Polymorphism of the FTO

The objective was to compare the impact of clinical and genetic factors on body mass index (BMI) in children with type 1 diabetes (T1DM) without severe obesity. A total of 1,119 children with T1DM (aged 4–18 years) were qualified to take part in the study. All children were genotyped for variants of FTO, MC4R, INSIG2, FASN, NPC1, PTER, SIRT1, MAF, IRT1, and CD36. Results. Variants of FTO showed significant association with BMI-SDS in the T1DM group. The main factors influencing BMI-SDS in children with T1DM included female gender (P=0.0003), poor metabolic control (P=0.0001), and carriage of the A allele of the FTO rs9939609 gene (P=0.02). Conclusion. Our research indicates, when assessing, the risk of overweight and obesity carriage of the A allele in the rs9939609 site of the FTO gene adds to that of female gender and poor metabolic control. This trial is registered with ClinicalTrials.gov (NCT01279161)

Polymorphism of the FTO Gene Influences Body Weight in Children with Type 1 Diabetes without Severe Obesity

The objective was to compare the impact of clinical and genetic factors on body mass index (BMI) in children with type 1 diabetes (T1DM) without severe obesity. A total of 1,119 children with T1DM (aged 4-18 years) were qualified to take part in the study. All children were genotyped for variants of FTO, MC4R, INSIG2, FASN, NPC1, PTER, SIRT1, MAF, IRT1, and CD36. Results. Variants of FTO showed significant association with BMI-SDS in the T1DM group. The main factors influencing BMI-SDS in children with T1DM included female gender ( = 0.0003), poor metabolic control ( = 0.0001), and carriage of the A allele of the FTO rs9939609 gene ( = 0.02). Conclusion. Our research indicates, when assessing, the risk of overweight and obesity carriage of the A allele in the rs9939609 site of the FTO gene adds to that of female gender and poor metabolic control. This trial is registered with ClinicalTrials.gov (NCT01279161)

Impact of ELKa, the Electronic Device for Prandial Insulin Dose Calculation, on Metabolic Control in Children and Adolescents with Type 1 Diabetes Mellitus: A Randomized Controlled Trial

Background. The ELKa system is composed of computer software, with a database of nutrients, and a dedicated USB kitchen scale. It was designed to automatize the everyday calculations of food exchanges and prandial insulin doses. Aim. To investigate the influence of the ELKa on metabolic control in children with type 1 diabetes mellitus (T1DM). Methods. A randomized, parallel, open-label clinical trial involved 106 patients aged 50% of meals achieved lower HbA1C levels (P=0.002), lower basal insulin amounts (P=0.049), and lower intrasubject standard deviation of blood glucose levels (P=0.023) in comparison with the control. Moreover, in the intervention group, significant reduction of HbA1C level, by 0.55% point (P=0.002), was noted. No intergroup differences were found in the hypoglycemic episodes, BMI-SDS, bolus insulin dosage, and total daily insulin dosage. Conclusions. The ELKa system improves metabolic control in children with T1DM under regular usage. The trial is registered at ClinicalTrials.gov, number NCT02194517

Prolonged Remission Induced by FENofibrate in children with newly diagnosed type 1 diabetes (PRIFEN): protocol of a randomised controlled trial

Introduction Sphingolipids regulate proinsulin folding, insulin secretion and control beta cells apoptosis. Recent evidence has demonstrated that, among other factors, reduced amounts of sulfatide may be relevant in the development of type 1 diabetes (T1D). Thus, fenofibrate, which activates sulfatide biosynthesis, may prolong remission in subjects with T1D. The aim of the study is to evaluate clinical efficacy of fenofibrate on the maintenance of residual beta-cell function in children with newly diagnosed T1D.Methods and analysis A total of 102 children aged 10–17 years with newly diagnosed T1D will be enrolled in a double-blind, two-centre randomised, non-commercial, placebo-controlled trial. Subjects who will meet all inclusion criteria will be randomly assigned to receive fenofibrate at a dose of 160 mg or an identically appearing placebo, orally, once daily, for 12 months. The primary endpoint will be the area under the curve of the C-peptide level during 2-hour responses to a mixed-meal tolerance test (MMTT). Secondary endpoints include fasting and maximum C-peptide concentration in the MMTT, parameters of diabetes control and glucose fluctuations, daily insulin requirement, inflammation markers, genetic analysis, safety and tolerance of the fenofibrateEthics and dissemination The study protocol was approved by the Bioethics Committee. The results of this study will be submitted to a peer-reviewed diabetic journal. Abstracts will be submitted to international and national conferences.Trial registration number EnduraCT 2020-003916-28

Sensitivity to Sweet and Salty Tastes in Children and Adolescents with Type 1 Diabetes

Taste function impairment is observed in people with type 1 diabetes (T1D). It is most often related to sweet taste. It is associated with such factors as diabetic neuropathy, smoking, age, duration of the disease and a rigorous diet that eliminates easily digestible carbohydrates. The aim of the study was to compare sensitivity to sweet and salty tastes between healthy children and adolescents and children and adolescents with T1D. The study group consisted of children with T1D (n = 35), with at least 5 years of disease history, while the group of healthy children included 46 individuals selected in terms of age, gender and BMI. A study concerning the perception of sweet and salty taste was carried out with the use of the specific gustometry method (examining the recognition and assessment of the intensity of taste sensations, performing a hedonic assessment). Children and adolescents from both groups had trouble recognising tastes. Children and adolescents with T1D were more likely to recognise sweet taste correctly even at its lower concentrations compared to healthy individuals (p = 0.04). Salty taste was significantly more often correctly identified by healthy children compared to T1D patients (p = 0.01). Children and adolescents with T1D reported a stronger intensity of perceived tastes than healthy ones. No significant differences in perceived pleasure were noted at lower sucrose concentrations in any group. The intensity score was higher in individuals with T1D at higher sucrose concentrations. No significant differences occurred in the assessment of salty taste intensity. The hedonic scoring of solutions with higher concentrations of sweet taste was higher in people with T1D than in healthy ones, while salty taste was assessed neutrally. Children and adolescents with T1D were demonstrated to have some taste recognition disorders. Therefore, monitoring taste function in pediatric diabetic clinical practice seems relevant, as it may be associated with important implications for the intake of a particular type of food and for the development of eating habits and preferences

Lack of effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function in children with newly diagnosed type 1 diabetes: a randomised controlled trial

Introduction The gut microbiota may be relevant in the development of type 1 diabetes (T1D). We examined the effects of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function in children with newly diagnosed T1D.Research design and methods Children aged 8–17 years with newly (within 60 days) diagnosed T1D were enrolled in a double-blind, randomised controlled trial in which they received L. rhamnosus GG and B. lactis Bb12 at a dose of 109 colony-forming units or placebo, orally, once daily, for 6 months. The follow-up was for 12 months. The primary outcome measure was the area under the curve (AUC) of the C-peptide level during 2-hour responses to a mixed meal.Results Ninety-six children were randomised (probiotics, n=48; placebo n=48; median age 12.3 years). Eighty-eight (92%) completed the 6-month intervention, and 87 (91%) completed the follow-up at 12 months. There was no significant difference between the study groups for the AUC of the C-peptide level. For the secondary outcomes at 6 months, there were no differences between the study groups. At 12 months, with one exception, there also were no significant differences between the groups. Compared with the placebo group, there was a significantly increased number of subjects with thyroid autoimmunity in the probiotic group. However, at baseline, there was also a higher frequency of thyroid autoimmunity in the probiotic group. There were no cases of severe hypoglycemia or ketoacidosis in any of the groups. No adverse events related to the study products were reported.Conclusions L. rhamnosus GG and B. lactis Bb12, as administered in this study, had no significant effect in maintaining the residual pancreatic beta-cell function in children with newly diagnosed T1D. It remains unclear which probiotics, if any, alone or in combination, are potentially the most useful for management of T1D.Trial registration number NCT03032354

Wskaźnik zachorowalności na niedziedziczną amyloidozę w Polsce

INTRODUCTION: In the present study we report on the incidence of non-hereditary amyloidosis based on data from public health services in Poland, covering both inpatients and outpatients. Data are given by amyloidosis subtypes between 2013 through 2015. MATERIAL AND METHODS: Amyloidosis patients were identified from the National Health Fund database. In order to ensure that the reported incidence data included only new patients, persons previously entered in the register with an amyloidosis diagnosis were excluded. Children and adults (males and females) were included in the study. The geographic region of residence was divided into six regions. People with a comparable genome live in all regions of Poland. RESULTS: In the years 2013 to 2015 a total of 287 patients with amyloidosis were identified, giving an incidence of 2.49 per million person-years. Unspecified amyloidosis was the largest disease category with 169 patients (1.46 per million person-years), and organ-limited amyloidosis – 60 patients (0.52 per million person-years) – was the second most frequent. Men had a somewhat higher incidence than women in each of the analysed disorders. There was no statistically significant difference between the recorded incidence in the analysed regions. There are no significant differences between men and women with senile amyloidosis. CONCLUSIONS: The incidence of amyloidosis in Poland is about 2.49 per million person-years, with a slightly higher risk in men than in women. The patients most often suffered from amyloidosis due to an undetermined cause unrelated to heredity. Organ-limited amyloidosis was second in terms of incidence. There were no statistically significant differences between the registered incidence of amyloidosis in the individual analysed regions of Poland. There were no significant differences between men and women with senile amyloidosis.WSTĘP: W pracy przedstawiono przypadki niedziedzicznej amyloidozy na podstawie danych z publicznej służby zdrowia w Polsce, obejmujących zarówno pacjentów hospitalizowanych, jak i ambulatoryjnych. Dane przedstawiono według podtypów amyloidozy rozpoznanych w okresie od 2013 r. do 2015 r. MATERIAŁ I METODY: Pacjenci z amyloidozą zostali wyłonieni z bazy danych Narodowego Funduszu Zdrowia. W celu zapewnienia, że zgłaszane dane dotyczące zachorowalności obejmowały tylko nowych pacjentów, osoby już wcześniej wpisane do rejestru z rozpoznaniem amyloidozy zostały wykluczone. Do badania włączono dzieci i dorosłych obojga płci. Obszar geograficzny (miejsce zamieszkania badanych) podzielono na sześć regionów. We wszystkich regionach Polski mieszkają osoby o porównywalnym genomie. WYNIKI: W latach 2013–2015 amyloidozę stwierdzono łącznie u 287 pacjentów, z częstością 2,49 na milion osobolat. Najczęstszą z chorób była amyloidoza nieokreślona, cierpiało z jej powodu 169 pacjentów (1,46 na milion osobolat). Druga co do częstości występowania była amyloidoza ograniczona do określonego narządu – 60 pacjentów (0,52 na milion osobolat). Biorąc pod uwagę wszystkie analizowane podtypy amyloidozy, mężczyźni chorowali częściej niż kobiety. Nie stwierdzono statystycznie istotnej różnicy między zarejestrowaną zapadalnością w analizowanych regionach. Brak istotnych różnic między mężczyznami i kobietami z amyloidozą starczą. WNIOSKI: Częstość występowania amyloidozy w Polsce wynosi około 2,49 na milion osobolat, z nieco większym ryzykiem zachorowań u mężczyzn niż u kobiet. Badani chorowali najczęściej na amyloidozę o nieokreślonej przyczynie niezwiązaną z dziedziczeniem. Na drugim miejscu pod względem częstości występowania była amyloidoza ograniczona narządowo. Brak istotnych statystycznie różnic pomiędzy zarejestrowaną zapadalnością na amyloidozę w analizowanych regionach Polski. Nie wykazano istotnych różnic pomiędzy kobietami i mężczyznami chorującymi na amyloidozę starczą

Supplementation with Bifidobacterium longum subspecies infantis EVC001 for mitigation of type 1 diabetes autoimmunity

INTRODUCTION The Global Platform for the Prevention of Autoimmune Diabetes-SINT1A Study is designed as a randomised, placebo-controlled, double-blind, multicentre, multinational, primary prevention study aiming to assess whether daily administration of Bifidobacterium infantis from age 7 days to 6 weeks until age 12 months to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies in childhood. METHODS AND ANALYSIS Infants aged 7 days to 6 weeks from Germany, Poland, Belgium, UK and Sweden are eligible for study participation if they have a \textgreater10.0% expected risk for developing multiple beta-cell autoantibodies by age 6 years as determined by genetic risk score or family history and HLA genotype. Infants are randomised 1:1 to daily administration of B. infantis EVC001 or placebo until age 12 months and followed for a maximum of 5.5 years thereafter. The primary outcome is the development of persistent confirmed multiple beta-cell autoantibodies. Secondary outcomes are (1) Any persistent confirmed beta-cell autoantibody, defined as at least one confirmed autoantibody in two consecutive samples, including insulin autoantibodies, glutamic acid decarboxylase, islet tyrosine phosphatase 2 or zinc transporter 8, (2) Diabetes, (3) Transglutaminase autoantibodies associated with coeliac disease, (4) Respiratory infection rate in first year of life during supplementation and (5) Safety. Exploratory outcomes include allergy, antibody response to vaccines, alterations of the gut microbiome or blood metabolome, stool pH and calprotectin. ETHICS AND DISSEMINATION The study was approved by the local ethical committees of the Technical University Munich, Medical Faculty, the Technische Universität Dresden, the Medizinische Hochschule Hannover, the Medical University of Warsaw, EC Research UZ Leuven and the Swedish ethical review authority. The results will be disseminated through peer-reviewed journals and conference presentations and will be openly shared after completion of the study. TRIAL REGISTRATION NUMBER NCT04769037