Background: Glucagon-like peptide 1 agonists differ in chemical structure, duration of action and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. Methods: We randomly assigned patients with type 2 diabetes and cardiovascular disease to the addition of once-weekly subcutaneous injection of albiglutide (30 mg to 50 mg) or matching placebo to standard care. We hypothesized that albiglutide would be noninferior to placebo for the primary outcome of first occurrence of cardiovascular death, myocardial infarction, or stroke. If noninferiority was confirmed by an upper limit of the 95% confidence interval for the hazard ratio of less than 1.30, closed-testing for superiority was prespecified. Findings: Overall, 9463 participants were followed for a median of 1.6 years. The primary composite outcome occurred in 338 of 4731 patients (7.1%; 4.6 events per 100 person-years) in the albiglutide group and in 428 of 4732 patients (9.0%; 5.9 events per 100 person-years) in the placebo group (hazard ratio, 0.78; 95% confidence interval [CI ], 0.68 to 0.90), indicating that albiglutide, was superior to placebo (P<0.0001 for noninferiority, P=0.0006 for superiority). The incidence of acute pancreatitis (albiglutide 10 patients and placebo 7 patients), pancreatic cancer (6 and 5), medullary thyroid carcinoma (0 and 0), and other serious adverse events did not differ significantly between the two groups. Interpretation: In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. (Funded by GlaxoSmithKline; Harmony Outcomes ClinicalTrials.gov number, NCT02465515.) noninferiority; P = 0.06 for superiority). There seems to be variation in the results of existing trials with GLP-1 receptor agonists, which if correct, might reflect drug structure or duration of action, patients studied, duration of follow-up or other factors.
Abstract-Temperature of the plantar foot surface is an important feature in type II diabetes as abnormal temperature variations can be an early sign of foot diseases. In this paper, automatic way to analyze these temperature variations is presented by using an infrared camera. A robust acquisition protocol is proposed and an image processing software is developed. Three types of analysis are performed. First, the mean plantar foot temperature of both feet results from a segmentation procedure based on the Chan and Vese active contour method. Second, the point-to-point absolute mean difference between the 2 feet is assessed by using a rigid registration method. Third, significant hyperthermia regions such that the point-to-point absolute difference is greater than 2.2°C are highlighted. All these measures are fully automatic and do not need manual intervention. 82 type II diabetic subjects in a preulcerative state were recruited in the Dos de Mayo hospital (HNDM) in Lima, Peru. These persons were classified in two risk groups of developing an ulcer based on a medical exam: a medium risk group, and a high risk group. Results show that the mean temperature of the plantar foot surface is higher of 1ºC in the high risk group compared to the medium risk group. The mean point-to-point absolute difference shows identical values in the 2 groups. Finally, 9 subjects out of the 82 ones show significant hyperthermia of one foot compared to the other (6 in the medium risk group and 3 in the high risk group). It is expected that the new opportunity to automatically analyze foot temperature in hospitals or in diabetic health centers will help in reducing foot ulcer occurrence for type II diabetic persons.
In diabetic foot, the occurrence of an ulcer is often associated with hyperthermia. Hyperthermia is defined as a temperature greater than 2.2°C in a given region of one of the foot compared to the temperature of the same region of the contralateral foot. Unfortunately, hyperthermia is not yet assessed in current diabetic foot therapy. In this paper, we propose an easy way to detect a possible hyperthermia by using an infrared camera. A specific acquisition protocol of the thermal images is proposed. A dedicated image analysis is developed: it is composed of a contour detection of the 2 feet using the Chan and Vese active contour method associated to the ICP rigid registration technique. Among 85 type II diabetes persons recruited in the Dos de Mayo hospital in Lima, Peru, 9 individuals show significant hyperthermia. It is expected that the new possibility of detecting hyperthermia in hospitals or in diabetic health centers which is now available, thanks to the proposed method, will help in reducing foot ulcer occurrence for diabetic persons.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) cytotoxicity may involve inhibition of peroxisome proliferator-activated receptor alpha. Fenofibrate activates peroxisome proliferator-activated receptor alpha and inhibits SARS-CoV-2 replication in vitro. Whether fenofibrate can be used to treat coronavirus disease 2019 (COVID-19) infection in humans remains unknown. Here, we randomly assigned inpatients and outpatients with COVID-19 within 14 d of symptom onset to 145 mg of oral fenofibrate nanocrystal formulation versus placebo for 10 d, in a double-blinded fashion. The primary endpoint was a severity score whereby participants were ranked across hierarchical tiers incorporating time to death, mechanical ventilation duration, oxygenation, hospitalization and symptom severity and duration. In total, 701 participants were randomized to fenofibrate (n = 351) or placebo (n = 350). The mean age of participants was 49 ± 16 years, 330 (47%) were female, mean body mass index was 28 ± 6 kg/m 2 and 102 (15%) had diabetes. Death occurred in 41 participants. Compared with placebo, fenofibrate had no effect on the primary endpoint. The median (interquartile range) rank in the placebo arm was 347 (172, 453) versus 345 (175, 453) in the fenofibrate arm (P = 0.819). There was no difference in secondary and exploratory endpoints, including all-cause death, across arms. There were 61 (17%) adverse events in the placebo arm compared with 46 (13%) in the fenofibrate arm, with slightly higher incidence of gastrointestinal side effects in the fenofibrate group. Overall, among patients with COVID-19, fenofibrate has no significant effect on various clinically relevant outcomes (NCT04517396).Infection with SARS-CoV-2, the virus responsible for COVID-19, is an important public health problem. Available data suggest that COVID-19 progression is dependent on metabolic mechanisms 1 . Individuals with COVID-19 who developed acute respiratory distress syndrome and death are characterized by older age and a higher prevalence of hypertension, obesity, diabetes and cardiovascular diseases compared to individuals with milder disease [1][2][3][4][5][6] . Hyperglycaemia and hyperlipidaemia are also risk factors for acute respiratory distress in patients with COVID-19 disease 1,7 . Indeed, type 2 diabetes mellitus and the metabolic syndrome are associated with a markedly increased risk of death in the setting of 5 ).Several experimental studies suggest a mechanistic link between abnormal metabolism and the severity of SARS-CoV-2 and other coronavirus infections. Palmitoylation of the SARS-CoV-2 spike protein has been shown to be essential for virus-cell fusion and infectivity [8][9][10] . Gene expression analyses in cultured human bronchial cells infected with
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