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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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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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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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Pre-emptive multimodal analgesic bundle with transversus abdominis plane block enhances early recovery after laparoscopic cholecystectomy.
Shim, JW, Ko, J, Bae, JH, Park, J, Lee, HM, Kim, YS, Moon, YE, Hong, SH, Chae, MS
Asian journal of surgery. 2022;(1):250-256
Abstract
BACKGROUND As postoperative pain after laparoscopic cholecystectomy may delay recovery and discharge, a multimodal and pre-emptive analgesic approach is necessary. This study demonstrated that a multimodal analgesic bundle improves postoperative recovery, using the Quality of Recovery-40K (QoR-40K) questionnaire during the first 24 h after laparoscopic cholecystectomy. METHODS In this prospective non-randomized study with two parallel groups, 80 patients undergoing laparoscopic cholecystectomy were allocated into either the multimodal analgesia group or the conventional analgesia group. The multimodal analgesia group received a pre-emptive analgesic bundle (preoperative intravenous administration of paracetamol, ketorolac, and dexamethasone, and a posterior approach to the transversus abdominis plane block), while the conventional analgesia group did not. The primary outcome was the QoR-40K score during the first 24 h after surgery. Secondary outcomes were the peak visual analog scale pain score at rest and the incidence rates of rescue analgesic use and nausea/vomiting during the first 24 h after surgery. RESULTS The QoR-40K score was higher in the multimodal analgesia group than in the conventional analgesia group (196 [190-199] vs. 182 [172-187], p < 0.001). The peak visual analog scale pain score was significantly lower in the multimodal analgesia group than in the conventional analgesia group. Multimodal analgesia also reduced the incidence rates of rescue analgesic use and postoperative nausea/vomiting (22.5% [95% CI, 9.6-35.4%] vs. 55.0% [39.6-70.4%], p = 0.003), compared to conventional analgesia. CONCLUSIONS Multimodal analgesia significantly improves the quality of early postoperative recovery after laparoscopic cholecystectomy, as shown by the QoR-40K score.
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Associations of ultra-processed food intake with maternal weight change and cardiometabolic health and infant growth.
Cummings, JR, Lipsky, LM, Schwedhelm, C, Liu, A, Nansel, TR
The international journal of behavioral nutrition and physical activity. 2022;(1):61
Abstract
BACKGROUND Excessive intake of ultra-processed foods, formulated from substances extracted from foods or derived from food constituents, may be a modifiable behavioral risk factor for adverse maternal and infant health outcomes. Prior work has predominately examined health correlates of maternal ultra-processed food intake in populations with substantially lower ultra-processed food intake compared to the US population. This longitudinal study investigated relations of ultra-processed food intake with maternal weight change and cardiometabolic health and infant growth in a US cohort. METHODS Mothers in the Pregnancy Eating Attributes Study were enrolled at ≤12 weeks gestation and completed multiple 24-Hour Dietary Recalls within six visit windows through one-year postpartum (458 mothers enrolled, 321 retained at one-year postpartum). The NOVA (not an acronym) system categorized food and underlying ingredient codes based on processing level. Maternal anthropometrics were measured throughout pregnancy and postpartum, and infant anthropometrics were measured at birth and ages 2 months, 6 months, and 1 year. Maternal cardiometabolic markers were analyzed from blood samples obtained during the second and third trimesters. RESULTS Holding covariates and total energy intake constant, a 1-SD greater percent energy intake from ultra-processed foods during pregnancy was associated with 31% higher odds of excessive gestational weight gain (p = .045, 95% CI [1.01, 1.70]), 0.68±0.29 mg/L higher c-reactive protein during pregnancy (p = .021, 95% CI [0.10, 1.26]), 6.7±3.4% greater gestational weight gain retained (p = .049, 95% CI [0.03, 13.30]), and 1.09±0.36 kg greater postpartum weight retention (p = .003, 95% CI [0.38, 1.80]). No other significant associations emerged. CONCLUSIONS Ultra-processed food intake during pregnancy may be a modifiable behavioral risk factor for adverse maternal weight outcomes and inflammation. Randomized controlled trials are needed to test whether targeting ultra-processed food intake during pregnancy may support optimal maternal health. TRIAL REGISTRATION Clinicaltrials.gov. Registration ID - NCT02217462 . Date of registration - August 13, 2014.
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The establishment of the gut microbiota in 1-year-aged infants: from birth to family food.
Vacca, M, Raspini, B, Calabrese, FM, Porri, D, De Giuseppe, R, Chieppa, M, Liso, M, Cerbo, RM, Civardi, E, Garofoli, F, et al
European journal of nutrition. 2022;(5):2517-2530
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PURPOSE With the aim of characterizing the gastrointestinal (GI) microbiota and contextually determine how different prenatal, perinatal, and postnatal factors affected its composition in early childhood, infants were enrolled in a longitudinal-prospective study named "A.MA.MI." (Alimentazione MAmma e bambino nei primi MIlle giorni; NCT04122612, October 2019). METHODS Forty-five fecal samples were collected at 12 months of infants' age, identified as the 3rd follow-up (T3). The evaluated variables were pre-gestational weight and weight gain during pregnancy, delivery mode, feeding, timing of weaning, and presence/absence of older siblings. Fecal alpha and beta-diversities were analyzed. Noteworthy, to determine the impact of the influencing factors, multivariate analyses were conducted. RESULTS At T3, all prenatal and perinatal variables did not result to be significant whereas, among the postnatal variables, type of milk-feeding and weaning showed the greatest contribution in shaping the microbiota. Although aged 1 year, infants exclusively breastfed until 6 months were mainly colonized by Lactobacillaceae and Enterobacteriaceae. Differently, Bacteroidaceae characterized the microbiota of infants that were never breastfed in an exclusive way. Moreover, although an early introduction of solid foods determined higher values of Faith's PD, high abundances of Ruminococcaceae and Faecalibacterium mainly associated with infants weaned after the 4th month of age. CONCLUSION The microbial colonization during the first year of life is likely affected by a simultaneous effect of multiple variables playing a significant role at different times. Therefore, these data contribute to add evidence concerning the complex multifactorial interaction between GI microbiota and various stimuli affecting infants during the early stages of life.
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A Prospective Study of the Relationship of Sleep Quality and Duration with Gestational Weight Gain and Fat Gain.
Hill, C, Lipsky, LM, Betts, GM, Siega-Riz, AM, Nansel, TR
Journal of women's health (2002). 2021;(3):405-411
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Objective/Background: Fewer than one-third of U.S. women meet the Institute of Medicine guidelines for healthy gestational weight gain (GWG). While poor sleep quality and short sleep duration have been associated with weight gain and obesity in the general population, the relationship of sleep with pregnancy weight and body composition changes is unclear. This study aimed to examine associations of sleep duration and quality with pregnancy-related changes in body weight and fat. Participants: Pregnant women obtaining obstetric care through the University of North Carolina at Chapel Hill Healthcare System (UNC) (n = 339 who reported any sleep data) participating in the Pregnancy Eating Attributes Study. Materials and Methods: Participants were recruited at ≤12 weeks gestation and followed through delivery. The Pittsburgh Sleep Quality Index measured sleep duration and quality in early and late pregnancy. Weight was measured at each pregnancy medical visit and skinfolds were measured each trimester. t-tests examined sleep changes from early to late pregnancy and regression analyses estimated associations of sleep quality and duration with GWG and gestational fat gain (GFG). Results: Sleep quality and duration declined across pregnancy. A greater proportion of women with high early pregnancy body mass index (>25) reported low sleep quality and short sleep duration. Sleep quality was not associated with GWG adequacy, whereas longer late pregnancy sleep duration was associated with greater odds of inadequate GWG. Shorter sleep duration and lower sleep quality in late, but not early, pregnancy were associated with greater GFG. Conclusions: Lower sleep quality and shorter sleep duration in late pregnancy were associated with greater GFG. Experimental studies are needed to test the direction of causality between GFG and sleep attributes. ClinicalTrials.gov ID: NCT02217462.
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Hemp Seeds in Post-Arthroplasty Rehabilitation: A Pilot Clinical Study and an In Vitro Investigation.
Maurotti, S, Mare, R, Pujia, R, Ferro, Y, Mazza, E, Romeo, S, Pujia, A, Montalcini, T
Nutrients. 2021;(12)
Abstract
Osteoarthritis is a type of degenerative joint disease that results from the breakdown of joint cartilage and underlying bone. Due to their antioxidants and anti-inflammatory action, the phytochemical constituents of many vegetable varieties could represent a new frontier for the treatment of patients with Osteoarthritis and are still being explored. The aim of this pilot human study was to investigate the effects of pasta enriched with hemp seed flour on osteoarticular pain and bone formation markers in patients in post-arthroplasty rehabilitation. Another purpose was to evaluate the effect of hemp seed extract on bone metabolism, in vitro. A pilot, controlled, clinical study was conducted to verify the feasibility of pain symptom reduction in patients with Osteoarthritis undergoing arthroplasty surgery. We also investigated the effect of hemp seed extract on the Wnt/β-catenin and ERK1/2 pathways, alkaline phosphatase, RANKL, RUNX-2, osteocalcin, and COL1A on Saos-2. After 6 weeks, the consumption of hemp seed pasta led to greater pain relief compared to the regular pasta control group (-2.9 ± 1.3 cm vs. -1.3 ± 1.3 cm; p = 0.02). A significant reduction in serum BALP was observed in the participants consuming the hemp seed pasta compared to control group (-2.8 ± 3.2 µg/L vs. 1.1 ± 4.3 µg/L; p = 0.04). In the Saos-2 cell line, hemp seed extract also upregulated Wnt/β-catenin and Erk1/2 pathways (p = 0.02 and p = 0.03) and osteoblast differentiation markers (e.g., ALP, OC, RUNX2, and COL1A) and downregulated RANKL (p = 0.02), compared to the control. Our study demonstrated that hemp seed can improve pain symptoms in patients with osteoarthritis undergoing arthroplasty surgery and also improves bone metabolism both in humans and in vitro. However, more clinical studies are needed to confirm our preliminary findings.
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A Single-Center Clinical Study to Evaluate Shenxiong Glucose Injection Combined with Edaravone in the Treatment of Acute Large-Area Cerebral Infarction.
Li, Z, Rong, X, Luo, J, Zeng, T, Huang, P, Xu, X
BioMed research international. 2021;:9935752
Abstract
OBJECTIVES To investigate the clinical efficacy and safety of Shenxiong glucose injection combined with edaravone in the treatment of acute large-area cerebral infarction. METHODS 156 patients with acute large-area cerebral infarction admitted to our hospital from July 2015 to January 2017 were included in the analysis. The patients were randomly divided into experimental (78 cases) and control (78 cases) groups. Patients in the experimental group were given a 30 mg injection of edaravone in 100 ml of 0.9% sodium chloride solution by intravenous drip, twice a day within 30 minutes and a daily 200 ml injection of Shenxiong glucose by intravenous drip. Patients in the control group were given a 30 mg edaravone injection in 100 ml of 0.9% sodium chloride solution by intravenous drip, twice a day, and the drip was completed within 30 minutes. Patients in both groups were treated for 2 weeks. The levels of fibrinogen (FIB), D-dimer, interleukin 6 (IL-6), P-selectin (CD62P), and hypersensitive C-reactive protein (hs-CRP) were evaluated in the two groups of patients. Neurological disability was evaluated using the modified Rankin scale (mRS) and the neurological deficit score (National Institute of Health Stroke Scale, NIHSS). Adverse reactions to the treatments were also recorded. RESULTS No significant differences in age, gender, medical histories, and blood biochemical indices were observed between the two groups before treatment (P > 0.05). After treatment, the levels of FIB, D-dimer, IL-6, CD62P, and hs-CRP were significantly lower following treatment and compared to the control group (P < 0.05). Also, the mRS and NIHSS scores were significantly lower after treatment and compared with the control group (P < 0.05). The total effective rate of the treatment in the experimental group was significantly higher compared to the control group (P < 0.05). During the treatment period, no obvious adverse reactions were observed in the two groups of patients. CONCLUSIONS In addition to the routine basic treatment of acute large-area cerebral infarction, the addition of Shenxiong glucose injection combined with edaravone injection can improve platelet aggregation and reduce inflammation by affecting P-selectin, D-dimer, and FIB. This treatment approach promotes the recovery of nerve defect function without obvious adverse reactions in patients with acute large-area cerebral infarction.
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Serum ACE2, Angiotensin II, and Aldosterone Levels Are Unchanged in Patients With COVID-19.
Rieder, M, Wirth, L, Pollmeier, L, Jeserich, M, Goller, I, Baldus, N, Schmid, B, Busch, HJ, Hofmann, M, Kern, W, et al
American journal of hypertension. 2021;(3):278-281
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BACKGROUND The role of the renin-angiotensin-aldosterone system (RAAS) in coronavirus disease 2019 (COVID-19) is controversially discussed. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) enters host cells by binding to angiotensin-converting enzyme 2 (ACE2) and activity of the RAAS may affect susceptibility to SARS-CoV-2 infection and outcome of patients with COVID-19. METHODS In this prospective single-center study, we determined the serum levels of ACE2, angiotensin II, and aldosterone in patients with COVID-19 compared with control patients presenting with similar symptoms in the emergency unit. RESULTS We analyzed serum samples from 24 SARS-CoV-2 positive and 61 SARS-CoV-2 negative patients. SARS-CoV-2 positive and control patients did not differ in baseline patients characteristics, symptoms, and clinical presentation. Mean serum concentrations of ACE2, angiotensin II, and aldosterone did not differ between the SARS-CoV-2 positive and the control group. In line with this, serum potassium as surrogate parameter for RAAS activity and blood pressure were similar in both groups. CONCLUSIONS In summary, we did not find evidence for altered RAAS activity including angiotensin II, aldosterone, or potassium levels, and blood pressure in patients with COVID-19. CLINICAL TRIALS REGISTRATION Trial Number DRKS00021206.