Changes in body weight and composition, metabolic parameters, and quality of life in patients with type 2 diabetes treated with subcutaneous semaglutide in real-world clinical practice.

Subcutaneous once-weekly (ow) semaglutide is a recent treatment option for type 2 diabetes (T2D) and obesity, but real-world data on weight loss and associated changes in body composition, nutrients intake, and quality of life are still scarce. This observational, prospective clinical study involved all T2D patients starting ow semaglutide according to routine care between December 2021 and February 2022. Clinical information was collected after 6 months (T6) and 12 months (T12) from semaglutide initiation (T0). Bioelectrical Impedance Analysis (BIA) was performed to measure changes in body composition. Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the 36 - items Short Form Health Survey (SF-36) were administered as patient-reported outcomes (PROs). Changes in continuous endpoints (weight, body composition, nutrients intake, other clinical parameters, and PROs) were assessed using mixed models for repeated measurements. Overall, 90 patients (age 63.0 ± 10.0 years; diabetes duration 7.6 ± 5.9 years; 58.9% men; HbA1c 7.7 ± 1.1%; weight 95.4 ± 19.4 Kg, BMI 34.6 ± 6.4 Kg/m2; 36.7% naïve to diabetes treatment, 43.3% on metformin, 10.0% on dual oral therapy, and 10.0% treated with schemes including insulin) were included in the study. After 6 months from semaglutide initiation, body weight significantly decrease by -4.69 Kg (95%CI -6.19;-3.19) (primary endpoint). After 12 months, body weight was further reduced (-5.38 Kg; 95%CI -7.79;-2.97). At BIA, fat mass was significantly reduced by 2.1 Kg after 6 months but only slightly reduced after 12 months vs. baseline; lean mass was also significantly reduced by over 3 Kg both at 6 and 12 months. Intake of all nutrients declined in the first 6 months of therapy, although only lipids reduction reached the statistical significance (-6.73 g; p=0.02). Statistically significant improvements in BMI, waist circumference, glycemic control, blood pressure and lipid profile were documented. Satisfaction with treatment (DTSQ questionnaire) and mental health (MCS score of SF-36 questionnaire) significantly increased during the follow-up. The study documented real-world benefits of semaglutide for treating obesity in T2D subjects, with important changes on clinical and patient-reported outcomes. Loss of lean mass associated with weight loss warrants attention; parallel strategies to preserve skeletal muscle and improve physical function, i.e. nutritional education and structured exercise, are of great importance.

Yoga or Mindfulness on Diabetes: Scoping Review for Theoretical Experimental Framework.

Background: About one in 11 adults worldwide suffers from diabetic disease with constantly increasing prevalence; from the 529 million patients registered in 2021, the number of people with diabetes was predicted to rise to approximately 1.31 billion in 2050. In Italy, 5.9% of the population is diabetic, with a higher prevalence with increasing age and in the South of the country. Yoga and Mindfulness could represent a valid support for the care of diabetic subjects especially in a stressful caring context such as the Covid-19 pandemic. Study Design: A scoping review was conducted to achieve the goals of the study. Yoga or Mindfulness interventions on diabetic subjects were specifically analyzed and qualitative-quantitative data collected in the selected randomized controlled trials were extensive for possible meta-analysis. Methods: The review was conducted by two independent practitioners and a third one was consulted in case of conflict. The PRISMA method was used for both the selection and reporting of the studies to be included. Specific PICOS and search strategies have been developed on PubMed, Embase and PsycINFO databases. Included in the review were: randomised controlled trials, full dissertation articles and papers in English with a time limit on May 31, 2022. Results: The Review included 22 studies; 12 on Mindfulness, 9 on Yoga and one about both disciplines; among these, one studied patients with Type 1 Diabetes, 14 with Type 2 Diabetes, 6 with both and one with Gestational Diabetes. Only one paper studied adolescent subjects while the other 21 focused on a range of adult subjects. The studies showed that Yoga and Mindfulness have strong potential not only on stress management, but also on clinical-metabolic parameters. Conclusions: The recent Covid-19 pandemic has certainly redesigned a new way of treating and managing chronic diseases, such as diabetes. An increasingly fragile population, and with the growing need to reduce overall stress levels, could find alternative practices in Yoga and Mindfulness to support conventional therapies.

Mediterranean Diet (MedDiet) and Lifestyle Medicine (LM) for support and care of patients with type II diabetes in the COVID-19 era: a cross-observational study.

INTRODUCTION: Diabetes affects 425 million people worldwide (range 20-79 years). Of these, between 87% and 91% are affected by type 2 diabetes mellitus (DM2), and 79% live in medium/low income countries. OBJECTIVES: the main objective of the study was to observe, through the administration of specific questionnaires, the relationship existing between metabolic clinical parameters, quality of life of patients with DM2 and adherence to the MedDiet at first access to Diabetes Center in the period after the COVID-19 pandemic. The secondary objective was to observe the results obtained both qualitatively and quantitatively. MATERIALS AND METHODS: the study was a cross-sectional study. Two types of questionnaires were administered; the first (Medi-Lite) that expresses with specific score the level of "Mediterraneanness" diet while the second concerns the assessment of the SF-36 quality of life. Quantitative data such as biochemical and anthropometric parameters were collected and, through multiple regression, based on the method of least squares (OLS Model) and through the Gretl open source software were analyzed. RESULTS: fifty-two of the 90 patients at first access to the recruiting center in the period considered, met the inclusion criteria and and written consent. None of the estimated coefficients was statistically significant except Diastolic Blood Pressure (DBP), with a p-value < 0.0466. With an improvement in the level of "Mediterraneanness" there is a favorable relationship regarding creatinine, High-Density Lipoprotein (HDL), DBP and glycemia. CONCLUSIONS: The necessary post-COVID-19 territorial management cannot fail to take into consideration this new method of care which puts the patient and the community to which they belong at the center of the complex process of assistance.

Metformin and Covid-19: a systematic review of systematic reviews with meta-analysis.

INTRODUCTION: the COVID-19 infection, caused by severe Coronavirus 2 syndrome (Sars-Cov-2), immediately appeared to be the most tragic global pandemic event of the twentieth century. Right from the start of the pandemic, diabetic patients treated with metformin experienced a reduction in mortality and complications from COVID-19 compared to those with different treatments or no treatment. Objective The main objective of the study was to observe the effects of metformin in hospitalized subjects infected with COVID-19. Specifically, the outcomes of hospitalization in Intensive Care Units or death were examined. Materials and Methods A specific research PICOS was developed and the Pubmed, Embase and Scopus databases were consulted down to April 30, 2022. To estimate the extent of the metformin effect and risk of severity in SARS-CoV-2 infection, the Odd Ratio (OR) with 95% Confidence Interval (CI) published by the authors of the selected systematic reviews was used. Results from five systematic reviews 36 studies were selected. The final meta-analysis showed that thanks to treatment with metformin, DM2 patients affected by COVID-19 had protection against risk of disease severity, complications (ES 0.80; 95% CI) and mortality (ES 0.69; 95% CI). Conclusions More in-depth studies on the use of metformin, compared to other molecules, may be required to understand the real protective potential of the drug against negative outcomes caused by COVID-19 infection in DM2 patients.

Diabetes and technology: A pilot study on the management of patients with insulin pumps during the COVID-19 pandemic.

BACKGROUND: The recent COVID-19 pandemic has accelerated the treatment process through IT/technological supports, useful in the management of chronic patients such as those affected by type 1 Diabetes Mellitus (T1DM). Specific routes for fragile patients such as those with micro-infusers have been created thanks to the application of "Diabetes Technology," which allows patients to monitor blood glucose quickly and easily. The present pilot study aimed to assess the quality of care provided to patients with micro-infusers in a delicate phase such as a pandemic lockdown. MATERIALS AND METHODS: A mixed-methods approach was used. In the first part, with prior written consent, patients with insulin pumps enrolled voluntarily. In the second part, the focus group discussion (FGD) was carried out with the voluntarily enrolled participants. The FGD data were organized and analyzed by the thematic areas. RESULTS: The number of patients with afferent insulin pumps at the center was 50 individuals. Among them, 20 patients voluntarily joined the first part of the study by completing the PACIC questionnaire, which gave an average result of 3.34 (min. 2.2 and max. 4.2). In the second part, the application of the focus group technique demonstrated that technology is decisive in the management of diabetic pathology, not only in the emergency phase. CONCLUSIONS: At the time of public health crises, alternative strategies such as Tele-Nursing or Telemedicine could be crucial for the management of patients with micro-infuser not only in critical moments, such as lockdown, but also in ordinary health management.

Potential role of incretins in diabetes and COVID-19 infection: a hypothesis worth exploring.

Patients with diabetes mellitus have been reported to be at a high risk of complications from SARS-CoV2 virus infection (COVID-19). In type 2 diabetes, there is a change in immune system cells, which shift from an anti-inflammatory to a predominantly pro-inflammatory pattern. This altered immune profile may induce important clinical consequences, including increased susceptibility to lung infections; and enhanced local inflammatory response. Furthermore, dipeptidyl peptidase 4 (DPP4) enzyme is highly expressed in the lung, and that it may have additional actions besides its effects on glucose metabolism, which might exert profound pro-inflammatory effects. We briefly review the impact on the inflammatory system of DPP4 for its possible detrimental effect on COVID-19 syndrome, and of DPP4 inhibitors (gliptins), currently used as glucose lowering agents, which may have the potential to exert positive pleiotropic effect on inflammatory diseases, in addition to their effects on glucose metabolism. Thanks to these ancillary effects, gliptins could potentially be "repurposed" as salutary drugs against COVID-19 syndrome, even in non-diabetic subjects. Clinical studies should be designed to investigate this possibility.

Food knowledge of patients at the first access to a Diabetology center. / Conoscenze alimentari in pazienti afferenti ad un centro di diabetologia

Il diabete rappresenta una patologia in costante aumento: familiarità, età e stili di vita rappresentano i principali fattori di rischio per questa malattia e per le complicanze ad essa correlate. Considerando l'importanza del regime alimentare per la prevenzione e il trattamento di questa patologia, scopo del presente studio è stato quello di valutare le conoscenze alimentari di pazienti al primo accesso presso un centro di Diabetologia e di indagare sulla loro eventuale influenza su alcuni parametri ematici. È stato somministrato il questionario di Moynihan. La relazione tra i punteggi ottenuti e le variabili emoglobina glicata, BMI, glicemia a digiuno, è stata analizzata attraverso regressione multipla basata sul metodo dei minimi quadrati ordinari (modello OLS). Il response rate è stato del 73,3%. Il punteggio medio totale ottenuto dal questionario è stato di 23,61 ed è stata osservata una correlazione statisticamente significativa (p<0,0473) tra i migliori punteggi del questionario e i valori di Hb1Ac. Questo studio è il primo passo di un'indagine più ampia che verrà condotta nell'ottica di promuovere una formazione del paziente volta a verificare nel tempo le ricadute positive sulle scelte alimentari e sui parametri clinici.

Glucose-lowering drugs and heart failure: implications of recent cardiovascular outcome trials in type 2 diabetes.

Heart failure (HF) is common in Type-2 diabetes mellitus (T2DM), and viceversa, leading to a mutual impact on prognosis. Knowledge about this complex interplay has dramatically changed recently, due to development of new glucose-lowering drugs, and to specific FDA and EMA Guidance mandating to perform cardiovascular outcome trials (CVOTs), aimed at establishing cardiovascular safety, for new anti-diabetic treatments before they enter the market. Such CVOTs have demonstrated that the effects of the new antidiabetic drugs on the mutual interactions between T2DM and HF may develop across different phases:Results of such trials can be summarized as: (a) all different classes of novel glucose-lowering drugs have good cardiovascular safety profile; (b) with respect to HF, DPP4 inhibitors might tend to increase risk; (c) sodium-glucose co-transporter 2 inhibitors (SGTLi), significantly reduce it; (d) glucagon-like peptide 1 receptor agonists (GLP1) tend to be neutral. These CVOTs data have led to guideline recommendations indicating appropriate therapy to T2DM patients with HF not at glycemic control target with metformin therapy.

Adipose tissue as an endocrine organ? A review of recent data related to cardiovascular complications of endocrine dysfunctions.

Clinical and experimental data obtained in the last few years have modified the concept of adipose tissue as one solely directed at energy storage and release. The adipose tissue is a target organ for glucocorticoids and several studies have been carried out on the function of hypothalamic-pituitary-adrenal axis in obese subjects without conclusive results. A recent and innovative finding is that adipose tissue can produce cortisol from its inactive precursor, cortisone. The identification of leptin, a hormone synthesised by fat tissue, has ushered in the modern view of this tissue as a true endocrine organ. Leptin is produced primarily by subcutaneous and to a lesser extent by visceral adipose tissue, and has a central role in controlling body weight and, especially in regulating fat stores. Leptin is also involved in several complex functions, including physiological processes associated with puberty. Another hormone of fat tissue is angiotensinogen, which is produced in larger amounts by visceral than subcutaneous fat. Human and animals adipose tissue express a whole renin-angiotensin system (RAS). Angiotensin II, the final effector of this system is probably produced locally by adipose tissue. The function of adipose RAS is not well known. RAS can participate together with other hormones and substances, in adipocyte differentiation and fat tissue growth, but could be also involved in the pathogenesis of complications of obesity including arterial hypertension.

Bone metabolism and mass in women with Cushing's syndrome and adrenal incidentaloma.

OBJECTIVE: The aim of this study was to compare bone turnover and mass in women with either Cushing's syndrome (CS) or adrenal incidentaloma (AI), which is a possible model for minimal hypersecretion of cortisol. DESIGN AND PATIENTS: We studied 15 patients with CS (seven premenopausal and eight postmenopausal women); 23 patients with AI (five premenopausal and 18 postmenopausal women) and 20 matched controls (seven premenopausal and 13 postmenopausal women). Alkaline phosphatase (ALP), bone alkaline phosphatase (bALP), osteocalcin (BGP), 24-h urinary pyridinoline (Pyr) and deoxypyridinoline (D-Pyr) and serum and 24-h urinary calcium and phosphorus were determined in all subjects. Bone mineral density (BMD) at lumbar spine and proximal femur was measured by dual energy X-ray absorptiometry (DEXA). RESULTS: We found a significant reduction of BGP and serum phosphorus in CS and AI (P < 0.05) vs. controls and significantly lower levels of Pyr only in CS (P < 0.05) vs. AI and controls. Spinal and femoral BMD z-values were significantly lower (P < 0.05) in patients with CS (z-score: lumbar spine -1.44 +/- 1.5 and femoral neck -1.07 +/- 1; mean +/- SD) compared to AI and controls. CONCLUSIONS: Our data show that hypercortisolism reduces osteoblastic function and bone resorption and that osteocalcin can contribute to the precocious diagnosis of silent glucocorticoid excess. Patients with active CS were found to have lower BMD, particularly at vertebral level.

Severe hypomagnesaemia-induced hypocalcaemia in a patient with Gitelman's syndrome.

Gitelman's syndrome (GS) is characterized by hyperreninaemic hyperaldosteronism, hypokalaemia, metabolic alkalosis, hypomagnesaemia and hypocalciuria and is due to a defect of the Na-Cl cotransporter at the distal tubule, which may appear in a sporadic or in a familial form. It is an autosomal recessive disorder associated with normal or reduced blood pressure. We report a case of severe hypomagnesaemia-induced hypocalcaemia in a 39-year-old Caucasian woman with GS. The patient had impaired parathormone (PTH) responsiveness to peripheral stimuli, as proved by the marked PTH increase and normalization of plasma calcium levels after acute and chronic administration of magnesium salts. Secondary normotensive hyperreninaemic hyperaldosteronism with hypokalaemia and metabolic alkalosis was also present. Normal plasma renin activity (PRA) and aldosterone levels were restored by administration of an inhibitor of prostaglandin synthesis. The electrolyte imbalance was successfully corrected with chronic treatment with magnesium and potassium salts. Genetic analysis identified a compound heterozygous mutation in the Na-Cl cotransporter gene (NCCT), confirming the diagnosis of GS. The striking feature of this case of GS was impaired PTH responsiveness to peripheral stimuli determined by hypomagnesaemia and the resulting severe hypocalcaemia, which had not previously been described in this syndrome.

Self image and quality of life in acromegaly.

Chronic effects of excessive GH secretion are not only disabling but also disfiguring. Most acromegalic patients present with 4-10 years history of changes in features, bony overgrowth, soft tissue swelling, skin changes, diabetes mellitus, hypertension and other cardiovascular symptoms. In addition to sign and symptoms of GH excess the patients demonstrate a loss initiative and spontaneity, mood swings, an impairments in self esteem, body image distortion, disruption in interpersonal relations and social withdrawal anxiety. Little research is available on the psychological features of acromegaly, despite their importance in this chronic and debilitating condition. Extremely little, however has appeared in the medical and psychological literature about mental and emotional disfunction in patients with acromegaly.