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Independent association of history of diabetic foot with all-cause mortality in patients with type 2 diabetes: the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicenter Study.
Vitale, M, Orsi, E, Solini, A, Garofolo, M, Resi, V, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Penno, G, et al
Cardiovascular diabetology. 2024;(1):34
Abstract
BACKGROUND Foot ulcers and/or infections are common long-term complications of diabetes and are associated with increased mortality, especially from cardiovascular disease, though only a few studies have investigated the independent contribution of these events to risk of death. This study aimed at assessing the association of history of diabetic foot with all-cause mortality in individuals with type 2 diabetes, independent of cardiovascular risk factors, other complications, and comorbidities. METHODS This prospective cohort study enrolled 15,773 Caucasian patients in 19 Italian centers in the years 2006-2008. Prior lower extremity, coronary, and cerebrovascular events and major comorbidities were ascertained by medical records, diabetic retinopathy by fundoscopy, diabetic kidney disease by albuminuria and estimated glomerular filtration rate, cardiovascular risk factors by standard methods. All-cause mortality was retrieved for 15,656 patients on 31 October 2015. RESULTS At baseline, 892 patients (5.7%) had a history of diabetic foot, including ulcer/gangrene and/or amputation (n = 565; 3.58%), with (n = 126; 0.80%) or without (n = 439; 2.78%) lower limb revascularization, and revascularization alone (n = 330; 2.09%). History of diabetic foot was associated with all-cause death over a 7.42-year follow-up (adjusted hazard ratio, 1.502 [95% confidence interval, 1.346-1.676], p < 0.0001), independent of confounders, among which age, male sex, smoking, hemoglobin A1c, current treatments, other complications, comorbidities and, inversely, physical activity level and total and HDL cholesterol were correlated independently with mortality. Both ulcer/gangrene and amputation alone were independently associated with death, with a higher strength of association for amputation than for ulcer/gangrene (1.874 [1.144-3.070], p = 0.013 vs. 1.567 [1.353-1.814], p < 0.0001). Both ulcer/gangrene/amputation and lower limb revascularization alone were independently associated with death; mortality risk was much higher for ulcer/gangrene/amputation than for revascularization (1.641 [1.420-1.895], p < 0.0001 vs. 1.229 [1.024-1.475], p = 0.018) and further increased only slightly for combined ulcer/gangrene/amputation and revascularization (1.733 [1.368-2.196], p < 0.0001). CONCLUSIONS In patients with type 2 diabetes, an history of diabetic foot event, including ulcer/gangrene, amputation, and lower limb revascularization, was associated with a ~ 50% increased risk of subsequent death, independent of cardiovascular risk factors, other complications and severe comorbidities, which were also significantly associated with mortality. The association with mortality was greatest for amputation, whereas that for revascularization alone was relatively modest. TRIAL REGISTRATION ClinicalTrials.gov, NCT00715481, retrospectively registered 15 July, 2008.
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Effects of 12 Months' Treatment with Testosterone Undecanoate on Markers for Erythropoietic Activity and Safety Aspects in Transgender and Cisgender Hypogonadal Men.
Lethin, K, Aardal, E, Lood, Y, Ekman, B, Wahlberg, J
The journal of applied laboratory medicine. 2024;(2):223-236
Abstract
BACKGROUND To investigate the erythropoietic activity and safety aspects of testosterone undecanoate (TU) injections in transgender men, assigned female at birth. METHODS Twenty-three men (13 hypogonadal cisgender men and 10 transgender men) who initiated TU at the study start (naïve) and 15 men (10 hypogonadal cisgender men and 5 transgender men) on steady-state treatment with TU (non-naïve) were included in this prospective 1-year observational study. A control group of 32 eugonadal cisgender men was investigated once at baseline. Complete blood count, testosterone in serum and saliva, and plasma lipids, and liver enzymes were assessed. RESULTS For naïve transgender men, a significant increase in hemoglobin concentration was noted (mean (SD)), 141 (8) g/L to 151 (13) g/L, while no increase was seen in naïve hypogonadal cisgender men. At the end of the study, naïve transgender men exhibited comparable levels of hemoglobin, hematocrit, and testosterone levels in serum and saliva to hypogonadal cisgender men, as well as to the eugonadal cisgender men. During the study, HDL-cholesterol decreased significantly in naïve transgender men, 1.4 (0.4) mmol/L to 1.2 (0.4) mmol/L, P = 0.03, whereas no significant change was noted in naïve hypogonadal cisgender men. Liver enzymes remained unchanged in all groups. CONCLUSIONS After 12 months of treatment with TU in naïve transgender men, hemoglobin and hematocrit increased to levels within the cisgender male reference range. A slight decrease in HDL-cholesterol was seen in naïve transgender men but liver enzymes remained unchanged.
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Caffeine, but Not Creatine, Improves Anaerobic Power Without Altering Anaerobic Capacity in Healthy Men During a Wingate Anaerobic Test.
Marinho, AH, Silva-Cavalcante, MD, Cristina-Souza, G, Sousa, FAB, Ataide-Silva, T, Bertuzzi, R, de Araujo, GG, Lima-Silva, AE
International journal of sport nutrition and exercise metabolism. 2024;(3):137-144
Abstract
There is a lack of evidence on the additional benefits of combining caffeine (CAF) and creatine (CRE) supplementation on anaerobic power and capacity. Thus, the aim of the present study was to test the effects of combined and isolated supplementation of CAF and CRE on anaerobic power and capacity. Twenty-four healthy men performed a baseline Wingate anaerobic test and were then allocated into a CRE (n = 12) or placebo (PLA; n = 12) group. The CRE group ingested 20 g/day of CRE for 8 days, while the PLA group ingested 20 g/day of maltodextrin for the same period. On the sixth and eighth days of the loading period, both groups performed a Wingate anaerobic test 1 hr after either CAF (5 mg/kg of body mass; CRE + CAF and PLA + CAF conditions) or PLA (5 mg/kg of body mass of cellulose; CRE + PLA and PLA + PLA conditions) ingestion. After the loading period, changes in body mass were greater (p < .05) in the CRE (+0.87 ± 0.23 kg) than in the PLA group (+0.13 ± 0.27 kg). In both groups, peak power was higher (p = .01) in the CAF (1,033.4 ± 209.3 W) than in the PLA trial (1,003.3 ± 204.4 W), but mean power was not different between PLA and CAF trials (p > .05). In conclusion, CAF, but not CRE ingestion, increases anaerobic power. Conversely, neither CRE nor CAF has an effect on anaerobic capacity.
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A double-blinded study for quantifiable assessment of the diagnostic accuracy of AI tool "ADVEN-i" in identifying diseased fundus images including diabetic retinopathy on a retrospective data.
Acharyya, M, Moharana, B, Jain, S, Tandon, M
Indian journal of ophthalmology. 2024;(Suppl 1):S46-S52
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Abstract
PURPOSE To quantifiably assess the diagnostic accuracy of Adven-I, a proprietary artificial intelligence (AI)-driven diagnostic system that automatically detects diseases from fundus images. The purpose is to quantify the performance of Adven-i in differentiating a nonreferable (within normal limits) image from a referable (diseased fundus) image and further segregating diabetic retinopathy (DR) from the rest of the abnormalities (non-DR) encompassing the wide spectrum of abnormal pathologies. The assessment is carried out in comparison to manual reading as the reference gold standard. Adven-i is the only AI system classifying retinal abnormalities into DR and non-DR classes separately, apart from predicting nonreferable fundus, while most existing systems classify fundus images into referable and nonreferable DR. METHODS The double-blinded study was conducted on retrospective data collected over the course of a year in the ophthalmology outpatient department (OPD) at a top Tier II eyecare hospital in Chandigarh, India. Three vitreoretina specialists who were blinded to one another read the images. The ground-truth was generated on the basis of majority agreement among the readers. An arbitrator's decision was regarded final if all three readers disagreed. RESULTS 2261 fundus images were analyzed by Adven-i. The sensitivity and specificity of Adven-i in diagnosing images with abnormalities were 95.12% and 85.77%, respectively, and for segregating DR from rest of the retinal abnormalities were 91.87% and 85.12%, respectively. CONCLUSIONS AND RELEVANCE Adven-i shows definite promise in automated screening for early diagnosis of referable fundus images including DR. Adven-i can be adopted to scale for mass screening in resource-limited settings.
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The outcome of medical nutrition therapy on glycemic control among type 2 diabetic patients.
Abdelsalam, SE, Ismaail, MAR, Sultan, EA, Elsherif, OE, Salama, HM, Hassan, SI
The Pan African medical journal. 2023;:85
Abstract
INTRODUCTION the global prevalence of type 2 diabetes in adults is estimated to be 6.4%. The current prevalence of type 2 diabetes in Egyptians aged 20 to 79 is approximately 15.6%. The objective of medical nutrition therapy (MNT) is to optimize the management of the "ABC" for diabetes control, glycated hemoglobin, blood pressure, and cholesterol. Our study aimed to assess the effect of MNT on glycemic control in patients with type 2 diabetes attending the family practice clinic. METHODS a quasi-experimental intervention trial was conducted with 40 diabetic patients seeking medical service in the Suez Canal University Hospital family practice clinic. The participants were over 20 years old and had uncontrolled type 2 diabetes. Patients were surveyed using El-Gilany questionnaire to evaluate the socio-demographic traits, physical examination data, and laboratory investigations at baseline and after 12 weeks. RESULTS medical nutrition therapy (MNT) significantly reduced glycated hemoglobin level (p<0.001); the median level of glycated hemoglobin was 10% with a minimum level of 7.5% vs. a maximum of 14% in the pre-intervention phase. In comparison, the median glycated hemoglobin level was 9.5%, with a minimum level of 5.6% vs. a maximum of 13.5% in the post-intervention phase. In addition, there was a significant improvement in blood pressure, weight, body mass index, fasting plasma glucose, and lipid profile. Conclusion: there is evidence that MNT is a crucial component of type 2 diabetes therapy.
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Histamine Skin Prick Tests: From Established Diagnostic Technique to Advanced Experimental Biomarker.
Bamps, D, Berdon, K, Hernandez, H, Schrijvers, R, de Hoon, J
Skin pharmacology and physiology. 2023;(2):87-97
Abstract
INTRODUCTION Skin prick tests have a long history as diagnostic and pharmacodynamic biomarker. Besides visual assessments of the wheal and flare, objective blood flow measurements using laser Doppler imaging (LDI) and laser speckle contrast imaging (LSCI) have been reported. In light of these advancements, an up-to-date characterization of the histamine-evoked response is worthwhile. METHODS A single-centre study was completed in healthy males. Two parameters were addressed: (1) dermal blood flow (DBF) within a 7.65-mm ring encircling the skin prick site (DBFring), and (2) surface area of the flare (AREAflare). First, the dose response was assessed using placebo (0.9% sodium chloride) or histamine (histamine dihydrochloride 1, 3, or 10 mg/mL) skin pricks on the volar surface of subjects' (n = 12) forearm. The DBFring was measured by LDI, and the AREAflare by LDI and by ruler. Secondly, the inter-arm and inter-period reproducibility of the DBFring and AREAflare, as evoked by histamine (10 mg/mL) and measured by LDI and LSCI, was examined (n = 14). Lastly, the effect of aprepitant (125 mg), ketotifen (1 mg), and a single (5 mg) and fourfold (20 mg) dose of desloratadine and levocetirizine on the histamine-induced (10 mg/mL) DBFring and AREAflare was evaluated with LSCI (n = 13 or 12). RESULTS All three histamine doses induced a time-dependent vasodilation. Ruler recordings did not conclusively correlate with LDI assessments of the AREAflare. The DBFring and AREAflare were reasonably reproducible when measured by using LDI or LSCI, with negligible bias between arms and study periods and poor to moderate within-subject reproducibility (0.23 ≤ ICC ≤ 0.71). While the fourfold dose of desloratadine (p = 0.0041) and the single and fourfold dose of levocetirizine (p < 0.0001) managed to reduce the AREAflare, only the fourfold dose of levocetirizine (p = 0.0052) reduced the DBFring. CONCLUSION Caution is warranted when translating years of clinical experience with histamine skin prick tests to objective recordings of the associated changes in skin perfusion. Ruler and LDI assessments of the AREAflare do not consistently correlate, and the reproducibility and histamine dependency of the measurements are not obvious. While 10 mg/mL histamine may be a good choice for qualitative diagnostic evaluations, a lower dose may be better suited to use as a quantitative biomarker.
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Influence of severe hypoglycemia definition wording on reported prevalence in adults and adolescents with type 1 diabetes: a cross-sectional analysis from the BETTER patient-engagement registry analysis.
Madar, H, Wu, Z, Bandini, A, Perkins, B, Messier, V, Pomey, MP, Brazeau, AS, Rabasa-Lhoret, R
Acta diabetologica. 2023;(1):93-100
Abstract
AIMS: Compare the self-reported prevalence of severe hypoglycemia (level-3-H) in people with type 1 diabetes (PWT1D) according to two wording of definition: by the International Hypoglycemia Study Group (IHSG) and an alternate simplified version developed by patient-partners (PP). METHODS Cross-sectional study (PWT1D > = 14 years) self-reporting risk factors, patient-year incidence and annual prevalence of level-3-H were defined according to either IHSG's wording (low sugar levels requiring help from another person, or use of glucagon, or hospitalization, or loss of consciousness) or with an alternative simpler wording developed by PP (low sugar levels that you would have been unable to treat). RESULTS Among 1430 eligible participants, in the last 12 months, the annual prevalence of level-3-H (IHSG: 242/100 vs. PP: 231/100 patient-years, p = 0.229) and median number of episodes (IHSG: 2.0 [1-3] vs. PP: 1.0 [1-3], p = 0.359) were similar. The prevalence of participants reporting hypoglycemia in the past year was higher with IHSG wording (13.5% vs. 10.5%; p < 0.001); this difference was significantly (p < 0.001) larger among patients with impaired awareness of hypoglycemia. Association of both definitions with level-3-H risk factors was comparable. CONCLUSIONS The level-3-H episodes by PP and IHSG wording were comparable. The simplicity of PP wording may allow better mutual understanding between patients and healthcare team. TRIAL REGISTRATION NCT03720197 (registered on October 19th 2018).
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The impact of experimentally shortened sleep on timing of eating occasions in adolescents: A brief report.
Duraccio, KM, Whitacre, C, Wright, ID, Summer, SS, Beebe, DW
Journal of sleep research. 2023;(3):e13806
Abstract
Short sleep increases the risk for obesity in adolescents. One potential mechanism relates to when eating occurs in the day. This study investigated the impact of shortened sleep on eating occasion timing in adolescents. Ninety-three healthy 14- to 17-year-olds (62% female) completed a within-subject experimental sleep manipulation, engaging in 5-night spans of Short Sleep (6.5-hr sleep opportunity) or Healthy Sleep (9.5-hr sleep opportunity), with order randomized. During each condition, adolescents completed three 24-hr diet recall interviews. Repeated-measure t-tests assessed the sleep manipulation effect on each adolescent's number of meals, first and last eating occasion (relative to the clock and time since sleep onset/offset), feeding window (timespan from first to last eating), and the midpoint of feeding. The timing of the first eating occasion was similar across conditions, relative to the clock (Short = 08:51, Healthy = 08:52) and to time since waking (Short = 2.0 hr, Healthy = 2.2 hr). The timing of the last eating occasion was later relative to the clock (Short = 20:34, Healthy = 19:39; p < 0.001), resulting in a longer feeding window (Short = 11.7 hr, Healthy = 10.8 hr, p < 0.001) and a later midpoint in the feeding window (Short = 14:41, Healthy = 14:18, p = 0.002). The gap between last eating occasion and sleep onset was larger in Short (4.2 hr) than Healthy Sleep (2.9 hr; p < 0.001), though the last eating occasion was much earlier than when they fell asleep during either condition. Shortened sleep resulted in adolescents eating later and lengthening the daily feeding window. These findings may help explain the link between shortened sleep and increased obesity risk in adolescents.
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Palmitoylethanolamide-based nutraceutical Calmux® in preventive treatment of migraine.
Hernández, AG
Clinical neurology and neurosurgery. 2022;:107282
Abstract
BACKGROUND The aim of this study was to determine the efficacy and tolerability of treatment with a Palmitoylethanolamide (PEA)-based nutraceutical in patients with episodic migraine. METHODS A pilot, prospective, open-label experimental study was designed in which patients with episodic migraine with and without aura seen in the general practice office of a tertiary centre during a period of 6 month were offered the possibility to participate. No control group was included. All included patients were treated with nutraceutical Calmux® taken every 12 h for 3 months. Monthly attack frequency, attack intensity, impact of migraine (HIT-6 and MIDAS scales) and quality of sleep at baseline and after 3 months of treatment were compared. RESULTS Twenty-five patients (22 women and 3 men) were included, with a mean age of 36.3 ± 12 years. Headache days per month decreased from 10 ± 2.1 days to 6.6 ± 3.6 days (p < 0.00001). Days of analgesic use decreased from 9.2 ± 2.6 days to 4.1 ± 2.1 (p < 0.0001). None of the patients included suffered from adverse events attributable to treatment. Pain intensity showed a mean reduction of 3.1 points, from 8.1 at baseline to 5 at 3 months of treatment (p < 0.005). CONCLUSIONS PEA nutraceuticals could be useful in migraine prevention. Further studies are necessary, but we consider that PEA-based nutraceutical could be a new approach in the treatment of migraine patients.
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Physical exercise habits, lifestyle behaviors, and motivation to change among men with prostate cancer: a cross-sectional study.
Bressi, B, Iotti, C, Cagliari, M, Fugazzaro, S, Cavuto, S, Bergamaschi, FAM, Moscato, A, Costi, S
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2022;(6):5017-5026
Abstract
PURPOSE To describe the physical exercise (PE) habits, lifestyle, and motivation to change toward healthier behaviors in patients newly diagnosed with prostate cancer (PCa). METHODS A cross-sectional study was conducted in an Italian hospital setting. Men newly diagnosed with PCa were consecutively invited to participate in a structured interview that was conducted either in person or by telephone. RESULTS The mean age of the 40 participants was 70.5 ± 6.6 (range 50-84). Most participants (65%) reported they were physically active, but more than half of the sample did not reach the recommended PE level. However, 40% of participants would be interested in participating in an exercise program. Only 10% of participants were current smokers, but 90% drank alcohol, and 62.5% were overweight/obese. Almost all participants were not willing to change their habits. CONCLUSIONS A high proportion of Italian men are insufficiently active when diagnosed with PCa. Moreover, even when exposed to behavioral risk factors, they are not willing to change their lifestyle. Health-care professionals who deal with men newly diagnosed with PCa should take advantage of the teachable moment and apply strategies that support patients' motivation to exercise and adherence to healthier lifestyles. TRIAL REGISTRATION The study was prospectively registered in ClinicalTrial.gov NCT03982095 on June 11, 2019.