Bezpieczeństwo i skuteczność dwufazowej insuliny aspart 30 (BIAsp30) u Irańczyków chorych na cukrzycę typu 2: otwarte, nierandomizowane, wieloośrodkowe badanie - irańska podgrupa badania IMPROVE™

Introduction: To evaluate the clinical profile of BIAsp 30 (30% soluble insulin aspart, 70% protamine-crystallized insulin aspart) (NovoMix®30) in type 2 diabetes patients in routine clinical practice in Iran. Material and methods: IMPROVE&#8482; was a 26-week, multinational, open-label, non-randomized study in patients with type 2 diabetes. The safety and efficacy of BIAsp 30 were assessed at baseline and at 13 and 26 weeks. The titration of BIAsp30 was at the physician&#8217;s discretion. Results: In Iran, 478 patients (47% male) previously treated with oral antidiabetic drugs (OADs) (N = 159, 33.3%) and/or insulin other than BIAsp30 (N = 317, 66.3%) or a few who were treatment-na&#239;ve (N = 2, 0.4%) participated in the study. After 26 weeks of treatment with BIAsp 30, the rate of reported major hypoglycaemic episodes was reduced by 88.1% from baseline (baseline v. Week 26: 0.303 v. 0.037 episodes/pt-year; p < 0.001). No significant differences in minor hypoglycaemic episodes between baseline and Week 26 were found. Glycaemic control was significantly improved from baseline to Week 26 with a mean HbA1c reduction of 1.2 &#177; 1.9%. Patients&#8217; quality of life as measured by the DiabMedSat questionnaire significantly improved from baseline (58.1) to the end of the study (75.4, p < 0.001). Conclusions: BIAsp 30 therapy appeared safe and effective and improved quality of life in Iranian patients with type 2 diabetes after 26 weeks of treatment. (Pol J Endocrinol 2010; 61 (4): 364-370)Wstęp: Celem badania była ocena profilu działania insuliny BIAsp 30 (30% rozpuszczalnej insuliny aspart, 70% insuliny krystalizowanej z protaminą) (NovoMix®30) u chorych na cukrzycę typu 2 w warunkach standardowej opieki zdrowotnej w Iranie. Materiał i metody: IMPROVE&#8482; było 26-tygodniowym, wieloośrodkowym, międzynarodowym, otwartym i nierandomizowanym badaniem z udziałem chorych na cukrzycę typu 2. Bezpieczeństwo i skuteczność insulin BIAsp 30 oceniano na początku badania oraz po 13 i 26 tygodniach. Dawkowanie insuliny BIAsp30 było zależne od zaleceń lekarskich. Wyniki: W irańskiej części badania uczestniczyło 478 chorych (47% stanowili mężczyźni) leczonych dotychczas doustnymi lekami hipoglikemizującymi (N = 159, 33,3%) i/lub insuliną inną niż BIAsp30 (N = 317, 66,3%) oraz nieliczna grupa pacjentów niestosujących wcześniej farmakoterapii (N = 2, 0,4%). Po 26 tygodniach leczenia insuliną BIAsp 30, częstość epizodów ciężkiej hipoglikemii zmniejszyła się o 88,1% (wartości wyjściowe v. tydzień 26: 0,303 v. 0,037 epizodów/pacjenta-rok; p < 0,001). Dane dotyczące częstości epizodów lekkiej hipoglikemii na początku badania i po 26 tygodniach leczenia nie różniły się istotnie. Odnotowano natomiast poprawę kontroli glikemii; po 26 tygodniach odsetek HbA1c obniżył się średnio o 1,2 &#177; 1,9% w stosunku do wartości wyjściowej. W okresie od rozpoczęcia do zakończenia badania nastąpiła istotna poprawa jakości życia chorych, oceniana przy użyciu kwestionariusza DiabMedSat; punktacja wynosiła odpowiednio 58,1 i 75,4 (p < 0,001). Wnioski: Terapia insuliną BIAsp 30 stosowana przez 26 tygodni u Irańczyków chorych na cukrzycę typu 2 okazała się bezpieczna i skuteczna, a ponadto spowodowała poprawę jakości życia pacjentów. (Endokrynol Pol 2010; 61 (4): 364-370

Gestational diabetes mellitus: Major risk factors and pregnancy-related outcomes: A cohort study

Background: Gestational diabetes mellitus (GDM) is a major pregnancy endocrine problem that has several confirmed risk factors and is associated with adverse pregnancy-related outcomes (PRO). Objective: To evaluate the relationship between GDM diagnosis and the associated risk factors of PRO (maternal, intrapartum, perinatal, and neonatal) in accordance with International Association of Diabetes and Pregnancy Study Groups criteria. Materials and Methods: This prospective cohort study was performed with 531 singleton parturient (265 GDM and 266 non-GDM). They were selected consecutively from referral hospitals, and the maternal, intrapartum, perinatal, and neonatal outcomes were assessed. Results: The major risk factors influencing the GDM diagnosis were maternal age, obesity, family history of diabetes, previous history of GDM, and previous history of macrosomia. In the comparison of PRO between the groups, significant associations were detected for emergency cesarean delivery, preeclampsia, polyhydramnios, premature rupture of membrane, preterm delivery, and neonatal hyperbilirubinemia in the GDM group. In the multivariate logistic regression analysis, a previous history of stillbirth was significantly associated with maternal and perinatal outcomes. The odds ratios (CI 95%) of the PRO in the women with a GDM diagnosis were: maternal = 2.43 (1.51-3.90), intrapartum = 2.05 (1.35- 3.11), perinatal = 2.00 (1.29-3.10), and neonatal = 1.68 (1.08-2.62). The PRO was significantly correlated with GDM diagnosis, but not with the risk factors. Conclusion: The adverse pregnancy outcomes were significantly correlated with GDM diagnosis, and the outcomes were not directly affected by the risk factors. Given the related adverse outcomes for mothers and offspring, early screening and management of GDM is necessary especially in Asians and in low-/middle-income countries. Key words: Gestational diabetes mellitus, Pregnancy outcomes, Risk factors

Psychometric properties of the Iranian version of the diabetes numeracy test‑15

Peer reviewedPublisher PD

Predictors of Glycemic Response and Change in HbA1c Following Newly Initiated Basal Insulin Among Insulin Naïve Adults With Type 2 Diabetes

This sub-analysis of the Iran-AFECT study was to determine the baseline characteristics are predicting the likelihood of attainment of HbA1c goal and changing in HbA1c after initiation of basal insulin glargine in insulin naïve people with type 2 diabetes not adequately controlled with oral glucose-lowering drugs. Iran-AFECT was a 24-week, prospective, multicenter, observational study of people with type 2 diabetes initiated or switched to insulin glargine. In this sub-analysis, we included all insulin naïve people. Glycemic response was defined as HbA1c≤7.0% and/or change in HbA1c at week 24. Data on 433 participants were included. The mean HbA1c was 8.9%±0.9% at baseline which decreased to 7.6%±1.2% (P<0.001). By week 24, 36% of the participants reached HbA1c≤7.0%. In univariate analysis, the strongest association was for the baseline HbA1c (r2=0.32, P<0.001). In multivariate analysis, predictors of change in HbA1c were baseline HbA1c (r2=0.29, P<0.001), and dosing of glargine (r2=0.01, P=0.02). The baseline HbA1c was accounting for 88% of explainable variances in HbA1c. The best cut-off predicting glycemic response for baseline HbA1c was 8.5%. Among factors predicting response to initiating basal insulin therapy with insulin glargine, baseline HbA1c is the strongest predictor explaining most of the variances in HbA1c change

Practical Focus on American Diabetes Association/European Association for the Study of Diabetes Consensus Algorithm in Patients with Type 2 Diabetes Mellitus: Timely Insulin Initiation and Titration (Iran-AFECT)

BackgroundThe aim of this study was to evaluate the safety and effectiveness of insulin glargine in a large population from a variety of clinical care in Iranian people with type 2 diabetes mellitus (T2DM) and to measure the percentage of patients achieving glycosylated hemoglobin (HbA1c) <7% by the end of 24 weeks of treatment in routine clinical practice.Methods This study was a 24 week, observational study of patients with T2DM, for whom the physician had decided to initiate or to switch to insulin glargine. The safety and efficacy of glargine were assessed at baseline and at week 24.ResultsSeven hundred and twenty-five people with T2DM (63% female) including both insulin naïve and prior insulin users were recruited in this study. The mean age of the participants was 54.2±11.2 years, and the mean HbA1c level was 8.88%±0.93% at baseline. By the end of the study, 27% of the entire participants reached to HbA1c target of less than 7% and 52% had HbA1c ≤7.5%. No serious adverse event was reported in this study. Furthermore, overall hypoglycemia did not increase in prior insulin users and the entire cohort. In addition, body weight did not change in participants while lipid profile improved significantly.ConclusionTreatment with insulin glargine could improve glycemic control without increasing the risk of hypoglycemic events in people with T2DM. In addition, a significant clinical improvement was observed in lipid profile

Mapping of Adrenal Gland Diseases Research in Middle East Countries: A Scientometric Analysis, 2007-2013

The aim of the study was to map scientific research on adrenal gland diseases in the Middle East countries through the Web of Science database using scientometric analysis. Data were analyzed with Excel software; and HistCite was used for mapping of the scientific texts. In this study, from a total of 268 retrieved records, 1125 authors from 328 institutions published their texts in 138 journals. Among 17 Middle East countries, Turkey ranked first with 164 documents (61.19%), Israel ranked second with 47 documents (15.53%) and Iran came in the third place with 26 documents. Most of the publications (185 documents, 69.2%) were articles. Among the universities of the Middle East, Istanbul University had the highest science production rate (9.7%). The Journal of Clinical Endocrinology & Metabolism had the highest TGCS (243 citations). In the scientific mapping, 7 clusters were formed based on TLCS (Total Local Citation Score) & TGCS (Total Global Citation Score). considering the study results, establishment of scientific connections and collaboration with other countries and use of publications on adrenal gland diseases from high ranking universities can help in the development of this field and promote the medical practice in this regard. Moreover, investigation of the formed clusters in relation to Congenital Hyperplasia and puberty related disorders can be research priorities for investigators

Relationship between patients' perception of the importance of diabetes and metabolic control and pursuing chronic complications of disease

Introduction: Type II diabetes is a metabolic disorder. Environmental factors and patient awareness have major roles on chronic complications. The purpose of this study was to determine the association of patients' perception of t the importance of diabetes and metabolic- control and pursuing of chronic complications. Material and Methods: 194 patients with diabetes enrolled from diabetes clinic of Institute Endocrinology & Metabolism in a cross-sectional study, from February to March 2010. Data were collected using a questionnaire to assess the personal demographics, individual approach in pursuit of complications, and glycemic control, as well as patient perception and attitude toward the importance of disease process and follow-up. Level of perceptions was determined as well, moderate and weak. Results: Out of 194 patients, 77(39.7%) were male and 117(60.3%) female. Mean age was 52.18±10.17years. 69.2% did not know what the glycosylated hemoglobin was. In 71.4%, willing to participate in decisions making on medical treatment was good and they knew that with initiation of insulin therapy, they would have better metabolic control. 68.9% of patients had regular follow-up for eye complications, and 51% for cardiac complications. Follow-up for diabetic foot complication was poor. Patients with good perception had regular follow-up regarding cardiac, eye and renal complications. Conclusion: These results indicate that better perception of diabetic patients might improve their compliance for regular follow- up regarding the pursuit of chronic complications, especially cardiac, eye and renal problems. Although, the metabolic- control of patients had not the association with patient perception about the importance of diabete

The challenge of living with diabetes in women and younger adults : A structural equation model

Background: Attitudes toward diabetes care are different between genders and age-groups. Furthermore, diabetes related challenges may cause psychosocial problems. Therefore, we were to compare the psychosocial status and glycemic control in women and men with type 2 diabetes (T2D) in different age-groups. Methods: 441 adults with T2D were recruited. Demographic, self-care behavior, resources and affective variables as well as the health related quality of life (HRQoL) were measured. The median age of 55 was used as the cut-off for the age comparison. Structured equation modeling (SEM) investigated the relationship between age, gender, psychosocial factors and glycemic control. Results: Finally, 203 women and 177 men completed the study (86.1%). There was no significant difference in mean duration of T2D, or glycemic control between genders or age-groups. Women, especially those below the median age of 55, had significantly higher level of diabetes-related distress (2.16. ±. 0.94 vs. 1.92. ±. 0.81), depression (9.67. ±. 5.37 vs. 7.54. ±. 5.06), and anxiety (19.81. ±. 12.04 vs. 12.81. ±. 9.04, P. <. 0.05 for all comparisons), while people above the age of 55 reported better self-management and patient-physician relationship. HRQoL was lower in women compared to men (0.77. ±. 0.23 vs. 0.81. ±. 0.18, P = 0.02). The final SEM suggested that the effect (standardized β coefficient) of gender and age on affective variables was 0.25 and -0.19 (P. <. 0.05), respectively, though psychosocial factors did not directly influence HbA1c. Conclusions: This study shows that psychosocial factors are associated with age and gender in patients with T2D; with younger women demonstrating higher level of depressive symptoms, anxiety, and diabetes-related distress independent of status of glycemic control

Early Insulin Glargine Initiation in Iranian People With Uncontrolled Type 2 Diabetes: Glycemic Control, and Adverse Events

To explore glycemic control, and adverse events of Iranian people with uncontrolled type 2 diabetes after initiation of long-acting basal insulin, glargine. People with uncontrolled type 2 diabetes that was on at least two oral anti-diabetic drugs (OAD) were enrolled in this observational prospective study. Insulin glargine was prescribed by physicians in the course of routine clinical practice. Patients were followed for 24 weeks. Insulin doses were titrated to reach fasting blood sugar (FBS) target between 90 mg/dl and 130 mg/dl. HbA1c and adverse events were recorded at baseline, week 12, and week 24. Form a total of 292 participants, 243 patients completed the study. HbA1c, FBS, postprandial glucose, total cholesterol, triglycerides, and low-density lipoprotein cholesterol, but not body mass index decreased during the study. The proportion of poorly controlled patients (HbA1C>9%) decreased from 172 (58.9%) to 39(13.4%), and 21(7.2%) during follow up. Controlled glycemia (HbA1C<7%) was detected in 7(2.4%), 48 (16.4%) and 56 (19.2%) of patients at baseline, week 12 and week 24. Hypoglycemia was reported in 5.1% and 3.4% of the participants in the week at 12 and 24, respectively. Patients felt more satisfied with their blood glucose control, timing and choices of meals, and hypo/hyperglycemic experiences. Insulin glargine initiation in people with uncontrolled type 2 diabetes on 2 OADs is associated with significant improvement in metabolic control.  Insulin glargine has good safety profile and well tolerated by the patients

Frequency of Latent Autoimmune Diabetes in Adults (LADA) in Phenotypically Type2 Diabetic Patients in Qom

Background: Latent autoimmune diabetes of adults (LADA) is a slowly progressive form of diabetes managed with diet and oral hypoglycemic agents before becoming insulin requiring. Islet autoantibodies are used for differential diagnosis between LADA and Type 2 diabetes mellitus. The aims of this study were to investigate the frequency of LADA using islet autontibodies in population with T2DM and characterize clinical and biochemical characteristics of them. Materials and methods: In this cross-sectional study, 86 T2DM patients aged between 28-67 years were tested for the presence of autoantibodies by ELISA technique. The Glutamic acid decarboxylase antibody, Islet Cell Antibody and Insulinoma Antigen2 Antibody were evaluated for diagnosis of LADA patients. Results: Of 86 T2DM, 35 (40.70%) were antibody positive and 51 (59.30%) persons were negative for any antibody. A significant difference was found between groups in age at study, insulin therapy, C- peptide levels and family history of autoimmune diseases. On the other hand, no significant difference was found between the two groups in other risk factors. Conclusions: Among our T2DM subjects, the number of LADA patients were not high. Also, multiple autoantibodies were more frequent than single autoantibodies in LADA patient