolic blood pressure, weight, body mass index, waist circumference, total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol. Glycated hemoglobin (HbA1c) concentration was highest within the NAFLD-2. NAFLD-2 showed higher mean CIMT. Every 1% rise in HbA1c for patients with NAFLD significantly increases the CIMT by 0.03 mm (95% CI: 0.009, 0.052, P = 0.006).Conclusion:These findings suggest additional atherosclerotic risks within the NAFLD-2 group with significantly higher HbA1c and CIMT compared to the NAFLD-1 and NAFLD-0 groups. It is, therefore, vital to incorporate stricter glycemic control among patients with T2DM and IHD with moderate NAFLD as part of atherosclerotic risk management strategy.

Impaired deformability and association with density distribution of erythrocytes in patients with type 2 diabetes mellitus under treatment.

Disturbed microcirculation is related to diabetic complications, and erythrocyte deformability is a critical factor regulating microcirculation. To know the relationship between the impaired deformability and density profile in diabetic erythrocytes. We recruited patients with type 2 diabetes (n = 15, diabetic group) and age- and sex-matched non-diabetic subjects (n = 15, control group). Erythrocyte density (ED) profile was obtained by the phthalate ester separation technique. ED distribution was fitted by sigmoidal curve, yielding specific gravity of phthalate ester allowing passage of half erythrocytes population (ED50) and slope factor. Erythrocyte deformability was estimated by our specific filtration technique. Diabetic group showed significantly (p < 0.001) higher HbA1c and fasting blood glucose concentration. Erythrocyte deformability in diabetic group was impaired as compared with that in control group (p < 0.001) and proportional to HbA1c (p = 0.009). However, ED50 and the slope factor in diabetic group did not differ from respective parameters in control group. This study demonstrated that erythrocyte deformability was impaired in diabetic patients even under treatment. HbA1c up to 7.5% is concluded not to alter the erythrocyte density but to impair the deformability, which might be a warning to clinicians for prevention of diabetic complications.

Mean glycosylated hemoglobin in children with type 1 diabetes at King Fahad Medical City, Riyadh, Saudi Arabia

BACKGROUND:Type 1 diabetes is the third most common chronic disease among teenagers. In Saudi Arabia, there is a gap of knowledge regarding hemoglobin A1C (HbA1c) concentration levels, and adherence to regular follow-up visits by patients. The aim of this study was to determine the mean glycosylated hemoglobin (HbA1c) levels in diabetic children who have been diagnosed with type 1 diabetes and were being followed up at a tertiary care center in Saudi Arabia.MATERIALS AND METHODS:This cross-sectional study was conducted among all diabetic children treated at King Fahad Medical City (KFMC) in Riyadh, Saudi Arabia. Data were retrieved and analysed during the period from September to December 2018. Diabetic patients of <18 years and who were being followed up at KFMC were included in the study. Data on age, sex, duration of illness, associated comorbidities, antidiabetic regimen, and HbA1c levels were obtained. Student t-test was used to compare quantitative parameters between two groups, and Chi-square employed to test for associations between categorical variables at 5% significance level.RESULTS:A total of 510 patients of were included in the study; about 53% were females. The mean HbA1c level was 10.6% and females showed higher HbA1c levels. Data showed a strong correlation between age and HbA1c levels (P < 0.001), with older patients showing higher HbA1c levels. The HbA1c levels also increased as the duration of disease increased. The median number of patient visits to KFMC was two per year. No statistically significant differences were observeed for type of treatment for diabetes. Celiac disease, the most frequent comorbidity, was seen in 50% of patients.CONCLUSION:Diabetic children who were followed up at KFMC had high HbA1C level (10.6%), and lower than recommended follow-up visits per year. The treating physicians should educate patients and their legal guardians on the importance of follow-up visits and their role in controlling HbA1C levels, and following healthier lifestyle.

A comparison of the effects of intermittent versus continuous exercise on blood glucose control in individuals with Type 1 Diabetes

AbstractExercise has many health benefits for individuals with Type 1 Diabetes (T1D), however it carries the risk of hypoglycaemia. Research has indicated that intermittent high intensity exercise reduces this risk compared to steady state exercise, potentially via a greater anaerobic component inducing increased lactate and catecholamine response.Six physically active males aged 23 ± 5 years, BMI 24.9 ± 1.8 kg•m-2, Vo2 max 47.9 ± 10.1 ml•kg-1•min-1 diagnosed with Type 1 Diabetes for 9 ± 3 years and a HbA1c concentration of 8.6 ± 0.3% participated in a randomised counterbalanced trial. Participants exercised for 60 min on a cycle ergometer on two occasions separated by 7 days, which consisted of a moderate continuous steady state exercise session at 40% o2 max (CONT), or the same exercise intensity interspersed with 7 s high intensity sprints at 100% Vo2 max every 2 min (INT). Blood glucose concentration was assessed via capillary blood sampling every 10 min during exercise and at regular intervals in the 60 min post exercise (Accu-Chek Aviva, Roche, UK). Additional metabolic measures such as blood lactate concentration and carbohydrate oxidation rates were assessed during exercise. Participants ingested small quantities of a carbohydrate drink, if required, to avoid hypoglycaemia during exercise. Magnitude based inferences were used to compare the two exercise trials and Effect Sizes (ES) calculated using Cohen's d and results presented as mean ± SD.Average blood glucose concentration was lower on the INT trial compared to CONT during both the exercise phase (8.9 ± 1.7 mmol•l-1 vs 7.1 ± 1.1 mmol•l-1; ES 0.55) and the 60 min post-exercise recovery phase (8.1 ± 1.9 mmol•l-1 vs 7.0 ± 1.8 mmol•l-1; ES 0.56). Carbohydrate oxidation was greater on the INT trial compared to CONT (1.9 ± 1.4 g•min-1 vs 1.5 ± 0.6 g•min-1; ES 0.35). Capillary blood lactate concentration was markedly elevated on INT when compared to CONT (5.0 ± 1.4 mmol•l-1 vs 2.4 ± 1.1 mmol•l-1; ES 2.48). Carbohydrate ingestion during exercise was 13 ± 11 g and differed little between trials (ES 0.18).Despite greater anaerobic metabolic response, the addition of intermittent high intensity sprints to 60 min steady-state cycle exercise resulted in greater declines in blood glucose concentration during the exercise and post-exercise period, potentially by inhibition of the counter regulatory hormone response expected on the INT trial. These results would indicate that additional exogenous carbohydrate ingestion may be required for individuals with T1D when intermittent sprints are added to prolonged continuous exercise.

Fasting glucose and HbA1c levels as risk factors for the presence of intracranial atherosclerotic stenosis.

Intracranial atherosclerotic stenosis (ICAS) is the most common cause of stroke, but the relationship of ICAS with fasting blood glucose (FBG) and glycated hemoglobin A1c (HbA1c) is unclear. This study aimed to investigate the effects of increased FBG and HbA1c concentration on ICAS. A total of 4,012 patients aged over 40 years who underwent cerebral magnetic resonance angiography (MRA) were enrolled in this study, including 1,434 non-stroke controls and 2,578 patients with ischemic stroke. Participants were classified into four groups according to stroke and ICAS status. ICAS was defined as the presence of ≥50% stenosis in any intracranial artery. Multivariate regression analysis was used to evaluate the associations of FBG and HbA1c with ICAS. Levels of fasting glucose and HbA1c in patients with ICAS were significantly higher than those in patients without ICAS among both stroke and non-stroke groups. Multivariate regression analysis showed that elevated levels of fasting glucose (OR 1.14, 95% CI, 1.11-1.18, P<0.001) and HbA1c (OR 1.22, 95% CI, 1.16-1.28, P<0.001) were independent risk factors for ICAS. In addition, patients with the DM (FBG ≥7.0 mmol/L) were at the high risk of ICAS in both non-stroke (OR 2.90, 95% CI, 2.11-3.99, P<0.001) and stroke (OR 1.99, 95% CI, 1.67-2.39, P<0.001) groups. Besides, subjects with the high risk of ICAS were found in the fourth HbA1c quartile in both non-stroke (OR 3.50, 95% CI, 2.23-5.61, P<0.001) and stroke (OR 1.98, 95% CI, 1.50-2.63, P<0.001) groups. The results suggest that elevated fasting glucose and HbA1c levels are associated with high risk for ICAS.

Interactive Nutrition Education Is More Effective in Terms of Improved Levels of Glycated Hemoglobin in Adolescent Patients with Poorly Controlled Type 1 Diabetes - A Randomized Study.

IntroductionEffectively conducted nutrition education is one of the key elements of the therapy of type 1 diabetes. The aim of the study was to compare the effectiveness of two methods of nutrition education.Material and methodsA noninvasive interventional randomized single-blind study included 151 patients (13.7±2.2 years old) with poorly controlled type 1 diabetes, treated with the use of insulin pumps. The participants were randomly divided into two groups: a control group (C) in which informative education methods were used (a lecture) and an experimental group (E) in which interactive methods (quiz and multimedia application) were additionally applied. The concentration of glycated hemoglobin (HbA1c) was the primary outcome. The secondary outcomes were: standard deviation score-body mass index (SDS-BMI), standard deviation score-systolic blood pressure (SDS-SBP), standard deviation score-diastolic blood pressure (SDS-DBP), scores of Nutrition Knowledge Survey (NKS) and indices of healthy and unhealthy diet.ResultsA marked reduction in HbA1c concentrations was observed after 3 months in group E [−0.47% (−0.77; −0.17), P<0.01; P=0.038 for the intergroup difference]. The positive effect was no longer present after 6 months. No significant changes regarding HbA1c were noted in group C at any stage of the study. After 6 months, both groups obtained better results in one part of NKS (“Blood glucose response to food”): group C [0.41 (0.15; 0.66), P<0.01], group E [0.80 (0.52; 1.08), P<0.001; P=0.042 for the intergroup difference]. No statistically significant differences between groups were noted as regards the remaining parameters.ConclusionInteractive nutrition education is more effective in terms of improved levels of HbA1c in children and adolescents with poorly controlled diabetes. However, an intensification of training frequency is recommended due to the transient effect of education.

Effectiveness of home or hospital initiation of treatment at diagnosis for children with type 1 diabetes (DECIDE trial): a multicentre individually randomised controlled trial

ObjectiveTo determine whether, in children with newly diagnosed type 1 diabetes who were not acutely unwell, management at home for initiation of insulin treatment and education of the child and...

Long-term follow-up of a randomized controlled trial of a text-message diabetes self-management support programme, SMS4BG.

AimsTo determine the long‐term effectiveness of an individually tailored text‐message diabetes self‐management support programme, SMS4BG, on glycaemic control at 2 years in adults with diabetes with an HbA1c concentration > 64 mmol/mol (8%).MethodsWe conducted a 2‐year follow‐up of a two‐arm, parallel, randomized controlled trial across health services in New Zealand. Participants were English‐speaking adults with type 1 or 2 diabetes and with an HbA1c >64 mmol/mol (8%). In the main trial participants randomized to the intervention group (N=183) received up to 9 months of an automated tailored text‐message programme in addition to usual care. Participants in the control group (N=183) received usual care for 9 months. In this follow‐up study, 293 (80%) of 366 randomized participants in the main trial were included. The primary outcome measure was change in glycaemic control (HbA1c) from baseline to 2 years. Mixed‐effect models were used to compare the group differences at 3, 6, 9 and 24 months, adjusted for baseline HbA1c and stratification factors (health district category, diabetes type and ethnicity).ResultsThe decrease in HbA1c at 2 years was significantly greater in the intervention group [mean (sd) –10 (18) mmol/mol or –0.9 (1.6)%] compared with the control group [mean (sd) –1 (20) mmol/mol or –0.1 (1.8)%], with an adjusted mean difference of –9 mmol/mol (95% CI –14, –5) or –0.8% (95% CI –1.2, –0.4; P<0.0001).ConclusionsImprovements in glycaemic control resulting from a text‐message diabetes self‐management support programme were sustained at 2 years after randomization. These findings support the implementation of SMS4BG in current practice.

A GIP/xenin hybrid in combination with exendin-4 improves metabolic status in db/db diabetic mice and promotes enduring antidiabetic benefits in high fat fed mice

The current study has determined the ability of exendin-4 to augment the antidiabetic benefits of the recently characterised GIP/xenin hybrid, (DAla2)GIP/xenin-8-Gln. As such, combined activation of metabolic pathways linked to various gut derived hormones has been shown to exert complementary beneficial metabolic effects in diabetes. (DAla2)GIP/xenin-8-Gln and exendin-4 were administered twice daily to high fat fed (HFF) or db/db mice for 28 days and antidiabetic benefits assessed. Persistence of beneficial metabolic effects in HFF mice was also examined. Twice-daily injection of (DAla2)GIP/xenin-8-Gln for 28 days in HFF mice significantly reduced energy intake, body weight, circulating glucose, HbA1c and improved glucose tolerance and insulin sensitivity. Overall pancreatic islet, alpha- and beta-cell areas were reduced, with concurrent reduction in alpha- and beta-cell proliferation that was more apparent in the combined treatment group. Addition of exendin-4 to (DAla2)GIP/xenin-8-Gln therapy did not significantly improve metabolic control. Remarkably, beneficial effects were still evident 14 days following complete cessation of peptide administration. Thus, circulating glucose and insulin, HbA1c concentrations and glucose tolerance were still significantly improved when compared to control HFF mice on day 42, with minimal changes to pancreatic islet architecture. In contrast to HFF mice, combined treatment of db/db mice with (DAla2)GIP/xenin-8-Gln plus exendin-4 was required to induce beneficial effects on key metabolic parameters, which were not observed with either treatment alone. This included improvements in glucose tolerance and insulin sensitivity, but no effect on pancreatic architecture. These studies highlight the clear, and persistent, metabolic advantages of sustained activation of GLP-1 receptors, alongside concurrent activation of related GIP and xenin cell signalling pathways, in diabetes.

Monetary reinforcement for self-monitoring of blood glucose among young people with type 1 diabetes: evaluating effects on psychosocial functioning.

To explore the auxiliary psychosocial effects of a monetary reinforcement intervention targeting self-monitoring of blood glucose among young people with Type 1 diabetes. Sixty young people with Type 1 diabetes, HbA1c concentrations between 58 and 119 mmol/mol (7.5-13.0%), and average self-monitoring of blood glucose <4 times per day were randomized to either enhanced usual care or a 24-week intervention of monetary rewards for self-monitoring of blood glucose and associated behaviours (e.g. uploading glucose meters). Data were collected from the young people and their parents at baseline, during the intervention (6, 12 and 24 weeks) and after the intervention (36 weeks). Linear mixed models were used to evaluate the intervention effects on psychosocial outcomes, adjusting for corresponding baseline levels and potential moderation by baseline level. The intervention reduced diabetes distress at week 6 among young people who had average and high baseline distress. It also reduced diabetes distress at weeks 12 and 24 among those with low baseline distress. The intervention also reduced young person-reported diabetes-related family conflict and diabetes-related interference among those with high baseline scores in these areas; however, the intervention worsened young person-reported diabetes interference among those with low baseline interference. Effects were medium-sized and time-limited. Findings indicate predominantly positive impacts of monetary reinforcement interventions on psychosocial outcomes, although effects varied by outcome and time point. Whereas early improvements in diabetes distress were observed for all who received the intervention, improvements in other areas varied according to the level of psychosocial challenge at baseline. Incorporating psychosocial interventions may bolster and maintain effects over time.

The Haematological Effects of Oleanolic Acid in Streptozotocin-Induced Diabetic Rats: Effects on Selected Markers.

Background Sustained hyperglycaemia leads to the development of haematological alterations which, if left untreated, is associated with cardiovascular complications. Insulin is the mainstay drug in type 1 diabetes mellitus (T1D); however, the use of insulin is associated with haematological alterations that could further worsen cardiovascular complications. Therefore, the aim of the study was to investigate the haematological effects of oleanolic acid (OA) in streptozotocin- (STZ-) induced diabetic rats. Methods The animals were separated into five groups; the nondiabetic group (ND), the diabetic control group (DC), and the treatment groups of insulin (170 μg/kg, s.c), metformin (500 mg/kg, p.o), and OA (80 mg/kg, p.o). OA was administered orally twice a day. Thereafter, the animals were sacrificed, and blood and tissues were collected for haematological, hormonal, and oxidative status analysis. Results Untreated diabetic rats exhibited hyperglycaemia, elevated glycated haemoglobin (HbA1c), oxidative stress, and a reduced erythropoietin (EPO) concentration when compared to ND rats. However, administration of OA attenuated hyperglycaemia, HbA1c, and EPO concentrations compared to DC rats. The reduction of blood glucose concentration, HbA1c, and improved EPO concentrations was further associated with a notable increase in red blood cell (RBC) count and other RBC indices. We also observed an increase in the antioxidant status of the RBCs with a concomitant decrease in oxidative stress. Conclusion These findings suggest that OA improves diabetes-induced haematological changes caused by hyperglycaemia and attenuates the progression of cardiovascular complications in DM individuals.

Imbalance in glycemic control between the treatment and placebo groups in cardiovascular outcome trials in type 2 diabetes

BackgroundGlycated hemoglobin (HbA1c) is accepted as the most reliable marker for assessing chronic glycemia. The present study aimed to investigate glycemic control in cardiovascular outcome trials (CVOTs) performed by pharmaceutical sponsors, at the request of the United States Food and Drug Administration (FDA) to ensure that newer hypoglycemic agents do not increase cardiovascular risk for patients with type 2 diabetes.MethodsWe chose ClinicalTrials.gov as a data source to identify randomized, double-blind, placebo-controlled non-inferiority trials of newer hypoglycemic agents for which the FDA 2008 guidance required a CVOT involving patients with type 2 diabetes.ResultsWe identified 12 CVOTs, all of which were performed in accordance with the FDA guidance and published as of December 2018. Participants received either active treatment or placebo in addition to their existing therapy. On the assumption that HbA1c concentrations would be higher in the placebo group than in the treatment group, the use of open-label glucose lowering agents was encouraged as required to help all patients reach appropriate HbA1c targets according to local guidelines. As a result, the number of patients who received additional hypoglycemic agents during the trial was greater in the placebo group than in the treatment group in 10 of the CVOTs. Although the CVOTs were designed to avoid any imbalance in glycemic control between the groups, HbA1c concentrations were substantially higher in the placebo group than in the treatment group in all CVOTs throughout the observational period. The inferior glycemic control in the placebo groups was not considered in analyzing the outcomes in any of the CVOTs.ConclusionsThe safety and efficacy of new hypoglycemic agents are potentially inflated because the participants in the placebo groups unexpectedly exhibited inferior glycemic control throughout the trial compared with the outcomes in the treatment groups. This imbalance may distort data interpretation and mask potential risks of the drugs. Re-analysis with adjustment for HbA1c concentrations would determine whether the results of these CVOTs were biased by the difference in glycemic control between the treatment and placebo groups and reveal potential effects of the test drugs independent of glycemic control.

Clinical performance of titanium-zirconium implants with a hydrophilic surface in patients with controlled type 2 diabetes mellitus: 2-year results from a prospective case-control clinical study.

Analyze the 2-year clinical performance of single-unit titanium-zirconium (TiZr) alloy narrow-diameter (3.3mm) dental implants with a hydrophilic surface (Straumann® Roxolid®, SLActive®) in patients with controlled type 2 diabetes mellitus (T2DM), measured using the glycated hemoglobin A (HbA1c) concentration test, compared with results in individuals without T2DM. The studied sample consisted of 28 patients, 14 with T2DM (study group) and 14 without (control group). The plaque index, bleeding on probing, probing depth, clinical attachment level, gingival biotype, and marginal bone loss (MBL) at the site of the implants were assessed. HbA1c levels were assessed in all patients during each checkup. Two years after implant placement and prosthetic restoration no implant failures were reported in either group, resulting in 100% survival and success rates in both groups. No statistically significant differences in MBL were found between the control and study groups (p > 0.05). Within the limitations of this study, it can be concluded that reduced-diameter TiZr alloy implants with a hydrophilic surface represent a safe and predictable treatment option for patients with well-controlled T2DM. The clinical performance was comparable with that observed in individuals without T2DM in the medium term. The narrow implants placed in patients with T2DM with well-controlled glycemia (HbA1c) showed a marginal bone loss and success and survival rates similar to those of the control group without DM2, in the medium term.

Glucose metabolism affects coagulation factors: The NEO study

BackgroundIt is insufficiently understood if there is an association between diabetes and VT, and what the underlying mechanism would be. ObjectivesWe aimed to study the association between glucose concentrations with several coagulation factors in the general population. MethodsThis is a cross‐sectional analysis of baseline measurements within 5778 participants of the Netherlands Epidemiology of Obesity (NEO) study, a population‐based cohort study of individuals 45 to 65 years. Associations between fasting glucose and HbA1c concentrations, and postprandial glucose response and factor (F) VIII, FIX, FXI, and fibrinogen levels were examined using linear regression analyses and by calculating mean levels per category of glucose concentrations while adjusting for confounding factors. ResultsPer each mmol/L higher fasting glucose concentration we observed higher levels of fasting FVIII (5.33%, 95% CI: 4.00‐6.65), FIX (6.19%, 95% CI: 5.15‐7.23), and FXI (2.11%, 95% CI: 1.20‐3.02). Results for fasting HbA1c and postprandial glucose response were similar. Participants with an impaired fasting glucose, high fasting glucose, and diabetes mellitus had higher mean levels of FVIII, FIX, and FXI than those with a normal glucose metabolism, with the highest differences in the levels of FVIII, FIX, and FXI between a high fasting glucose and a normal glucose metabolism. All associations attenuated after adjustment for total body fat, yet all of the above associations remained after adjustment for the confounding factors, except for fibrinogen when contrasted to glucose. ConclusionConcentrations of fasting glucose and HbA1c and postprandial glucose response were positively associated with FVIII, FIX, and FXI, and to some extent also with fibrinogen.

Abdominal Fat Is Directly Associated With Inflammation In Persons With Type-2 Diabetes Regardless Of Glycemic Control -A Jordanian Study.

Background and aimSystemic inflammation is related to the progression of complications associated with diabetes. This study aimed to investigate the association between general and abdominal obesity and inflammation in patients with type-2 diabetes with or without glycemic control.MethodsA total of 198 men (n=73) and women (n=125) diagnosed with type 2 diabetes participated in this study. General obesity markers, body mass index (BMI), and abdominal fat were assessed. Circulating concentrations of glycated hemoglobin (HbA1C), C-reactive protein (CRP), and serum interleukin-6 (IL-6) were determined. Poor glycemic control and good glycemic control were defined as having fasting HbA1C concentrations ≥7% and <7%, respectively. Multivariate adjusted analysis of covariance was used to determine the relation between BMI and abdominal fat and markers of inflammation in patients with good and poor glycemic control.ResultsPatients in <7% HbA1C category, those with high abdominal fat had ≈262% higher CRP and ≈30.6% higher IL-6 compared to those with low abdominal fat (p˂0.05). Patients in ≥7% HbA1C category, those with high abdominal fat had ≈41.4% higher CRP and ≈33.9% higher IL-6 compared to those with low abdominal fat (p˂0.05). Abdominal fat was directly related to CRP (p˂0.023) and IL-6 (p˂0.002) concentrations in both groups of type-2 diabetic patients with <7% and ≥7% HbA1C. In patients with ≥7% HbA1C, BMI was directly related to CRP (p˂0.02) and IL-6 (p˂0.047). Whereas in patients with <7% HbA1C, BMI was not associated with CRP or IL-6 concentrations.ConclusionHigh level of abdominal fat is associated with systemic inflammation in type-2 diabetes regardless of glycemic control. Abdominal fat is a better predictor (determinant) of inflammation than BMI in patients with type-2 diabetes with or without glycemic control.

C-peptide concentrations in patients with type 2 diabetes treated with insulin

AimsTo determine beta cell reserves of patients with type 2 diabetes who are treated with insulin by using fasting C-peptide concentrations and to investigate the clinical features related to C-peptide concentrations. Materials and methodsPatients with type 2 diabetes, who were using insulin as monotherapy or in combination therapy, were divided into three groups; those with an insufficient beta cell reserve (C-peptide: <0.5 ng/mL), borderline reserve (C-peptide: 0.5–2 ng/mL) and sufficient reserve (C-peptide:> 2 ng/mL). ResultsIn the 249 patients (mean age, 61.77 ± 9.34 years; 40.6% male), the mean duration of diabetes was 13.9 ± 8.43 years. The mean HbA1c concentrations, fasting glucose and C-peptide concentrations were 8.88 ± 1.87%, 184.29 ± 77.88 mg/dL and 1.95 ± 1.37 ng/mL, respectively. Fifty-seven percent of patients (n = 142) had a borderline beta cell reserve and 37% (n = 92) had high C-peptide concentrations. Only 6% of patients (n = 15) had an insufficient beta cell reserve. C-peptide levels were positively correlated with waist circumference (r: 0.282; p = 0.001), hip circumference (r: 0.251; p = 0.001), body mass index (r: 0.279; p = 0.001), fasting glucose concentrations (r: 0.309; p = 0.001) and triglyceride concentrations (r: 0.358; p = 0.001). ConclusionIn this study, almost all patients with type 2 diabetes using insulin were found to have sufficient or borderline beta cell reserves and insulin resistance-related parameters were prominent in those with adequate beta cell reserve. Clinical trials noNCT04005261

Impact of Exercise-Nutritional State Interactions in Patients with Type 2 Diabetes.

This study examines the role of nutritional status during exercise training in patients with type 2 diabetes mellitus by investigating the effect of endurance-type exercise training in the fasted versus the fed state on clinical outcome measures, glycemic control, and skeletal muscle characteristics in male type 2 diabetes patients. Twenty-five male patients (glycated hemoglobin (HbA1c), 57 ± 3 mmol·mol (7.4% ± 0.3%)) participated in a randomized 12-wk supervised endurance-type exercise intervention, with exercise being performed in an overnight-fasted state (n = 13) or after consuming breakfast (n = 12). Patients were evaluated for glycemic control, blood lipid profiles, body composition and physical fitness, and skeletal muscle gene expression. Exercise training was well tolerated without any incident of hypoglycemia. Exercise training significantly decreased whole-body fat mass (-1.6 kg) and increased high-density lipoprotein concentrations (+2 mg·dL), physical fitness (+1.7 mL·min·kg), and fat oxidation during exercise in both groups (PTIME < 0.05), with no between-group differences (PTIME × GROUP > 0.05). HbA1c concentrations significantly decreased after exercise training (PTIME < 0.001), with a significant greater reduction after consuming breakfast (-0.30% ± 0.06%) compared with fasted state (-0.08% ± 0.06%; mean difference, 0.21%; PTIME × GROUP = 0.016). No interaction effects were observed for skeletal muscle genes related to lipid metabolism or oxidative capacity. Endurance-type exercise training in the fasted or fed state do not differ in their efficacy to reduce fat mass, increase fat oxidation capacity, and increase cardiorespiratory fitness and high-density lipoprotein concentrations or their risk of hypoglycemia in male patients with type 2 diabetes. HbA1c seems to be improved more with exercise performed in the postprandial compared with the postabsorptive state.