Transcutaneous Delivery of Dexamethasone Sodium Phosphate Via Microneedle-Assisted Iontophoretic Enhancement - A Potential Therapeutic Option for Inflammatory Disorders.

AIM: This study aimed to fabricate dexamethasone sodium phosphate loaded microneedle arrays (MNA) and investigate their efficiency in combination with iontophoresis for the treatment of hind paw oedema in rats. METHODS: Drug loaded polyvinyl alcohol, polyvinyl pyrrolidone and D-sorbitol-based MNA11 were fabricated by vacuum micromolding. Physicochemical, morphological, thermal, in-silico, in-vitro insertion ability (on parafilm) and drug release studies were performed. Ex-vivo permeation, in-vivo insertion and anti-inflammatory studies were performed in combination with iontophoresis. RESULTS: MNA11 displayed sharp-tipped projections and acceptable physicochemical features. Differential scanning calorimetry results indicated that drug loaded MNA11 were amorphous solids. Drug interacted with PVP and PVA predominately via hydrogen bonding. Parafilm displayed conspicuously engraved complementary structure of MNA11. Within 60 min, 91.50 ± 3.1% drug released from MNA11. A significantly higher i.e., 95.06 ± 2.5% permeation of drug was observed rapidly (within 60 min) from MNA11-iontophoresis combination than MNA11 i.e., 84.07 ± 3.5% within 240 min. Rat skin treated using MNA11 and MNA11-iontophoresis showed disruptions / microchannels in the epidermis without any damage to underlying anatomical structures. MNA11-iontophoresis combination led to significant reduction (83.02 ± 3.9%) in paw oedema as compared to MNA11 alone (72.55 ± 4.1%). CONCLUSION: MNA11-iontophoresis combination can act as a promising candidate to deliver drugs transcutaneously for treating inflammatory diseases.

Improved Transdermal Delivery of Rabies Vaccine using Iontophoresis Coupled Microneedle Approach.

AIM: This study was aimed to develop rabies vaccine incorporated microneedle (MN) patches and evaluate the immunogenicity of prepared formulations in combination with iontophoresis. METHODS: Patches comprising of polyvinyl pyrrolidone, hyaluronic acid and polyethylene glycol 400 were engineered by vacuum micromolding technique. Physical evaluation of patches included determination of folding endurance, % swelling and morphological features. In vitro release study was performed in skin simulant agarose gel using model drug (methylene blue) loaded patches. In vitro insertion ability was assessed using stratum corneum simulant parafilm. In vivo insertion study was performed in rats. Immunogenicity was evaluated in dogs by determining immunoglobulin G (IgG) and rabies virus neutralizing antibodies (RVNA) titer. RESULTS: Patches displayed uniformly distributed microprojections with pointed tips and smooth surface, ~ 70% swelling, remained intact for ~ 200 foldings and successfully penetrated the parafilm. The area covered by model drug across agarose gel was almost double following treatment with MN-iontophoresis combination (MNdi) compared to MN alone (MNdo). Histological examination of rat skin treated with vaccine laden MN (MNvo) and MN-iontophoresis combination (MNvi) confirmed the formation of grooves in epidermis without any damage to the deep vasculature. A ~ 73% and ~ 206% increase (compared to untreated counterpart) was observed in the IgG titer of MNvo and MNvi treated dogs, respectively. The RVNA titer was increased by ~ 1.2 and ~ 2.2 times (compared to threshold value) after MNvo and MNvi treatment, respectively. CONCLUSION: MN-iontophoresis combination provided relatively potent immunogenic response over the conventional intramuscular injection, hence, can be used for administering vaccines transcutaneously.

3'-(Phenyl alkynyl) analogs of abscisic acid: synthesis and biological activity of potent ABA antagonists.

We report here the synthesis and biological testing of 3'-(phenyl alkynyl) abscisic ABA analogs, a new class of potent ABA antagonists. These ABA analogs incorporate a rigid framework of eight carbon atoms attached at the 3'-carbon atom of ABA that prevents folding of the ABA analog-bound receptor required for ABA signalling. The two-step synthesis is based upon the optimized conversion of natural (S)-ABA to 3'-iodo ABA which can be coupled to phenyl acetylenes using Sonogashira conditions, or to styryl compounds through Suzuki chemistry. The parent 3'-(phenyl alkynyl) ABA analog 7 was obtained in 29% yield, 74% yield based on recovered starting material. In a lentil seed germination assay, compound 7 was found to have more potent activity than other known 3'-substituted ABA antagonists to date. In a structure activity study parasubstituted phenyl alkynyl analogs had comparable activity to the analog 7 while the 3'-styryl ABA 18 was only slightly less active. Analog 7 overcame ABA inhibition of germination and seedling growth in a wide range of mono and dicot plant species, including canola, lentil, soybean, rice, wheat, barley, cannabis and canary seed. 3'-(Phenyl alkynyl) ABA analogs have numerous potential practical agricultural applications including promoting ripening of crops, dormancy breaking of seeds and woody perennials, as well as promoting seed germination, and growth under stress conditions as demonstrated in this report.

Effects of Azilsartan, Aliskiren or their Combination on High Fat Diet-induced Non-alcoholic Liver Disease Model in Rats.

INTRODUCTION: In addition to its role in regulation of blood pressure, fluid and electrolyte homeostasis, the renin-angiotensin system (RAS) components were expressed in many other tissues suggesting potential roles in their functions. AIM: The present study aims to evaluate the protective effect aliskiren, when used alone or in combination with azilsartan against high fat diet-induced liver disease in rats. MATERIAL AND METHODS: Thirty-two Wistar male rats, weighing 150-200 gm were allocated evenly into four groups and treated as follow: group I, rats were fed a specially formulated high-fat diet for 8 weeks to induce non-alcoholic liver disease and considered as control group; groups II, III and IV, the rats were administered azilsartan (0.5 mg/kg), aliskiren (25 mg/kg) or their combination orally via gavage tube once daily, and maintained on high fat diet for 8 weeks. The possible treatment outcome was evaluated through measuring serum levels of glucose, insulin, lipid profile, TNF-α, IL-1ß and liver enzymes. Additionally, the liver tissue contents of glycogen and lipids and histological changes were also evaluated. RESULT: The results showed that azilsartan significantly improves the studied markers greater than aliskiren, and their combination o has no additive or synergistic effects on the activity of each one of them. CONCLUSION: Both azilsartan and aliskiren protects the rats against high-fat diet induced NAFLD with predominant effects for the former, and their combination showed no beneficial synergistic or additive effects.

Coronary microvascular rarefaction and myocardial fibrosis in heart failure with preserved ejection fraction.

BACKGROUND: Characterization of myocardial structural changes in heart failure with preserved ejection fraction (HFpEF) has been hindered by the limited availability of human cardiac tissue. Cardiac hypertrophy, coronary artery disease (CAD), coronary microvascular rarefaction, and myocardial fibrosis may contribute to HFpEF pathophysiology. METHODS AND RESULTS: We identified HFpEF patients (n=124) and age-appropriate control subjects (noncardiac death, no heart failure diagnosis; n=104) who underwent autopsy. Heart weight and CAD severity were obtained from the autopsy reports. With the use of whole-field digital microscopy and automated analysis algorithms in full-thickness left ventricular sections, microvascular density (MVD), myocardial fibrosis, and their relationship were quantified. Subjects with HFpEF had heavier hearts (median, 538 g; 169% of age-, sex-, and body size-expected heart weight versus 335 g; 112% in controls), more severe CAD (65% with ≥1 vessel with >50% diameter stenosis in HFpEF versus 13% in controls), more left ventricular fibrosis (median % area fibrosis, 9.6 versus 7.1) and lower MVD (median 961 versus 1316 vessels/mm(2)) than control (P<0.0001 for all). Myocardial fibrosis increased with decreasing MVD in controls (r=-0.28, P=0.004) and HFpEF (r=-0.26, P=0.004). Adjusting for MVD attenuated the group differences in fibrosis. Heart weight, fibrosis, and MVD were similar in HFpEF patients with CAD versus without CAD. CONCLUSIONS: In this study, patients with HFpEF had more cardiac hypertrophy, epicardial CAD, coronary microvascular rarefaction, and myocardial fibrosis than controls. Each of these findings may contribute to the left ventricular diastolic dysfunction and cardiac reserve function impairment characteristic of HFpEF.

Natural Polyphenols in Cancer Chemoresistance.

Resistance to chemotherapy remains a major impediment to the management of most types of cancer. Both intrinsic and acquired drug resistance are mediated by several cellular and molecular mechanisms, including alternative growth-signaling pathways unaffected by specific therapies, alterations in the tumor microenvironment (e.g., hypoxia and angiogenesis), and active transport of drugs out of the cell. Epidemiological studies have validated an inverse correlation between the consumption of dietary polyphenols and the risk of cancer, which has been attributed to polyphenol antioxidant capacity and their potential to inhibit activation of procarcinogens, cancer cell proliferation, metastasis, and angiogenesis, and inhibition or downregulation of active drug efflux transporters. Moreover, polyphenols can induce apoptosis in cancer cells and modulate immune responses and inflammatory cascades. Augmentation of the efficacy of chemotherapy and prevention of multidrug resistance are other important effects of dietary polyphenols that deserve further research, especially after the discovery of tight "crosstalk" between aberrant growth signaling and metabolic dysfunction in cancer cells. In this review, we cover what is currently known about the role of natural polyphenolic compounds in overcoming cancer drug resistance mediated by diverse primary and secondary resistance mechanisms.

Correlation between glycated haemoglobin levels and random blood glucose.

BACKGROUND: Glycated haemoglobin or glycosylated haemoglobin (HbA1c) is a form of haemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Levels of HbA1c represent the average blood glucose levels of diabetic patients over the previous 120 days. The objective of this study was to see the correlation between HbA1c levels and random glucose levels. METHODS: This descriptive study included 106 randomly selected patients with known diabetes from the outpatients department. Random sugar levels were measured by using venous blood samples. HbA1c levels were measured in venous blood by BIO-RAD D-10 HPLC Method. Data were recorded on a proforma. Pearson's correlation was applied to find out any significant correlation between the glycated haemoglobin levels and the random blood glucose levels. Results were plotted onl simple scatter plot and p < 0.01 was considered significant. CONCLUSIONS: A significant linear positive correlation exists between levels of HbA1c and random blood sugar.

Cost-Effectiveness Analysis of the Culturally Developed Diabetes Self-Management Education and Support Program among Type 2 Diabetes Mellitus Patients in Iraq.

Background: Diabetes mellitus (DM) is a chronic disease associated with a major economic burden on persons, health care systems, and countries. Diabetes self-management education and support (DSME(S)) programs are highly effective method in the management of T2DM patients. Therefore, this study aimed to determine the cost-effectiveness of the developed culturally-specific DSME(S) program regarding glycemic control, lipid profile, and body weight for Iraqi type 2 DM patients. Methods: A randomized controlled clinical trial design was used to assess the cost-effectiveness of the culturally-specific DSME(S) program from the perspective of health care providers. In the cost-effectiveness analysis (CEA), cost per patient and clinical outcomes over 6 months were compared between the intervention and control group. Incremental cost-effectiveness ratios (ICERs) were expressed as cost per unit improvement in glycosylated hemoglobin (HbA1c), fasting blood glucose (FBG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high density lipoprotein- cholesterol (HDL-C), systolic blood pressure (SBP), diastolic blood pressure (DBP), and body weight. Results: The effectiveness of most outcomes was better in the intervention group compared with the control group. The ICER per unit improvement in HbA1c, SBP, DBP, serum TC, and TG levels was <1 of the minimum CET compared with the control group, thus meeting the definition of being highly cost-effective. Conclusion: The currently developed DSME(S) was cost effective method to improve glycemic control, blood pressure, TC, and TG for T2DM patients in Iraq.

Combined Coronary Orbital Atherectomy and Intravascular Lithotripsy for the Treatment of Severely Calcified Coronary Stenoses: The First Case Series.

OBJECTIVE: Severely calcified coronary stenoses remain a significant challenge during contemporary percutaneous coronary intervention (PCI), often requiring advanced therapies to circumvent suboptimal lesion preparation and major adverse cardiac events (MACEs). Recent reports suggest combined coronary atherectomy and intravascular lithotripsy (IVL) may achieve superior preparation of severely calcified coronary stenoses during PCI. We sought to evaluate the safety and utility of combined orbital atherectomy (OA) and IVL for the modification of coronary artery calcification (CAC) prior to drug-eluting stent (DES) implantation in PCI. METHODS: We performed a retrospective review of all patients who underwent coronary OA and IVL within a single PCI procedure at our institution. The primary outcome was procedural success, defined as successful DES implantation with a residual percent diameter stenosis of <30% and Thrombolysis in Myocardial Infarction (TIMI) 3 flow following PCI without occurrence of in-hospital MACE (cardiac death, myocardial infarction, or target-vessel revascularization). MACE was additionally assessed at 30 days post intervention. RESULTS: Eight patients underwent combined coronary OA and IVL within a single PCI procedure. The mean percent diameter stenosis prior to intervention was 80.5 ± 8.3%, with a mean calcific arc of 338 ± 42°. Procedural success was achieved in 7 of 8 cases (87.5%). Both in-hospital and 30-day MACE rates were 0%. CONCLUSION: We report the safe and effective use of combined coronary OA and IVL for the preparation of severely calcified coronary stenoses during PCI. Through their distinct yet complementary mechanisms of action, the combined use of these therapies may achieve superior preparation of severely calcified coronary stenoses during PCI.

Adverse effects associated with the use of N95 mask among health-care workers at the COVID-19 care units: A cross-sectional study in Sulaimani city, Iraq.

BACKGROUND: Health-care workers have to use the N95 mask as a part of the protection kit during the COVID-19 pandemic. The adverse effects of such practice are not fully elucidated. The study aims to evaluate negative impacts of N95 face masks on health-care personnel at COVID-19 care units. MATERIALS AND METHODS: One hundred and twenty-two health-care workers (aged 20-58 years) from various health-care settings in Sulaimani, Iraq, from January to August 2020, were enrolled in this prospective, cross-sectional study. The physiological variables (blood pressure, heart rate, and oxygen saturation) were recorded before putting on the N95 mask and postremoval of the mask. The incidence of adverse effects such as headache, difficulty breathing, redness, irritation, and dizziness were also reported as a number and percent at the end of the work shift. RESULTS: There was a statistically significant difference in the physiological parameters after removal of the mask compared with baseline. Only diastolic pressure was significantly lower in those working >6 h when compared to those working 1-6 h. The changes in physiological markers were poorly and nonsignificantly associated with the duration of wearing the mask. Moreover, 67.2%-70.5% of the participants complain of headaches and breathing difficulties, while 45.9%-51.6% reported signs of itching, redness, and irritation. However, health-care workers who put on the face mask >6 h showed signs of headache, breathing difficulties, and itching at the exposed areas higher than those working for 1-6 h. CONCLUSION: N95 mask negatively impacts the physiological variables of health-care providers. The adverse effects may lead to excessive exhaustion after long shifts in the intensive care unit during treatment of COVID-19 patients.

Adjuvant use of melatonin for treatment of fibromyalgia.

Fibromyalgia syndrome (FMS) is a chronic musculoskeletal disorder characterized by generalized muscular pain accompanied by fatigue and tenderness at specific anatomic sites called tender points. Although preliminary evidence indicates that melatonin may be effective in treating the pain associated with FMS, no definitive evidence supports this claim. This study was designed to evaluate the significance of using different doses of melatonin, alone or in combination with fluoxetine for the management of FMS. A double-blind, placebo-controlled clinical study was performed on 101 patients (95 women and 6 men) who fulfilled the criteria of the American College of Rheumatology (ACR) of FMS. The patients were randomized into four groups: group A (24 patients) treated with 20 mg/day fluoxetine alone; group B (27 patients) treated with melatonin 5 mg alone; group C (27 patients) treated with 20 mg fluoxetine plus 3 mg melatonin; group D (23 patients) treated with 20 mg fluoxetine plus 5 mg melatonin. Both drugs were given once daily in the morning and night time, respectively, for 8 wk. Each patient was clinically evaluated through direct interview with the patients using the Fibromyalgia Impact Questionnaire (FIQ) at zero time and after 8 wk. Using melatonin (3 mg or 5 mg/day) in combination with 20 mg/day fluoxetine resulted in significant reduction in both total and different components of FIQ score compared to the pretreatment values. In conclusion, administration of melatonin, alone or in a combination with fluoxetine, was effective in the treatment of patients with FMS.

Frequencies of congenital anomalies among newborns admitted in nursery of Ayub Teaching Hospital Abbottabad, Pakistan.

BACKGROUND: Congenital anomalies play a significant role in perinatal and neonatal morbidity and mortality. The frequency of these congenital anomalies varies in different populations. Objective of this study was to find out the frequencies of congenital anomalies admitted in nursery of Ayub Teaching Hospital, Abbottabad. METHODS: In this descriptive, cross-sectional study all patients admitted in NICU from October 2009 to January 2010 were included. The patients were examined for major and minor congenital anomalies. The observations were recorded in tabulated form. RESULTS: A total of 2,360 patients were admitted in NICU during the study period. One hundred patients were noted to have congenital anomalies. The most frequent anomalies involved the central nervous system (31%). Meningomyelocele was the commonest defect (71%, 22 out of 31 cases of CNS defects), among these males were more (77%, 17 out of 22 of meningomyelocele cases) than females (14 out of 31). These were followed by patients born with congenital heart defects (16%). Patients with urogenital anomalies (6%) were all male except for one who had ambiguous genitalia. CONCLUSIONS: Cases of meningomyelocele were the commonest presenting congenital anomaly. More stress should be laid on the role of peri-conceptional vitamin supplementation like folic acid for the primary prevention of congenital defects.

Anti-inflammatory activity of telmisartan in rat models of experimentally-induced chronic inflammation: Comparative study with dexamethasone.

Recently, significant progress has been made through the application of peroxisome proliferator activated receptor-γ (PPAR-γ) agonists as anti-inflammatory drugs that are efficacious, relatively free of side effects, and can be used effectively for a long time. The present study was designed to evaluate the dose-response relationship of the anti-inflammatory activity of telmisartan in rat models of chronic inflammation. The study protocol includes four stages: First stage: 48 rats were allocated into eight groups, each containing six rats, for the study of the anti-inflammatory activity of different doses of telmisartan in rat model of formaldehyde-induced chronic inflammation. Second stage: six rats were used to study the anti-inflammatory activity of telmisartan (1.5 mg/kg) in combination with dexamethasone (0.5 mg/kg) in the same model. Third stage: 48 rats were allocated into eight groups, each containing six rats, for the study of the anti-inflammatory activity of telmisartan in rat model of cotton pellet-induced granuloma. Fourth stage: six rats were used to study the anti-inflammatory activity of telmisartan (1.5 mg/kg) when used as adjuvant with dexamethasone (0.5 mg/kg) in the same model. Telmisartan in a dose-dependent pattern (0.1, 0.2. 0.4, 0.6, 1.5, 3 mg/kg) significantly suppressed inflammation in rat models of formaldehyde-induced chronic inflammation and cotton pellet-induced granuloma. When combined with dexamethasone, telmisartan (1.5 mg/kg body weight) significantly suppressed inflammation in both models, which is significantly higher than all of the effects produced by other approaches of treatment when telmisartan used alone. In conclusion, telmisartan decreased formaldehyde-induced chronic inflammation and cotton-pellet induced granuloma in rats in a dose-dependent pattern. Therefore, it may be considered as a potential treatment for chronic inflammatory conditions in human.

Free radical scavenging activity of silibinin in nitrite-induced hemoglobin oxidation and membrane fragility models.

Free radical formation in heme proteins is recognized as a factor in mediating the toxicity of many drugs. Xenobiotics and drug therapy-related toxicity, due to oxidative modification of hemoglobin (Hb), has been attributed in part to the uncontrolled oxidative reactions. A variety of antioxidant strategies to ameliorate potential oxidative damage in vivo have been suggested. The present study was designed to evaluate the dose-response relationship of the free radical scavenging properties of silibinin dihemisuccinate (SDH) in nitrite-induced Hb oxidation in vitro and in vivo. Different concentrations of SDH were added, before and after different intervals of inducing Hb oxidation in erythrocytes lysate, and formation of methemoglobin (MetHb) was monitored spectrophotometrically; the same approach was utilized to evaluate the effect of the same doses of SDH on the integrity of erythrocytes after induction of hemolysis. Moreover, the most effective dose of SDH was administered in rats before challenge with toxic dose of sodium nitrite, and MetHb formation was monitored as mentioned before. The results showed that in both in vitro and in vivo models, SDH successfully attenuates Hb oxidation after challenge with sodium nitrite; this protective effect was not related to the stage of the catalytic stage of Hb oxidation, though the effect was more prominent when the compound was administered before nitrite. In conclusion, SDH can effectively, in concentration-dependent pattern, attenuate sodium nitrite-induced Hb oxidation and maintain integrity of red blood cells both in vitro and in vivo.

Validation of newly developed culturally specific diabetes self-management education and support program for Iraqi type 2 diabetes mellitus patients.

BACKGROUND: Diabetes self-management (DSM) is the cornerstone in diabetes mellitus (DM) management. Unfortunately, the practice of DSM by Iraqi type 2 DM (T2DM) patients is poor that mainly resulted from their poor knowledge about the required DSM behaviors. This lack of knowledge may be attributed to the lack of DSM education and support (DSMES) program in Iraq. Thus, this study was conducted with aim of developing and validating a culturally specific DSMES program for Iraqi T2DM patients. MATERIALS AND METHODS: The development and validation of the DSMES program was done according to the Hilda Taba model. Content validity of the program was done by a panel of 6 health-care experts in management of Iraqi DM patients. Face validity was confirmed by conducting a pilot study for six adults with uncontrolled T2DM at the National Diabetes Center, Baghdad, Iraq. Both the experts and patients were asked to evaluate the developed program in regard to its contents, design, and supporting material (booklet). The evaluation was done by filling in a questionnaire that based on a 5-point scale. Items with a score ≥4 by <70% of the experts and patients were subjected to revision and further assessment. RESULTS: No total disagreement for any item was expressed by all participants (experts and patients). Content and face validity was ensured through obtaining a positive feedback from all participants at which all items about the program had scores of ≥4 by at least 75% of participants. CONCLUSION: The developed culturally based DSMES program is highly suitable for educating Iraqi T2DM patients.

Correlation between serum pro inflammatory cytokines and clinical scores of knee osteoarthritic patients using resveratrol as a supplementary therapy with meloxicam.

OBJECTIVE: The objective of this study was to analyze the associations between the pro-inflammatory markers with the clinical outcomes of knee osteoarthritis (OA) in patients using resveratrol as an add-on treatment with meloxicam. MATERIALS AND METHODS: This was a double-blind controlled clinical investigation, with 110 eligible patients with OA assigned randomly to receive 15 mg a day meloxicam with either resveratrol 500 mg a day or placebo for 90 days. The standard tools for assessment of pain severity and physical functions were utilized. The tumor necrosis factor-α (TNF-α), interleukin-1ß (IL-1ß), and IL-6 in the blood were evaluated. Spearman's correlation coefficient test was used to determine the significance of correlations. RESULTS: The regression analysis to determine the correlation between reductions of the inflammatory biomarkers with the amelioration of the clinical scores showed a nonsignificant weak correlation between these variables. Total clinical scores of each assessment tool that was used "Knee Injury and OA Outcome Score (KOOS) and WOMAC" displayed a weak and nonsignificant correlation with TNF-α, IL-1ß blood level. The Spearman's correlation shows a relatively nonsignificant association between IL-6 levels and KOOS, WOMAC, and Visual Analog Scale scores after incorporating resveratrol as an adjuvant with meloxicam for 90 days. CONCLUSION: A weak and nonsignificant correlation between serum biomarkers and the clinical outcomes has been suggested in patients with painful knee OA treated with meloxicam and resveratrol.

Effectiveness of Diabetes Self-Management Educational Programs For Type 2 Diabetes Mellitus Patients In Middle East Countries: A Systematic Review.

AIM: This review study aimed to determine the effectiveness and factors affecting the success of DSME programs in T2DM patients living in ME countries. METHODS: An extensive manual literature search was conducted using PubMed and Google Scholar for clinical trials assessing the effect of diabetes self-management education (DSME) for type 2 diabetes mellitus patients in Middle East countries. Information from the included studies was summarized in relation to study population, sample size, duration of follow-up, characteristics of DSME program, and follow-up time, besides in addition to parameters used in assessment, results, and conclusions. The risk of bias in the included studies was assessed using the Cochrane risk of bias tool. The effect of DSME on clinical and patient-reported outcomes was measured by calculation of the percentage of DSME studies that produce a significant improvement in these outcomes for patients in intervention group as compared to those in control group. Additionally, the effect of DSME on each clinical outcome was assessed by calculating the mean for the absolute effect of DSME on that outcome. RESULTS: Twelve studies were included in this review. Heterogeneity was found among included studies in terms of DSME program characteristics, the enrolled patients, duration of follow-up, assessment methods, and obtained outcomes. All clinical glycemic outcomes (glycosylated hemoglobin, fasting, and non-fasting blood glucose), lipid profile (total cholesterol and triglycerides), and body mass index were significantly improved for patients in intervention group as compared to those in control group in at least 60% of the included studies. All patients' reported outcomes (medication adherence, self-management behavior, knowledge, self-efficacy, health belief and quality of life) were significantly improved by the DSME program. CONCLUSION: DSME programs are highly effective in improving glycemic control, lipid profile and BMI, and modestly effective in improving BP. Thus, they can reduce the risks of developing diabetes complications. Patient diabetes knowledge, DSM behaviors, adherence to medications, self-efficacy, and quality of life can also be significantly improved by DSME.

The Development and Validation of Quality of Life Scale for Iraqi Patients with Type 2 Diabetes Mellitus.

BACKGROUND AND AIM: The current trend for determining the effectiveness of new treatment or services provided for diabetes mellitus (DM) patients is based on assessing the improvement in both glycemic control and the patient quality of life. Many scales have been developed to assess quality of life among DM patients, but unfortunately, no one can be considered as gold standard. Therefore, this study aimed to develop and validate a brief and specific scale to assess quality of life among Iraqi type 2 DM patients. METHODS: An extensive literature review was done using Google-Scholar and PubMed to find out scales that utilized to assess quality of life among DM patients. Four relevant scales, three diabetes specific and one general, were selected. The selected scales were carefully evaluated to find out domains that are commonly used to assess quality of life and then the items within the selected domains were reviewed to choose relevant and comprehensive items for Iraqi type 2 DM patients. Ten items were selected to formulate the quality of life scale for Iraqi DM patients (QOLSID). The content validity of QOLSID was established via an expert panel. For concurrent validity QOLSID was compared to glycosylated hemoglobin (HbA1C). For psychometric evaluation, a cross sectional study for 103 type 2 DM patients was conducted at the National Diabetes Center, Iraq. Test-retest reliability was measured by re-administering QOLSID to 20 patients 2-4 weeks later. RESULTS: The internal consistency of the QOLSID was 0.727. All items had a corrected total-item correlation above 0.2. There was a negative significant correlation between QOLSID score and the HbA1C level (-0.518, P = 0.000). A significant positive correlation was obtained after re-testing (0.967, P = 0.000). CONCLUSION: The QOLSID is a reliable and valid instrument that can be used for assessing quality of life among Iraqi type 2 DM patients.

Association of Visceral Adiposity Index, Lipid Profile, and Serum Leptin with Glucose Intolerance Risks in Iraqi Obese Patients: A Cross-sectional Study.

AIMS: The aim of this study was to evaluate the possibility of using visceral adiposity index (VAI), serum leptin, and lipid profile as indicators of impaired glucose tolerance in Iraqi obese patients. SUBJECTS AND METHODS: A cross-sectional study was performed in Iraqi obese patients of both sexes. Body mass index (BMI), waist circumference, hip circumference, triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), VAI, waist-to-hip ratio (WHR), serum leptin, and 2-h glucose tolerance test (2-h GT) were determined and compared with those of healthy non-obese control group. A correlation analysis was performed to determine the strength of association between the studied markers. Data were adjusted to determine gender differences in this regard. STATISTICAL ANALYSIS: Kolmogorov-Smirnov, Shapiro-Wilk analyses, Mann-Whitney U test, and unpaired t test were used for the two-group comparisons once applicable. Pearson's and Spearman's correlation analyses were used to measure the relationship levels between the studied variables. RESULTS: A total of 144 obese patients were included; the mean age was 37.11 ± 8.2 years and 92 (63.9%) were females. Compared with non-obese subjects, the participants had significantly higher levels of BMI, WC, WHR, VAI, TG, leptin, and 2-h GTObese male subjects had significantly higher values of body weight, WC, HC, VAI, and TG compared with obese females. Elevated 2-h GT was significantly associated with VAI (r = 0.291, P = 0.0004), TG (r = 0.319, P = 0.0001), and LDL-C/HDL-C ratio (r = 0.435, P < 0.0001) in the obese patients only. CONCLUSIONS: The results provide evidence that VAI, TG, and LDL-C/HDL-C ratio can be suggested as potential markers for the risk assessment of impaired glucose tolerance in Iraqi obese patients.