Metabolic control and incidence of hypoglycaemia, hospitalisation and complications among Saudi patients with type 2 diabetes initiating second-line therapy: an analysis of the Saudi Arabia data from the DISCOVER Observational Study programme.

OBJECTIVES: The aim of the global DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings (DISCOVER) Study was to provide a comprehensive real world assessment of the treatment pattern changes for patients with type 2 diabetes. The aim of this analysis was to assess the metabolic control and the annual incidence of hypoglycaemia, hospitalisation and complications among Saudi patients with type 2 diabetes initiating second-line therapy. DESIGN: This study is part of the observational, longitudinal, prospective multinational DISCOVER Study. SETTING: Governmental and private health sectors from different regions within Saudi Arabia. PARTICIPANTS: The study recruited 519 patients with type 2 diabetes aged ≥18 years who were switching to second-line therapy. Patients who were already using insulin/injectable agents, patients with type 1 diabetes, pregnant women, and patients undergoing dialysis or with a history of renal transplantation were excluded. PRIMARY AND SECONDARY OUTCOME MEASURES: Metabolic control among patients with type 2 diabetes mellitus; fear of hypoglycaemia; quality of life; and the incidence of complications, hypoglycaemic events and/or hospitalisations. Data were analysed using descriptive statistics. RESULTS: A total of 519 patients were recruited with a mean age of 52.4±11 years. Of these participants, 54.7% were male and 45.3% were female. The incidence of hypoglycaemia was 56.72/1000 patient-years. The Hypoglycemia Fear Survey II showed a significant increase in patient worry related to hypoglycaemia from 6.4±11.9 at baseline to (p=0.0446) at the 36-month follow-up. The incidence of hospitalisation was 30.81/1000 patient-years. There was a moderate improvement in glycaemic control, represented as an HbA1c reduction from 8.8% at baseline to 8.2% at the 36-month follow-up. The incidence of macroangiopathy was 24.51/1000 patient-years and the incidence of microvascular complications such as retinopathy and albuminuria was 47.00/1000 patient-years and 221.71/1000 patient-years, respectively. The mean score of fear of hypoglycaemia showed an increase with 13.0±21.5 at baseline to 16.1±22.2 at the 36-month follow-up. When assessing the patients' quality of life, there was an improvement in the mental component score from 47.4±9.1 at baseline to 53.0±6.7 at the 36-month follow-up. CONCLUSIONS: Treatment intensification decisions should be made individually, weighing the benefit of good glycaemic control against the risk of hypoglycaemia. TRIAL REGISTRATION NUMBER: NCT02322762 and NCT02226822.

Fasting Ramadan in patients with T1DM - Saudi Arabia versus other countries during the COVID-19 pandemic.

BACKGROUND AND AIMS: To compare Saudi Arabia with other countries regarding patient attitudes towards fasting Ramadan and complications related to fasting during the COVID-19 pandemic. METHODS: Data collected from Saudi Arabia and 12 other mostly Muslim majority countries, via physician administered questionnaire within post Ramadan 2020. RESULTS: 1485 Type1 diabetes (T1DM) patients analyzed; 705 (47.5%) from Saudi Arabia vs. 780 (52.5%) from other countries. 1056 (71.1%) fasted Ramadan; 636 (90.2%) of Saudi patients vs. 420 (53.8%) of other countries. Experiencing Ramadan during the COVID-19 pandemic did not affect the Saudi T1DM patients' decision to fast while it significantly influenced their decision in other countries (1.4 vs 9.9%, P < 0.001). More Saudi patients needed to break the fast due to a diabetes related complication compared to other countries (67.4% vs. 46.8%, p=<0.001). The mean number of days fasted in Saudi and other countries was 24 ± 7 and 23 ± 8 days respectively. Hypoglycemic events were more common among Saudi patients during Ramadan compared to other countries 72% and 43.6% (p < 0.001) respectively. There was a significant difference in timing; the largest peak for Saudi Arabia patients was after dawn (35% vs 7%, p < 0.001), while it was pre-sunset for the other countries (23 vs 54%, p = 0.595). Day time-hyperglycemia was also more common among Saudi patients (48.6% vs. 39%, p < 0.001), however it was a less likely cause to break the fast (25.6% vs 38.3%, p < 0.001). CONCLUSION: Observing the fast of Ramadan is extremely common among Saudi T1DM patients compared to other Muslim countries and was not affected by the COVID-19 pandemic. However, it was associated with higher frequency of hypoglycemic and hyperglycemic episodes.

Longitudinal assessment of the quality of life and patterns of antidiabetic medication use in patients with type 2 diabetes, Saudi Arabia perspective, DISCOVER study.

OBJECTIVES: Patients with type 2 diabetes nowadays have a wide range of new antidiabetic medications with better efficacy and safety. Physicians' attitude toward selecting antidiabetic medications to reach targeted glycemic control and better quality of life (QOL) has not been studied prospectively. The global DISCOVER study aims to comprehensively provide a real-world assessment of the treatment pattern changes for patients with type 2 diabetes, in addition to QOL assessment. The Kingdom of Saudi Arabia was one of the countries participating in the DISCOVER study program. METHODS: This study is a part of the prospective, longitudinal multinational DISCOVER study conducted in 38 countries including Saudi Arabia, a country facing an epidemic of type 2 diabetes, recruited 519 adult patients with type 2 diabetes with a mean age of 52.4 ± 11 years, where, they were followed up for three years period, where 477 patients completed the follow-up period. The clinical, biochemical, and patient lifestyle data were assessed periodically during the study period. DISCOVER study is registered with ClinicalTrials.gov identifiers: NCT02322762. RESULTS: The most frequently used antidiabetic medications (ADMs) initially and during the follow-up were biguanides (metformin) and sulfonylureas (gliclazide, glibenclamide, glimepiride, glipizide, and glyclopyramide). Insulin (premix Insulin, basal insulin, and basal/bolus insulin) and dipeptidyl peptidase-4 (DPP-4) inhibitors (sitagliptin, vildagliptin, saxagliptin, and linagliptin) were the most frequent second and alternative of therapy. Other medications namely thiazolidinediones (TZds) (pioglitazone and rosiglitazone), incretins (exenatide and liraglutide), and Sodium-glucose co-transporter-2 (SGLT-2) inhibitors (canagliflozin) were used at a lesser rate. Drug availability, efficacy, and safety were the main determinants for choosing antidiabetic medications. The physical component score of the QOL had shown a significant decrease, while the mental component score has demonstrated an increase in QOL using SF36v2 Survey. CONCLUSIONS: There is an increasing trend of using of newly available ADMs, mainly DPP-4 inhibitors. The major limitation of ADMs use is related to efficacy, availability, and safety. This warrant taking all the measures to overcome these limitations through adopting a multidisciplinary team approach for close monitoring of the patients and any unfavorable side effects. Additionally, global insurance coverage for all patients with type 2 diabetes could be a solution for the drug availability factor.

Evaluation of 34 Cytokines and Vitamin D Status Reveal A Sexually-Dimorphic Active Immune Response to SARS-CoV-2.

Background: Several observational studies have inconsistently demonstrated that vitamin D deficiency is a risk factor for coronavirus disease-19 (COVID-19) infection and severity. Discrepancies in results may partially be explained by the individuals' immune profiles, which are modulated, in varying degrees, by vitamin D status and sex hormones. Methods: In this study we evaluated the differences and associations of serum levels of 25(OH)D with 34 cytokines in 220 adults (82 controls (41 males; 41 females) and 138 SARS-CoV-2 patients (79 males and 59 females)) with and without COVID-19. Results: Serum 25(OH)D levels were significantly lower in the SARS-CoV-2 group than in the controls. Serum IP-10, MCP-1, CRP, IFNγ, IL-10, IL-13, IL-17α, IL-23, and IL-6 were significantly higher in COVID-19 patients compared to controls. Serum levels of VEGF, IFNγ, IL-13, and IL-5 were significantly higher in male patients than in females. 25(OH)D was significantly correlated with EFG (R = 0.39, p < 0.05) and IL-15 (R = 0.39, p < 0.05) in male patients, while it was inversely correlated with CRP (R = −0.51, p < 0.05) in female patients. Conclusions: Altered levels of cytokines, chemokines, and vitamin D were observed in SARS-CoV-2 adult patients. These expressions were sexually dimorphic and thus highlight the sex-specific nature of the active immune response following SARS-CoV-2 infection.

Risk factors associated with in-hospital mortality patients with COVID-19 in Saudi Arabia.

Risk factors for in-hospital mortality of COVID-19 patients in Saudi Arabia have not been well studied. Previous reports from other countries have highlighted the effect of age, gender, clinical presentation and health conditions on the outcome of COVID-19 patients. Saudi Arabia has a different epidemiological structure with a predominance of young population, which calls for separate study. The objective of this study is to assess the predictors of mortality among hospitalized patients with COVID-19 in Saudi Arabia. This is a retrospective observational cohort study of hospitalized adult COVID-19 patients at two tertiary hospitals in Saudi Arabia between May to July 2020. Electronic charts were retrospectively reviewed comparing survivors and non-survivors in terms of demographic and clinical variables and comorbid conditions. A total of 564 hospitalized patients with COVID-19 were included in the study. The overall in-hospital mortality rate was 20%. The non-survivors were significantly older than survivors (59.4 ± 13.7 years and 50.5 ± 13.9 years respectively P< 0.001). Diabetes mellitus, hypertension, heart failure and ischemic heart disease were more prevalent among non-survivors (P< 0.001). The mean values of glycosylated hemoglobin HgA1C, D-dimer, ferritin, lactate dehydrogenase LDH, Alanin aminotransferase ALT and creatinine were significantly higher among non-survivors (P < 0.05). Multivariate logistic regression analysis revealed that age (aOR = 1.04; 95% CI 1.02-1.08; P < 0.01), chronic kidney disease (aOR = 4.04; 95% CI 1.11-14.77; P < 0.05), acute respiratory distress syndrome ARDS (aOR = 14.53; 95% CI 5.42-38.69; P < 0.01), Mechanical Ventilation (aOR = 10.57; 95% CI 5.74-23.59; P < 0.01), Shock (aOR = 3.85; 95% CI 1.02-14.57; P < 0.05), admission to intensive care unit (ICU) (aOR = 0.12; 95% CI 0.04-0.33; P < 0.01) and length of stay (aOR = 0.96; 95% CI 0.93-0.99; P < 0.05) were significant contributors towards mortality. The in-hospital mortality rate of COVID-19 patients admitted to tertiary hospitals in Saudi Arabia is high. Older age, chronic kidney disease and ARDS were the most important predictors of mortality.

Parents' perceptions of quality of life of their children and adolescents with type 1 diabetes during Ramadan fasting in Riyadh.

This study aimed to assess parents' perceptions of the quality of life (QoL) of their children with type 1 diabetes (T1D) during Ramadan fasting (RF). In this cross-sectional study, an Arabic-translated version of the standard diabetes-specific QoL questionnaire (PedsQL™ version 3.0) was used to compare perceptions of QoL during Ramadan month (Rm) versus non-Rm (NRm) of parents of children/adolescents with T1D from two tertiary hospitals in Riyadh. We used regression analysis to compare proxies (parents' reports) of their perceptions on their children/adolescents' QoL during Rm compared to NRm. A sample of 61 proxies (parents') of two age groups T1D offspring: 8-12 years (41%) and 13-18 years (59%) who reported their perceptions of their children/adolescents QoL during Rm were matched by children/adolescents' age and gender of 61 proxies in NRm. QoL scores of all domains were significantly lower in Rm compared to NRm; p < 0.0001, however, worries domain showed no statistical differences p = 0.052 in a regression analysis. The total aggregate median (IQR) in Rm was 850 (612-1,062) compared to 1,750 (1,475-2,062) in NRm, p < 0.001. The highest differences in NRm and Rm median scores were observed in communications (OR = 3.64; 95% CI 2.7-5.57) and treatment adherence (OR = 3.09; 95% CI 2.48-3.84) domains especially in the age of 13-18 years. Parents of adolescent boys, who are usually risk-takers and more exposed to outdoor activities, perceived lower QoL for them. Parents of adolescents with T1D perceived a lower QoL for their children during RF, especially in the treatment adherence and communication domains.

The application of FRAX in Saudi Arabia.

Assessment and treatment pathways based on age-specific intervention thresholds in Saudi Arabi can be used to identify patients at high risk of fracture and avoid unnecessary treatment in those at low fracture risk. PURPOSE: Intervention thresholds for the treatment of osteoporosis have historically been based on the measurement of bone mineral density. The aim of the present study was to explore treatment paths and characteristics of women eligible for treatment in Saudi Arabia based on fracture probabilities derived from FRAX®. METHODS: The approach to the setting of intervention and assessment thresholds used the methodology adopted by the National Osteoporosis Guideline Group for FRAX-based guidelines in the UK but based on the epidemiology of fracture and death in Saudi Arabia. The methodology was applied to women age 40 years or more drawn from a tertiary referral population for skeletal assessment. Missing data for the calculation of FRAX was simulated using data from the referral and FRAX derivation cohorts. RESULTS: Intervention thresholds expressed as a 10-year probability of a major osteoporotic fracture ranged from 2.0% at the age of 50 years increasing to 7.6% at the age of 70 years. A total of 163 of 1365 women (11.9%) had a prior fragility fracture and would be eligible for treatment for this reason. An additional 5 women were eligible for treatment in that MOF probabilities lay above the upper assessment threshold. A BMD test would be recommended for 593 women (43.4%) so that FRAX could be recalculated with the inclusion of femoral neck BMD. Of these, 220 individuals would be eligible for treatment after a BMD test and 373 women categorised at low risk after a BMD test. CONCLUSION: Probability-based assessment of fracture risk using age-specific intervention thresholds was developed for Saudi Arabia to help guide decisions about treatment.

Effects of a 2-Week 5000 IU versus 1000 IU Vitamin D3 Supplementation on Recovery of Symptoms in Patients with Mild to Moderate Covid-19: A Randomized Clinical Trial.

OBJECTIVE: Vitamin D deficiency has been associated with an increased risk of COVID-19 severity. This multi-center randomized clinical trial aims to determine the effects of 5000 IU versus 1000 IU daily oral vitamin D3 supplementation in the recovery of symptoms and other clinical parameters among mild to moderate COVID-19 patients with sub-optimal vitamin D status. STUDY DESIGN AND SETTING: A total of 69 reverse transcriptase polymerase chain reaction (RT-PCR) SARS-CoV-2 positive adults who were hospitalized for mild to moderate COVID-19 disease were allocated to receive once daily for 2 weeks either 5000 IU oral vitamin D3 (n = 36, 21 males; 15 females) or 1000 IU oral vitamin D3 (standard control) (n = 33, 13 males; 20 females). Anthropometrics were measured and blood samples were taken pre- and post-supplementation. Fasting blood glucose, lipids, serum 25(OH)D, and inflammatory markers were measured. COVID-19 symptoms were noted on admission and monitored until full recovery. RESULTS: Vitamin D supplementation for 2 weeks caused a significant increase in serum 25(OH)D levels in the 5000 IU group only (adjusted p = 0.003). Within-group comparisons also showed a significant decrease in BMI and IL-6 levels overtime in both groups (p-values < 0.05) but was not clinically significant in between-group comparisons. Kaplan-Meier survival analysis revealed that the 5000 IU group had a significantly shorter time to recovery (days) than the 1000 IU group in resolving cough, even after adjusting for age, sex, baseline BMI, and D-dimer (6.2 ± 0.8 versus 9.1 ± 0.8; p = 0.039), and ageusia (loss of taste) (11.4 ± 1.0 versus 16.9 ± 1.7; p = 0.035). CONCLUSION: A 5000 IU daily oral vitamin D3 supplementation for 2 weeks reduces the time to recovery for cough and gustatory sensory loss among patients with sub-optimal vitamin D status and mild to moderate COVID-19 symptoms. The use of 5000 IU vitamin D3 as an adjuvant therapy for COVID-19 patients with suboptimal vitamin D status, even for a short duration, is recommended.

Vitamin D status of Arab Gulf residents screened for SARS-CoV-2 and its association with COVID-19 infection: a multi-centre case-control study.

OBJECTIVES: Vitamin D status in patients with COVID-19 is an on-going controversial issue. This study aims to determine differences in the serum 25(OH)D concentrations of Arab Gulf adult residents screened for SARS-CoV-2 and its association with risk of COVID-19 infection together with other comorbidities. METHODS: In this multi-center, case-control study, a total of 220 male and female adults presenting with none to mild symptoms were screened for COVID-19 (n = 138 RT-PCR-confirmed SARS-CoV-2 positive and 82 negative controls). Medical history was noted. Anthropometrics were measured and non-fasting blood samples were collected for the assessment of glucose, lipids, inflammatory markers and serum 25(OH)D concentrations. RESULTS: Serum 25(OH)D levels were significantly lower in the SARS-CoV-2 positive group compared to the negative group after adjustment for age and BMI (52.8 nmol/l ± 11.0 versus 64.5 nmol/l ± 11.1; p = 0.009). Being elderly (> 60 years) [Odds ratio 6 (95% Confidence Interval, CI 2-18; p = 0.001) as well as having type 2 diabetes (T2D) [OR 6 (95% CI 3-14); p < 0.001)] and low HDL cholesterol (HDL-c) [OR 6 (95% CI 3-14); p < 0.001)] were significant risk factors for COVID-19 infection independent of age, sex and obesity. CONCLUSIONS: Among Arab Gulf residents screened for SARS-CoV-2, serum 25(OH) D levels were observed to be lower in those who tested positive than negative individuals, but it was the presence of old age, diabetes mellitus and low-HDL-c that were significantly associated with risk of COVID-19 infection. Large population-based randomized controlled trials should be conducted to assess the protective effects of vitamin D supplementation against COVID-19.

Prevalence of diabetes, management and outcomes among Covid-19 adult patients admitted in a specialized tertiary hospital in Riyadh, Saudi Arabia.

This retrospective study aimed to characterize comorbidities and associated with mortality among hospitalized adults with Covid-19 managed as perthe Saudi Ministry of Health protocol in a specialized tertiary hospital in Riyadh, Saudi Arabia. Medical records of 300 adult patients with PCR-confirmed SARS-CoV2 infection and admitted in King Salman Hospital (KSH) from May 1 to July 31, 2020 were included. Medical history, management and outcomes were noted. Males significantly outnumber females (259 versus 41). South Asians comprise 41% of all admitted patients. Mortality rate was 10% and highest among Saudi males (28.9%). Type 2 diabetes mellitus (T2DM) was the most common comorbidity (45.7%). Almost all patients (99%) had pneumonia. Patients > 50 years were three times more likely to die (confidence interval, CI 1.3-6.9; p = 0.01) from Covid-19. Congestive heart failure (odds ratio OR 19.4, CI-1.5-260.0; p = 0.02) and acute kidney injury (OR 11.7, CI-4.7-28.6; p < 0.001) were significantly associated with higher mortality. Dexamethasone use significantly improved the final outcome based on net reclassification improvement (NRI) and integrated discrimination improvement (IDI) (p < 0.05). In this single-center study, T2DM was very common among hospitalized Covid-19 patients. Patients > 50 years, those with congestive heart failure and acute kidney injury are at higher risk for worse Covid-19 outcome.

Physicians' choices in the first- and second-line management of type 2 diabetes in the Kingdom of Saudi Arabia.

OBJECTIVES: The DISCOVER study is a global, prospective, three- year- observational (non-interventional) study that was conducted in 37 countries throughout the world including Saudi Arabia and aimed to assess variations in treatment patterns and therapeutic outcomes in type 2 diabetic patients. The current manuscript is reporting data of DISCOVER study across different health sectors of various provinces in the Kingdom of Saudi Arabia. METHODS: In this study, 519 Saudi type 2 diabetics, non-insulin users, aged 18 years or older, initiating second line therapy, were selected from nine health institutes, in four out of five provinces in Saudi Arabia. Data was collected at baseline (initiation of 2nd line therapy) by the treating physician using an electronic case report form (eCRF) via a web-based data capture system. Each selected subject was asked to complete four self-administered questionnaires. RESULTS: The mean age of the studied population was 52.4 ± 11 years. Among the subjects selected from the nine medical centers, 55% were men, with almost 65% between the ages of 46 and 65 years. The oral agent used as 1st line in the majority of patients was metformin, prescribed in 89.2% of the study cohort. In the second line, sitagliptin was the most frequently used, at 61.8%. followed by gliclazide, glibenclamide, and glimepiride at 35.6%, 13.1%, and 12.7%, respectively. CONCLUSION: Metformin, with or without sulfonylureas, is the most commonly prescribed first-line treatment for patients with type 2 diabetes, managed either in governmental institutions, or in the private sector. The most common second line drugs were DPP4 inhibitors, mainly sitagliptin, followed by the third and second generation of sulfonylureas. Drug affordability was not an issue, since the vast majority of the patients received medication free of charge.

Association of health literacy and self-management practices and psychological factor among patients with type 2 diabetes mellitus in Saudi Arabia.

OBJECTIVES: To determine the association between sociodemographic, clinical, and health literacy and the presence of depressed mood and their relationships  to diabetes self-management among type 2 diabetes mellitus (T2DM) patients in Saudi Arabia. METHODS: A total of 352 T2DM patients from 2 public tertiary hospitals in Saudi Arabia participated in this descriptive cross-sectional study between December 2016 and February 2017. All respondents answered a 4-part questionnaire, which includes demographic data, Diabetes Self-Management Questionnaire (DSMQ), 36-item test based Short Test of Functional Health Literacy in Adults, and a 2-item Patient Health Questionnaire (PHQ-2). The Chi-square test and logistic regression analysis were conducted to determine the relationship and significant predictors for self-management among T2DM patients. Results: The analysis showed that majority of the participants had low to marginal functional health literacy. The overall DSM-16 score was good, indicating more effective self-care, while 20% of the participants had a score of 2 or more in the PHQ-2 indicating presence of depressed mood.  No significant association was found between DSM and health literacy among the study participants while age, gender, educational level, employment status, and level of the depressive symptom were significantly associated with differences in the level of functional literacy of the participants. Conclusion: The study shows that nearly half of the T2DM patients that exhibited low level of functional health literacy had low diabetes self-management.  Our findings also show that gender significantly affects diabetes self-management in which odds are a lot higher among females than males with diabetes self-management. This study underscores the importance of proper counselling and education about diabetes control on both patients and family members.

Metabolic Syndrome in Arab Adults with Low Bone Mineral Density.

There are discrepancies in the reports on the association of metabolic syndrome (MetS) and its components with bone mineral density (BMD) and hence more population-based studies on this subject are needed. In this context, this observational study was aimed to investigate the association between T-scores of BMD at lumbar L1-L4 and full MetS and its individual components. A total of 1587 participants (84.7% females), >35 years and with risk factors associated with bone loss were recruited from February 2013 to August 2016. BMD was done at L1-L4 using dual-energy X-ray absorptiometry (DXA). T-Scores were calculated. Fasting blood samples and anthropometrics were done at recruitment. Fasting lipid profile and glucose were measured. Screening for full MetS and its components was done according to the National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) criteria. Logistic regression analysis revealed that the odds of having full MetS increased significantly from the lowest T-score tertile to the highest one in both sexes (OR, odd ratio (95% CI, confidence interval) of tertile 2 and 3 at 1.49 (0.8 to 2.8) and 2.46 (1.3 to 4.7), p = 0.02 in males and 1.35 (1.0 to 1.7) and 1.45 (1.1 to1.9), p < 0.01 in females). The odds remained significant even after adjustments with age, body mass index (BMI), and other risk factors associated with bone loss. Among the components of MetS, only central obesity showed a significant positive association with T-score. The study suggests a significant positive association of T-score (spine) with full MetS irrespective of sex, and among the components of MetS this positive association was seen specifically with central obesity.

Safe driving practices and factors associated with motor-vehicle collisions among people with insulin-treated diabetes mellitus: Results from the Diabetes and Driving (DAD) study.

INTRODUCTION: The aim of this study was to assess the prevalence of people with insulin-treated diabetes mellitus (ITDM) who have discussed issues related to diabetes and driving with their health care providers (HCPs). We also sought to determine the safe driving practices that are currently employed by this group. Finally, we investigated the factors that might increase the risk of motor-vehicle collisions (MVCs) among this group in Saudi Arabia. METHOD: This cross-sectional study surveyed a representative sample of 429 current male drivers with ITDM using a structured questionnaire in Saudi Arabia. RESULTS: Most of the participants (76.5%) never discussed topics regarding diabetes and driving with their HCPs. The majority of the participants (61.8%) reported at least never doing one of the following: (a) carrying a blood glucose testing kit while driving, (b) testing their blood glucose level before driving or during a journey, or (c) having thought of a specific threshold of blood glucose level that would preclude driving. Three factors were associated with a higher risk of MVCs among participants with ITDM: (a) being on a basal/boluses regimen, (b) never having a discussion regarding diabetes and driving with their HCPs, and (c) having experienced hypoglycemia during driving. CONCLUSIONS: The majority of people with ITDM had not had a discussion regarding diabetes and driving with their HCPs, which was reflected by a lack of safe driving practices. People with ITDM should be encouraged to take precautions while driving in order to prevent future MVCs. PRACTICAL APPLICATIONS: This research highlights the importance of investing more effort in educating drivers who have diabetes about safe driving practices by their health care providers. Also, it will attracts the attention of policymakers for an urgent need to establish clear policies and procedures for dealing with drivers who have diabetes.

Lower vitamin D levels in Saudi pregnant women are associated with higher risk of developing GDM.

BACKGROUND: Gestational diabetes mellitus (GDM) has serious consequences such as increased risks of preeclampsia, macrosomia and cesarean delivery. Even though the mechanistic basis of GDM has not been completely understood, several risk factors have been identified and one of these is vitamin D. However, the link between vitamin D deficiency and development of GDM is yet to be proven with certainty. METHODS: This study aimed to investigate the link between the incidence of GDM and serum vitamin D level in pregnant women of Saudi Arabia. 515 Saudi women (ages 18-46) in their 24-28th week of pregnancy, visiting various hospitals of Riyadh, participated in this study. Serum vitamin D and various biochemical and anthropometric parameters were determined in the first trimester and the recruits were screened for GDM by OGTT according to IADPSG criteria in their 2nd trimester. The association between vitamin D deficiency and development of GDM was calculated based on odds ratio of the incidence of GDM among vitamin D deficient and normal women. RESULTS: In this study cohort of 515 pregnant women, in the first trimester vitamin D deficiency (< 50 nmol/l) was detected in 425 (82.5%). On their 2nd visit (2nd trimester), 116 (27.7%) were diagnosed with GDM out of 419 with OGTT, according to IADPSG criteria. GDM risk was significantly higher among vitamin D deficient than non-deficient women (Odds Ratio: 2.87; Confidence Interval: 1.32-6.25; P = 0.008) even after adjusting for season, sun exposure and vitamin D intake (OR: 2.9; CI: 1.07-7.89). Of the various anthropometric and biochemical parameters, the GDM women differed significantly from non-GDM women with respect to serum levels of triglycerides (in mmol/l) (1.3 ± 0.6; 1.5 ± 0.6, p = 0.018) and fasting glucose (in mmol/l) [4.7 (4.3-5.2); 5.1 (4.6-5.6), p < 0.01]. Also, fasting glucose level in the 2nd trimester correlated inversely to serum vitamin D level determined during the 1st trimester (r = - 0.121; p = 0.014). CONCLUSIONS: Results of our study reveal a significantly higher risk of development of GDM among pregnant women having deficient vitamin D status.

Inflammation as a contributing factor among postmenopausal Saudi women with osteoporosis.

Postmenopausal osteoporosis is an important metabolic bone disease characterized by rapid bone loss occurring in the postmenopausal period. Recently, the most prevalent form of clinically significant osteopenia and osteoporosis involves various inflammatory conditions. The aim of the study is to evaluate the association between proinflammatory markers (interleukin [IL]-1ß, IL-6, TNF-α) with bone turnover markers (BTMs) in postmenopausal Saudi women with and without osteoporosis. A total of 200 postmenopausal Saudi women ≥50 years old, 100 with osteoporosis and 100 without osteoporosis (control) were recruited under the supervision of qualified physicians in King Salman Hospital and King Fahd Medical City, Riyadh, Saudi Arabia. Serum tumor necrosis factor alpha (TNF-α), IL-1, IL-4, IL-6, and parathyroid hormone (PTH) were determined using Luminex xMAP technology. N-telopeptides of collagen type I (NTx) was assessed using ELISA, 25(OH) vitamin D and osteocalcin were determined using electrochemiluminescence, serum calcium and inorganic phosphate (Pi) were measured by a chemical analyzer. Serum IL-1ß, IL-6, NTx, and PTH levels in women with osteoporosis were significantly higher than controls. Although IL-4 and osteocalcin were significantly lower than controls. IL-1ß and TNF-α were positively associated with NTx in osteoporosis women. TNF-α, IL-6, and TNF-α were positively correlated with IL-lß in both groups. A significant negative correlation between osteocalcin and IL-1ß in healthy women and women with osteoporosis were observed. Findings of the present study implicate a role for cytokine pattern-mediated inflammation in patients with osteoporosis.

Preconception care in Saudi women with diabetes mellitus.

BACKGROUND: The rate of preexisting diabetes mellitus (DM) in Saudi Arabia is one of the highest in the world. The role of preconception care (PCC) is well-established as a means of improving pregnancy outcomes in DM. OBJECTIVES: To assess the rate of preconception counseling, the level of PCC knowledge, and the rate of unplanned pregnancies in Saudi women with DM. MATERIALS AND METHODS: A cross-sectional study was conducted among 355 Saudi women aged 18-49 years with self-reported DM. The study questionnaire contained variables about the provision of preconception counseling, knowledge of PCC facts, and the number of unplanned pregnancies after developing DM. The level of PCC knowledge was evaluated using a modified Likert scale. Statistical Package for Social Sciences 20 was used for statistical analysis. Descriptive statistics, mean and standard deviation, and percentages were calculated; t-test was used for statistical significance. RESULTS: About one-third of the participants had received preconception counseling after being diagnosed with DM. Counseling on PCC for older and married participants was significantly less. Of the 355 participants, 42.8% had little or no PCC knowledge. All pregnancies that occurred after developing DM were unplanned. CONCLUSIONS: The rate of preconception counseling, the level of PCC knowledge in the studied Saudi women with DM is suboptimal, and none of the pregnancies that occurred after developing DM was planned. The study highlights the need for PCC programs that target all Saudi women of child-bearing age with DM, and their families starting at the age of puberty and at diagnosis of type 2DM, to optimize women's health and improve pregnancy outcomes.

Vitamin D deficiency and dyslipidemia in early pregnancy.

BACKGROUND: Vitamin D deficiency is a common nutritional issue and dietary supplementation in the general population, including pregnant women, is generally advised. Appropriately high levels of vitamin D are expected to play a role in containing the glycemic and atherogenic profiles observed in pregnancy. However, the relation between vitamin D status and the lipid metabolic profile in Saudi women, who are known to suffer from chronic vitamin D deficiency and high incidence of obesity and type II DM, during the course of pregnancy is not known. METHODS: In this study, we analyzed the relation between serum vitamin D level and various serum metabolic markers among Saudi women (n = 515) in their first trimester of pregnancy (11.2 ± 3.4 weeks). Coefficients of Pearson correlation and Spearman rank correlation were calculated for Gaussian and non-Gaussian variables, respectively. Serum vitamin D status was defined as (in nmol/L): deficient (<25), insufficient (25-50); sufficient (50-75) and desirable (>75). RESULTS: Results indicated that vitamin D status was sufficient in only 3.5% of the study participants and insufficient and deficient in 26.2% and 68.0% of participants, respectively. Serum vitamin D values in the overall study population correlated positively with serum levels of total cholesterol (R = 0.172; p < 0.01), triglycerides (R = 0.184; p < 0.01) and corrected calcium (R = 0.141; p < 0.05). In the subgroup of vitamin D deficient subjects (n = 350), log serum vitamin D values correlated with serum triglycerides (R = 0.23; p = 0.002) and cholesterol (R = 0.26; p = 0.001). CONCLUSIONS: The positive correlations between serum vitamin D and the atherogenic factors such as total cholesterol and triglycerides indicate a pro-atherogenic metabolic status in vitamin D deficient expectant mothers. This may represent an adaptation to the high metabolic demands of pregnancy.