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Patients suffering from acromegaly and Cushing's Disease (CD) face the risk of several clinical complications. The onset of diabetes mellitus (DM) is among the most important: exposure to elevated growth hormone or cortisol levels is associated with insulin resistance (IR). DM contributes to increasing cardiovascular risk for these subjects, which is higher compared to healthy individuals. Hyperglycemia may also be caused by pasireotide, a second-generation somatostatin receptor ligand (SRLs), currently used for the treatment of these diseases. Accordingly, with 2014 medical expert recommendations, the management of hyperglycemia in patients with CD and treated with pasireotide is based on lifestyle changes, metformin, DPP-4 inhibitors (DPP-4i) and, subsequently, GLP-1 Receptor Agonists (GLP-1 RAs). There is no position for SGLT2-inhibitors (SGLT2-i). However, a very recent experts' consensus regarding the management of pasireotide-induced hyperglycemia in patients with acromegaly suggests the use of GLP-1 RAs as first line treatment (in suitable patients) and the use of SGLT2-i as second line treatment in patients with high cardiovascular risk or renal disease. As a matter of fact, beyond the hypoglycemic effect of GLP1-RAs and SGLT2-i, there is increasing evidence regarding their role in the reduction of cardiovascular risk, commonly very high in acromegaly and CD and often tough to improve despite biochemical remission. So, an increasing use of GLP1-RAs and SGLT2-i to control hyperglycemia is desirable in these diseases. Obviously, all of that must be done with due attention in order to minimize the occurrence of adverse events. For this reason, large studies are needed to analyze the presence of potential limitations.
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Type 1 diabetes mellitus (T1DM) represents a complex clinical challenge for health systems. The autoimmune destruction of pancreatic beta cells leads to a complete lack of insulin production, exposing people to a lifelong risk of acute (DKA, coma) and chronic complications (macro and microvascular). Physical activity (PA) has widely demonstrated its efficacy in helping diabetes treatment. Nutritional management of people living with T1DM is particularly difficult. Balancing macronutrients, their effects on glycemic control, and insulin treatment represents a complex clinical challenge for the diabetologist. The effects of PA on glycemic control are largely unpredictable depending on many individual factors, such as intensity, nutrient co-ingestion, and many others. Due to this clinical complexity, we have reviewed the actual scientific literature in depth to help diabetologists, sport medicine doctors, nutritionists, and all the health figures involved in diabetes care to ameliorate both glycemic control and the nutritional status of T1DM people engaging in PA. Two electronic databases (PubMed and Scopus) were searched from their inception to January 2024. The main recommendations for carbohydrate and protein ingestion before, during, and immediately after PA are explained. Glycemic management during such activity is widely reviewed. Micronutrient needs and nutritional supplement effects are also highlighted in this paper.
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Diabetes Mellitus Tipo 1 , Humanos , Diabetes Mellitus Tipo 1/terapia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Glicemia/metabolismo , Insulina/uso terapêutico , Suplementos Nutricionais , AtletasRESUMO
Regular physical activity (PA) and healthy nutrition are effective strategies to improve crucial modifiable lifestyle factors that affect health status, both in healthy people and in special populations suffering from metabolic disorders [...].
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Exercício Físico , Saúde Pública , Humanos , Estilo de Vida , Inquéritos Nutricionais , Nível de SaúdeRESUMO
Although the important contribution of nutrition and physical activity to people's health is known, it is equally well known that there are many barriers to adherence to healthy habits (i.e., of an organizational, economic, and/or psychological nature) experienced by the general population, as well as by people with non-communicable diseases. Knowledge of these barriers seems essential to the implementation of the activities and strategies needed to overcome them. Here, we aim to highlight the most frequent barriers to nutrition and exercise improvement that patients with chronic-degenerative diseases experience. Drawing from the Pubmed database, our analysis includes quantitative or mixed descriptive studies published within the last 10 years, involving adult participants with non-communicable diseases. Barriers of an organizational nature, as well as those of an environmental, economic, or psychological nature, are reported. The study of patients' barriers enables healthcare and non-health professionals, stakeholders, and policymakers to propose truly effective solutions that can help both the general population and those with chronic pathologies to adhere to a healthy lifestyle.
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Doenças não Transmissíveis , Adulto , Humanos , Dieta/psicologia , Exercício Físico/psicologia , Estilo de Vida Saudável , Cuidados PaliativosRESUMO
Maintenance of plasma glucose (PG) homeostasis is due to a complex network system. Even a minor fall in PG activates multiple neuroendocrine actions promoting hormonal, metabolic and behavioral responses, which prevent and ultimately recover hypoglycemia, primarily neuroglycopenia. Among these responses, gastric emptying (GE) plays an important role by coordinated mechanisms which regulate transit and absorption of nutrients through the small intestine. A bidirectional relationship between GE and glycemia has been established: GE may explain the up to 30-40 % variance in glycemic response following a carbohydrate-rich meal. In addition, acute and chronic hyperglycemia induce deceleration of GE after meals. Hypoglycemia accelerates GE, but its role in counterregulation has been poorly investigated. The role of GE as a counterregulatory mechanism has been confirmed in pathophysiological conditions, such as gastroparesis or following recurrent hypoglycemia. Therefore, it could represent an "ancestral" mechanism, highly conservative and effective in all individuals, conditions and clinical contexts. Recent guidelines recommend GLP-1 receptor agonists (GLP-1RAs) either as the first injectable therapy for type 2 diabetes mellitus or in combination with insulin. Considering the potential impact on GE, it would be important to study subjects on GLP-1 RAs during hypoglycemia, to establish whether a possible deceleration of GE impairs glucose counterregulation.
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The aim of this study was to establish the contribution of insulin resistance to the morning (a.m.) versus afternoon (p.m.) lower glucose tolerance of people with type 2 diabetes (T2D). Eleven subjects with T2D (mean [SD] diabetes duration 0.79 [0.23] years, BMI 28.3 [1.8] kg/m2, A1C 6.6% [0.26%] [48.9 (2.9) mmol/mol]), treatment lifestyle modification only) and 11 matched control subjects without diabetes were monitored between 5:00 and 8:00 a.m. and p.m. (in random order) on one occasion (study 1), and on a subsequent occasion, they underwent an isoglycemic clamp (a.m. and p.m., both between 5:00 and 8:00, insulin infusion rate 10 mU/m2/min) (study 2). In study 1, plasma glucose, insulin, C-peptide, and glucagon were higher and insulin clearance lower in subjects with T2D a.m. versus p.m. and versus control subjects (P < 0.05), whereas free fatty acid, glycerol, and ß-hydroxybutyrate were lower a.m. versus p.m. However, in study 2 at identical hyperinsulinemia a.m. and p.m. (â¼150 pmol/L), glucose Ra and glycerol Ra were both less suppressed a.m. versus p.m. (P < 0.05) in subjects with T2D. In contrast, in control subjects, glucose Ra was more suppressed a.m. versus p.m. Leucine turnover was no different a.m. versus p.m. In conclusion, in subjects with T2D, insulin sensitivity for glucose (liver) and lipid metabolism has diurnal cycles (nadir a.m.) opposite that of control subjects without diabetes already at an early stage, suggesting a marker of T2D. ARTICLE HIGHLIGHTS: In people with type 2 diabetes (T2D), fasting hyperglycemia is greater in the morning (a.m.) versus the afternoon (p.m.), and insulin sensitivity for glucose and lipid metabolism is lower a.m. versus p.m. This pattern is the reverse of the physiological diurnal cycle of people without diabetes who are more insulin sensitive a.m. versus p.m. These new findings have been observed in the present study in people without obesity but with recent-onset T2D, with good glycemic control, and in the absence of confounding pharmacological treatment. It is likely that the findings represent a specific marker of T2D, possibly present even in prediabetes before biochemical and clinical manifestations.
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Diabetes Mellitus Tipo 2 , Resistência à Insulina , Humanos , Resistência à Insulina/fisiologia , Diabetes Mellitus Tipo 2/metabolismo , Glicemia/metabolismo , Glicerol , Insulina/metabolismo , Glucose/metabolismoRESUMO
The study of the effects of a water-based exercise program in overweight/obese people with or without type 2 diabetes is a topic of relatively recent interest. This type of exercise presents some advantages in reducing the risk of injury or trauma, and it can be a valuable therapeutic card to play for sedentary or physically inactive patients who have chronic metabolic diseases. This work aims to make a contribution showing the effects of a water-based exercise intervention, supervised by graduates in sports sciences, in a group of overweight/obese people with or without type 2 diabetes. In total, 93 adults (age 60.59 ± 10.44 years), including 72 women (age 60.19 ± 10.97 years) and 21 men (age 61.95 ± 8.48 years), were recruited to follow a water-based exercise program (2 sessions/week, for 12 weeks) at the C.U.R.I.A.Mo. Healthy Lifestyle Institute of Perugia University. Results showed an improvement in body mass index (−0.90 ± 1.56, p = 0.001), waist circumference (−4.32 ± 6.03, p < 0.001), and systolic (−7.78 ± 13.37, p = 0.001) and diastolic (−6.30 ± 10.91, p = 0.001) blood pressure. The supervised water-based intervention was useful in managing patients with metabolic diseases who often present with other health impairments, such as musculoskeletal problems or cardiovascular or rheumatic disease that could contraindicate gym-based exercise.
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Diabetes Mellitus Tipo 2 , Adulto , Masculino , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Projetos Piloto , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/terapia , Água , Obesidade/complicações , Obesidade/terapia , Exercício Físico , Índice de Massa Corporal , Sobrepeso/complicações , Sobrepeso/terapiaRESUMO
Pediatric excess weight has reached severity worldwide, affecting physical health. Decreasing weight and body mass index (BMI) after exercise intervention reduces the cardiometabolic consequences; the role of age and gender on the effectiveness of exercise in overweight youth was debated in this study. A total of 138 overweight/obese young (75 girls, 63 boys) were recruited at Perugia (Italy) University to follow an exercise program. Participants were allocated into two groups (children, n = 88 and adolescents, n = 50). The study aimed to verify the efficacy of a mixed resistance-endurance exercise program in anthropometric and physical performance measures, evaluating the influence of gender and age on two groups of young overweight/obese participants. In children, we observed a statistically significant improvement in fat mass percentage, fat-free mass, waist circumference (WC), fat mass, as well as in strength, endurance, speed, and flexibility measures. We also observed reduced WC and waist-to-height ratio (WHtR) values in girls. In the adolescents' subgroup, results showed a statistically significant variation in fat mass percentage, BMI, WC, and WHtR, and strength of the upper and lower limbs; we also observed a weight reduction in girls. A clinical approach, with the combination of strength and dynamometric tests plus the body composition study using air plethysmography methodology, is health-effective and allows for the monitoring of the efficacy of an exercise program in overweight/obese young people.
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Sobrepeso , Obesidade Infantil , Adolescente , Índice de Massa Corporal , Criança , Terapia por Exercício , Feminino , Humanos , Masculino , Sobrepeso/terapia , Obesidade Infantil/prevenção & controle , Circunferência da CinturaRESUMO
Purpose: Dysfunctional eating is strongly associated with obesity and worsens type 2 diabetes (T2DM) outcomes. The aim of this study was to investigate the effectiveness of the psycho-nutritional treatment (PNT) of "Centro DAI e Obesità" of Città della Pieve on weight loss and glucose management in dysfunctional eaters with obesity and T2DM. Methods: PNT includes psychotherapeutical, nutritional, physical and social activities. Subjects with obesity, T2DM and dysfunctional eating habits who completed the 8 weeks residential program between 2010 and 2019 were compared with obese, T2DM, dysfunctional eaters who underwent to a conventional, hospital-based, nutritional treatment (CT). Anthropometric variables, glucolipid panel, and body composition were assessed at baseline and at the end of the program. Weight and HbA1c were also measured after one year from the completion. Results: Sixty-nine patients completed the PNT and reduced weight (-7 ± 3.2%; p < 0.001), BMI (-7 ± 3.1%; p < 0.001), and triglycerides, AST, GGT and ALT (p ≤ 0.008); glycemic control improved (HbA1c: -1.1 ± 1.5%, mean fasting glucose: -41 ± 46 mg/dl, p < 0.001). Eleven% of subjects requiring diabetes medications at baseline discontinued the therapy. In the insulin treated group (49%), mean daily units were halved (-32.6 ± 26.0, p < 0.001). At one year, weight loss (-6 ± 7.4%, p < 0.001) and HbA1c reduction (-0.52 ± 1.4%, p = 0.029) persisted. Fifty-five patients completed the CT: HbA1c reduced (p = 0.02), but weight (-0.6 ± 3.7%), BMI (-0.7 ± 3.8%), and insulin units' reduction (-2.5 ± 11.7, p = 0.20) were lower compared to the PNT. Conclusion: PNT is effective in improving T2DM management in patients with obesity and dysfunctional eating.
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Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease in which destruction of the insulin-producing ß-cells in the pancreatic islets requires regular lifelong insulin replacement therapy, the only lifesaving treatment available at this time. In young persons with a genetic predisposition, it usually manifests after being exposed to environmental triggers. A subtype of autoimmune diabetes mellitus (ADM) that typically occurs in adulthood is often referred to as latent autoimmune diabetes of adults (LADA). LADA is characterized by a milder process of ß-cells destruction and less intensive insulin treatment, which may become necessary even many years after diagnosis. Genetic predisposition of T1D carries an increased risk for other autoimmune diseases, such as autoimmune thyroiditis, the most frequently associated condition, and pernicious anaemia (PA), present in approximately 4% of all individuals with T1D. Here, we describe the case of a 90-year-old woman with vitiligo and a mute medical history who was admitted to our University Hospital in Perugia with hyperglycaemia and severe anaemia due to vitamin B12 (VB12) depletion. A short time after setting the beginning treatment with a basal-bolus insulin regimen, her insulin requirement rapidly declined and treatment with sitagliptin, a dipeptidyl peptidase-4 inhibitor (DPP4), was started. A complete autoimmunity screening panel showed that GAD65 and intrinsic factor autoantibodies were positive.
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Physical activity level and sedentary behaviors affect health status in people with obesity and type 2 diabetes (DM2); their assessment is mandatory to properly prescribe exercise programs. From January 2011 to February 2014, 293 overweight/obese adults (165 women and 128 men, mean age of 51.9 ± 9.5 years and 54.6 ± 8.3 years, respectively), with and without DM2, participated in a three-month intensive exercise program. Before starting, participants were allocated into three subgroups (overweight, body mass index or BMI = 25-29.9; class 1 of obesity, BMI = 30-34.4; or class 2 (or superior) of obesity, BMI > 35). The international physical activity questionnaire (IPAQ-it) was used to evaluate participants' baseline sitting time (SIT) and physical activity level (PAL). Stratified multiple analyses were performed using four subgroups of SIT level according to Ekelund et al., 2016 (low, 8 h/day of SIT) and three subgroups for PAL (high, moderate, and low). Health-related measures such as anthropometric variables, body composition, hematic parameters, blood pressure values, and functional capacities were studied at the beginning and at the end of the training period. An overall improvement of PAL was observed in the entire sample following the three-month intensive exercise program together with a general improvement in several health-related measures. The BMI group factor influenced the VO2 max variations, leg press values, triglycerides, and anthropometric variables, while the SIT group factor impacted the sitting time, VO2 max, glycemic profile, and fat mass. In this study, baseline PAL and SIT did not seem to influence the effects of an exercise intervention. The characteristics of our educational program, which also included a physical exercise protocol, allowed us to obtain positive results.
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The first insulin preparation injected in humans in 1922 was short-acting, extracted from animal pancreas, contaminated by impurities. Ever since the insulin extracted from animal pancreas has been continuously purified, until an unlimited synthesis of regular human insulin (RHI) became possible in the '80s using the recombinant-DNA (rDNA) technique. The rDNA technique then led to the designer insulins (analogs) in the early '90s. Rapid-acting insulin analogs were developed to accelerate the slow subcutaneous (sc) absorption of RHI, thus lowering the 2-h post-prandial plasma glucose (PP-PG) and risk for late hypoglycemia as comparing with RHI. The first rapid-acting analog was lispro (in 1996), soon followed by aspart and glulisine. Rapid-acting analogs are more convenient than RHI: they improve early PP-PG, and 24-h PG and A1C as long as basal insulin is also optimized; they lower the risk of late PP hypoglycemia and they allow a shorter time-interval between injection and meal. Today rapid-acting analogs are the gold standard prandial insulins. Recently, even faster analogs have become available (faster aspart, ultra-rapid lispro) or are being studied (Biochaperone lispro), making additional gains in lowering PP-PG. Rapid-acting analogs are recommended in all those with type 1 and type 2 diabetes who need prandial insulin replacement.
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Diabetes Mellitus/tratamento farmacológico , Hipoglicemiantes/história , Insulina/história , História do Século XX , História do Século XXI , Humanos , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/uso terapêutico , Insulina/administração & dosagem , Insulina/uso terapêuticoAssuntos
Diabetes Mellitus Tipo 2 , Hipoglicemia , Glicemia , Automonitorização da Glicemia , Diabetes Mellitus Tipo 2/diagnóstico , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/diagnóstico , Hipoglicemia/prevenção & controle , Hipoglicemiantes/efeitos adversos , Insulina GlarginaRESUMO
Hypoglycemia represents a dark and tormented side of diabetes mellitus therapy. Patients treated with insulin or drug inducing hypoglycemia, consider hypoglycemia as a harmful element, which leads to their resistance and lack of acceptance of the pathology and relative therapies. Severe hypoglycemia, in itself, is a risk for patients and relatives. The possibility to have novel strategies and scientific knowledge concerning hypoglycemia could represent an enormous benefit. Novel available glucagon formulations, even now, allow clinicians to deal with hypoglycemia differently with respect to past years. Novel scientific evidence leads to advances concerning physiopathological mechanisms that regulated glycemic homeostasis. In this review, we will try to show some of the important aspects of this field.
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Antídotos/uso terapêutico , Glucagon/uso terapêutico , Hipoglicemia/tratamento farmacológico , Insulina/metabolismo , Animais , Diabetes Mellitus/tratamento farmacológico , Glucagon/administração & dosagem , Homeostase , Humanos , Hipoglicemia/fisiopatologiaRESUMO
Insulin therapy has been in use now for 100 years, but only recently insulin replacement has been based on physiology. The pancreas secretes insulin at continuously variable rates, finely regulated by sensitive arterial glucose sensing. Pancreatic insulin is delivered directlyin the portal blood to insulinize preferentially the liver. In the fasting state, insulin is secreted at a low rate to modulate hepatic glucose output. After liver extraction (50%), insulin concentrations in peripheral plasma are 2.4-4 times lower than in portal, but still efficacious to restrain lipolysis. In the prandial condition, insulin is secreted rapidly in large amounts to increase portal and peripheral concentrations to peaks 10-20 times greater vs the values of fasting within 30-40 min from meal ingestion. The prandial portal hyperinsulinemia fully suppresses hepatic glucose production while peripheral hyperinsulinemia increases glucose utilization, thus limitating the post-prandial plasma glucose elevation. Physiology of insulin indicates that insulin should be replaced in people with diabetes mimicking the pancreas, i.e. in a basal-bolus mode, for fasting and prandial state, respectively. Despite the presently ongoing limitations (subcutaneous and peripheral rather than portal and intravenous insulin delivery), basal-bolus insulin allows people with diabetes to achieve A1c in the range with minimal risk of hypoglycaemia, to prevent vascular complications and to ensure good quality of life.
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Glicemia/metabolismo , Diabetes Mellitus Tipo 1/tratamento farmacológico , Insulina/uso terapêutico , Qualidade de Vida/psicologia , Diabetes Mellitus Tipo 1/sangue , Feminino , Humanos , Insulina/farmacologia , MasculinoRESUMO
OBJECTIVE: To prove equivalence of individual, clinically titrated basal insulin doses of glargine 300 units â mL-1 (Gla-300) and degludec 100 units â mL-1 (Deg-100) under steady state conditions in a single-blind, randomized, crossover study, on the glucose pharmacodynamics (PD) in people with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: Subjects with T1D (N = 22, 11 men, age 44.3 ± 12.4 years, disease duration 25.5 ± 11.7 years, A1C 7.07 ± 0.63% [53.7 ± 6.9 mmol â mL-1], BMI 22.5 ± 2.7 kg · m-2), naïve to Gla-300 and Deg-100, underwent 24-h euglycemic clamps with individual clinical doses of Gla-300 (0.34 ± 0.08 units â kg-1) and Deg-100 (0.26 ± 0.06 units â kg-1), dosing at 2000 h, after 3 months of optimal titration of basal (and bolus) insulin. RESULTS: At the end of 3 months, Gla-300 and Deg-100 reduced slightly and, similarly, A1C versus baseline. Clamp average plasma glucose (0-24 h) was euglycemic with both insulins. The area under curve of glucose infused (AUC-GIR[0-24 h]) was equivalent for the two insulins (ratio 1.04, 90% CI 0.91-1.18). Suppression of endogenous glucose production, free fatty acids, glycerol, and ß-hydroxybutyrate was 9%, 14%, 14%, and 18% greater, respectively, with Gla-300 compared with Deg-100 during the first 12 h, while glucagon suppression was no different. Relative within-day PD variability was 23% lower with Gla-300 versus Deg-100 (ratio 0.77, 90% CI 0.63-0.92). CONCLUSIONS: In T1D, individualized, clinically titrated doses of Gla-300 and Deg-100 at steady state result in similar glycemic control and PD equivalence during euglycemic clamps. Clinical doses of Gla-300 compared with Deg-100 are higher and associated with quite similar even 24-h distribution of PD and antilipolytic effects.
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Diabetes Mellitus Tipo 1 , Adulto , Glicemia , Estudos Cross-Over , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemiantes/uso terapêutico , Insulina Glargina , Insulina de Ação Prolongada , Masculino , Pessoa de Meia-Idade , Método Simples-CegoRESUMO
AIMS: Insulin glargine 300 U/mL (Gla-300) contains the same units versus glargine 100 U/mL (Gla-100) in three-fold lower volume, and higher subcutaneous (SC) doses are required in people with diabetes. To investigate blood glucose (BG) lowering potency, Gla-300 and Gla-100 were compared after intravenous (IV, for 4 h) and SC (for 24 h) injection in healthy Beagle dogs. MATERIALS AND METHODS: The dose of 0.15 U/kg Gla-300 and Gla-100 was injected IV in 12 dogs. BG, C-peptide, glucagon and the active metabolite 21A-Gly-human insulin (M1; liquid chromatography-tandem mass spectrometry method) were measured. Twelve other dogs were studied after SC injection of 0.3 U/kg Gla-300 and Gla-100. RESULTS: After IV injection, Gla-300 and Gla-100 were equally potent [BG_AUC0-4 h ratio 1.01 (95% confidence interval, 0.94; 1.09)]. After SC injection, BG decreased slower and less with Gla-300. Similar metabolism of Gla-300 and Gla-100 to M1 occurred with IV dosing [M1_AUC0-1 h ratio 0.99 (95% confidence interval, 0.82; 1.22)], but with SC dosing M1_Cmax and AUC0-24h were 44% and 17% lower; mean residency time and bioavailability were 32% longer and 50% lower, with Gla-300. CONCLUSIONS: IV Gla-300 and Gla-100 have the equivalent of BG-lowering potency and M1 metabolism. SC Gla-300 has lower M1 bioavailability with a reduced BG-lowering effect and need for greater doses versus Gla-100.
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Diabetes Mellitus Tipo 2 , Hipoglicemiantes , Animais , Disponibilidade Biológica , Glicemia , Cães , Insulina Glargina , Insulina de Ação ProlongadaRESUMO
There is evidence that promoting physical activity programs and decreasing sedentary behavior is a potential strategy for improving health-outcomes, peer relationships and social/emotional well-being in at-risk youth. The World Health Organization recommends enhancing physical education and school-based programs with multi-component and evidence-based assessment methodology. In Umbria (Italy) an uncontrolled pilot study project referred to as "Improving Umbrian kids' healthy lifestyle" was implemented as a systemic school-based intervention directed at 6-year-old primary school children. The intervention applied a consolidated assessment methodology developed by the C.U.R.I.A.Mo. and Eurobis projects that inserted two hours per week of physical education activity into the school curriculum, structured and supervised by specialists with Exercise and Sport Science degrees, for eight months (from October to June) of the school year. We measured anthropometric values (BMI, waist circumference, waist-to-height ratio index) with objective tools. Moreover, we evaluated physical performance variables (speed, strength, and flexibility) using standard tests. Additionally, self-report measures (measured physical activity during the week, sedentary habits, and psychological well-being) were assessed using validated questionnaires. We observed a significant decrease in waist to height ratio, and improvements in physical performance values and self-report questionnaire measures. Our study suggests that the promotion of physical activity in the school setting is likely to result in physically, mentally, and psycho-socially healthier primary-school-age children.
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Exercício Físico , Promoção da Saúde , Estilo de Vida Saudável , Criança , Feminino , Hábitos , Humanos , Itália , Masculino , Projetos Piloto , Serviços de Saúde EscolarRESUMO
AIMS: People with uncontrolled type 2 diabetes (T2DM) often delay initiating and titrating basal insulin. Patient-managed titration may reduce such deferral. The Italian Titration Approach Study (ITAS) compared the efficacy and safety of insulin glargine 300 U/mL (Gla-300) initiation and titration using patient- (nurse-supported) or physician-management in insulin-naïve patients with uncontrolled T2DM. MATERIALS AND METHODS: ITAS was a multicentre, phase IV, 24-week, open-label, randomized (1:1), parallel-group study. Insulin-naïve adults with T2DM for ≥1 year with poor metabolic control initiated Gla-300 after discontinuation of SU/glinides, and were randomized to self-titrate insulin dose (nurse-assisted) or have it done by the physician. The primary endpoint was change in HbA1c . Secondary outcomes included hypoglycaemia incidence and rate, change in fasting self-monitored plasma glucose, patient-reported outcomes (PROs), and adverse events. RESULTS: Three hundred and fifty five participants were included in the intention-to-treat population. At Week 24, HbA1c reduction from baseline was non-inferior in patient- vs physician-managed arms [least squares mean (LSM) change (SE): -1.60% (0.06) vs -1.49% (0.06), respectively; LSM difference: -0.11% (95% CI: -0.26 to 0.04)]. The incidence and rates of hypoglycaemia were similarly low in both arms: relative risk of confirmed and/or severe nocturnal (00:00-05:59 hours) hypoglycaemia was 0.77 (95% CI: 0.27 to 2.18). No differences were observed for improvement in PROs. No safety concerns were reported. CONCLUSIONS: In the T2DM insulin-naïve, SU/glinides discontinued population, patient-managed (nurse-assisted) titration of Gla-300 may be a suitable option as it provides improved glycaemic control with low risk of hypoglycaemia, similar to physician-managed titration.