Sarcopenia (low muscle mass/muscle function MM/MF) and sarcopenic obesity (sarcopenia+obesity, SO) have relevant clinical implications, but few data are available on pts with type 2 diabetes (T2D), ...especially in Western populations. We assessed the proportion of Caucasian pts with T2D and sarcopenia/SO and clinical correlates of sarcopenia. During routine follow-up outpatient visits (Jun-Dec 2022), we measured skeletal MM by bioelectrical impedance analysis (BIA) and MF by hand-grip strength in all pts except those with contraindications to BIA. Low MM and low MF were diagnosed using validated sex- and sex-/age-specific cut-offs, respectively, as recommended by ESPEN & EASO. Anthropometrics, glycemic control (HbA1c) and type/number of complications were recorded for all pts. A total of 116 pts with T2D were included (64.7% F, median 25°; 75° percentile age 70.0 62.3; 78.0 years, 35.3% with obesity). Sarcopenia was diagnosed in 12.9% of pts. Of these, 40% (5.2% of the total) had SO. Low MM with normal MF (LMM) and low MF with normal MM (LMF) were found in 16.4% and 21.6% of pts. There were no significant differences in sex, age, HbA1c, or number of complications between patients with or without sarcopenia nor among subgroups, but the proportion of elderly pts (age ≥65y) was lower among those with vs those without sarcopenia (26.7% vs 57.4%, p=0.026). Median BMI was greater (p<0.05) in pts with LMM or sarcopenia vs those with normal MM/MF or LMF (31.6 30.5; 34.6, 29.2 26.1; 34.8, 26.7 23.4; 30.4 and 24.5 21.3; 29.8 kg/m2, respectively). At logistic regression adjusted by sex and age, the likelihood of sarcopenia increased by 11.4% for each unit increase in BMI (odds ratio 1.114, 95%CI 1.01; 1.23 p=0.037). In conclusion, the majority of Caucasian pts with T2D has low MM, MF or both (sarcopenia), the risk of sarcopenia increasing with greater BMI. The lower proportion of elderly suggests reduced life expectancy in T2D pts with sarcopenia. The assessment of sarcopenia in T2D should be implemented in routine clinical practice.
Disclosure
C.Conte: None. S.Boussetta: None. F.Leva: None. P.Moro: None. C.C.Berra: None. L.Luzi: Advisory Panel; Eli Lilly and Company, Medtronic, Research Support; Gelesis, Speaker's Bureau; A. Menarini Diagnostics, Amgen Inc., Boehringer Ingelheim and Eli Lilly Alliance, Eli Lilly and Company, Novo Nordisk, Novartis.
Low Blood Oxygen Saturation (BOS) is associated with increased overall morbidity / mortality and prevalence of diabetes is known to increase with altitude (lower 02 partial pressure). Individuals ...with complicated diabetes commonly have low blood oxygen saturation compared with nondiabetic patients. To unravel the link between low BOS and glucose metabolism, we investigated the correlation between BOS and glucose, BOS and HbA1c levels, BOS and VO2 consumption (Resting Energy Expenditure) in a cohort of adults with diabetes mellitus. The study included 1362 adults with diabetes (616 F, 746 M; 66.4 ± 14.2 years, range 18-85 years; BMI 27.6 ± 5.0 kg/m2, range 18-49.6 kg/m2; SpO2 97.2 ± 1.4%, range 88-100%; glucose 137.7 ± 45.0 mg/dl, range 50.0-323.0 mg/dl). A significant inverse correlation (Pearson) between the glucose (glucometer) and the BOS (pulsoximeter) (p<0.0001*; r = -0.1530). An inverse correlation (Pearson correlation) between the HbA1c levels and the BOS (n=1295; 568 F, 727 M; 67.5 ± 13.1 years, range 18-85 years; BMI 27.8 ± 5.2 kg/m2, range 18-49.8 kg/m2; HbA1c 52.9 ± 13.0, range 25-152 mmol/mol; p<0.0001*; r = -0.1351). In summary, we showed an inverse relationship between oxygen saturation and both glucose and glycosylated hemoglobin levels. Although the exact mechanisms behind lower blood oxygen saturation in diabetes are unknown, we speculate that a reduced pulmonary diffusion capacity as a consequence of pulmonary microvascular damage could play an important role. In conclusion, present preliminary data indicate the routine measurement of BOS along with glucose and glycosylated hemoglobin in the outpatient visit setting of diabetic patients as a biomarker of seriousness of disease.
Disclosure
L. Luzi: Speaker's Bureau; A. Menarini Diagnostics, Amgen Inc., Boehringer Ingelheim and Eli Lilly Alliance. Advisory Panel; Eli Lilly and Company. Speaker's Bureau; Eli Lilly and Company. Research Support; Gelesis. Advisory Panel; Medtronic. Speaker's Bureau; Novo Nordisk, Novartis. C. Macrì: None. A. Ferrulli: None. C.C. Berra: None. C. Romano: None. S. Massarini: None.
Funding
IRCCS MultiMedica (Ricerca Corrente)
Growth of male genitalia represents an important marker of sexual development. Testicle size is the primary measure and little is known regards penile length changes during puberty.
This work aims to ...assess penis growth and testosterone levels in obese vs normal-weight children and adolescents, to evaluate a possible influence of obesity on genital development in boys, and to establish a new method for measuring penis length that allows comparison of normal-weight and overweight boys.
We assessed anthropometric and genital development in 1130 boys from birth to age 20 years. Testosterone levels were also measured. A new method for penile length measurement was employed to minimize errors when comparing obese and nonobese children. Penis length was measured with a gentle, painless, straight positioning on a centimetric ruler without stretching, which is doable from the first years of life until the end of adolescence.
Penis length and testosterone are strongly related in children during puberty. Penile length growth is significantly decreased (by about 10%) in obese boys when compared to normal-weight boys, with concomitantly reduced testosterone levels, across puberal phases.
Childhood obesity represents an important determinant of lower testosterone level and reduced penis development. A new method should be employed to improve penis measurement in normal-weight and overweight/obese boys. The possible significance of these observations for adult genital development and reproductive potential will require large longitudinal studies.
Display omitted
In the last years, due to new regulatory guidelines requiring a stringent documentation of cardiovascular (CV) safety of novel drugs for type 2 diabetes, cardiovascular outcomes ...safety trials (CVOTs) are requested. CVOTs increase the knowledge about the safety profile of the new drugs, but they have intrinsic limits that make difficult their transferability to clinical practice. For this reason, real world evidence is considered an important complement to experimental data.
Among the glucagon-like peptide-1 receptor agonists, liraglutide in the LEADER CVOT demonstrated superiority in reducing the risk of major CV events (MACEs) vs. placebo.
We conducted an observational, retrospective, longitudinal study based on 307 patients with T2DM treated with liraglutide under routine clinical practice conditions. Real world impact of liraglutide on metabolic control, CV risk factors, hypoglycemia and CV events was assessed.
Improvements during 36 months were found in HbA1c (–1.0%; p < 0.0001), fasting blood glucose (–17.6 mg/dL; p < 0.0001), body weight (–3.2 kg; p < 0.0001), waist circumference (-1.45 cm; p = 0.004), systolic blood pressure (-10.41 mmHg; p < 0.0001), diastolic blood pressure (-3.69 mmHg; p < 0.0001), total cholesterol (–7.96 mg/dL; p =0.008) and triglycerides (-20.60 mg/dl; p = 0.01). No severe hypoglycemia occurred.
Incidence of MACEs in this cohort was lower than in the LEADER study (2.59 vs. 3.4 events per 100 person-years), confirming CV safety of liraglutide even in the real world. On the other hand, a higher incidence of CV event in patients with established CV disease was documented (8.1 events per 100 person-years), in spite of the use of liraglutide.
In conclusion, 36-month durability and CV safety of liraglutide were documented in a real world cohort of T2DM patients, with sustained benefits on a large array of CV risk factors.
Background
Since 2010, more than half of World population lives in Urban Environments. Urban Diabetes has arisen as a novel nosological entity in Medicine. Urbanization leads to the accrual of a ...number of factors increasing the vulnerability to diabetes mellitus and related diseases. Herein we report clinical-epidemiological data of the Milano Metropolitan Area in the contest of the Cities Changing Diabetes Program. Since the epidemiological picture was taken in January 2020, on the edge of COVID-19 outbreak in the Milano Metropolitan Area, a perspective addressing potential interactions between diabetes and obesity prevalence and COVID-19 outbreak, morbidity and mortality will be presented. To counteract lock-down isolation and, in general, social distancing a pilot study was conducted to assess the feasibility and efficacy of tele-monitoring via Flash Glucose control in a cohort of diabetic patients in ASST North Milano.
Methods
Data presented derive from 1. ISTAT (National Institute of Statistics of Italy), 2. Milano ATS web site (Health Agency of Metropolitan Milano Area), which entails five ASST (Health Agencies in the Territories). A pilot study was conducted in 65 screened diabetic patients (only 40 were enrolled in the study of those 36 were affected by type 2 diabetes and 4 were affected by type 1 diabetes) of ASST North Milano utilizing Flash Glucose Monitoring for 3 months (mean age 65 years, HbA1c 7,9%. Patients were subdivided in 3 groups using glycemic Variability Coefficient (VC): a. High risk, VC > 36, n. 8 patients; Intermediate risk 20 < VC < 36, n. 26 patients; Low risk VC < 20, n. 4 patients. The control group was constituted by 26 diabetic patients non utilizing Flash Glucose monitoring.
Results
In a total population of 3.227.264 (23% is over 65 y) there is an overall prevalence of 5.65% with a significant difference between Downtown ASST (5.31%) and peripheral ASST (ASST North Milano, 6.8%). Obesity and overweight account for a prevalence of 7.8% and 27.7%, respectively, in Milano Metropolitan Area. We found a linear relationship (
R
= 0.36) between prevalence of diabetes and aging index. Similarly, correlations between diabetes prevalence and both older people depending index and structural dependence index (
R
= 0.75 and
R
= 0.93, respectively), were found. A positive correlation (
R
= 0.46) with percent of unoccupied people and diabetes prevalence was also found. A reverse relationship between diabetes prevalence and University level instruction rate was finally identified (
R
= − 0.82). Our preliminary study demonstrated a reduction of Glycated Hemoglobin (
p
= 0.047) at 3 months follow-up during the lock-down period, indicating Flash Glucose Monitoring and remote control as a potential methodology for diabetes management during COVID-19 lock-down.
Hypothesis and discussion
The increase in diabetes and obesity prevalence in Milano Metropolitan Area, which took place over 30 years, is related to several environmental factors. We hypothesize that some of those factors may have also determined the high incidence and virulence of COVID-19 in the Milano area. Health Agencies of Milano Metropolitan Area are presently taking care of diabetic patients facing the new challenge of maintaining sustainable diabetes care costs in light of an increase in urban population and of the new life-style. The COVID-19 pandemic will modify the management of diabetic and obese patients permanently, via the implementation of approaches that entail telemedicine technology. The pilot study conducted during the lock-down period indicates an improvement of glucose control utilizing a remote glucose control system in the Milano Metropolitan Area, suggesting a wider utilization of similar methodologies during the present “second wave” lock-down.
Sodium-glucose co-transporter-2 inhibitors (SGLT2i) may have important benefits for the elderly with type 2 diabetes (T2D), however some safety concerns still limit their use in patients over 70 ...years of age. The SOLD study (SGLT2i in Older Diabetic patients) is a multicenter study, aimed to evaluate the effectiveness and safety of SGLT2i in the older diabetic patients in a real-life setting.
We analyzed a population of 739 adults (mean age 75.4 ± 3.9 years, M/F 420/319) with T2D, which started a SGLT2i-based treatment after the age of 70, with at least one year of follow-up. Data were collected at baseline, at 6 and 12 months of follow-up.
SGLT2i (37.5% Empagliflozin, 35.7% Dapagliflozin, 26.1% Canagliflozin, 0.7% Ertugliflozin) were an add-on therapy to Metformin in 88.6%, to basal insulin in 36.1% and to other antidiabetic drugs in 29.6% of cases. 565 subjects completed the follow up, while 174 (23.5%) discontinued treatment due to adverse events which were SGLT2i related. A statistically significant reduction of glycated hemoglobin (baseline vs 12 months: 7.8 ± 1.1 vs 7.1 ± 0.8%, p < 0.001) and body mass index values (baseline vs 12 months: 29.2 ± 4.7 vs 28.1 ± 4.5 kg/m2, p < 0.001) were evident during follow-up. Overall, estimated glomerular filtration rate remained stable over time, with significant reduction of urinary albumin excretion. In the subgroup of patients which were ≥ 80 years, a significant improvement in glycated hemoglobin values without renal function alterations was evident. Overall discontinuation rate during the follow-up period was different across age groups, being urinary tract infections and worsening of renal function the most common cause.
SGLT2i are well-tolerated and safe in the elderly and appear as an effective therapeutic option, though some caution is also suggested, especially in more fragile subjects.
Display omitted
Aim of the present study was to evaluate the real-world impact of once-weekly (OW) subcutaneous semaglutide on different end-points indicative of metabolic control, cardiovascular risk factors, and ...beta-cell function in type 2 diabetes (T2D).
This was a retrospective, observational study conducted in 5 diabetes clinics in Italy. Changes in HbA1c, fasting blood glucose (FBG), body weight, blood pressure, lipid profile, renal function, and beta-cell function (HOMA-B) during 12 months were evaluated.
Overall, 594 patients (97% GLP-1RA naïve) were identified (mean age 63.9 ± 9.5 years, 58.7% men, diabetes duration 11.4 ± 8.0 years). After 6 months of treatment with OW semaglutide, HbA1c levels were reduced by 0.90%, FBG by 26 mg/dl, and body weight by 3.43 kg. Systolic blood pressure, total and LDL-cholesterol significantly improved. Benefits were sustained at 12 months. Renal safety was documented. HOMA-B increased from 40.2% to 57.8% after 6 months (p<0.0001).
The study highlighted benefits of semaglutide on metabolic control, multiple CV risk factors, and renal safety in the real-world. Semaglutide seems to be an advisable option for preservation of β-cell function and early evidence suggests it might have a role in modifying insulin resistance (HOMA-IR), the pathogenetic basis of prediabetes and T2D.
Dapagliflozin, a sodium-glucose co-transporter-2 inhibitor and semaglutide, a glucagon-like peptide 1 receptor agonist, have both demonstrated efficacy in glycemic control, reducing blood pressure, ...body weight, risk of renal and heart failure in type 2 diabetes mellitus. In this observational, real-world, study we aimed to investigate the efficacy of the combination therapy with those two agents over glycemic control. We thus obtained the data of 1335 patients with type 2 diabetes followed by 11 Diabetes centers in Lombardia, Italy. A group of 443 patients was treated with dapagliflozin alone, the other group of 892 patients was treated with the combination therapy of dapagliflozin plus oral semaglutide. We analyzed changes in glycated hemoglobin from baseline to 6 months of follow-up, as well as changes in fasting glycemia, body weight, body mass index, systolic and diastolic pressure, heart rate, creatinine, estimated glomerular filtration rate and albuminuria. Both groups of patients showed an improvement of glycometabolic control after 6 months of treatment; indeed, the treatment with dapagliflozin plus oral semaglutide showed a reduction of glycated hemoglobin of 1.2% as compared to the 0.5% reduction observed in the dapagliflozin alone group. Significant changes were observed in body mass index, fasting plasmatic glucose, blood pressure, total cholesterol, LDL and albumin to creatinine ratio, with a high rate (55%) of near-normalization of glycated hemoglobin. Our real world data confirmed the potential of the oral combination therapy dapagliflozin with semaglutide in inducing pharmacological remission of type 2 diabetes mellitus.
Dapagliflozin has been demonstrated to improve glycemic control, blood pressure, and body weight in type 2 diabetes mellitus (T2D); indeed, it can also reduce the risk of progression to renal ...failure, of hospitalization for heart failure and of cardiovascular death. We aim to investigate the acute effect of Dapagliflozin on kidney function in the common clinical practice in T2D. This is a study including 1402 patients with T2D recruited from 11 centers in Lombardia, Italy, who were evaluated at baseline and after 6 months of treatment with Dapagliflozin 10 mg per day. The primary outcome of the study was the change in HbA1c, while the secondary outcomes were modification of weight, BMI, systolic and diastolic pressure, creatinine, eGFR and albuminuria status. After 24 weeks of treatment with Dapagliflozin, a reduction in Hb1Ac was observed (−0.6 ± 1.8%) as well as in BMI (−1.5 ± 5.2 kg/m2). Statistically significant changes were also found for systolic and diastolic blood pressure, cholesterol and triglycerides. Interestingly, a statistically significant acute improvement of kidney function was evident. Our analyses confirm the beneficial effects of dapagliflozin after 6 months of therapy, with improvements of glycemic and lipid profiles, blood pressure, BMI. Finally, an acute positive effect on albuminuria and KIDGO classes was observed during a 6 months treatment with dapagliflozin in patients with T2D.
Display omitted
Aim
To describe the development of the AWARE App, a novel web application for the rapid assessment of cardiovascular risk in Type 2 Diabetes Mellitus (T2DM) patients. We also tested the feasibility ...of using this App in clinical practice.
Methods
Based on 2019 European Society of Cardiology/European Association for the Study of Diabetes criteria for cardiovascular risk stratification in T2DM, the AWARE App classifies patients into very high (VH
CVR
), high (H
CVR
) and moderate (M
CVR
) cardiovascular risk categories. In this retrospective clinical study, we employed the App to assess the cardiovascular risk of T2DM patients, while also collecting data about current glycaemic control and pharmacological treatment.
Results
2243 T2DM consecutive patients were evaluated. 72.2% of the patients were VH
CVR
, 8.9% were H
CVR
, 0.8% were M
CVR
while 18.2% did not fit into any of the risk categories and were classified as “moderate-to-high” (MH
CVR
). Compared with the other groups, patients with VH
CVD
were more frequently ≥ 65 years old (68.9%), with a longer disease duration (≥ 10 years 56.8%), a history of cardiovascular disease (41.4%), organ damage (35.5%) and a higher numbers of cardiovascular risk factors. Patients with MH
CVD
generally had disease duration < 10 years (96%), younger age (50–60 years 55%), no history of cardiovascular disease, no organ damage, and 1–2 cardiovascular risk factors (89%). Novel drugs such as Glucagon Like Peptyde 1 Receptor Agonists or Sodium-Glucose Linked Transporter 2 inhibitors were prescribed only to 26.3% of the patients with VH
CVR
and to 24.7% of those with H
CVR
. Glycaemic control was unsatisfactory in this patients population (HbA1c 7.5 ± 3.4% 58.7 ± 13.4 mmol/mol).
Conclusions
The AWARE App proved to be a practical tool for cardiovascular risk stratification of T2DM patients in real-world clinical practice.
PDF
