Diagnosing gestational diabetes during the Covid-19 pandemic using HbA1c rather than oral glucose tolerance test (OGTT)

The Royal College of Obstetrics and Gynaecology advocated replacing OGTT with HbA1c for gestational diabetes (GDM) screening for women with risk factors during the Covid-19 pandemic. HbA1c >=48mmol/mol/random plasma glucose (RPG) >=11.1mmol/l at booking indicated diabetes, and 41-47mmol/ mol/9-11mmol/ l prediabetes or possible GDM. Testing was repeated at 26 weeks if normal previously, with HbA1c >=39mmol/mol, fasting PG >=5.6mmol/l, or RPG >=9mmol/l diagnostic for GDM. A) At her clinic booking visit at 10 weeks gestation, 36 year-old South Asian female had HbA1c 55mmol/mol/RPG 9.5mmol/l suggesting undiagnosed type 2 diabetes. Initially managed with dietary advice and home blood glucose monitoring, metformin was added when self-monitored glucose above pregnancy targets (fasting and pre-meal <5.3mmol/l or 1 h post meal <7.8mmol/l) but insulin was required later. Metformin and insulin were stopped after delivery at 38 weeks with HbA1c 50mmol/mol three months postpartum, supporting the earlier diagnosis of type 2 diabetes. B) 32 year-old White Caucasian female was screened for GDM on booking at 11 weeks as BMI 38 kg/m2. HbA1c 44mmol/mol and RPG 6.9mmol/l confirmed GDM which was managed by dietary/lifestyle changes with glucose and pregnancy targets achieved until 28 weeks when metformin added. Normal delivery at 40 weeks with HbA1c 40mmol/mol three months postpartum triggered advice on long-term dietary/lifestyle changes and annual HbA1c checks. HbA1c was useful during the pandemic but most centres reverted to OGTT for GDM screening due to a significant fall in diagnoses using HbA1c >=39mmol/mol at 26 weeks. But, HbA1c testing was advantageous at booking to diagnose type 2 diabetes earlier.

Association between Type 2 Diabetes Mellitus and Covid-19 Severity: A Literature Review

We conducted a review and evaluated the already documents reports for the relationship among diabetes and COVID-19. The review outcome shows that the COVID-19 severity seems to be greater among patients with diabetes as comorbidity. So, strict glycemic control is imperative in patients infected with COVID-19. Thus, world-wide diabetes burden and COVID-19 pandemic must be deliberated as diabetes increases the COVID-19 severity. Established on this, it is precise significant to follow specific treatment protocols and clinical management in COVID-19 patients affected with diabetes to prevent morbidity and mortality.Copyright © 2023 The Authors.

Was the diagnosis of gestational diabetes from 34 weeks gestation of pregnancy more prevalent during Covid-19 due to the change in how gestational diabetes was diagnosed?

Aim: During Covid we noticed that more women were being diagnosed with Gestational Diabetes (GDM) from 34 weeks gestation than prior to Covid. It was suspected that this was due to how GDM was diagnosed, from Oral Glucose Tolerance Test (OGTT) prior to Covid to HbA1c with Fasting or Random Blood Glucose (RBG) during Covid. Method(s): An audit of our GDM database was performed, looking at rates of late GDM diagnosis from 2018-present. Result(s): Prior to Covid the late diagnosis rate was 14-15%. In 2020 and 2021 this increased to 27.7%. This year diagnosis is only by OGTT, and the rate has dropped to 21%. There was also a significant rise in the number of women who were being diagnosed from 34 weeks gestation whom had previously been tested for GDM earlier in their pregnancy. In 2018 and 2019 52-56% of these women had previously been tested. In 2020 this increased up to 84% and fell to 74% in 2021. This year the rate has fallen to 67%. In 2018 and 2019 all women had been diagnosed using OGTT's. In 2020 61% of women had previously been tested for GDM by HbA1c and RBG, with this increasing to 84% in 2021. This year only 10% had previously been tested using HbA1 and RBG. Conclusion(s): The sharp increase in late diagnosis of GDM during the Covid seems to be related to the change in diagnostic testing and shows that OGTT is the more accurate way to diagnose GDM and not HbA1c with RBG.

COVID-19 among Hospitalized Patients with Diabetes in Karachi: A Single Centre Study

Aim: To evaluate the clinical characteristics, severity, and outcomes of local COVID-19 patients with diabetes. Study Design: Case series Place and duration of study: Orthopedic Medical Institute Hospital, Karachi from 1st September 2020 to 28th February 2021. Method(s): One hundred and forty seven COVID-19 positive patients with diabetes and pre-diabetes were enrolled. The patients' demographic and clinical information specific to COVID-19 and diabetes was collected and analyzed. Result(s): The mean age of 64.03+/-11.56 years. The ischemic heart disease (39.9%) and hypertension (74.3%) were the two most prevalent comorbid conditions. The overall mortality rate of 20.3%. Between patients with diabetes receiving steroids and those receiving no steroids, the mean fasting (FBG) and random blood glucose (RBG) were relatively elevated. Glycemic control had no discernible impact on the severity, results, or length of the COVID-19 hospital stay (p>0.05). Conclusion(s): No significant effect of diabetes millitus control on COVID severity and outcomes, but the altered blood glucose levels suggest a need to define specific targeted intervention for COVID-19 patients with comorbidities, specifically diabetes mellitus.Copyright © 2023 Lahore Medical And Dental College. All rights reserved.

Ramadan fasting in people with diabetes and chronic kidney disease (CKD) during the COVID-19 pandemic: The DaR global survey.

BACKGROUND AND AIMS: The DaR Global survey was conducted to observe the impact of the COVID-19 pandemic on the intentions to fast and the outcomes of fasting in people with diabetes and chronic kidney disease (CKD). METHODS: Muslim people with diabetes and CKD were surveyed in 13 countries shortly after the end of Ramadan 2020, using a simple Survey Monkey questionnaire. RESULTS: This survey recruited 6736 people with diabetes, of which 707 (10.49%) had CKD. There were 118 (16.69%) people with type1 diabetes (T1D), and 589 (83.31%) were with type2 diabetes (T2D). 62 (65.24%) people with T1D and 448 (76.06%) people with T2D had fasted with CKD. Episodes of hypoglycaemia and hyperglycaemia were more frequent among people with T1D compared to T2D, 64.52% and 43.54% vs 25.22% and 22.32% respectively. Visits to the emergency department and hospitalization were more frequent among people with CKD, however no significant difference was found between people with T1D and T2D. CONCLUSION: The COVID-19 pandemic had only a minor effect on the intention to fast during Ramadan in people with diabetes and CKD. However, hypoglycaemia and hyperglycaemia were found to be more frequent, as well as emergency visits and hospital admissions among people with diabetic kidney disease. Prospective studies are needed in future to evaluate the risk indicators of hypoglycaemia and hyperglycaemia among fasting people with CKD, especially in the context of different stages of kidney disease.

Review of the Literature on Ramadan Fasting and Health in 2022

Objectives The literature on health and disease during Ramadan fasting (RF) is widely spread in many journals making it not readily accessible to those interested in the subject. Here, we provide an overview of the research on the interplay of RF with various aspects of well-being published in 2022.Materials and Methods A narrative, nonsystematic review of the international literature from a single major medical online database, PubMed, in one calendar year (2022) was conducted. The search term "Ramadan fasting" was used to retrieve the appropriate records. The relevant literature with substantial data-based content was presented in a concise thematic account, excluding those concerned with diabetes.Results Themes that emerged from the review included the pathophysiology of metabolic changes during RF, nutritional aspects including body composition and energy metabolism, cardiovascular disease and risk factors, renal function and structure, endocrinology (mainly thyroid), neurological disorders, mental health, pregnancy and fetal life, and infections (including COVID). Some miscellaneous clinical themes were identified, such as patients' and professional perspectives.Conclusions In 2022, the medical interest in RF was again widely spread across specialties. Cardiovascular disease and risk factors attract the most interest in terms of original articles and professional guidelines. We hope with this review to present a concise summary of the scholarly work on the subject in this year.

The First Reported Case of Lorlatinib-Associated Diabetic Ketoacidosis

Introduction: Lorlatinib is a third-generation tyrosine kinase inhibitor that inhibits anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1). Although 2-10% of patients with non-small cell lung cancer developed hyperglycemia in phase 2 and 3 studies of lorlatinib, only one case has subsequently reported hyperglycemia >500 mg/dL, and no cases of diabetic ketoacidosis (DKA) have been previously reported. Phase 1 trials in neuroblastoma are ongoing. Case Description: A 34-year-old woman with ALK-mutated paraspinal neuroblastoma presented with DKA 14 months after initiation of lorlatinib. Prior to starting lorlatinib, her hemoglobin A1c had been 5.0% (n: < 5.7%). After 12 months of therapy, her A1c increased to 7.8%, prompting the initiation of metformin 500 mg daily. However, two months later she was admitted for DKA with a blood glucose of 591 mg/dL (n: 65-99 mg/dL), CO2 17 mmol/L (n: 20-30 mmol/L), anion gap 18 (n: 8-12), moderate serum ketones, and 3+ ketonuria. Her A1c was 14.8%, C-peptide was 1.2 ng/mL (n: 1.1-4.3 ng/mL), and her glutamic acid decarboxylase-65 and islet antigen-2 autoantibodies were negative. She was also found to be incidentally positive for COVID-19 but was asymptomatic without any oxygen requirement. The patient's DKA was successfully treated with IV insulin infusion, and she was discharged after 3 days with insulin glargine 27 units twice daily and insulin aspart 16 units with meals. One month later, her hemoglobin A1c had improved to 9.4%, and the patient's oncologist discontinued lorlatinib due to sustained remission of her neuroblastoma and her complication of DKA. After stopping lorlatinib, her blood glucose rapidly improved, and she self-discontinued all her insulin in the following 3 weeks. One month later, she was seen in endocrine clinic only taking metformin 500 mg twice daily with fasting and post-prandial blood glucose ranging 86-107 mg/dL. Discussion(s): This is the first reported case of DKA associated with lorlatinib. This case highlights the importance of close glucose monitoring and the risk of severe hyperglycemia and DKA while on lorlatinib therapy. Discontinuation of lorlatinib results in rapid improvement of glycemic control, and glucose-lowering treatments should be promptly deescalated to avoid hypoglycemia.Copyright © 2023

Hyperglycemia and Hypoglycemia Contributions to Acute Respiratory Distress Syndrome

Purpose of Study Non-diabetic COVID-19 patients with elevated admission fasting blood glucose levels ('hyperglycemia') inexplicably have an increased 28 day mortality and higher inhospital complications including the Acute Respiratory Distress Syndrome (ARDS) but potentially contributing blood glucose changes during ARDS development were not reported (Wang S et al: Diabetologia 2020). Our goal was to determine blood glucose alterations before and during acute lung injury development in a rat model used to study ARDS. Methods Used We sequentially evaluated blood glucose levels for 24 hours and lung lavage protein levels (lung permeability) and lung lavage neutrophil numbers (lung inflammation) at 24 hours to assess acute lung injury ('ARDS') in young (~3 month) and old (~12 month) control and a novel strain of hyperoxia surviving 'resistant' rats before and after administering high and low insulin doses and before and after interleukin- 1/lipopolysaccharide (IL-1/LPS) insufflation. Summary of Results Glucose levels increase rapidly and sequentially in young control, but not young resistant, rats peaking ~2 hours after insufflation. Glucose levels also increase in old control and old resistant rats after insufflation compared to young control and young resistant rats after insufflation. The pattern of glucose levels at 2 hours after insufflation resembles lung lavage proteins and neutrophils at 24 h after insufflation (table 1). Administering high insulin (High In) doses decreases glucose levels ('hypoglycemia') and worsens ARDS while administering low insulin (Low In) doses correct glucose levels and improve ARDS. Conclusions Hyperglycemia develops in both young and old rats developing ARDS and high or low glucose levels parallel worse acute lung inflammation and acute lung injury ('ARDS'). Controlling glucose judiciously with insulin may be beneficial in combatting ARDS caused by SARS-CoV-2 infection and other insults.

High HBV-DNA serum levels are associated with type 2 diabetes in adults with positive HBsAg: An observational study.

Background: The prevalence of diabetes is higher in hepatitis B virus (HBV)-infected population. We aimed to examine the relationship between different serum HBV-DNA levels and type 2 diabetes in adults with positive HBV surface antigen (HBsAg). Methods: We conducted cross-sectional analyses of data obtaining from the Clinical Database System of Wuhan Union Hospital. Diabetes was defined by self-report of type 2 diabetes, fasting plasma glucose (FPG) ≥7mmol/L, or glycated hemoglobin (HbA1c) ≥6.5%. Binary logistic regression analyses were performed to investigate the factors associated with diabetes. Results: Among 12,527 HBsAg-positive adults, 2,144 (17.1%) were diabetic. Patients with serum HBV-DNA <100, 100-2000, 2000-20000 and ≥20000 IU/mL accounted for 42.2% (N=5,285), 22.6% (N=2,826), 13.3% (N=1,665) and 22.0% (N=2,751), respectively. The risk of type 2 diabetes, FPG ≥7mmol/L and HbA1c ≥6.5% in individuals with highly elevated serum HBV-DNA level (≥20000 IU/mL) were 1.38 (95% confidence interval [CI]: 1.16 to 1.65), 1.40 (95% CI: 1.16 to 1.68) and 1.78 (95% CI: 1.31 to 2.42) times relative to those with negative or lowly elevated serum HBV-DNA (<100 IU/mL). However, the analyses showed no association of moderately (2000-20000 IU/mL) to slightly (100-2000 IU/mL) raised serum HBV-DNA levels with type 2 diabetes (OR=0.88, P=0.221; OR=1.08, P=0.323), FPG ≥7mmol/L (OR=1.00, P=0.993; OR=1.11, P=0.250) and HbA1c ≥6.5% (OR=1.24, P=0.239; OR=1.17, P=0.300). Conclusion: In HBsAg-positive adults, highly elevated level rather than moderately to slightly raised levels of serum HBV-DNA is independently associated with an increased risk of type 2 diabetes.

Remote telemedicine strategy based on multi-risks intervention by intelligent wearable health devices in elderly comorbidities patients with coronary heart disease

Background: Telemedicine based on wearable intelligent health devices becomes increasingly promissing for the elderly due to the accelerated aging population. Especially during COVID-19 pandemic, more elderly coronary heart disease patients with chronic comorbidities are in less secondary prevention management at home. Objective(s): To explore the prevention effect on main cardiovascular risk factors and repeated hospitalization in elderly comorbidities patients by telemedicine intervention based on multi-parameter wearable monitoring devices. Method(s): Total of 337 patients with comorbidities of coronary heart disease, hypertension and diabetes, with age more than 65 years old were recruited in the study from October 2019 to January 2021. They were randomly divided into control group and telemedcine intervention group. The latter used remote multi-parameter wearable devices to measure blood pressure, glycemic and electrocardiograph at home every day. A real-time monitoring platform would alarm any abnormal data to the doctors. Both doctors and patients can read the measurement results on a real-time mobile phone APP and interact with each other remotely twice a week routinely. A medical team remotely indicated the medications, while offering guidance on lifestyle. In contrast, the control group adopted traditional outpatient medical strategy to manage diseases. Result(s): A total of 306 patients were enrolled in the follow-up experiment finally: 153 in the intervention group and 153 in the control group. Patient characteristics at baseline were balanced between two groups. After 12 months, compared with the control group, the intervention group saw the following metrics significantly reduced: Systolic blood pressure (SBP) (131.66+/-9.43 vs 137.20+/-12.02 mmHg, P=0.000), total cholesterol (TC) (3.65+/-0.79 vs 4.08+/-0.82 mmol/L, P=0.001), low density lipoprotein cholesterol (LDL-C) (2.06+/-0.53 vs 2.38+/-0.61 mmol/L, P=0.002), and fasting blood glucose (FBG) (6.26+/-0.75 vs 6.81+/-0.97 mmol/L, P=0.000), while the following metrics went up significantly: Blood pressure control rate (77.3% vs 59.1%, P=0.039), blood lipid control rate(39.4% vs 21.2%, P=0.037), glycemic control rate (71.2% vs 51.5%, P=0.031), and medication adherence score (7.10+/-0.77 vs 6.80+/-0.73, P=0.020). Linear regression model analysis indicates that when interaction frequency >=1.53, 2.47 and 1.15 times/week, the SBP, LDL-C and FBG levels would be controlled, respectively. Cox survival analysis finds that the hospitalization rate of intervention group is significantly lower than that of the control group (24.18% vs 35.29%, P=0.031). Conclusion(s): The telemedicine interactive intervention based on multiparameter wearable devices provides effectively improvement of cardiovascular risk controlling, medication adherence, while reducing the hospitalization rate of patients. A frequency of doctor-patient interactions more than 2 times/week is beneficial for disease management the elderly at home. (Figure Presented) .

Sublingual allergen immunotherapy: Safety, adherence, efficacy in adolescents during COVID-19 pandemic

Background: Allergic rhinitis, one of the most common chronic allergic diseases, commonly associated with asthma, has a disease modifying therapy, allergen-specific immunotherapy (AIT). AIT can play a significant role in the reduction of clinical and immunological reaction to the culprit allergen, decreasing the onset of new sensitizations, preventing the onset of asthma, and reducing use of pharmacological treatments. This latter aspect is highly relevant for adolescents, a category of patients that frequently prefer to use "as few drugs as possible". AIT continuation may be difficult in some situations, such as the COVID-19 pandemic. Difficulty in accessing hospitals was experienced by many leading to a discontinuation of therapies for chronic conditions, such as allergic rhinitis. Method(s): We report our experience on the management, safety and adherence to sublingual immunotherapy (SLIT) prescribed to 25 adolescents affected by allergic rhinitis (house dust mite (HDM) -8 patients, SLIT grass pollen -12 patients, SLIT parietaria -5 patients), during the COVID-19 pandemic, following EAACI recommendations. The first administration of SLIT was carried out under medical supervision. We used a personalized monitoring approach according to the type of SLIT prescribed and according to the needs presented by each patient, advising them how to recognize and manage a possible reaction. Result(s): No immediate severe adverse reactions were reported by patients. Between the 2nd and 5th day of SLIT, 4 patients in therapy with HDM SLIT, experienced an exacerbation of rhinitis symptoms, with resolution after the use of oral antihistamine and topical cortisone+antihistamine before taking the daily dose of SLIT (for 30 days). Two patients on grass pollen SLIT and 2 patients on HDM SLIT, with gastric upset after taking SLIT daily while fasting, presented a resolution of the symptom after we advised them to take the daily dose in the morning after breakfast. Five patients interrupted SLIT for COVID-19 infection, until complete resolution. To date, all 25 patients are continuing SLIT, with good tolerability, with an improvement of rhinitis symptoms. Conclusion(s): We have reported real-life SLIT adherence and safety in adolescents that started SLIT during the COVID-19 pandemic to confirm how SLIT is a winning strategy and the only modifying treatment for allergic conditions.

Myocardial infarction with non-obstructive coronary arteries (MINOCA) complicating myocarditis

Myocarditis can lead to myocardial infarction in the absence of coronary artery obstruction. We report a case of probable myocarditis, complicated by myocardial infarction with non-obstructive coronary arteries. A 19-year-old man presented with chest pain typical of myocarditis. He was a smoker but was otherwise well. Electrocardiogram revealed diffuse ST-elevation and echocardiography revealed a thin, akinetic apex. Troponin-T levels on admission were raised leading to an initial diagnosis of myocarditis being made. However, late gadolinium enhancement study on cardiac magnetic resonance imaging demonstrated transmural enhancement typical of ischaemia. Coronary angiogram was normal, leading to a likely diagnosis of myocardial infarction with non-obstructive coronary arteries. It is important to highlight that coronary assessment remains important when working up for myocarditis, as myocardial infarction with non-obstructive coronary arteries can often complicate myocarditis in cases of normal angiography. Another important lesson was on how cardiac magnetic resonance imaging provided vital evidence to support underlying ischaemia despite normal coronary angiogram, leading to a diagnosis of myocardial infarction with non-obstructive coronary arteries. Myocardial infarction with non-obstructive coronary arteries remains a broad 'umbrella' term and cardiac magnetic resonance imaging, as well as more invasive coronary imaging techniques during angiography, can further assist in its diagnosis. Our case provides a reminder that myocardial infarction with non-obstructive coronary arteries, although increasingly recognised, remains under-diagnosed and can often overlap with peri-myocarditis, highlighting the need to employ multi-modality imaging in guiding management.Copyright © The Author(s) 2021.

SIGNIFICANCE OF APPLYING INTERNAL ELEMENTS OF MENTAL ILLNESS, PATIENCE (SABR) AND RESILIENCE AMONG COVID-19 PATIENTS FROM AN ISLAMIC PERSPECTIVE

The study examined the relationship between elements of mental illness, resilience and patience (sabr) during the COVID 19 pandemic. Resilience means the ability to survive by recovering from a situation or returning to its original shape after been compressed, stretched or bent. When the term resilience is used in psychology it means a person's ability to quickly recover from changes, sickness, accidents, or adversities. Patience is the withholding of natural inclinations to avoid inappropriate occurrences, withholding from complaining and withholding oneself (body) from doing something negative, such as slapping one's own face or tearing one's clothes when something unfortunate happens. Patience has a positive relationship with resilience, which translates to not giving up easily when faced with a direct situation. This is indicated that internal factors do strongly influence an individual's resilience. [ABSTRACT FROM AUTHOR] Copyright of Journal of Pharmaceutical Negative Results is the property of ResearchTrentz and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Development and evaluation of web-based Self-care Management Health Education e-Learning Program for type 2 diabetes patients: A pilot study

Aims: Diabetes mellitus (DM) is an incurable chronic disease that can be controlled by self-care management. Health education assisted by technology can improve self-care management. This pilot study aims to: (a) identify the concerns, issues, and challenges faced by type 2 diabetes mellitus (T2DM) patients and healthcare providers, especially during the COVID-19 pandemic;(b) develop a Self-care Management Health Education e-Learning Program (ScMHEeLP);and (c) pilot whether ScMHEeLP can improve knowledge, self-care management, and glycemic controls of T2DM patients. Method: This pilot study uses a multiphase mixed-methods design. Twenty-three participants were involved in in-depth interviews as the basis for developing ScMHEeLP, and thirty-seven voluntary participants were recruited for the evaluation phase. The ScMHEeLP was piloted for 3 months to test its effectiveness in improving the knowledge, self-care management, and glycemic controls of T2DM patients. Thematic analysis was used to examine the qualitative data, and the Wilcoxon test was used for quantitative data. Results: In the development phase revealed patients' and healthcare providers' concerns, issues, and challenges regarding diabetic care, especially during the COVID-19 pandemic. Based on these findings, the ScMHEeLP was developed in the form of web-based. ScMHEeLP consists of seven animatic videos, completed with a feature to evaluate patients' understanding of the disease and treatments. ScMHEeLP was downloadable and accessible anywhere and anytime (online–offline). In the evaluation phase showed a significant difference in the levels of knowledge (Z = −5.306, p = 0.000), levels of self-care activities (Z = −5.139, p = 0.000), and level of fasting blood sugar (Z = −4.282, p = 0.000), before and after the implementation of ScMHEeLP. Conclusions: ScMHEeLP was able to improve knowledge and self-care activities and able to lower fasting blood sugar levels. ScMHEeLP still needs continuous improvement and further testing for better outcome. © 2023 Elsevier España, S.L.U.

Single-Dose Bioequivalence Study of Rivaroxaban-Containing Medicinal Products in Healthy Volunteers.

Therapeutically, new oral anticoagulants (NOACs) are considered to be non-inferior or superior to vitamin K antagonists (warfarin). NOACs are included in current guidelines for the treatment of various cardiovascular diseases. Rivaroxaban medicinal products have been shown to effectively fight thrombotic complications of the new coronavirus infection, COVID-19. The wide clinical use of rivaroxaban products motivates the development of generics. The aim of the study was to compare the pharmacokinetics and safety of rivaroxaban medicinal products in a single-dose bioequivalence study in healthy volunteers under fasting conditions. Material(s) and Method(s): the bioequivalence study compared single-dose oral administration of Rivaroxaban, 10 mg film-coated tablets (NovaMedica Innotech LLC, Russia), and the reference product Xarelto, 10 mg film-coated tablets (Bayer AG, Germany), in healthy volunteers under fasting conditions. The open, randomised, crossover trial included 46 healthy volunteers. Each of the medicinal products (the test product and the reference product) was administered once;blood samples were collected during the 48 h after the administration. The washout between the study periods lasted 7 days. Rivaroxaban was quantified in plasma samples of the volunteers by high performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). Result(s): no adverse events or serious adverse events were reported for the test and reference products during the study. The following pharmacokinetic parameters were obtained for Rivaroxaban and Xarelto, respectively: Cmax of 134.6 +/- 58.0 ng/mL and 139.9 +/- 49.3 ng/mL, AUC0-48 of 949.7 +/- 354.5 ngxh/mL and 967.6 +/- 319.9 ngxh/mL, AUC0- of 986.9 +/- 379.7 ngxh/mL and 1003.6 +/- 320.4 ngxh/mL, T1/2 of 8.2 +/- 3.2 h and 7.8 +/- 3.3 h. The 90% confidence intervals for the ratios of Cmax, AUC0-48, and AUC0- geometric means were 88.04-108.67%, 89.42-104.92% and 89.44-104.81%, respectively. Conclusion(s): the test product Rivaroxaban and the reference product Xarelto were found to have similar rivaroxaban pharmacokinetics and safety profiles. The study demonstrated bioequivalence of the medicinal products.Copyright © 2022 Obstetrics, Gynecology and Reproduction. All rights reserved.

Ramadan fasting research during the COVID-19 pandemic in the United Kingdom: recruitment challenges

Background: Many Muslims in the UK perform a dawn to dusk fasting, with no food and water, for 29–30 days during the month of Ramadan. Adults and some children, with type 2 diabetes (T2D), also engage in fasting often without medical guidance. The potential benefits or harms associated with this have not been well investigated. This report discusses and reflects the experience of developing questionnaire-based studies and the challenges faced in engaging Ramadan fasting (RF) children and young adults in this research during the COVID-19 pandemic in the UK. Methods: SoGoSurvey software was used to design retrospective and prospective questionnaires, which gathered information on medical history, lifestyle and COVID-19 pandemic-related impacts. The questionnaires were sent to healthy people and patients with T2D aged from 12 to 80 years old, who planned to fast during Ramadan for a minimum of 10 days. The participants were recruited from several communities and medical centres in the UK. Participants were contacted by phone and email. Results: The response rate for the retrospective questionnaire (27.5%), which included people with and without T2D, was lower than expected even though it was close to the average of the current online surveys responses at about 30%. The majority of the respondents were from the "other ethnicities group” at 65.4%. Moreover, the response rate for the prospective study among only patients with T2D was at 22.5%. The youngest people with T2D who fasted during Ramadan were 14 years old. Conclusions: The low percentage of completion of the questionnaires may be due to COVID-19 pandemic restrictions. Furthermore, it is known that participation in research is low amongst ethnic minority population in the UK. Creating greater awareness about the importance of participation in research studies within ethnic minority groups in the UK is needed. Face-to-face completion of questionnaires with the researcher could be the most effective approach for engaging 12 to 16 years old children in research. © Journal of Public Health and Emergency. All rights reserved.

Is The Co-administration of Metformin and Clomiphene Superior to Induce Ovulation in Infertile Patients with Poly Cystic Ovary Syndrome and Confirmed Insulin-resistance: A Double Blind Randomized Clinical Trial

Objective: This study aimed to compare the effects of clomiphene citrate (CC) combined with metformin or placebo on infertile patients with poly cystic ovary syndrome (PCOS) and insulin resistance (IR). Material(s) and Method(s): We included 151 infertile women with PCOS and IR in a university hospital from November 2015 to April 2022 in this prospective, double-blind, randomized, placebo-controlled trial. Patients were randomized into two groups;group A: received CC plus metformin (n = 76) and group B: received CC plus placebo (n = 75). The ovulation rate was the main outcome measure. Clinical pregnancy, ongoing pregnancy, live birth and abortion rates were secondary outcome measures. Result(s): There was no remarkable difference in ovulation rate in two groups. Moreover, no significant changes were observed in clinical pregnancy, ongoing pregnancy, live birth and abortion rates between two groups. A larger proportion of women in group A suffered from side effects of metformin (9.3% versus 1.4%;p=0.064), although this was not significant. Conclusion(s): In IR infertile women with PCOS, metformin pre-treatment did not increase the ovulation, clinical pregnancy and live birth rates in patients on clomiphene citrate.Copyright © 2023 Tehran University of Medical Sciences.

Analysis of influencing factors of blood glucose levels in diabetic patients during epidemic of COVID-19.

Objective: To investigate the blood glucose control of diabetic patients during the Coronavirus disease 2019 (COVID-19) epidemic, and to explore the factors affecting blood glucose. Method(s): Three hundred and fifty patients with diabetes mellitus hospitalized in the Endocrinology Department of the Second Affiliated Hospital of Air Force Military Medical University from 2017 to 2019 were selected, and we send questionnaires (a self-made questionnaire containing 39 questions, Zung anxiety self-assessment scale, Zung depression self-assessment scale) to the patients through WeChat group. After the effective questionnaires were collected, the patients were divided into good blood glucose control group (fasting blood glucose <=7 mmol/L and 2 h postprandial blood glucose <=10 mmol/L) and poor blood glucose control group (fasting blood glucose>7 mmol/L and/or 2 hours postprandial blood glucose>10 mmol/L). Chi square test or Fisher exact probability method and t test were used to compare the differences between the two groups. In Multi-factor logistic regression, the backward regression method was performed. Result(s): A total of 310 questionnaires were collected, 4 of which did not meet the requirements were eliminated, and a total of 306 valid questionnaires were analyzed. There were 108 cases (35.3%) in the well-controlled group and 198 cases (64.7%) in the poorly controlled group. Compared with well-controlled group, there was a higher percentage of patients with aged >=45 years, diabetes course >=5 years, combined with chronic complications of diabetes, weekly exercise time during the epidemic period<150 min,weekly monitoring of blood glucose frequency <=1 to 2 times and sleep disorders during the epidemic, anxiety, and depression in poorly controlled group, and there were statistically significant differences (P<0.05).The above 8 factors with P<0.05 were included in the logistic regression model. Diabetes course >=5 years, weekly exercise time during the epidemic<150 min, sleep disturbance during the epidemic, weekly monitoring of blood glucose frequency <= 1 to 2 times, depression were risk factors for poor blood glucose control (P<0.05). Conclusion(s): During the epidemic period, the blood glucose level of diabetes patients was generally high. The factors that affected blood glucose control included a long course of diabetes, short exercise time, low monitoring frequency of blood glucose, sleep disorders, and depression.Copyright © 2020 by the Chinese Medical Association.

Diabcovid a New Type of Diabetes Following Sars Cov2 Infection?

Background and Aims: During the SARS COV 2 pandemic, the number of cases of unrecognized diabetes increased in those hospitalized for pneumonia. It has been hypothesized that some forms of diabetes not classified as classic are attributable to SARS COV 2 infection. Method(s): We studied the prevalence of diabetes in those admitted to our Covid Hospital from January 2021 to September 2022. A total of 1200 subjects studied by cross-analysis of hospital discharge forms with diabetes mellitus and final therapy as research item. Result(s): The prevalence of diabetes mellitus was 2.16%. Of the subjects diagnosed with diabetes, 26.9% were not classifiable as type 1 or type 2 and the condition of diabetes mellitus was not previously known. HbA1c values were not statistically (7,86+/-0,95 vs 8,1+/-1,1 p = NS) different among subjects with diabetes and autoimmune markers were not present. Fasting C-peptide levels (ng/ml) were significantly lower (0,8- 0,23 vs 2,36+/-0,8 p < 0.05) in those with not previously known diabetes, 57.2% were discharged on insulin therapy. and continued it after 92- 18 days of follow-up. Conclusion(s): The interrelationship between COVID-19 and diabetes remain uncertain and researchers hope to understand whether Covid-19 causes a new form of diabetes or more simply a stress response that triggers classic diabetes. In our experience those individuals with fasting C-peptide levels lower than usual obeserved in Type 2 diabetic subjects continued insulin theraphy for a limited time. They could be a new entity of diabetes classification but longitudinal data are further required to confirm what we can call DIabCovid.