Hormone and Metabolic Research最新文献

{"title":"Clinical and Biochemical Characteristics of Non-Diabetic Hypoglycemia in a Tertiary Care Cohort.","authors":"Avni Oncu, Senay Topsakal, Sema Taban, Ibrahim Celik","doi":"10.1055/a-2961-6659","DOIUrl":"https://doi.org/10.1055/a-2961-6659","url":null,"abstract":"<p><p>Non-diabetic hypoglycemia is a heterogeneous condition with diverse etiologies and remains a diagnostic challenge in clinical practice. This study aimed to characterize the clinical and biochemical features of patients evaluated for non-diabetic hypoglycemia and to assess the diagnostic utility of the supervised prolonged fasting test in distinguishing reactive hypoglycemia from endogenous hyperinsulinemic conditions. This retrospective observational study included 92 non-diabetic adults evaluated for suspected hypoglycemia at a tertiary referral center between 2020 and 2023. Demographic, clinical, laboratory, and fasting test data were reviewed. All patients underwent a standardized supervised prolonged fasting test, and biochemical parameters were analyzed according to final etiological diagnosis. Reactive hypoglycemia was diagnosed in 80 patients (87.0%), while insulinoma or other neuroendocrine tumors (NETs) were identified in 12 patients (13.0%). Compared with reactive hypoglycemia, patients with insulinoma/NET had significantly lower plasma glucose levels (39.73 ± 9.74 vs. 55.38 ± 9.69 mg/dL, p < 0.001), higher insulin levels (6.17 vs. 2.57 μIU/mL, p = 0.010), and higher C-peptide concentrations (2.50 vs. 0.88 ng/mL, p = 0.006). The median time to hypoglycemia during fasting was shorter in the insulinoma/NET group (47 vs. 72 hours, p < 0.001). No significant differences were observed in HbA1c, HOMA-IR, vitamin D, or hematological indices. The supervised prolonged fasting test, combined with glucose, insulin, and C-peptide measurements, effectively differentiated endogenous hyperinsulinemic hypoglycemia from reactive hypoglycemia. Earlier onset of hypoglycemia during fasting provided additional diagnostic value beyond standard biochemical parameters. Prospective studies with larger cohorts are needed to confirm these findings.</p>","PeriodicalId":12999,"journal":{"name":"Hormone and Metabolic Research","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149080745","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Levothyroxine Administration in Intensive Care Unit Patients with Low Thyroxine Levels: A Retrospective Comparison Study.","authors":"Aviv Benedick, Avraham Meyer, Elad Dana, Sara Dichtwald","doi":"10.1055/a-2961-7316","DOIUrl":"https://doi.org/10.1055/a-2961-7316","url":null,"abstract":"<p><strong>Abstract: </strong>Nonthyroidal illness syndrome is a common condition among intensive care unit patients. Previous studies showed conflicting findings regarding association with poor clinical outcomes. Studies examining whether levothyroxine administration improves clinical outcomes in critical patients with nonthyroidal illness syndrome and low free thyroxine levels are lacking. We aimed to examine whether levothyroxine administration in intensive care unit patients with the nonthyroidal illness syndrome and low thyroxine levels (< 0.8 ng/dL) resulted in differences in 28-day mortality and in-hospital morbidity. A retrospective study using electronic data retrieval for patients admitted to a general intensive care unit who presented with low free thyroxine levels and nonthyroidal illness syndrome. This study included 123 patients. A total of 53 patients received levothyroxine. No significant differences were found between groups regarding demographics, comorbidities or reasons for intensive care unit admission. Hospital length of stay was significantly longer in the treatment group (39±24 d) compared to that in the non-treatment group (30±19 d; <i>p</i><0.05). The duration of mechanical ventilation was significantly longer in the treatment group (21±21 d) vs. non-treatment group (14±14 d; <i>p</i><0.05). Intensive care unit length of stay showed a trend toward being longer in the treatment group (22±20 d) compared to that in the non-treatment group (16±13 d; <i>p</i>=0.058). Higher free thyroxine levels were associated with better clinical outcomes, including the reduced need for vasopressors and dialysis, and lower 28-day mortality. Low free thyroxine levels in intensive care unit patients with nonthyroidal illness syndrome are associated with higher morbidity. Levothyroxine administration did not improve clinical outcomes in this population.</p>","PeriodicalId":12999,"journal":{"name":"Hormone and Metabolic Research","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149080791","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Glucagon-Like Peptide-1 Receptor Agonists as Weight Loss Drugs on Pancreatitis and Pancreatic Cancer: A Meta-Analysis.","authors":"Xinai Zhong, Yueqi Zhao, Mengyao Han, Qianqian Zheng, Qianqian Cheng, Beixi Shi, Yu Zhang","doi":"10.1055/a-2923-3830","DOIUrl":"10.1055/a-2923-3830","url":null,"abstract":"<p><strong>Abstract: </strong>This meta-analysis aimed to clarify the association between glucagon-like peptide-1 receptor agonists, used for weight management in obesity, and the risks of pancreatitis and pancreatic cancer. We systematically searched PubMed, Web of Science, Embase, the Cochrane Library, and Scopus through June 15, 2026, for clinical studies conducted in obese populations. Peto odds ratios with 95% confidence intervals were calculated. Heterogeneity was assessed using <i>I</i>² statistic, and random-effects models were applied when <i>I</i>² exceeded 60%. Subgroup analyses were conducted according to study design, follow-up duration, control type, glucagon-like peptide-1 receptor agonist agent type, and dose regimen. Leave-one-out sensitivity analyses were additionally performed. This meta-analysis included 52 studies. The pooled analysis demonstrated no significant association between glucagon-like peptide-1 receptor agonist use and pancreatic cancer (odds ratio=1.34; 95% confidence interval: 0.76-2.34; <i>p</i>=0.31) or pancreatitis (odds ratio=1.29; 95% confidence interval: 0.91-1.84; <i>p</i>>0.05). Additional subgroup analyses according to study design, follow-up duration, control type, and dose regimen yielded findings consistent with the primary analyses. Leave-one-out sensitivity analyses were performed to assess the robustness of the pooled estimates. Glucagon-like peptide-1 receptor agonists used for weight management in obesity were not associated with an increased risk of pancreatitis or pancreatic cancer. The consistency of findings across multiple subgroup and sensitivity analyses further supports the pancreatic safety profile of glucagon-like peptide-1 receptor agonists.</p>","PeriodicalId":12999,"journal":{"name":"Hormone and Metabolic Research","volume":" ","pages":"354-363"},"PeriodicalIF":2.3,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148759661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recent Advances in Glucagon-Like Peptide-1 Receptor and Melanocortin-4 Receptor Agonists for the Treatment of Obesity and Type 2 Diabetes.","authors":"Chang-Min Lee, Jin-Young Kim, Jeong-Hyun Shim, Gwang-Won Cho","doi":"10.1055/a-2928-5204","DOIUrl":"10.1055/a-2928-5204","url":null,"abstract":"<p><strong>Abstract: </strong>The global rise in aging populations has been accompanied by increasing rates of obesity and type 2 diabetes, both of which pose significant public health and economic challenges. This review aims to investigate the pathophysiological link between obesity and diabetes and evaluate emerging therapeutic strategies that involve glucagon-like peptide-1 receptor and melanocortin-4 receptor agonists, including their dual and triple agonist developments. A comprehensive literature review was conducted focusing on the mechanisms of glucagon-like peptide-1 receptor and melanocortin-4 receptor agonists, their clinical efficacy, and the evolution of combination therapies. Emphasis was placed on recent clinical trials and the development of oral agonist formulations to improve patient compliance. Glucagon-like peptide-1 receptor agonists, such as semaglutide and liraglutide, promote insulin secretion, suppress appetite, and result in effective weight loss and glycemic control. Semaglutide is available in both injectable and oral forms, improving accessibility. Liraglutide also reduces cardiovascular risk. Melanocortin-4 receptor agonists act via the central nervous system to reduce appetite and increase energy expenditure, with setmelanotide showing efficacy in genetic obesity. Dual and triple agonists, such as tirzepatide, simultaneously target glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide, and glucagon receptors, leading to enhanced metabolic outcomes. Oral drugs like rybelsus improve long-term adherence. Glucagon-like peptide-1 receptor and melanocortin-4 receptor agonists, particularly when used as dual or triple agents, represent promising therapeutic innovations for obesity and type 2 diabetes. The development of oral formulations further enhances treatment convenience and adherence, paving the way for improved clinical outcomes.</p>","PeriodicalId":12999,"journal":{"name":"Hormone and Metabolic Research","volume":" ","pages":"339-353"},"PeriodicalIF":2.3,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148891396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Effectiveness and Safety of Recombinant Human Growth Hormone in Chinese Children with Noonan Syndrome: Long-Term Follow-Up and a 2-Year Comparison of Short- and Long-Acting Formulations.","authors":"Xinying Gao, Jiajia Chen, Beibei Zhang, Manman Zhao, Yaguang Peng, Chunxiu Gong","doi":"10.1055/a-2900-8976","DOIUrl":"10.1055/a-2900-8976","url":null,"abstract":"<p><strong>Abstract: </strong>This retrospective real-world cohort study evaluated the effectiveness and safety of recombinant human growth hormone therapy in Chinese children with Noonan syndrome, with a predefined comparison between short-acting growth hormone and long-acting growth hormone during the first 2 years of treatment. Twenty children with Noonan syndrome were included; 16 were boys, and the median age at recombinant human growth hormone initiation was 5.55 years. The baseline height standard deviation score was-3.01. During the first 2 years, 10 patients received short-acting growth hormone and 10 patients received long-acting growth hormone. The median height standard deviation score increased to-2.20 after 1 year and-1.84 after 2 years, with significant longitudinal improvement over time. The cumulative change in height standard deviation score did not differ significantly between short-acting growth hormone and long-acting growth hormone at year 1 (0.58 vs. 0.71) or year 2 (1.01 vs. 1.30). First-year growth velocity was comparable between groups, whereas the apparent second-year difference was no longer significant after excluding short-acting growth hormone-treated patients who entered puberty and received adjunctive therapy. Among 16 patients with PTPN11 variants, the median cumulative change in height standard deviation score was 1.20 and 56.3% achieved an HtSDS of above-2 standard deviation score at the last follow-up. No diabetes mellitus, malignancy, new cardiovascular events, intracranial hypertension, or slipped capital femoral epiphysis occurred. Insulin-like growth factor-1 standard deviation score elevations were transient. Recombinant human growth hormone therapy was associated with sustained linear growth in children with Noonan syndrome, and short-acting growth hormone and long-acting growth hormone showed broadly comparable short-term efficacy under regular safety monitoring.</p>","PeriodicalId":12999,"journal":{"name":"Hormone and Metabolic Research","volume":" ","pages":"380-386"},"PeriodicalIF":2.3,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148619478","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Relationship Between TPOAb and Osteoporosis: Moderating Effect of Visceral-to-Subcutaneous Fat Area Ratio.","authors":"Ying Yang, Gang Tian, Shuyun Li, Zijuan Guo, Lu Bai, Siwei Tao, Haihong Lv","doi":"10.1055/a-2920-5112","DOIUrl":"10.1055/a-2920-5112","url":null,"abstract":"<p><strong>Abstract: </strong>This cross-sectional study aimed to explore the relationship between thyroid peroxidase antibody (TPOAb) and osteoporosis, and the moderating effect of visceral-to-subcutaneous fat area ratio (VSR). A total of 128 males aged over 60 years with normal thyroid function and positive TPOAb (>9 IU/ml) were included. Lumbar spine, femoral neck, and whole-body bone mineral density (BMD) were measured by dual-energy X-ray absorptiometry. Visceral fat area (VFA) and subcutaneous fat area (SFA) were measured by the Omron DUALSCAN device. The relationships between TPOAb, VSR, interaction term (VSR*TPOAb) and BMD were analyzed using multiple linear regression models. Further subgroup analyses were performed stratified by VSR tertiles. TPOAb showed a significant negative correlation with BMD in the unadjusted model (p<0.01). However, when adjusted for confounding covariates, the correlation between TPOAb and BMD was no longer statistically significant (p>0.05). Further analysis showed VSR and the interaction term (VSR*TPOAb) were significantly negative associated with BMD in fully adjusted model (p<0.01). Subgroup analysis, stratified by VSR tertiles, showed that TPOAb only in T3 group (VSR>0.67) was negatively associated with lumbar spine and whole-body BMD (p<0.05). Hence, the relationship between TPOAb and BMD in elderly males varies with VSR. The abnormal body fat distribution may be a key moderator of the TPOAb-BMD relationship, suggesting the necessity for personalized bone health monitoring. Specifically, for patients with VSR>0.67, TPOAb screening is of great significance for the early prevention of osteoporosis.</p>","PeriodicalId":12999,"journal":{"name":"Hormone and Metabolic Research","volume":" ","pages":"371-379"},"PeriodicalIF":2.3,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148759796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Is Hashimoto's Thyroiditis Associated with Insulin Resistance Markers?","authors":"Ummugulsum Can, Sadinaz Akdu, Oguzhan Aksu, Hatice Çalışkan Burgucu","doi":"10.1055/a-2930-0189","DOIUrl":"10.1055/a-2930-0189","url":null,"abstract":"<p><strong>Abstract: </strong>Hashimoto's thyroiditis causes cell death, hypothyroidism, and insulin resistance. Cholecystokinin, orexin-A, and cocaine and amphetamine-regulated transcript are essential regulators of various endocrine and autonomic processes, including food intake. We aimed to determine the cocaine and amphetamine-regulated transcript, orexin-A, and cholecystokinin levels in Hashimoto's thyroiditis patients and assess the relationships between the metabolic parameters and Hashimoto's thyroiditis. The present study was carried out in 45 Hashimoto's thyroiditis patients and 40 healthy control groups. Serum cocaine and amphetamine-regulated transcript levels (<i>p</i><0.05), homeostatic model assessment for insulin resistance (<i>p</i><0.05) and body mass index (<i>p</i><0.05) were significantly higher in Hashimoto's thyroiditis patients compared to the controls. Serum orexin-A levels were lower in Hashimoto's thyroiditis patients than those in the controls (<i>p</i><0.05). Serum cholecystokinin levels were similar between the two groups. A negative correlation was observed between orexin-A levels and cocaine and amphetamine-regulated transcript and cholecystokinin levels (<i>r </i>=-0.365, <i>p</i><0.05; <i>r</i>=- 0.297, <i>p</i><0.05, respectively). A positive correlation was observed between cocaine and amphetamine-regulated transcript levels and body mass index, insulin, and homeostatic model assessment for insulin resistance levels (<i>r</i>=0.448, <i>p</i><0.01; <i>r</i>=0.489, <i>p</i><0.01; <i>r</i>=0.492, <i>p</i><0.01, respectively). Increased cocaine and amphetamine-regulated transcript and decreased orexin-A levels may be involved in the pathogenesis of Hashimoto's thyroiditis by controlling the thyroid-dependent immune system, insulin resistance, appetite, and body weight. We believe that our findings will lead to new developments in the diagnosis and treatment of this disease.</p>","PeriodicalId":12999,"journal":{"name":"Hormone and Metabolic Research","volume":" ","pages":"364-370"},"PeriodicalIF":2.3,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148792311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Severe Acute Respiratory Syndrome Coronavirus-2 Infection and New Changes in Thyroid Function Parameters During Hospitalization and Follow-Up.","authors":"Francisca Leitão Henriques, Catarina Pestana Santos, Ana Quítalo, Tiago Judas, Ana Gonçalves Ferreira, Henrique Vara Luiz, Maria Carlos Cordeiro, Francisca Delerue","doi":"10.1055/a-2874-9616","DOIUrl":"10.1055/a-2874-9616","url":null,"abstract":"<p><strong>Abstract: </strong>Severe acute respiratory syndrome coronavirus-2 infection is a systemic disease associated with metabolic and hormonal disturbances, including thyroid dysfunction such as primary hypothyroidism, subacute thyroiditis, and non-thyroidal illness syndrome. This study aimed to investigate the association between severe acute respiratory syndrome coronavirus-2 infection and changes in thyroid function during hospitalization and follow-up and evaluate whether these alterations are related to disease severity. We retrospectively analyzed a random cohort of 500 patients admitted to the Medicine Department of a central hospital between March 2020 and 2022. After excluding deaths, prior thyroid disease, and cases without thyroid evaluation, 218 patients were included. Serum thyroid-stimulating hormone, free triiodothyronine and free thyroxine values were measured at admission and after hospitalization. Patients were classified as having thyrotoxicosis, hypothyroidism, isolated hypothyroxinemia, and non-thyroidal illness syndrome. Thyroid dysfunction was defined by compatible biochemical findings with serological and/or imaging evidence of thyroid pathology and/or the need for therapy. COVID-19 cases were grouped by severity. Non-thyroidal illness syndrome was the most frequent abnormality, followed by isolated hypothyroxinemia and primary hypothyroidism. Non-thyroidal illness syndrome was more common in severe cases of COVID-19, although no statistically significant association was found between disease severity and type of thyroid abnormality. Most reassessed patients showed normalization of thyroid function during follow-up. The small sample size may have limited statistical power. Thyroid function alterations are common in severe acute respiratory syndrome coronavirus-2 infection, transient, and more frequent in severe disease. These findings suggest an adaptive response to systemic stress and inflammation. Larger prospective studies are needed to clarify evolution and clinical impact.</p>","PeriodicalId":12999,"journal":{"name":"Hormone and Metabolic Research","volume":" ","pages":"318-322"},"PeriodicalIF":2.3,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147987225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inflammatory Profile of Lipedema: A Comparative Evaluation with Obese and Normal-Weight Women.","authors":"Esra Şahingöz Bakırcı, Gülseren Demir Karakılıç","doi":"10.1055/a-2897-4203","DOIUrl":"10.1055/a-2897-4203","url":null,"abstract":"<p><strong>Abstract: </strong>Lipedema is a chronic disorder characterized by disproportionate subcutaneous fat accumulation and pain, with an incompletely understood inflammatory component. It remains unclear whether this inflammatory profile is disease-specific or primarily driven by coexisting adiposity. This study aimed to evaluate systemic inflammatory markers in women with lipedema compared with women with obesity and normal-weight controls. This retrospective study included 229 women aged 30-65 years: 78 with lipedema, 76 with obesity without lipedema, and 75 normal-weight controls. Demographic and laboratory data were obtained from medical records. Inflammatory indices, including the neutrophil-to-lymphocyte ratio, monocyte-to-lymphocyte ratio, platelet-to-lymphocyte ratio, systemic immune-inflammation index, C-reactive protein-to-albumin ratio, and C-reactive protein-albumin-lymphocyte index, were calculated. Group comparisons were performed using one-way analysis of variance with appropriate post hoc tests. Age was similar across groups, whereas body mass index was significantly higher in the lipedema and obesity groups than in controls (<i>p</i><0.001). The erythrocyte sedimentation rate, C-reactive protein level, and CAR were significantly higher in both the lipedema and obesity groups compared with controls, whereas no significant differences were observed between lipedema and obesity groups. The neutrophil-to-lymphocyte ratio, monocyte-to-lymphocyte ratio, platelet-to-lymphocyte ratio, systemic immune-inflammation index, and C-reactive protein-albumin-lymphocyte index did not differ significantly among groups. Inflammatory indices were generally comparable across lipedema grades. These findings suggest that lipedema is associated with low-grade systemic inflammation; however, its inflammatory profile largely overlaps with obesity, indicating shared inflammatory mechanisms rather than a distinct systemic inflammatory phenotype. Among the evaluated markers, C-reactive protein-based parameters, particularly the C-reactive protein-to-albumin ratio, appeared to better reflect inflammatory burden than hematological composite indices.</p>","PeriodicalId":12999,"journal":{"name":"Hormone and Metabolic Research","volume":" ","pages":"291-298"},"PeriodicalIF":2.3,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148360576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Determinants of Infant Participation and Non-Participation in Primary Prevention Trials.","authors":"Franziska Wörl, Peter Achenbach, Ezio Bonifacio, Kristina Casteels, Gita Gemulla, Florian Haupt, Sophia Hawkins, Angela Hommel, Sharon King, Olga Kordonouri, Helena Elding Larsson, Anja Loff, Markus Lundgren, Hannah Nenonen, Mariusz Ołtarzewski, Catherine Owen, Jasmin Paulus, Stephen Robson, Frank Roloff, Matthew Snape, Agnieszka Szypowska, Manu Vatish, Andreas Weiß, Christiane Winkler, Anna Zych, Anette-G Ziegler, Sandra Hummel","doi":"10.1055/a-2884-2277","DOIUrl":"10.1055/a-2884-2277","url":null,"abstract":"<p><strong>Abstract: </strong>Understanding the determinants that influence parents' decisions to participate with their infants in primary prevention trials is essential for achieving representative study samples and ensuring the generalizability of outcomes. We analyzed quantitative and qualitative data collected from infants eligible for the Primary Oral Insulin Trial (<i>N</i>=2,750) or the Supplementation with <i>B.</i> <i>INfantis</i> for Mitigation of Type 1 Diabetes Autoimmunity Trial (<i>N</i>=3,309). Both trials were conducted within the Global Platform for the Prevention of Autoimmune Diabetes between 07/2017 and 04/2024. Among all eligible infants, a longer decision time (odds ratio: 1.01, 95% confidence interval: 1.00-1.01, and <i>p</i>=0.002), having a first-degree relative with type 1 diabetes (odds ratio: 2.18, 95% confidence interval: 1.95-2.43, and <i>p</i><0.001), and a higher maternal age (odds ratio: 1.03, 95% confidence interval: 1.01-1.05, and <i>p</i>=0.003) were associated with a higher likelihood of participation, whereas infants born in fall (odds ratio: 0.85, 95% confidence interval: 0.73-0.98, and <i>p</i>=0.03) and families with longer travel distances to the study center (odds ratio: 0.97, 95% confidence interval: 0.95-0.99, and <i>p</i>=0.01) were less likely to participate. Participation was lower in the Supplementation with <i>B. INfantis</i> for Mitigation of Type 1 Diabetes Autoimmunity Trial than in the Primary Oral Insulin Trial (odds ratio: 0.86, 95% confidence interval: 0.78-0.96, and <i>p</i>=0.005), and stratified analyses indicated that some factors, such as recruitment during the COVID-19 pandemic, affected participation differently between studies. Analysis of qualitative data from 638 families identified additional factors, including the parental perception of the child's risk for type 1 diabetes and the burden of participation. In conclusion, this study identifies both general and study-specific determinants and reasons of participation and non-participation in infant primary prevention trials.</p>","PeriodicalId":12999,"journal":{"name":"Hormone and Metabolic Research","volume":" ","pages":"323-333"},"PeriodicalIF":2.3,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13456943/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148368222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}