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IntroductionChildren and adolescents with recent-onset type 1 diabetes (T1D) commonly maintain a certain level of insulin production during the remission phase, which can last months to years. Preserving β-cell function can reduce T1D complications and improve glycaemic control. Influenza vaccination has pleiotropic effects and administration of the vaccine during the early phases of T1D may offer β-cell protection. This study aims to assess the effect of influenza vaccination on preserving β-cell function in children and adolescents with recent-onset T1D.Methods and analysisThe INfluenza VaccInation To mitigate typE 1 Diabetes trial is a randomised, double-blind, placebo-controlled, multicentre trial in paediatric patients with recent-onset T1D aged 7–17 years. 100 participants will be randomised in a 1:1 ratio to receive either a standard inactivated quadrivalent influenza vaccine or a placebo within 14 days of diagnosis. The primary outcome is a difference in mean change (from baseline to 12 months) in C-peptide level between groups during a 2-hour mixed-meal tolerance test. Secondary outcomes include mean change (from baseline to 6 months) in C-peptide levels, haemoglobin A1c, ambulatory glucose profiles and insulin requirements. Exploratory outcomes are diabetes-related autoantibodies, inflammatory markers and serum haemagglutinin inhibition antibody titres against the influenza viruses. The current treatment for T1D is largely symptomatic, relying on insulin administration. There is a pressing need for novel pharmacological approaches aimed at modulating the immune system to preserve residual β-cell function. Existing immunotherapies are cost-prohibitive and associated with multiple side effects, whereas influenza vaccination is inexpensive and generally well tolerated. A positive outcome of this study holds potential for immediate implementation into standard care for children and adolescents with recent-onset T1D and may guide future research on immune modulation in T1D.Ethics and disseminationEthical approval was obtained from Danish Health Authorities prior to participant enrollment. The trial results will be submitted to a peer-reviewed journal.Trial registration numberClinicalTrials.gov NCT05585983 and EudraCT Number 2022-500906-17-01.

Background Childhood obesity is associated with impaired Quality-of-Life (QoL), increased stigmatization and higher risk of development of depression compared to their peers. This report describes the long-term development in QoL for cohort of children with obesity after a sustainable weight reduction. Methods This pragmatic descriptive intervention study enrolled 120 children with obesity, age 5–17 years, in a multifactorial lifestyle intervention. The intervention was an across sectors collaboration between a department of pediatrics and community health care workers. QoL was assessed yearly throughout the intervention and evaluated by a 6-item Visual Analogue Scale (VAS). For analyzing changes in VAS, as function BMI-SDS, regression models were used, while ANOVA and Wilcoxon test were applied for normal and not-normal distributed data. 95% confidence interval not containing 0 and p-value < 0.05 was considered statistically significant. Results After 26.4 months (13.9 SD) an overall decrease in bullying (0.6 vs. 0.0 median) and motivation (10.0 vs. 9.6) was observed. QoL increased in children with a BMI-SDS reduction (0.65 (2.49 SD)) opposite children with no-change or increasing BMI-SDS who reported reduced QoL (-0.36 (1.55 SD) and -0.96 (2.27 SD)). A significant inverse relationship was observed for Joy of Life, QoL and body perception as a function of BMI-SDS per year. Conclusion Weight reduction causes improvement in QoL for children with obesity and an inverse relationship for QoL and changing BMI-SDS / year was establish.

Introduction Childhood obesity has psychological consequences and increases the risk of continuous obesity into adulthood, associated with development of non-communicable disease (e.g. type 2 diabetes). Short-term weight loss intervention studies show good results but long-term studies are limited. Methods One hundred ninety-nine obese children (4–18 years of age), with a BMI-SDS (standard deviation score) above + 2 SDS were enrolled into a multifactorial family-centered lifestyle intervention study. The children had yearly visits in the outpatient clinic for anthropometrics, blood samples and DXA-scans, and 6–8 meeting with community health workers between these visits. The children followed the intervention up to 3 years. Results After a follow-up of 26.7 ± 17.5 months a reduction in BMI-SDS of − 0.25 SDS ( p  < 0.001) was observed. The 57 children who were adherent to the intervention for ≥ 2 years had significantly reduced BMI-SDS compared to the 142 children with shorter intervention (BMI-SDS: − 0.38 ± 0.67 vs. − 0.20 ± 0.50, p  = 0.036). All weight loss was accompanied by decrease in fat mass and increase in muscle mass ( p  < 0.001). Conclusion The intervention was found to induce long-term reduction in BMI-SDS in obese children, with beneficial change in body composition. Children who followed the intervention the longest had the greatest reduction in BMI-SDS. Level of evidence Level III, longitudinal cohort study.

Introduction: Obesity in children and adolescents are increasing worldwide with a parallel increase in the risk of developing severe psychosocial problems, type 2 diabetes, non-alcoholic fatty liver disease, hypertension, and in adulthood overt cardiovascular disease, cancer and premature death. In Denmark 3% of children (9-13 yrs.) and 7% of adolescents (16-24 yrs.) are considered obese and it is essential to prevent and treat obesity in order to attenuate the development of obesity-related diseases. Theory and Methods: Obesity is defined as a body mass index (BMI=kg/m2) above the 99th percentile for age and sex, or an iso-BMI > 30 kg/m2. We identified 201 children age 3-17 yrs. with obesity in our outpatient clinic. The children and their families (aka patients) were included from January 2014 to December 2017 and they were referred from general practitioners and healthcare providers in the municipalities of Randers, other hospital departments, or as self-directed to our clinic. Each patient received an individual treatment plan according to the guidelines as described in the Holbaek-method. This treatment plan describes in a very structured and detailed manner the number of daily meals, contents of the meals, recommendations for grocery shopping, amount and type of activity, screen time, amount of weekly sweetened beverages, candy, chips, and daily fruit. After initial screening the patients were followed-up as a joint-venture between healthcare providers in their local community/municipality and the department of pediatrics. The patients were supported by their healthcare provider in their local community/municipality 4-5 times each year, where they were encouraged to comply to their individual treatment plan and body weight, height, waist and hip circumference, and bioimpedance were assessed. The patients were invited to the department of pediatrics once yearly where their body weight, height, waist, hip, BMI, and bioimpedance were assessed. In addition, total body fat and lean body mass was measured by a DEXA-scan. Blood samples were drawn to measure liver enzymes, thyroid function, HbA1c, fasting blood glucose, blood lipids, and electrolytes including urea. Quality of life was examined by visual analogue scales. Our criteria of success was, that at least 65% patients had obtained a reduction in z-score BMI after 2 years and/or that 90% of the patients performed exercise on a regular basis (several times each week). Results: All 201 patients have completed their participation in the project and data analyses are pending. Conclusion: We propose that this trial will assist us in the development of new knowledge in order to empower families and thereby provide better strategies to engage communities and understand, treat, and prevent obesity in children.

Background Mutations in the KCNJ11 gene encoding the adenosine triphosphate (ATP)-sensitive potassium channel (K ATP ) subunit Kir6.2 are the most frequent cause of diabetes in infancy. Sulfonylurea (SU) treatment restores insulin secretion in patients with KCNJ11 mutations. Materials and methods We report a 9-year-old boy who presented at the age of three months with diabetic ketoacidosis. Results Sequencing of the KCNJ11 gene revealed an R201H mutation. Therefore, he was transferred from insulin to oral SU therapy. He required a high-threshold dose before insulin could be discontinued. After transition, a subsequent dose reduction was necessary to avoid hypoglycemia. Improved sustained metabolic control without complications was achieved on a low SU maintenance dose twice daily over 36 months. Conclusion SU therapy is safe for patients with diabetes due to KCNJ11 mutations. The mechanism of a threshold dose and the twice-daily requirement needs further attention.