Purpose
Laparoscopic sleeve gastrectomy (LSG) is an effective weight loss procedure, but detrimental effects on bone health have been described. We aimed to assess the dynamics of regional and total ...bone mineral density (BMD) in a cohort of patients undergoing LSG and to capture gender differences in terms of evolution.
Materials and Methods
We conducted a retrospective study on 241 patients who underwent LSG to determine the regional and total BMD changes at 6 and 12 months after the intervention.
Results
One hundred ten males and 140 females (97 pre-, 43 postmenopausal) were included. Mean baseline body mass index (BMI) was 44.16 ± 6.11 kg/m
2
in males and 41.60 ± 5.54 kg/m
2
in females, reaching 28.62 ± 4.26 kg/m
2
and 27.39 ± 4.2 kg/m
2
, respectively, at 12 months. BMD showed a continuous decline, with significant loss from 6 months postoperatively. There was a positive correlation between BMD and BMI decline at 12 months (
r
= 0.134,
p
< 0.05). Total BMD loss at 12 months was significantly greater in males than premenopausal females, independent of BMI variation and age. During the first 6 months, men lost significantly more bone mass than premenopausal and postmenopausal women (BMD variation was 2.62%, 0.27%, 1.58%, respectively). The second period (6–12 months) was similar in all three groups, revealing a further steady (~ 1.4%) BMD decline.
Conclusions
Our results are consistent with previous findings that LSG negatively impacts BMD, stressing the importance of bone health-oriented measures in postoperative care. Moreover, the impact that seems more significant in males warrants future exploration, as it might change clinical practice.
Graphical abstract
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
To test the hypothesis that cumulative exposure to insulin and long-acting insulin analogs might be associated with cancer mortality in diabetes patients.
All consecutive diabetes patients aged over ...40 years, residing in a major urban area were screened at their first diabetes outpatient visit between 01/01/2001-12/31/2008 (n = 79869). Exclusion criteria were insulin treatment at screening, no insulin treatment until 12/31/2008, less than 6 months of glucose-lowering treatment alone before insulin initiation, insulin prescription before glargine became available, age <40/≥ 80 years at first insulin prescription, and <6 months of insulin exposure. A total 4990 subjects were followed-up for death based on death certificate, until 12/31/2011. Adjusted time-dependent competing risk regression analysis, with daily updates of treatment modalities was performed. Results are expressed for every 10,000 IU of cumulative dose or one year of cumulative time exposure to insulin.
Mean baseline age was 62 ± 9 years, and follow-up 4.7 ± 1.9 years. Glargine cumulative dose was associated with lower cancer mortality risk (subhazard ratio, SHR: 0.94 (95%CI 0.89-0.99, p = 0.033)). Cumulative exposure limited to that attained one year prior to death revealed lower SHRs for cumulative time (0.94 (95%CI 0.89-0.99, p = 0.018)) and cumulative dose of glargine (0.92 (95%CI 0.86-0.98, p = 0.014)). Glargine cumulative time and cumulative dose were significant predictors for lower pancreatic and breast cancer mortality, but not for deaths from lung, colorectal, female genital, liver, and urinary tract cancer. No increased hazards were found for any other subtypes of insulins.
The cumulative dose exposure to insulin glargine was associated with a lower risk of cancer mortality in general, and of breast and pancreatic cancer in particular. This effect remained even after additional "fixed" cohort or propensity score analyses.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Background: The increasing incidence of autoimmune diseases in type 1 diabetes mellitus (T1DM) patients highlights the influence of human leukocyte antigen (HLA) haplotypes on their development. This ...study aims to determine genetic predisposition to autoimmune diseases in T1DM patients, including thyroid disease and celiac diseases, and explore its correlation with vitamin D deficiency. Methods: A cross-sectional study involving thirty-six T1DM children was conducted. Typing was performed for the HLA A, B, C, DP, DR, and DQ loci. Regression analysis linked DR-DQ haplotypes to T1DM and the associated conditions. Results: The most frequent predisposing alleles and haplotypes were HLA-DR3 (70.27%), DQ2 (70.27%), DR3-DQ2 (70.27%), DQB1*02:01 (70.27%), A02 (54.05%), whereas the most prevalent protecting allele was DPB1*04:01 (52.63%). Positive correlations were observed between positive anti-thyroid peroxidase antibodies and the absence of protective alleles (DPB1*04:02, p = 0.036; DPB1*04:01, p = 0.002). Associations were found between the absence of DPB1*04:01 and anti-thyroglobulin antibodies (p = 0.03). HLA allele DPB1*03:01 was linked with vitamin D deficiency (p = 0.021). Positive anti-transglutaminase antibodies correlated with C03:03 (p = 0.026) and DRB1*04:01-DQA1*03-DQB1*03:01 (p < 0.0001) and the lack of DQA1*01:03-DQB1*06:03-DRB1*13:01 (p < 0.0001). Conclusions: The predisposing T1DM haplotypes were associated with the presence of anti-transglutaminase and anti-thyroid antibodies, indicating a genetic predisposition to autoimmune diseases.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
In this report, we present the first known case of intermediate developmental delay, epilepsy and permanent neonatal diabetes (DEND) syndrome caused by a Q52R mutation in the KCNJ11 gene who was ...successfully switched (at age 1.3 years) to sulphonylurea monotherapy, namely glibenclamide. The most recent evaluation, after 2 years, showed a glycated hemoglobin level of 6.0% (42 mmol/mol). This mutation is so severe that none of the previously reported four cases were able to switch from insulin to sulphonylurea monotherapy. The Q52R mutation seems to have a chance of positive response to glibenclamide administered every 3–6 h instead of the classical 8–12 h, in doses around or above 2.5 mg/kg/day.
DEND syndrome represents the association of developmental delay, epilepsy and permanent neonatal diabetes. The Q52R mutation seems to have a chance of positive response to glibenclamide administered every 3–6 h instead of the classical 8–12 h, in doses around or above 2.5 mg/kg/day.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
The study investigated the impact of insulin glargine exposure on cardiovascular mortality in type 2 diabetes patients with incident insulin initiation. All consecutive diabetes patients aged >40 ...years were screened at their first diabetes outpatient visit between 01/01/2001 and 12/31/2008 (n=79869). Exclusion criteria restricted the cohort to 4990 incident insulin users, aged 40–79 years, who were followed up for death until 12/31/2011. Baseline was defined 6 months after insulin initiation. Adjusted time-dependent competing risk regression analysis was performed. Mean baseline age was 62±9 years, with mean follow-up of 4.7±1.9 years. During 23179 person-years of exposure time, there were 887 deaths (521 cardiovascular). Glargine cumulative time exposure significantly lowered overall cardiovascular, subhazard ratio (SHR) 0.963 (CI 95% 0.944–0.981, p<0.001), and myocardial infarction mortality, SHR 0.945 (CI 95% 0.899–0.994, p=0.028), but not stroke mortality. Glargine cumulative dose exposure (10,000 IU increments) significantly lowered cardiovascular mortality, SHR 0.977 (CI 95% 0.960–0.993, p=0.006), but not for myocardial infarction and stroke. Both cumulative dose and time exposure to insulin glargine were associated with lower cardiovascular mortality. The effect was mostly driven by myocardial infarction end point, supporting the concept of macrovascular benefit for basal analogue insulin use in type 2 diabetes.
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FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UL, UM, UPUK
Background: Research has been conducted to extend the life of a subcutaneously implanted CGM System (Eversense®, Senseonics, Maryland U.S.A) using several strategies including the use of different ...configurations of an anti-inflammatory agent and improvement in glucose sensing and calculation methods. The current study investigated the longevity of the Eversense® XL CGM over the first 250 days of the planned 365-day evaluation period.
Methods: Thirty-four adult participants with T1D were enrolled in a prospective, unblinded, single-center 365-day study. Sensors were inserted in the upper arm and assessed every 30-60 (±14) days for sensor longevity, safety and effectiveness. An interim analysis of sensor longevity was performed using the Kaplan-Meier method to estimate the probability of sensor survival through 250 days. CGM wear duration was also assessed to monitor subject compliance. Serious adverse events related to the device or insertion or removal procedures were assessed.
Results: Participant baseline demographics were 22 males/12 females, 30 ± 7.9 years of age, with BMI of 24 ± 3.6 kg/m2 (mean ± SD). At this interim analysis, all sensors had a range of 124-365 days of use. Survival analysis at post-implant 90, 120, 150, 180 and 250 days showed an estimated probability of sensor survival of 97%, 94%, 84%, 80% and 51%, respectively. Median wear compliance of the subjects was 23.1 hours/day (96% of time). No insertion, removal or device-related serious adverse events were reported.
Conclusions: The Eversense XL CGM demonstrated good survival and safety up to 250 days of sensor wear.
Disclosure
S. Ioacara: Research Support; Self; Senseonics. R. Rastogi: Employee; Self; Senseonics. C. Mdingi: Employee; Self; Senseonics. X. Chen: Employee; Self; Senseonics. K. Tweden: Employee; Self; Senseonics.
This study analyzed the overall nocturnal performance during home use of a long-term subcutaneous implantable continuous glucose monitoring (CGM) sensor.
In this study, 12 subjects with type 1 ...diabetes mellitus (T1DM) (mean±SD age, 37±8 years; mean±SD disease duration, 11±6 years) were implanted with an investigational continuous glucose sensor in the upper arm for up to 90 days. All subjects received full access to real-time glucose display and user programmable hypo- and hyperglycemic alarms. Subjects calibrated the sensors with a self-monitoring of blood glucose (SMBG) meter and continued to rely on their regular SMBG measurements for their diabetes management. Accuracy of the sensors during the home-use study was calculated using SMBG as the reference. The nocturnal sensor attenuation (NSA) concept was tested. Sensitivity and specificity of the nocturnal hypoglycemic alarm were calculated.
Mean±SD glucose sensor life span was 87±7 days. The mean±SE absolute relative difference over the range of 40-400 mg/dL for the sensors in this home-use study was 12.3±0.7% using SMBG as the reference. The hypoglycemia alarms were set to be triggered when the glucose level went below 70 mg/dL. Percentage of nights with hypoglycemic alarms triggered for at least 10 min was 13.6%. Recovery into euglycemia within 30 min from the timestamp of the immediate confirmatory SMBG testing was obtained in 74% of all episodes (n=20). The implanted continuous glucose sensor showed a hypoglycemia detection sensitivity and specificity of 77% and 96%, respectively. The NSA-associated high negative rate of change of at least -4 mg/dL/min was not encountered during night use of the system.
This home-use study of a fully implantable, long-term continuous glucose sensor shows excellent performance in nocturnal hypoglycemia detection in T1DM patients. The apparent lack of NSA affecting the implanted sensor and the high specificity of the hypoglycemic alarm expedite the recovery from nighttime hypoglycemia.
Aims
As there are no published articles on country-level diabetes-related mortality in Romania, we aimed to investigate this aspect for the 1998–2015 period.
Methods
Anonymized demographic and ...diabetes-related mortality data (underlying or first secondary cause of death) were retrospectively obtained from the National Institute of Statistics/Eurostat microdata. Age-standardized mortality rates (ASMR) and their annual percentage change (APC) were analysed.
Results
During 1998–2015, 4,567,899 persons died in Romania, among whom, diabetes was responsible for 168,854 cases. The ASMR for diabetes was 39.34 per 100,000 person-years (p-y) (95% CI 39.32–39.35). There was an increase in ASMR from 27.10 per 100,000 p-y (95% CI 27.01–27.19) in women and 30.88 per 100,000 p-y (95% CI 30.77–30.99) in men in 1998 to 35.42 per 100,000 p-y (95% CI 35.34–35.51) in women and 48.41 per 100,000 p-y (95% CI 48.29–48.52) in men, in 2015. The mean APC in women was 3.8% per year (95% CI 3.5–4.0,
p
< 0.001) during 1998–2010 and − 1.9% per year (95% CI − 2.7 to − 1.1,
p
< 0.001) during 2010–2015. The mean APC in men was 5.3% per year (95% CI 5.0–5.5,
p
< 0.001) during 1998–2010 and − 1.5% per year (95% CI − 2.2 to − 0.8,
p
< 0.001) during 2010–2015. Diabetes-related mortality rates increased with age, with men experiencing higher mortality rates than women for most age groups and calendar years.
Conclusions
Diabetes-related mortality rates increased significantly in Romania during 1998–2010, followed by a steady decline during 2010–2015.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OBVAL, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Background:
Continuous glucose monitoring (CGM), which enables real-time glucose display and trend information as well as real-time alarms, can improve glycemic control and quality of life in ...patients with diabetes mellitus. Previous reports have described strategies to extend the useable lifetime of a single sensor from 1-2 weeks to 28 days. The present multisite study describes the characterization of a sensing platform achieving 90 days of continuous use for a single, fully implanted sensor.
Method:
The Senseonics CGM system is composed of a long-term implantable glucose sensor and a wearable smart transmitter. Study subjects underwent subcutaneous implantation of sensors in the upper arm. Eight-hour clinic sessions were performed every 14 days, during which sensor glucose values were compared against venous blood lab reference measurements collected every 15 minutes using mean absolute relative differences (MARDs).
Results:
All subjects (mean ± standard deviation age: 43.5 ± 11.0 years; with 10 sensors inserted in men and 14 in women) had type 1 diabetes mellitus. Most (22 of 24) sensors reported glucose values for the entire 90 days. The MARD value was 11.4 ± 2.7% (range, 8.1-19.5%) for reference glucose values between 40-400 mg/dl. There was no significant difference in MARD throughout the 90-day study (P = .31). No serious adverse events were noted.
Conclusions:
The Senseonics CGM, composed of an implantable sensor, external smart transmitter, and smartphone app, is the first system that uses a single sensor for continuous display of accurate glucose values for 3 months.
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NUK, OILJ, SAZU, UKNU, UL, UM, UPUK
To assess the prevalence of cardiovascular risk factors (CVRFs) in children and adolescents with type 1 diabetes (T1D) in the International SWEET registry and the possible role of clinical variables ...in modifying the risk of having single or multiple CVRFs.
The study is a cross-sectional study. Cut-off points for CVRFs were fixed according to International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines and WHO parameters: LDL cholesterol (LDL-C) > 100 mg/dL; Systolic Blood Pressure (BP-SDS) > 90th percentile for sex, age, and height; BMI-SDS > 2SD for sex and age. Logistic regression models were applied to evaluate variables associated with at least 1 or 2 CVRFs among registry children and adolescents.
29,649 individuals with T1D (6–18 years, T1D ≥ 2 years) participating in the SWEET prospective multicenter diabetes registry were included. In the cohort, 41 % had one or more CVRFs, and 10 % had two or more CVRFs. Thirty-five percent of enrolled individuals had LDL-C > 100 mg/dL, 26 % had BMI-SDS > 2SD, and 17 % had Systolic BP-SDS > 90th percentile. Females had higher frequency than males of having 1 or 2 CVRFs (45.1 % vs 37.4 %, 11.8 % vs 7.8 %; p < 0.001). Multivariable logistic regression models showed that sex (female), HbA1c category (>7.0 %), and age (>10 years) were associated with a higher chance of having at least 1 or 2 CVRFs (p < 0.001).
In children and adolescents with T1D, female sex, in addition to HbA1c above 7 %, and older age (>10 years) was associated with a higher risk of having at least a CVRF (LDL-C, BMI-SDS, BP) according to internationally defined cut-offs.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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