Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Glargine (Gan & Lee Glargine) Compared With Originator Insulin Glargine (Lantus) in Patients With Type 1 Diabetes After 26 Weeks Treatment.

OBJECTIVE: To compare the immunogenicity, safety, and efficacy of Gan & Lee insulin glargine (GL Glargine) with that of the originator insulin glargine (Lantus) in patients with type 1 diabetes mellitus (T1DM). METHODS: This was a phase 3, multicenter, randomized, open-label, equivalence study. Five hundred seventy-six subjects with T1DM were randomized 1:1 to receive either GL Glargine or Lantus treatment for 26 weeks. The primary end point was the percentage of subjects in each treatment group who developed treatment-induced anti-insulin antibody after baseline and up to visit week 26, which was evaluated using a country-adjusted logistic regression model. The study also compared the changes in glycated hemoglobin, and adverse events including hypoglycemia. RESULTS: The percentage of subjects positive for treatment-induced anti-insulin antibody by Week 26 was 25.8% in the GL Glargine treatment group and 25.3% in the Lantus treatment group, with a 90% confidence interval (-5.4, 6.5) of the difference in proportions that fell completely between the similarity margins (-11.3, 11.3). The least squares mean difference between treatment groups for changes in glycated hemoglobin was -0.08 (90% confidence interval: -0.23, 0.06), and the other immunogenicity and safety profiles were comparable. CONCLUSION: GL Glargine demonstrated similar immunogenicity, efficacy, and safety compared to Lantus over 26 weeks in patients with T1DM.

Future lines of research on phase angle: Strengths and limitations.

Bioelectrical impedance analysis (BIA) is the most widely used technique in body composition analysis. When we focus the use of phase sensitive BIA on its raw parameters Resistance (R), Reactance (Xc) and Phase Angle (PhA), we eliminate the bias of using predictive equations based on reference models. In particular PhA, have demonstrated their prognostic utility in multiple aspects of health and disease. In recent years, as a strong association between prognostic and diagnostic factors has been observed, scientific interest in the utility of PhA has increased. In the different fields of knowledge in biomedical research, there are different ways of assessing the impact of a scientific-technical aspect such as PhA. Single frequency with phase detection bioimpedance analysis (SF-BIA) using a 50 kHz single frequency device and tetrapolar wrist-ankle electrode placement is the most widely used bioimpedance approach for characterization of whole-body composition. However, the incorporation of vector representation of raw bioelectrical parameters and direct mathematical calculations without the need for regression equations for the analysis of body compartments has been one of the most important aspects for the development of research in this area. These results provide new evidence for the validity of phase-sensitive bioelectrical measurements as biomarkers of fluid and nutritional status. To enable the development of clinical research that provides consistent results, it is essential to establish appropriate standardization of PhA measurement techniques. Standardization of test protocols will facilitate the diagnosis and assessment of the risk associated with reduced PhA and the evaluation of changes in response to therapeutic interventions. In this paper, we describe and overview the value of PhA in biomedical research, technical and instrumental aspects of PhA research, analysis of Areas of clinical research (cancer patients, digestive and liver diseases, critical and surgical patients, Respiratory, infectious, and COVID-19, obesity and metabolic diseases, Heart and kidney failure, Malnutrition and sarcopenia), characterisation of the different research outcomes, Morphofunctional assessment in disease-related malnutrition and other metabolic disorders: validation of PhA with reference clinical practice techniques, strengths and limitations. Based on the detailed study of the measurement technique, some of the key issues to be considered in future PhA research. On the other hand, it is important to assess the clinical conditions and the phenotype of the patients, as well as to establish a disease-specific clinical profile. The appropriate selection of the most critical outcomes is another fundamental aspect of research.

Complex axial growth patterns in an early Cambrian trilobite from South Australia.

The exceptional fossil record of trilobites provides our best window on developmental processes in early euarthropods, but data on growth dynamics are limited. Here, we analyse post-embryonic axial growth in the Cambrian trilobite Estaingia bilobata from the Emu Bay Shale, South Australia. Using threshold models, we show that abrupt changes in growth trajectories of different body sections occurred in two phases, closely associated with the anamorphic/epimorphic and meraspid/holaspid transitions. These changes are similar to the progression to sexual maturity seen in certain extant euarthropods and suggest that the onset of maturity coincided with the commencement of the holaspid period. We also conduct hypothesis testing to reveal the likely controls of observed axial growth gradients and suggest that size may better explain growth patterns than moult stage. The two phases of allometric change in E. bilobata, as well as probable differing growth regulation in the earliest post-embryonic stages, suggest that observed body segmentation patterns in this trilobite were the result of a complex series of changing growth controls that characterized different ontogenetic intervals. This indicates that trilobite development is more complex than previously thought, even in early members of the clade.

Confusion in the nomenclature of ketogenic diets blurs evidence.

Ketogenic diets have been proposed as a non-pharmacological strategy for the management of several chronic conditions. Their efficacy and safety have been evaluated in the field of neurology, oncology and endocrinology for disorders including cancer, dementia, drug-resistant epilepsy, migraines, obesity, polycystic ovary syndrome and type 2 diabetes mellitus. The nutritional requirements of these subjects are expected to differ significantly. Indeed, although all ketogenic diets restrict carbohydrates, each intervention is characterized by a specific daily calorie intake, macronutrient composition and duration. However, the adopted nomenclature was often unclear to the general reader; also, the same abbreviations for different protocols were used. This possibly resulted in mistakes in the interpretation of the available evidence and limited the impact of studies on the topic in the clinical practice. Adopting a clear and consistent vocabulary is key in any context. Here, we present a practical and clinically-based proposal for the classification and abbreviation of ketogenic diets.

Ketogenic diets as treatment of obesity and type 2 diabetes mellitus.

During the last decades, several interventions for the management of overweight and obesity have been proposed. Among diets, the first studies focused on the effect of water only and total fasting diets with or without proteins. Unfortunately, they were found to be associated with adverse events which lead to the abandon of these strategies. Interestingly, despite the radical approach, total fasting was effective and generally well tolerated. A strict connection between protein-calorie malnutrition and increased in morbidity and mortality in hospitalized patients was found at that time. Then, the seminal works of Blackburn and his collaborators lead to the introduction of the protein-sparing modified fast. Encouraged by the early results using this intervention, diets evolved to the current very-low-calorie ketogenic diets (VLCKD). In the present review, results of studies on the VLCKDs are presented and discussed, with a particular reference to the protocolled VLCKD. Also, a recent proposal on the nomenclature on the ketogenic diets is reported. Available evidence suggests VLCKDs to be effective in achieving a rapid and significant weight loss by means of an easily reversible intervention which could be repeated, if needed. Muscle mass and strength are preserved, resting metabolic rate is not impaired, hunger, appetite and mood are not worsened. Symptoms and abnormal laboratory findings can be there, but they have generally been reported as of mild intensity and transient. Preliminary studies suggest VLCKDs to be a potential game-changer in the management of type 2 diabetes too. Therefore, VLCKDs should be considered as an excellent initial step in properly selected and motivated patients with obesity or type 2 diabetes, to be delivered as a part of a multicomponent strategy and under strict medical supervision.

Effect of Telephone-Delivered Interventions on Glycemic Control in Type 2 Diabetes Treated with Glargine Insulin.

Background:Telephone-delivered intervention can provide support in diabetes self-management to improve glycemic control. "eStar® program" is a telephone support platform for type 2 diabetes on glargine insulin treatment. Its objective is to help patients to perform insulin titration to reach target fasting blood glucose levels. Patients are contacted by trained nurses on a regular basis to adjust the basal insulin dose and reinforce the diabetes education. This study aimed to evaluate if eStar program was effective in helping patients reach their optimal insulin glargine dose within 6 months.Materials and Methods:An observational prospective study was conducted with type 2 diabetes patients who were initiating insulin glargine or requiring dose titration and were eligible to be included in the eStar program. Those participants who followed the program comprised the intervention group, while those who discontinued, the control group. The primary outcome was to evaluate if this program was effective in helping patients reach their optimal insulin glargine dose within 6 months. Secondary outcomes included changes in glycosylated hemoglobin (HbA1C), fasting plasma glucose (FPG), insulin dose, and body mass index after 6 months.Results:A total of 228 subjects [intervention group, 143 (62.7%); control group, 85 (37.3%)] were included in the study. A significantly greater percentage of patients in the intervention group reached their optimal glargine dose than in the control group (83.8% vs. 31.5%; p < 0.001). After 6 months, significant reductions in mean HbA1C levels were observed in both groups: 1.49% (p < 0.001) for the intervention group and 1.08% (p < 0.001) for the control group. Furthermore, a mean reduction in FPG between group was achieved (34.96 mg/dL; p < 0.001).Conclusions:The eStar program is an effective way to help patients reach their optimal insulin glargine dose, besides improving their glycemic control.

Intensification of Basal Insulin Therapy with Lixisenatide in Patients with Type 2 Diabetes in a Real-World Setting: The BASAL-LIXI Study.

BACKGROUND: Basal insulin reduces fasting blood glucose levels, but postprandial blood glucose levels may remain higher. Traditional strategies with rapid insulin intensification can cause hypoglycemic episodes and weight gain. Glucagon-like peptide-1 receptor agonists, such as the short-acting lixisenatide, are able to control postprandial excursions, without weight gain, and with a low risk of hypoglycemic events. OBJECTIVE: Due to the limited data on the combination of lixisenatide with basal insulin (with or without oral antidiabetes drugs) in clinical practice, this study evaluated changes in parameters associated with glycemic control and anthropometric data after 24 weeks of this therapy intensification. METHODS: This was a multicenter, retrospective observational study of 129 patients with type 2 diabetes that was uncontrolled by basal insulin. Their treatment was intensified by the addition of lixisenatide at least 24 weeks before being included in the study. Data were retrospectively collected to determine changes in glycated hemoglobin (HbA1c) levels, blood glucose levels, weight, and body mass index. Adverse reactions and hypoglycemic events were also recorded. RESULTS: After 24 weeks of therapy intensification with lixisenatide, a significant reduction in HbA1c levels was observed (-1.1%; P < 0.001). An HbA1c <7% was achieved in 30.2% of patients, and 17.1% reached an HbA1c <6.5%. There was a reduction in fasting blood glucose (31.8 [60.3] mg/dL; P < 0.001) and postprandial blood glucose (55.0 [49] mg/dL; P < 0.001) levels, as well as body weight (4.0 [5.4] kg; P < 0.001) and body mass index (1.5 [1.9]; P < 0.001). The most commonly observed adverse reactions were nausea (n = 9), in line with previous studies. Hypoglycemia events were rare; only reported in 2 patients. CONCLUSIONS: Intensification strategy based on lixisenatide added to basal insulin (with or without oral antidiabetes drugs) can be an effective treatment option in patients with uncontrolled type 2 diabetes. In this small, selected population, glycemic control was significantly improved in terms of HbA1, fasting blood glucose levels, and postprandial glucose levels, with a reduction of body weight and low risk of hypoglycemic events. (Curr Ther Res Clin Exp. 2018; 79:XXX-XXX).

Modern optics in exceptionally preserved eyes of Early Cambrian arthropods from Australia.

Despite the status of the eye as an "organ of extreme perfection", theory suggests that complex eyes can evolve very rapidly. The fossil record has, until now, been inadequate in providing insight into the early evolution of eyes during the initial radiation of many animal groups known as the Cambrian explosion. This is surprising because Cambrian Burgess-Shale-type deposits are replete with exquisitely preserved animals, especially arthropods, that possess eyes. However, with the exception of biomineralized trilobite eyes, virtually nothing is known about the details of their optical design. Here we report exceptionally preserved fossil eyes from the Early Cambrian (∼ 515 million years ago) Emu Bay Shale of South Australia, revealing that some of the earliest arthropods possessed highly advanced compound eyes, each with over 3,000 large ommatidial lenses and a specialized 'bright zone'. These are the oldest non-biomineralized eyes known in such detail, with preservation quality exceeding that found in the Burgess Shale and Chengjiang deposits. Non-biomineralized eyes of similar complexity are otherwise unknown until about 85 million years later. The arrangement and size of the lenses indicate that these eyes belonged to an active predator that was capable of seeing in low light. The eyes are more complex than those known from contemporaneous trilobites and are as advanced as those of many living forms. They provide further evidence that the Cambrian explosion involved rapid innovation in fine-scale anatomy as well as gross morphology, and are consistent with the concept that the development of advanced vision helped to drive this great evolutionary event.

Acute vision in the giant Cambrian predator Anomalocaris and the origin of compound eyes.

Until recently, intricate details of the optical design of non-biomineralized arthropod eyes remained elusive in Cambrian Burgess-Shale-type deposits, despite exceptional preservation of soft-part anatomy in such Konservat-Lagerstätten. The structure and development of ommatidia in arthropod compound eyes support a single origin some time before the latest common ancestor of crown-group arthropods, but the appearance of compound eyes in the arthropod stem group has been poorly constrained in the absence of adequate fossils. Here we report 2-3-cm paired eyes from the early Cambrian (approximately 515 million years old) Emu Bay Shale of South Australia, assigned to the Cambrian apex predator Anomalocaris. Their preserved visual surfaces are composed of at least 16,000 hexagonally packed ommatidial lenses (in a single eye), rivalling the most acute compound eyes in modern arthropods. The specimens show two distinct taphonomic modes, preserved as iron oxide (after pyrite) and calcium phosphate, demonstrating that disparate styles of early diagenetic mineralization can replicate the same type of extracellular tissue (that is, cuticle) within a single Burgess-Shale-type deposit. These fossils also provide compelling evidence for the arthropod affinities of anomalocaridids, push the origin of compound eyes deeper down the arthropod stem lineage, and indicate that the compound eye evolved before such features as a hardened exoskeleton. The inferred acuity of the anomalocaridid eye is consistent with other evidence that these animals were highly mobile visual predators in the water column. The existence of large, macrophagous nektonic predators possessing sharp vision--such as Anomalocaris--within the early Cambrian ecosystem probably helped to accelerate the escalatory 'arms race' that began over half a billion years ago.

A new vetulicolian from Australia and its bearing on the chordate affinities of an enigmatic Cambrian group.

BACKGROUND: Vetulicolians are one of the most problematic and controversial Cambrian fossil groups, having been considered as arthropods, chordates, kinorhynchs, or their own phylum. Mounting evidence suggests that vetulicolians are deuterostomes, but affinities to crown-group phyla are unresolved. RESULTS: A new vetulicolian from the Emu Bay Shale Konservat-Lagerstätte, South Australia, Nesonektris aldridgei gen. et sp. nov., preserves an axial, rod-like structure in the posterior body region that resembles a notochord in its morphology and taphonomy, with notable similarity to early decay stages of the notochord of extant cephalochordates and vertebrates. Some of its features are also consistent with other structures, such as a gut or a coelomic cavity. CONCLUSIONS: Phylogenetic analyses resolve a monophyletic Vetulicolia as sister-group to tunicates (Urochordata) within crown Chordata, and this holds even if they are scored as unknown for all notochord characters. The hypothesis that the free-swimming vetulicolians are the nearest relatives of tunicates suggests that a perpetual free-living life cycle was primitive for tunicates. Characters of the common ancestor of Vetulicolia + Tunicata include distinct anterior and posterior body regions - the former being non-fusiform and used for filter feeding and the latter originally segmented - plus a terminal mouth, absence of pharyngeal bars, the notochord restricted to the posterior body region, and the gut extending to the end of the tail.

The Emu Bay Shale: A unique early Cambrian Lagerstätte from a tectonically active basin.

The Emu Bay Shale (EBS) of South Australia is anomalous among Cambrian Lagerstätten because it captures anatomical information that is rare in Burgess Shale-type fossils, and because of its inferred nearshore setting, the nature of which has remained controversial. Intensive study, combining outcrop and borehole data with a compilation of >25,000 fossil specimens, reveals that the EBS biota inhabited a fan delta complex within a tectonically active basin. Preservation of soft-bodied organisms in this setting is unexpected and further underscores differences between the EBS and other Cambrian Lagerstätten. Environmental conditions, including oxygen fluctuations, slope instability, high suspended sediment concentrations, and episodic high-energy events, inhibited colonization of the lower prodelta by all but a few specialist species but favored downslope transportation and preservation of other largely endemic, shallow-water benthos. The EBS provides extraordinary insight into early Cambrian animal diversity from Gondwana. These results demonstrate how environmental factors determined community composition and provide a framework for understanding this unique Konservat-Lagerstätte.

Nutritional and Morphofunctional Assessment of Post-ICU Patients with COVID-19 at Hospital Discharge: NutriEcoMuscle Study.

This paper presents baseline results from the NutriEcoMuscle study, a multicenter observational study conducted in Spain which focused on changes in nutritional status, body composition, and functionality in post-intensive care unit (ICU) COVID-19 patients following a nutritional intervention. Assessments at hospital discharge included Subjective Global Assessment (SGA), Global Leadership Initiative on Malnutrition (GLIM) criteria, the Barthel index, handgrip strength (HGS) and the Timed Up-and-Go test, bioelectrical impedance analysis (BIA), and nutritional ultrasound (US). The study involved 96 patients (71.9% male, mean age 58.8 years, mean BMI 28.8 kg/m2, 36.5% obese). All patients were malnourished at discharge according to GLIM and SGA. Functional status declined from admission up to hospital discharge. A total of 33.3% of patients had a low fat-free mass index (FFMI) and 29.5% had a low phase angle (PhA). Myosteatosis was observed in 83.7% of the population. There was a positive correlation between rectus femoris cross-sectional area, PhA, FFMI, and HGS. In conclusion, post-critically ill COVID-19 patients commonly suffer from malnutrition and reduced muscle mass, causing a loss of independence at hospital discharge. BIA and US could be valuable tools for assessing body composition in these patients. The NutriEcoMuscle study highlights the need for a thorough nutritional and morphofunctional status assessment of post-ICU patients.

Identifying advanced MAFLD in a cohort of T2DM and clinical features.

Background: MAFLD is the most common cause of chronic liver disease, affecting 25% of the global population. Patients with T2DM have an increased risk of developing MAFLD. In addition, patients with T2DM have a higher risk of advanced forms of steatohepatitis and fibrosis. Identifying those patients is critical in order to refer them to specialist and appropriate management of their disease. Aims and Objectives: To estimate advanced fibrosis prevalence in a cohort of patients with T2DM and to identify possible predictors. Methods: subjects with T2DM during regular health check-up were enrolled. Demographic and general characteristics were measured, including metabolic parameters and homeostasis model assessment of insulin resistance (HOMA2-IR). Four non-invasive fibrosis scores (NAFLD fibrosis scores, FIB-4, APRI, Hepamet fibrosis score) were measure and compared with transient elastography (TE). Results: 96 patients (21%) presented risk of significant fibrosis (≥F2) measured by TE and 45 patients (10%) presented with risk of advanced fibrosis F3-F4. Liver fibrosis was related to BMI, AC, HOMA2-IR. The results of the non-invasive fibrosis scores have been validated with the results obtained in the TE. It is observed that the index with the greatest area under the curve (AUC) is APRI (AUC=0.729), with a sensitivity of 62.2% and a specificity of 76.1%. However, the test with better positive likelihood ratio (LR+) in our study is NAFLD fibrosis score. Conclusions: Our results show that in a general T2DM follow up, 10% of patients were at risk of advanced fibrosis. We found a positive correlation between liver fibrosis and BMI, AC and HOMA2-IR. Non-invasive fibrosis markers can be useful for screening, showing NAFLD Fibrosis score a better LHR+ compared to TE. Further studies are needed to validate these results and elucidate the best screening approach to identify those patients at risk of advanced MAFLD.

Protocol for a prospective cohort study on the feasibility of application of nutritional ultrasound in the diagnosis and follow-up of patients with nutritional risk at hospital discharge: study on body composition and function (DRECO).

INTRODUCTION: Nutritional ultrasound (US) is an emerging technique in clinical nutrition for the morphological and structural study of muscle mass. Currently, all definitions of malnutrition include the measurement of muscle mass; however, there is no single way to assess it. It is necessary to develop new techniques to identify muscle involvement in malnutrition that are valid, standardised, reliable, accurate and profitable. OBJECTIVE: To value the new muscle US techniques aimed to measure muscle and functional status, to make a more accurate diagnosis and a better prediction of complications and morbidity and mortality in patients at nutritional risk. PRIMARY OUTCOME: to assess the feasibility of US or muscle US techniques in both nutritional diagnosis and follow-up in a nutritional intervention programme. METHODS AND ANALYSIS: Disease-Related caloric-protein malnutrition EChOgraphy (DRECO) is a prospective, multicentre (25 Spanish hospitals), uncontrolled clinical study in standard clinical practice to value the usefulness of nutritional US (muscle US) in the nutritional diagnosis and follow-up, over 3-6 months, after standard nutritional clinical practice intervention and physical activity, to control their disease-related malnutrition. 1000 patients are expected to be included in. DISCUSSION: This study will standardise nutritional US measures. It will validate and define specific cut-off values for nutritional US and correlate it with already well-known nutritional tools such as Subjective Global Assessment or Global Leadership Initiative on Malnutrition criteria. Thus, muscle US will become not only a tool to diagnose malnutrition, but it will also be integrated in the daily practice to evaluate nutritional interventions. ETHICS AND DISSEMINATION: All DRECO study materials have been approved by each of the IRB/IEC of all the sites enrolled (either approval of the own IRB/IEC or validating the approval of the IRB/IEC of another hospital). The study has been registered with ClinicalTrials.gov, on 27 June 2022. The results from this study will be presented at scientific conferences and in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT05433831.

Efficacy of a Connected Insulin Pen Cap in People With Noncontrolled Type 1 Diabetes: A Multicenter Randomized Clinical Trial.

OBJECTIVE: To assess the efficacy of the insulin pen cap Insulclock on improving glycemic control, treatment adherence, and user satisfaction in people with type 1 diabetes. RESEARCH DESIGN AND METHODS: This multicenter, open-label, randomized controlled trial comprised a 4-week run-in phase and a 6-week double-arm phase in which participants were randomly assigned into an active or masked mode. RESULTS: Fifty-five participants were evaluable (active group, n = 26, masked group, n = 29). The increase in time in range was higher in the active versus masked group (5.2% vs. -0.8%; P = 0.016). The active group showed a higher reduction in mean glucose, glucose management indicator, time above range, and high blood glucose index. On-time insulin doses increased in the active group and decreased in the masked group. CONCLUSIONS: Insulclock system use was associated with improved glycemic control, glycemic variability, hyperglycemia risk, and treatment adherence in people with uncontrolled type 1 diabetes.

Descriptive study of a clinical and educational telemedicine intervention in patients with diabetes receiving glargine 300 U/ml (Toujeo) in Spain: results of the T-Coach programme.

Background: Diabetes is one of the most prevalent chronic diseases worldwide, and innovative patient support programmes can help and inform patients about their disease and improve their quality of life. The purpose of this study was to evaluate the effect of the T-Coach programme in terms of improvement of disease knowledge, self-management and adherence to treatment in a real-world setting in Spain between July 2016 and October 2018. Methods: We analyzed data from the T-Coach programme, a telephone platform that gives support to patients with type 2 diabetes mellitus treated with insulin glargine 300 U/ml (Gla-300). Support was provided by diabetes care nurses. Patients followed their treatment and aimed to achieve fasting blood glucose targets through diabetes education. Results: A total of 479 patients were included in the programme. The mean (SD) dose of Gla-300 was 28.5 (16.3) U at baseline and 31.8 (16.1) U, 31.4 (16.4) U and 32.2 (16.3) U, respectively, at 3, 6 and 12 months. A satisfaction survey was completed by 240 (50.1%) patients, who, on average, were very highly satisfied with the programme, general assistance provided, recommendations received, and calls from nurses. Conclusions: T-Coach could be an effective tool to help patients achieve their optimal dose of Gla-300 insulin and manage their blood glucose levels. It could also act as an effective support for diabetes education.

Expert Consensus on Morphofunctional Assessment in Disease-Related Malnutrition. Grade Review and Delphi Study.

Disease-related malnutrition (DRM) affects approximately a third of hospitalized patients and is associated with an increased risk of morbimortality. However, DRM is often underdiagnosed and undertreated. Our aim is to evaluate the prognostic value of morphofunctional tools and tests for nutritional assessment in clinical practice. A systematic literature review was conducted to identify studies relating to the morphofunctional assessment of nutritional status and mortality or complications. Evidence was evaluated using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) method. Twelve GRADE recommendations were made and divided into seven topics: food intake and nutrient assimilation, anthropometry, biochemical analysis, hand grip strength, phase angle, muscle imaging, and functional status and quality of life. From these recommendations, 37 statements were developed and scored in a two-survey Delphi method by 183 experts. A consensus was reached on accepting 26/37 statements. Surveys had high internal consistency and high inter-rater reliability. In conclusion, evidence-based recommendations were made on the prognostic value of morphofunctional assessment tools and tests to assess malnutrition, most of which were found to be feasible in routine clinical practice, according to expert opinions.

Reducing Metabolic Syndrome through a Group Educational Intervention Program in Adults with Obesity: IGOBE Program.

Metabolic syndrome (MetS) increases the risk of cardiovascular disease, type 2 diabetes mellitus, and cancer. Despite the higher prevalence of MetS in obese adults, little is known about the effectiveness of intensive and group interventions in improving MetS prevalence. This study aimed to investigate the effectiveness of an intensive lifestyle program in reducing the prevalence of MetS in adults with obesity. Patients with obesity (n = 456, 48.8 ± 12.8 years, 18.5% male) were randomized in two groups as indicated in a prospective interventional real-life study: a control group (CG), in which patients received usual care, and an interventional group (IG), in which the patients participate in a healthy lifestyle habits program in six weekly sessions, IGOBE program. Anthropometric, body composition, medications, and MetS features data were analyzed in both groups at the pre-intervention and post-intervention stages using a completer's analysis. At 12 months of follow-up, the IG showed a relative reduction of 13.4% in the prevalence of MetS from baseline, while the CG showed a reduction of 2.1% (p < 0.001). A significant reduction was also observed in four of five MetS features. In this trial, implementation of the IGOBE program resulted in a significant reduction in MetS prevalence and better control of MetS features compared with the standard of care.

Epigenetic Effects of Healthy Foods and Lifestyle Habits from the Southern European Atlantic Diet Pattern: A Narrative Review.

Recent scientific evidence has shown the importance of diet and lifestyle habits for the proper functioning of the human body. A balanced and healthy diet, physical activity, and psychological well-being have a direct beneficial effect on health and can have a crucial role in the development and prognosis of certain diseases. The Southern European Atlantic diet, also named the Atlantic diet, is a unique dietary pattern that occurs in regions that present higher life expectancy, suggesting that this specific dietary pattern is associated with positive health effects. In fact, it is enriched with nutrients of high biological value, which, together with its cooking methods, physical activity promotion, reduction in carbon footprint, and promoting of family meals, promote these positive effects on health. The latest scientific advances in the field of nutri-epigenetics have revealed that epigenetic markers associated with food or nutrients and environmental factors modulate gene expression and, therefore, are involved with both health and disease. Thus, in this review, we evaluated the main aspects that define the Southern European Atlantic diet and the potential epigenetic changes associated with them based on recent studies regarding the main components of these dietary patterns. In conclusion, based on the information existing in the literature, we postulate that the Southern European Atlantic diet could promote healthy aging by means of epigenetic mechanisms. This review highlights the necessity of performing longitudinal studies to demonstrate this proposal.

Leading Factors for Weight Gain during COVID-19 Lockdown in a Spanish Population: A Cross-Sectional Study.

The increase in sedentary behaviors during the COVID-19-induced lockdown may have led to a significant weight gain. To investigate this hypothesis, a representative sample of the Spanish adult population comprising 1000 subjects was enrolled in a cross-sectional study between 26 May and 10 June 2020. Computer-assisted telephone interviews were conducted consisting of 29 questions on the topic of lifestyle habits during the lockdown. The cohort comprised 51.5% women and 51% overweight or obese subjects and had a mean age of 50 ± 18 years. Of the respondents, 44.5% self-reported weight gain during the lockdown; of these, 58.0% were women, 69.9% had previous excess weight, 44.7% lived with a relative who also gained weight, and 73.5 experienced increased appetite. Further, an increased consumption of energy-dense products was found relative to respondents who did not gain weight (p ≤ 0.016 for all). Additionally, respondents were unaware that obesity is a poor prognostic factor for COVID-19 infection, lived in smaller flats, and had a lower level of education and lower monthly income. The factors independently associated with weight gain were female gender, previous overweight or obesity, lack of food care, increased appetite, and increased consumption of sugar-sweetened beverages, alcoholic beverages, and snacks (p ≤ 0.023 for all). Should another lockdown be mandated, extra caution is warranted to prevent weight gain.