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Type 1 diabetes and fasting in Ramadan: time to rethink classification of risk?
Hussain, S, Choudhary, P, Hopkins, D
The lancet. Diabetes & endocrinology. 2020;(8):656-658
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Fasting prior to cardiac catheterisation: a single-centre observational study.
Bacus, SB, Parsons, J, Benatar, J, Somaratne, J, Webster, M, Parke, R
The New Zealand medical journal. 2020;(1510):16-22
Abstract
AIM: Previous generation contrast agents were associated with high rates of nausea, vomiting and risk of aspiration leading to recommendations to fast prior to the procedure. However, modern contrast agents are well tolerated with a low risk of aspiration. Our current guidelines recommend fasting four to six hours before elective and semi-urgent cardiac catheterisation despite a lack of evidence to support this. We sought to determine the duration and effects of fasting at our centre. METHODS A single-centre prospective observational study in patients undergoing elective cardiac catheterisation over a six-month period between 7 August 2017 to 7 February 2018 at Auckland City Hospital, New Zealand. RESULTS One thousand and thirty patients with a mean age of 66±12 years underwent catheterisation. Sixty-seven percent were male, 26% had diabetes, 72% had hypertension and 23% had stage 3 or worse chronic kidney disease. The mean duration of fasting was 11.6±4.9 hours with 80% fasting longer than recommended. One hundred and eight (48%) patients with documented chronic kidney disease did not receive recommended pre-hydration. The most common symptoms related to fasting were hunger (47 %), nausea (3.9%) and vomiting (0.8%). Hypertension (4.1%) and hyperglycaemia (0.8%) occurred due to missed medication. There were no reports of aspiration. CONCLUSION Most patients were fasted for significantly longer than recommended and pre-hydration was underutilised in patients at high risk of contrast-induced nephropathy. There were no episodes of aspiration with modern contrast agents. Further studies are required to evaluate the need for fasting prior to non-emergency cardiac catheterisation.
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Patterns of Diabetes Care Among People with Type 1 Diabetes During Ramadan: An International Prospective Study (DAR-MENA T1DM).
Al Awadi, FF, Echtay, A, Al Arouj, M, Sabir Ali, S, Shehadeh, N, Al Shaikh, A, Djaballah, K, Dessapt-Baradez, C, Omar Abu-Hijleh, M, Bennakhi, A, et al
Advances in therapy. 2020;(4):1550-1563
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INTRODUCTION To describe the characteristics and care of participants with type 1 diabetes during Ramadan in the Middle East and North Africa. METHODS The DAR-MENA (Diabetes and Ramadan-Middle East and North Africa) study was a prospective, observational study of adults with type 1 and type 2 diabetes who were Muslim and did/did not intend to fast during Ramadan 2016. Baseline data were collected 6 weeks prior to Ramadan, with a follow-up visit 1-2 months after Ramadan. This is the analysis of the population with type 1 diabetes. Measurements included proportion who fasted, reasons for fasting and not fasting, changes in diabetes treatment, hypoglycemic events, and proportion with access to diabetes education. RESULTS Of 136 participants with type 1 diabetes, 76.9% (100/130) fasted for at least 1 day, 72.3% (94/130) fasted for at least 15 days, and 48.5% (63/130) fasted for 30 days. The majority (63.0%, 63/100) reported personal decision as a reason to fast. Fear of diabetic complications (58.6%, 17/29) and previous complications related to fasting (48.3%, 14/29) were the most common reasons for not fasting. Adjustment of diabetic medication regimen occurred for 84.6% (115/136) of participants, and 72.8% (99/136) changed their treatment dose. The incidence and number of adverse events for confirmed and severe hypoglycemia were similar before and during Ramadan. Almost half of participants had access to diabetes education (45.6%, 62/136). CONCLUSION The DAR-MENA study showed that despite the risks associated with fasting for people with type 1 diabetes, almost half fasted for the full 30 days of Ramadan with no significant change in hypoglycemia events. Since the current International Diabetes Federation and Diabetes and Ramadan guidelines do not endorse fasting for people with type 1 diabetes, it is important that those who insist on fasting work closely with their healthcare practitioner to avoid any complications.
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Glycaemic target attainment in people with Type 2 diabetes treated with insulin glargine/lixisenatide fixed-ratio combination: a post hoc analysis of the LixiLan-O and LixiLan-L trials.
Davidson, JA, Desouza, C, Fonseca, V, Frias, JP, Van Gaal, L, Giorgino, F, Chao, J, Dex, TA, Roberts, M, Saremi, A, et al
Diabetic medicine : a journal of the British Diabetic Association. 2020;(2):256-266
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AIMS: Both fasting (FPG) and postprandial plasma glucose (PPG) contribute to HbA1c levels. We investigated the relationship between achievement of American Diabetes Association (ADA) and American Association of Clinical Endocrinologists (AACE) recommended FPG and/or PPG targets and glycaemic efficacy outcomes in two trials. METHODS In this post hoc analysis, data from participants with Type 2 diabetes in the phase 3 LixiLan-O (NCT02058147) and LixiLan-L (NCT02058160) trials were evaluated to compare the relationship between achievement of society-recommended FPG and/or PPG targets and efficacy (HbA1c change, HbA1c goal attainment, weight change) and safety outcomes in the treatment groups. RESULTS Across treatment arms, iGlarLixi achieved the highest proportion of participants meeting both ADA- and AACE-recommended FPG and PPG targets at study end in both trials. A higher proportion of participants in the iGlarLixi (fixed-ratio combination of insulin glargine and lixisenatide) vs. insulin glargine alone or lixisenatide alone treatment arms achieved HbA1c goals (P < 0.001 for overall comparisons), irrespective of ADA- or AACE-defined targets. Hypoglycaemia rates [any, documented symptomatic (plasma glucose ≤ 3.9 mmol/l), and clinically important (plasma glucose < 3.0 mmol/l)] were low across all groups. Participants treated with iGlarLixi tended to show weight loss or less weight gain compared with participants receiving insulin glargine alone. No differences were observed in average daily basal insulin dose at week 30 between the two treatment arms or across the different FPG and PPG target groups. CONCLUSION Insulin glargine and lixisenatide as a fixed-ratio combination resulted in more participants reaching both FPG and PPG targets, leading to better HbA1c target attainment.
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A Sensitive Plasma Insulin Immunoassay to Establish the Diagnosis of Congenital Hyperinsulinism.
Siersbæk, J, Larsen, AR, Nybo, M, Christesen, HT
Frontiers in endocrinology. 2020;:614993
Abstract
BACKGROUND The diagnosis of congenital hyperinsulinism (CHI) may be hampered by a plasma (p-) insulin detection limit of 12-18 pmol/L (2-3 mU/L). OBJECTIVE To evaluate the diagnostic performance of a sensitive insulin immunoassay and to find the optimal p-insulin cut-off for the diagnosis of CHI. METHODS Diagnostic fasting tests, performed without medication or i.v.-glucose, were investigated in children with a clinical diagnosis of CHI, or idiopathic ketotic hypoglycemia (IKH). The CHI diagnosis was either clinical or by the alternative, p-insulin-free criteria; hypoglycemia plus disease-causing genetic mutations and/or CHI-compatible pancreatic histopathology. We included diagnostic p-insulin samples with simultaneous p-glucose <3.2 mmol/L and used a sensitive insulin assay (Cobas e411 immunoassay analyzer; lower detection limit 1.2 pmol/L; normal range 15.1-147.1 pmol/L). Receiver operating characteristics area under the curve (ROC AUC) values and optimal cut-offs were analyzed for the performance of p-insulin to diagnose CHI. RESULTS In 61 CHI patients, the median (range) p-insulin was 76.5 (17-644) pmol/L compared to 1.5 (1.5-7.7) pmol/L in IKH patients (n=15). The ROC AUC was 1.0 for the diagnosis of CHI defined both by the clinical diagnosis (n=61) and by alternative criteria (n=57). The optimal p-insulin cut-offs were 12.3 pmol/L, and 10.6 pmol/L, at p-glucose <3.2 mmol/L (n=61), and <3.0 mmol/L (n=49), respectively. CONCLUSIONS The sensitive insulin assay performed excellent in diagnosing CHI with optimal p-insulin cut-offs at 12.3 pmol/L (2.0 mU/L), and 10.6 pmol/L (1.8 mU/L), at p-glucose <3.2 mmol/L, and <3.0 mmol/L, respectively. A sensitive insulin assay may serve to simplify the diagnosis of CHI.
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Application of a Backpropagation Artificial Neural Network in Predicting Plasma Concentration and Pharmacokinetic Parameters of Oral Single-Dose Rosuvastatin in Healthy Subjects.
Xu, Y, Lou, H, Chen, J, Jiang, B, Yang, D, Hu, Y, Ruan, Z
Clinical pharmacology in drug development. 2020;(7):867-875
Abstract
A backpropagation artificial neural network (BPANN) model was established for the prediction of the plasma concentration and pharmacokinetic parameters of rosuvastatin (RVST) in healthy subjects. The data (demographic characteristics and results of clinical laboratory tests) were collected from 4 bioequivalence studies using reference 10-mg RVST calcium tablets. After the data were cleaned using extreme gradient boosting, 13 important factors were extracted to construct the BPANN model. The model was fully validated, and mean impact values (MIVs) were calculated. The model was used to predict the plasma concentration and pharmacokinetic parameters of oral single-dose RVST in healthy subjects under fasting and fed conditions. The predicted and measured values were compared in order to evaluate the accuracy of prediction. The constructed model performed well in validation. The top 3 factors ranked by MIV related to RVST concentration are fasting/fed, time, and creatinine clearance. The time-concentration profiles of the measured and predicted data agreed well. There were no significant differences (P > .05) in the area under the concentration-time curve from 0 to the last measurable concentration (AUC0-t ) and extrapolated to infinity (AUC0-∞ ), half-time of elimination, peak concentration, and time to peak concentration of the measured data and data predicted by BPANN. The BPANN model has an accurate prediction ability and can be used to predict RVST concentration and pharmacokinetic parameters in healthy subjects.
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Intermittent Fasting and Metabolic Health: From Religious Fast to Time-Restricted Feeding.
Hoddy, KK, Marlatt, KL, Çetinkaya, H, Ravussin, E
Obesity (Silver Spring, Md.). 2020;(Suppl 1):S29-S37
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Over the past 10 to 15 years, intermittent fasting has emerged as an unconventional approach to reduce body weight and improve metabolic health beyond simple calorie restriction. In this review, we summarize findings related to Ramadan and Sunnah fasting. We then discuss the role of caloric restriction not only as an intervention for weight control, but importantly, as a strategy for healthy aging and longevity. Finally, we review the four most common intermittent fasting (IF) strategies used to date for weight management and to improve cardiometabolic health. Weight loss is common after IF but does not appear to be different than daily caloric restriction when compared directly. IF may also provide additional cardiometabolic benefit, such as insulin sensitization, that is independent from weight loss. While no specific fasting regimen stands out as superior at this time, there is indeed heterogeneity in responses to these different IF diets. This suggests that one dietary regimen may not be ideally suited for every individual. Future studies should consider strategies for tailoring dietary prescriptions, including IF, based on advanced phenotyping and genotyping prior to diet initiation.
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Predictive value of random blood glucose versus fasting blood glucose on in-hospital adverse events in patients with ST-segment elevation acute myocardial infarction.
Qin, Y, Yan, G, Qiao, Y, Wang, D, Luo, E, Hou, J, Tang, C
BMC cardiovascular disorders. 2020;(1):95
Abstract
BACKGROUND We aim to find out the relationship between random blood glucose (RBG), fasting blood glucose (FBG) and in-hospital adverse events in ST-segment elevation acute myocardial infarction (STEMI) patients. We evaluate and compare the predictive value of RBG and FBG on in-hospital adverse events, and give an appropriate cut-off value of RBG and FBG. METHOD A retrospective study enrolled 958 consecutive AMI patients undergoing emergency coronary angiography at Zhongda Hospital were enrolled from January 1, 2016, to December 31, 2018 was performed. RBG and FBG, baseline data and adverse events were recorded. Major adverse cardiovascular and cerebrovascular events (MACCE) were defined as death, nonfatal recurrent myocardial infarction and stroke. Other adverse events included malignant arrhythmia, cardiac shock and hemorrhage. Patients with RBG > 11.1 mmol/L were divided into elevated RBG group. Patients with FBG > 6.1 mmol/L were divided into elevated FBG group. The incidence of in-hospital adverse events were compared in elevated RBG/FBG group and the control group. ROC curve was used to evaluate the predictive value of RBG and FBG on in-hospital adverse events. RESULT The incidence of death, hemorrhage, cardiac shock and malignant arrhythmia significantly increases in elevated RBG and FBG group. Binary logistic regression showed that age, hypertension, diabetes, FBG and RBG were independent risk factors for in-hospital adverse events in STEMI patients. The AUC and 95% CI of RBG and FBG in predicting death of AMI patients were 0.789, 0.759~0.816; 0.810, 0.783~0.835, respectively. The cut-off values were 13.82 and 7.35 mmol/L. RBG and FBG also had fine predictive value on cardiac shock and malignant arrhythmia, no statistical difference was found in the predictive value on in-hospital adverse events (P = 0.462, P = 0.570, P = 0.694). CONCLUSION Incidence of in-hospital adverse events significantly increases in AMI patients combined with elevated RBG or FBG. Both RBG and FBG were independent risk factors for in-hospital adverse events, they had good value on predicting in-hospital adverse events and there was no statistical difference in their predictive value.
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Association Between Fasting Glucose Variability in Young Adulthood and the Progression of Coronary Artery Calcification in Middle Age.
Feng, W, Li, Z, Guo, W, Fan, X, Zhou, F, Zhang, K, Ou, C, Huang, F, Chen, M
Diabetes care. 2020;(10):2574-2580
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OBJECTIVE To investigate whether intraindividual variability of fasting glucose (FG) in young adulthood is associated with coronary artery calcification (CAC) progression in middle age. RESEARCH DESIGN AND METHODS We included 2,256 CARDIA (Coronary Artery Risk Development Study in Young Adults) participants with CAC assessment by computed tomography scanner at baseline (2000-2001) and 10 years later (2010-2011). CAC progression was assessed for each individual as the difference of logarithmic CAC scores at follow-up and baseline (log[CAC (follow-up) + 1] - log[CAC (baseline) + 1]). FG variability was defined by the coefficient of variation about the mean FG (FG-CV), the SD of FG (FG-SD), and the average real variability of FG (FG-ARV) during the 10-year follow-up. We investigated the association between FG variability and CAC progression with adjustment for demographics, clinical risk factors, mean FG level, change in FG level, diabetes incidence, and medication use. RESULTS After multivariable adjustment, 1-SD increment in FG-CV was associated with worse progression of CAC as demonstrated as percent change in CAC, with incident CAC 5.9% (95% CI 1.0, 10.7) and any CAC progression 6.7% (95% CI 2.3, 11.1) during 10 years. Similar findings were also observed in FG-SD and FG-ARV. CONCLUSIONS Higher FG variability during young adulthood was associated with greater CAC progression in middle age, suggesting its value in predicting risk for subclinical coronary artery diseases.
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Micronutrients in support to the one carbon cycle for the modulation of blood fasting homocysteine in PCOS women.
Schiuma, N, Costantino, A, Bartolotti, T, Dattilo, M, Bini, V, Aglietti, MC, Renga, M, Favilli, A, Falorni, A, Gerli, S
Journal of endocrinological investigation. 2020;(6):779-786
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PURPOSE Fasting blood homocysteine is increased in PCOS women and is involved in several of its co-morbidities including cardiovascular disease and infertility. Corrective interventions based on the administration of supra-physiologic doses of folic acid work to a low extent. We aimed to test an alternative approach. METHODS This was a prospective, randomized, parallel group, open label, controlled versus no treatment clinical study. PCOS women aged > 18, free from systemic diseases and from pharmacological treatments were randomized with a 2:1 ratio for treatment with activated micronutrients in support to the carbon cycle (Impryl, Parthenogen, Switzerland-n = 22) or no treatment (n = 10) and followed-up for 3 months. Fasting blood homocysteine, AMH, testosterone, SHBGs, and the resulting FTI were tested before and at the end of the follow-up. RESULTS The mean baseline fasting blood homocysteine was above the normal limit of 12 μMol/L and inversely correlated with SHBG. AMH was also increased, whereas testosterone, SHBG, and FTI were within the normal limit. The treatment achieved a significant reduction of homocysteine, that did not change in the control group, independently of the starting value. The treatment also caused an increase of AMH and a decrease of SHBGs only in the subgroup with a normal homocysteine at baseline. CONCLUSIONS In PCOS ladies, blood homocysteine is increased and inversely correlated with the SHBGs. Physiologic amounts of activated micronutrients in support to the carbon cycle achieve a reduction virtually in all exposed patients. Whether this is of clinical benefit remains to be established.