The causes and metabolic consequences of lipohypertrophy (LH) from incorrect insulin injection techniques have been well-known for a long time and are the subject of countless publications. However, ...only some researchers propose structured research modalities for LH and programs to teach patients how to prevent them and minimize their effects, thus contributing to complete rehabilitation. Experts and scientific societies have produced consensus documents and recommendations to spread the culture of LH and its complications among clinicians. However, they should go deeper into LH detection methods. This short article analyzes the recent literature on the best way to explore and find more or less evident LH lesions by using a structured and validated clinical methodology to benefit the many clinicians without access to technological equipment such as ultrasonography. This text also aims to bring awareness that since the last published recommendations on injection techniques, new needles for insulin injection, more technologically advanced and suitable for specific populations, have come to market but still need a thorough evaluation.
Oxytocin is a neuropeptide that is active in the central nervous system and is generally considered to be involved in prosocial behaviors and feelings. In light of its documented positive effect on ...maternal behavior, we designed a study to ascertain whether oxytocin exerts any therapeutic effects on depressive symptoms in women affected by maternal postnatal depression. A group of 16 mothers were recruited in a randomized double-blind study: the women agreed to take part in a brief course of psychoanalytic psychotherapy (12 sessions, once a week) while also being administered, during the 12-weeks period, a daily dose of intranasal oxytocin (or a placebo). The pre-treatment evaluation also included a personality assessment of the major primary-process emotional command systems described by Panksepp () and a semi-quantitative assessment by the therapist of the mother's depressive symptoms and of her personality. No significant effect on depressive symptomatology was found following the administration of oxytocin (as compared to a placebo) during the period of psychotherapy. Nevertheless, a personality trait evaluation of the mothers, conducted in our overall sample group, showed a decrease in the narcissistic trait only within the group who took oxytocin. The depressive (dysphoric) trait was in fact significantly affected by psychotherapy (this effect was only present in the placebo group so it may reflect a positive placebo effect enhancing the favorable influence of psychotherapy on depressive symptoms) but not in the presence of oxytocin. Therefore, the neuropeptide would appear to play some role in the modulation of cerebral functions involved in the self-centered (narcissistic) dimension of the suffering that can occur with postnatal depression. Based on these results, there was support for our hypothesis that what is generally defined as postnatal depression may include disturbances of narcissistic affective balance, and oxytocin supplementation can counteract that type of affective disturbance. The resulting improvements in well-being, reflected in better self-centering in post-partuent mothers, may in turn facilitate better interpersonal acceptance of (and interactions with) the child and thereby, improved recognition of the child's needs.
Introduction
Lipohypertrophies (LHs) due to incorrect insulin injection techniques have been described in the literature for decades. Their rate averages 38%, but this is still controversial because ...of the vast range reported by different publications, most of which fail to describe the selected detection protocol and therefore are not entirely reliable. We still need to identify the real LH rate, and only consistently using a standardized method in a large cohort of insulin-treated (IT) patients make this possible.
Methods
Our group performed thorough clinical skin examinations on patients suffering from type 2 diabetes mellitus (T2DM): 1247 IT T2DM outpatients were examined according to a standardized protocol, previously published elsewhere, as well as an ultrasound scan of the same skin areas to assess the degree of concordance between the two methods and to evaluate the demographic, clinical, and behavioral risk factors (RF) as well as metabolic consequences of identified LHs.
Results
The concordance between the two methods was 99%. Identified risk factors for LHs were needle reuse, failure to rotate injection sites, and ice-cold insulin injections. High HbA1c values, wide glycemic variability, and longstanding proneness to hypoglycemia with a high rate of ongoing hypoglycemic events proved to be significantly associated with LHs, too; the same applied to cardiovascular and renal complications as well as to living alone and being retired.
Conclusions
Based on a strict well-structured methodology, our data confirmed what has already been reported in the literature on factors leading to, or associated with, LHs and, for the first time in adults, indicated cryotrauma from ice-cold insulin injections and specific social conditions as factors facilitating LH occurrence. HCPs should therefore plan a yearly clinical examination of all injection sites to improve patient quality of life through better glucose control and a reduced rate of hypoglycemic events.
Trial Registration
Trial registration no. 127-11.01.2019, approved by the Scientific and Ethics Committee of Campania University “Luigi Vanvitelli,” Naples, Italy.
Introduction
End-stage renal disease (ESRD) is associated with increased cardiovascular mortality (CVM) and diabetes mellitus (DM), which in many cases is treated with insulin. Skin lipohypertrophy ...(LH) very often occurs in insulin-treated (IT) patients as a consequence of inadequate injection technique and is one of the most prominent contributors to hypoglycemia (HYPO), glycemic variability (GV), and poor metabolic control (PMC).
Method
The aim of our multicenter observational study was to assess LH prevalence at self-injection sites and any possible factors predicting high LH/HYPO rates and GV in 296 dialyzed ITDM patients characterized by 64 ± 7 years of age, 7 ± 2 years disease duration, 2.6 ± 2.2 years dialysis duration, preferred pen utilization (80%), and basal-bolus regimen (87.4%) with self-injections (62.6%) largely surpassing caregiver-assisted ones (16.9%), and a mix of the two injection methods (20.5%).
Results
LH was detected in 57% of patients. Univariate analysis followed by backwards stepwise multivariate logistic regression function showed increased odds for developing LH in patients characterized by needle reuse, smaller injection areas, missed injection site rotation, higher HbA1c levels, and more prominent rates of HYPO and GV.
Conclusion
This was the first time such observation was made. It is now time for further studies aimed at providing evidence also in ESRD ITDM patients for the cause–effect relationship among wrong injection behavior, LH, and poor metabolic control and for the long-term preventative role of suitable educational countermeasures.
Introduction: Metabolic syndrome (MetS) is increasingly common in adults as well as in children and adolescents. However, preventing and treating MetS is one of the most pressing challenges for ...public health services worldwide. At present, the only approved treatments for MetS are dietary changes and physical activity, which are associated with a high rate of non-compliance. On the contrary, no drugs are licensed to treat metabolic syndrome, although a number of drugs are used to treat individual metabolic abnormalities, which increases the risk of adverse events, particularly in children. Policaptil Gel Retard ® (PGR), an oral macromolecule complex based on polysaccharides, has been demonstrated to significantly reduce body weight, peak blood glucose (BG) levels, insulin levels, and lipid levels, providing an interesting non-pharmacological therapeutic option for MetS-associated metabolic abnormalities, especially in younger patients. Aims: To review available studies on the use of PGR in children, adolescents, or adults with obesity or metabolic syndrome. Methods: A systematic search of electronic databases for PGR and MetS. A total of six studies were identified and included. Results: Across four randomized clinical studies and one retrospective clinical study including a total of 359 obese children and adolescents with or without MetS and 157 overweight/obese adults with or without MetS and/or T2DM, a single dose of PGR resulted in a reduction in appetite and postprandial triglyceride levels in younger patients and peak postprandial BG levels in adults. Decreased lipid levels were observed in adults following a normocaloric diet who received PGR for 30 days. As a long-term treatment, in combination with a low-glycemic index diet with or without metformin, PGR resulted in reduced body mass index and waist circumference, improved insulin sensitivity with reduction of glucose-metabolism abnormalities, increased insulin reserve and, finally, an improved circulating lipid profile, regardless of age. No safety issues were reported. Conclusion: Policaptil Gel Retard ® is an effective and safe non-pharmacological approach to improve the treatment of MetS-associated cardiovascular risk factors in children, adolescents, and adults.
Background & aims: Hepatic encephalopathy in cirrhosis is contributed to by toxic products deriving from the proteolytic bacterial flora–related degradation of dietary nitrogen substances. Acarbose ...is a novel hypoglycemic agent acting through the inhibition of glucose absorption in the gut and the promotion of intestinal saccharolytic bacterial flora at the expense of proteolytic flora. We assessed whether acarbose exerts a beneficial effect on hepatic encephalopathy and on postprandial hyperglycemia in cirrhotic patients with low-grade hepatic encephalopathy and type 2 diabetes mellitus.
Methods: One hundred seven cirrhotic patients with grade 1–2 hepatic encephalopathy and type 2 diabetes mellitus were randomized to acarbose 100 mg 3 times daily or placebo for 8 weeks; after a 2-week washout period, treatments were switched, and patients were followed for 8 more weeks. Ammonia blood levels, Reitan’s number connection test, intellectual function, fasting and postprandial glucose levels, glycated hemoglobin values, and C peptide values were determined 2 weeks before and 4, 8, 11, 14, and 18 weeks after treatment.
Results: (1) Acarbose significantly decreased ammonia blood levels and improved Reitan’s test score and intellectual function score compared with placebo (
P < .01). (2) Acarbose caused a 33% decrease in fasting glucose level and an approximately 50% decrease in postprandial glucose level compared with placebo (
P < .01). (3) Acarbose significantly lowered glycated hemoglobin values and postprandial C peptide compared with baseline values, whereas placebo did not. (4) No change in biochemical parameters of liver function was observed after acarbose treatment.
Conclusions: Acarbose is a safe and effective drug in cirrhotic patients with low-grade hepatic encephalopathy and type 2 diabetes mellitus.
Abstract
BACKGROUND AND AIMS
Patients with type 2 diabetes mellitus (T2DM) often discontinue sodium–glucose cotransporter-2-inhibitors (SGLT2 i) despite high efficacy and safety due to genital ...infection (GI).
SGLT2i, also called gliflozins, represent the newest class of anti-hyperglycemic agents 1 whose effects depend on the ability to dramatically reduce the threshold for maximum glucose tubular resorption rate in patients with type 2 diabetes mellitus (T2DM), with consequently enhanced glycosuria. Due to elevated urinary glucose output, T2DM increases the risk for urinary tract infections (UTIs) and non-sexually transmitted genital infections (GIs) 15. Massive glycosuria might, indeed, already cause commensal genital microorganism overgrowth in people with T2DM 16 and is likely to increase the risk for GIs and UTIs when further aggravated by SGLT2i. To assess real-life GI risk profile in post-menopausal T2DM patients educated on strict hygiene-based prevention practices (SHBPPs) due to their intrinsic GI susceptibility.
METHOD
21 post-menopausal T2DM patients willing to follow SHBPPs were randomly assigned to three different SGLT2-Is (intervention group, IG, n = 318) or other drugs (control group, CG, n = 403) for 3 months. Before and after treatment, they underwent routine lab tests and completed a specific questionnaire. The present study was carried out by a network of five identically organized outpatient diabetes care units (DCUs) previously documented to attain the same performance levels and to come from a single institution. For the study, we specifically prepared the Female Genital Infection Symptoms Questionnaire (FGISQ) based on GIPR recommendations and checked for appropriate question comprehension and answer concordance as described below by previously administering it to 40 post-menopausal women with T2DM three times at 5-day intervals. Answer concordance was 97%. Based on a specific nurse’s inquiry and help request rate by patients completing the test, question comprehension was 98%. FGISQ consisted of sections A and B (Figure 1/A and 1/B). In greater detail, we changed question n.5 from Section A by considering that some women had Figure 1A: Female Genital Infection Symptoms Questionnaire. Part A (FGISQ-A) is addressed to the general prevention recommendations of GIs in women, taken from the recommendations (reference number 28, and Supplementary data, Table S1A, supplementary material), only six of which have been transformed into general questions. Part B (FGISQ-B), investigating GI symptoms and sexual habits is unscored and resumes GIPR questions 5 and 8 (see supplementary material), kept sexually active, and question n.8 to assess the intensity of eventually occurring GI symptoms. We also refrained from formulating any question related to recommendation n.9 as useless (all were post-menopausal, indeed).
RESULTS: GIs more often occurred (9.6%; P < 0.001) among IG women non-adhering to SHBPPs (41.5%) versus the 2.9% of adhering ones. Conversely CG women had superimposable GI rates (2.7% versus 3.1%, respectively, p n.s.) whether or not adhering to SHBPPs (51.4% versus 49.6%, respectively, p n.s.). The typical profile of women on SGLT2-Is at higher risk for GIs included (i) poor adherence to SHBPPs, (ii) older age, (iii) higher BMI, (iv) poor glucose control as witnessed by high HbA1c levels, and (v) antihypertensive drug utilization.
CONCLUSION
Physicians should consider the importance of strict hygiene control in their post-menopausal T2DM patients undergoing SGLT2-I treatment and thus utilize better-focused education strategies in that specific subgroup to prevent or rehabilitate from repeated GIs.
Tirzepatide is the first ever once-weekly, injectable gastric inhibitory peptide/glucagon-like peptide 1 (GIP/GLP-1) dual agonist approved by the European Medicines Agency for type 2 diabetes. The ...efficacy and safety of tirzepatide have been evaluated in five global, randomized, double-blind or open-label, phase 3 studies which enrolled over 7000 people living with type 2 diabetes, across various stages of disease and with different characteristics at baseline. In this short commentary we report the salient data of the most recent trials on tirzepatide and GLP-1 receptor agonists from a clinical point of view, with the aim of highlighting similarities and mutual differences.Tirzepatide is the first ever once-weekly, injectable gastric inhibitory peptide/glucagon-like peptide 1 (GIP/GLP-1) dual agonist approved by the European Medicines Agency for type 2 diabetes. The efficacy and safety of tirzepatide have been evaluated in five global, randomized, double-blind or open-label, phase 3 studies which enrolled over 7000 people living with type 2 diabetes, across various stages of disease and with different characteristics at baseline. In this short commentary we report the salient data of the most recent trials on tirzepatide and GLP-1 receptor agonists from a clinical point of view, with the aim of highlighting similarities and mutual differences.
Background
Lipohypertrophy (LH) is a major complication of subcutaneous insulin treatment brought about by multiple overlapping injections and/or needle reuse. It is responsible for unacceptable ...glucose oscillations due to a high rate of hypoglycaemic episodes and rebound glucose spikes. Skin ultrasound scans (USS), the gold standard for its detection, is too expensive for screening purposes.
Aims
To define a structured method allowing health professionals (HPs) to identify LH lesions as inexpensively and correctly as possible.
Methods
Out of 129 insulin-treated people with diabetes identified by USS as having LH lesions, only 40 agreed to participate in the study (24 females, age 54 ± 15 years, daily insulin dosage 57 ± 12 IU). Each was blindly examined by four well trained and four non-trained HPs according to a standard method involving repeated well codified maneuvers.
Results
A specific training allowed inexperienced HPs to acquire high diagnostic accuracy in identifying LH lesions independent of site, size, shape, and even BMI. This kind of training also allowed to reach a 97 % consistency rate among HPs as compared to USS, while the lack of training was associated with a wide variability and inconsistency of identification results.
Conclusions
Diabetes teams should follow systematically the simple procedure reported in this paper for the diagnosis of LH and try to get it further implemented and progressively refined in large scale studies. This would have a major impact on patient education in terms of (1) correct injection technique and (2) ability to identify lesions early enough to prevent poor metabolic outcome.
Non-alcoholic fatty liver disease (NAFLD) is part of a disease spectrum ranging from steatosis to steatohepatitis (NASH), fibrosis, and cirrhosis, and when associated with metabolic syndrome (MS), ...and overt diabetes is defined as metabolic NAFLD (MAFLD). Some easily available, inexpensive biomarkers have been validated based on common anthropometric and laboratory parameters, including the Fatty Liver Index (FLI), the Fibrosis (FIB)-4 Score (FIB-4), and the NAFLD Fibrosis Score (NFS). In people with overweight/obesity, MS, and diabetes, the pathogenesis of fatty liver involves parameters known to be positively affected by Policaptil Gel Retard (PGR), a phytocomplex already successfully used in adolescents and adults with MS and type 2 diabetes mellitus (T2DM). This study's primary outcome was to assess PGR's ability to improve indirect validated signs of liver steatosis and fibrosis, i.e., FLI, FIB-4, and NFS Scores; as the secondary outcome, we aimed to confirm PGR's positive effects on anthropometric parameters and lipid levels and to assess any eventually occurring cytolysis liver marker changes in patients with MS/T2DM and MAFLD/NASH.
In this spontaneous, longitudinal, single-blind, randomized clinical study, 245 outpatients with MS/T2DM were enrolled and randomized to PGR or placebo for 24 weeks. All underwent a low-calorie diet (20-25% less than the calories required to maintain current weight) and were encouraged to intensify physical activity. Fat distribution, liver fat content/fibrosis, and biochemical parameters were evaluated at baseline and after 24 weeks.
Our data show for the first time in adults with MAFLD that, when added to lifestyle changes including a hypocaloric diet and intensified physical activity, PGR improves lipid and glucose metabolism-related parameters, including insulin-resistance, and significantly reduces not only visceral fat but also liver fat content and related liver fibrosis severity. The prevalence of subjects with severe steatosis (FLI > 60) significantly decreased from 95.08 to 47.53% (p < 0.001) only in the treatment group, which also displayed a significantly decreased prevalence of medium-severe cases (F3-F4) from 83.62% to 52.35% (p < 0.001) and a markedly increased prevalence of low degree cases (F0-F1) from 9.01 to 42.15% (p < 0.001).
The effect of PGR is related to a reduction in the post-meal blood glucose and insulin peaks. As glucose absorption (GA) directly regulates pancreatic insulin release, the attenuated insulin response is likely due to delayed GA with decreased body weight, visceral fat, and cardiovascular risk. Also, an effect on the intestinal microbiota, already documented in the animal model, cannot be excluded, especially considering the reported PGR-related shift from the Firmicutes, notoriously responsible for increased lipid gut absorption, to the Bacteroides phylum.
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