The Journal of clinical endocrinology and metabolism最新文献

{"title":"Preexisting Diabetes and Pregnancy: An Endocrine Society and European Society of Endocrinology Joint Clinical Practice Guideline.","authors":"Jennifer A Wyckoff, Annunziata Lapolla, Bernadette D Asias-Dinh, Linda A Barbour, Florence M Brown, Patrick M Catalano, Rosa Corcoy, Gian Carlo Di Renzo, Nancy Drobycki, Alexandra Kautzky-Willer, M Hassan Murad, Melanie Stephenson-Gray, Adam G Tabák, Emily Weatherup, Chloe Zera, Naykky Singh-Ospina","doi":"10.1210/clinem/dgaf288","DOIUrl":"https://doi.org/10.1210/clinem/dgaf288","url":null,"abstract":"<p><strong>Background: </strong>Preexisting diabetes (PDM) increases the risk of maternal and perinatal mortality and morbidity. Reduction of maternal hyperglycemia prior to and during pregnancy can reduce these risks. Despite compelling evidence that preconception care (PCC), which includes achieving strict glycemic goals, reduces the risk of congenital malformations and other adverse pregnancy outcomes, only a minority of individuals receive PCC. Suboptimal pregnancy outcomes demonstrated in real-world data highlight the need to further optimize prenatal glycemia. New evolving technology shows promise in helping to achieve that goal. Dysglycemia is not the only driver of poor pregnancy outcomes in PDM. The increasing impact of obesity on pregnancy outcomes underscores the importance of optimal nutrition and management of insulin sensitizing medications during prenatal care for PDM.</p><p><strong>Objective: </strong>To provide recommendations for the care of individuals with PDM that lead to a reduction in maternal and neonatal adverse outcomes.</p><p><strong>Methods: </strong>The Guideline Development Panel (GDP) composed of a multidisciplinary panel of clinical experts, along with experts in guideline methodology and systematic literature review, identified and prioritized 10 clinically relevant questions related to the care of individuals with diabetes before, during and after pregnancy. The GDP prioritized randomized controlled trials (RCTs) evaluating the effects of different interventions (eg, PCC, nutrition, treatment options, delivery) during the reproductive life cycle of individuals with diabetes, including type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). Systematic reviews queried electronic databases for publications related to these 10 clinical questions. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology was used to assess the certainty of evidence and develop recommendations. The approach incorporated perspectives from 2 patient representatives and considered patient values, costs and resources required, acceptability and feasibility, and impact on health equity of the proposed recommendations.</p><p><strong>Results: </strong>In individuals with diabetes mellitus who have the possibility of becoming pregnant, we suggest asking a screening question about pregnancy intention at every reproductive, diabetes, and primary care visit. Screening for pregnancy intent is also suggested at urgent care/emergency room visits when clinically appropriate (2 | ⊕OOO). This was suggested based on indirect evidence demonstrating a strong association between PCC and both reduced glycated hemoglobin (HbA1c) at the first prenatal visit and congenital malformations.In individuals with diabetes mellitus who have the possibility of becoming pregnant, we suggest use of contraception when pregnancy is not desired (2 | ⊕⊕OO). This was suggested based on indirect evidence in women with diabetes, wh","PeriodicalId":520805,"journal":{"name":"The Journal of clinical endocrinology and metabolism","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144629422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Systematic Review Supporting the Clinical Practice Guidelines on the Management of Preexisting Diabetes and Pregnancy.","authors":"Alaa Al Nofal, Khalid Benkhadra, Alzhraa Abbas, Marie-Joy Nduwimana, Mohammad Al-Kordi, Adel Kabbara Allababidi, Jennifer Wyckoff, Annunziata Lapolla, Larry J Prokop, Zhen Wang, M Hassan Murad","doi":"10.1210/clinem/dgaf289","DOIUrl":"https://doi.org/10.1210/clinem/dgaf289","url":null,"abstract":"<p><strong>Context: </strong>Women with preexisting diabetes mellitus (PDM) are at increased risk of pregnancy-related complications.</p><p><strong>Objective: </strong>To summarize the available supporting evidence for the Endocrine Society guidelines about management of PDM in pregnancy.</p><p><strong>Data sources: </strong>MEDLINE, EMBASE, Scopus, and other sources through February 2025.</p><p><strong>Study selection: </strong>Studies were selected by pairs of independent reviewers.</p><p><strong>Data extraction: </strong>Data were extracted by pairs of independent reviewers.</p><p><strong>Data synthesis: </strong>We included 17 studies. Meta-analysis showed no significant difference between hybrid closed-loop insulin pump (HCL) and standard of care regarding time in range (TIR), time above range (TAR), and time below range (TBR). HCL had better overnight TIR and TBR. For women with type 2 diabetes mellitus (T2DM), intermittent use of continuous glucose monitoring (CGM) was not associated with a significant change in the risk of large for gestational age (LGA) neonates (2 randomized controlled trials [RCTs], 102 patients). Adding metformin to insulin was associated with a lower risk of LGA (2 RCTs, 1126 patients). Three retrospective studies (1724 patients) suggested increased neonatal complications when delivery was induced before 39 weeks of gestation (particularly before 38 weeks) in women with preexisting type 1 (T1DM) and T2DM, although this evidence was subject to likely confounding. One retrospective study showed no increase in neonatal complications with periconceptional exposure to glucagon-like peptide-1 receptor agonists. We could not identify comparative studies assessing a screening question about the possibility of pregnancy or a carbohydrate restrictive diet.</p><p><strong>Conclusion: </strong>This systematic review addresses various aspects of managing PDM in pregnancy and will support the development of the Endocrine Society guidelines.</p>","PeriodicalId":520805,"journal":{"name":"The Journal of clinical endocrinology and metabolism","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144629421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Integrating Artificial Intelligence in Thyroid Nodule Management: Clinical Outcomes and Cost-Effectiveness Analysis.","authors":"Javier Bodoque-Cubas, José Fernández-Sáez, Sergio Martínez-Hervás, María José Pérez-Lacasta, Misericòrdia Carles-Lavila, Raquel María Pallarés-Gasulla, Juan José Salazar-González, José Vicente Gil-Boix, Marcel la Miret-Llauradó, Anna Aulinas-Masó, Iñaki Argüelles-Jiménez, Santiago Tofé-Povedano","doi":"10.1210/clinem/dgaf399","DOIUrl":"https://doi.org/10.1210/clinem/dgaf399","url":null,"abstract":"<p><strong>Objective: </strong>The increasing incidence of thyroid nodules (TN) raises concerns about overdiagnosis and overtreatment. This study evaluates the clinical and economic impact of KOIOS, an FDA-approved artificial intelligence (AI) tool for the management of TN.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on 176 patients who underwent thyroid surgery between May 2022 and November 2024. Ultrasound images were evaluated independently by an expert and novice operators using the American College of Radiology Thyroid Imaging Reporting and Data System (ACR-TIRADS), while KOIOS provided AI-adapted risk stratification. Sensitivity, specificity, and Receiver-Operating Curve (ROC) analysis were performed. The incremental cost-effectiveness ratio (ICER) was defined based on the number of optimal care interventions (FNAB and thyroid surgery). Both deterministic and probabilistic sensitivity analyses were conducted to evaluate model robustness.</p><p><strong>Results: </strong>KOIOS AI demonstrated similar diagnostic performance to the expert operator (AUC: 0.794, 95% CI: 0.718-0.871 vs. 0.784, 95% CI: 0.706-0.861; p = 0.754) and significantly outperformed the novice operator (AUC: 0.619, 95% CI: 0.526-0.711; p < 0.001). ICER analysis estimated the cost per additional optimal care decision at -€8,085.56, indicating KOIOS as a dominant and cost-saving strategy when considering a third-party payer perspective over a one-year horizon. Deterministic sensitivity analysis identified surgical costs as the main drivers of variability, while probabilistic analysis consistently favored KOIOS as the optimal strategy.</p><p><strong>Conclusion: </strong>KOIOS AI is a cost-effective alternative, particularly in reducing overdiagnosis and overtreatment for benign TNs. Prospective, real-life studies are needed to validate these findings and explore long-term implications.</p>","PeriodicalId":520805,"journal":{"name":"The Journal of clinical endocrinology and metabolism","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144621743","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Measuring hypothyroidism disease control using a TSH-based \"time-in-range\".","authors":"Matthew D Ettleson, Nikita Thomas, Marcelo Ramirez, Wen Wan, Donald Hedeker, Antonio C Bianco, Neda Laiteerapong","doi":"10.1210/clinem/dgaf393","DOIUrl":"https://doi.org/10.1210/clinem/dgaf393","url":null,"abstract":"<p><strong>Context: </strong>Time-in-range (TIR) using sequential thyroid stimulating hormone (TSH) levels during levothyroxine (LT4) treatment could serve as a measure of chronic disease control in hypothyroidism.</p><p><strong>Objectives: </strong>Primary objectives: 1) develop a method of estimating TIR, and 2) determine the impact of patient sociodemographic characteristics on TIR. Secondary objective: investigate the relationship between TIR and time to cardiovascular event.</p><p><strong>Methods: </strong>The study was conducted using longitudinal clinical data (2016-2022) from a single academic institution. Study participants were ≥18 years old, LT4-treated, and had ≥3 unique TSH levels collected over a minimum of 2 years. For each patient, TIR, time-above-range (TAR), and time-below-range (TBR) were estimated using linear interpolation of log-transformed TSH levels. Fitted linear regression was used to evaluate the relationship between TIR/TAR/TBR and LT4 dose over the study period. Generalized estimating equations (GEE) were used to model annualized TIR/TAR/TBR with sociodemographic and clinical covariates. Survival analysis was used to characterize the relationship between TIR and occurrence of cardiovascular events.</p><p><strong>Results: </strong>A total of 2752 LT4-treated patients had a median TIR of 86% over the study enrollment period (median 3.8 years). For both males and females, LT4 dose was negatively correlated with TIR (R = -0.23 and -0.30, respectively; p <0.001 for both). Male sex and Black race were associated with TIR <75% (OR 1.30, p <0.001; OR 1.37, p <0.001). The association between TAR and cardiovascular events approached significance (OR 1.03 per +10% TAR, p = 0.078).</p><p><strong>Conclusion: </strong>We used TIR estimation to identify differences in disease control between sociodemographic groups and the impact of LT4 dose. In future studies, we aim to better characterize the association between TIR and clinically meaningful outcomes.</p>","PeriodicalId":520805,"journal":{"name":"The Journal of clinical endocrinology and metabolism","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144621744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Abdominal and Thigh Intermuscular Adipose Tissue on Glucose and Cardiometabolic Risk in Adults With Obesity.","authors":"Alba Camacho-Cardenosa, Antonio Clavero-Jimeno, Alessandro Gatti, Manuel Dote-Montero, Mara Concepción, Víctor Manuel Alfaro-Magallanes, Juan J Martin-Olmedo, Rafael Cabeza, Fernando Idoate, José L Martín-Rodríguez, Patricia V García Pérez, Manuel Muñoz-Torres, Jonatan R Ruiz, Idoia Labayen","doi":"10.1210/clinem/dgaf362","DOIUrl":"https://doi.org/10.1210/clinem/dgaf362","url":null,"abstract":"<p><strong>Context: </strong>Intermuscular adipose tissue (IMAT) at different anatomical locations may exert distinct effects on cardiometabolic risk.</p><p><strong>Objective: </strong>The present study investigated the relationships of abdominal and mid-thigh IMAT with glucose homeostasis and cardiometabolic risk in adults with overweight or obesity.</p><p><strong>Design: </strong>Multicenter cross-sectional study.</p><p><strong>Setting: </strong>Outpatient clinic.</p><p><strong>Participants: </strong>One hundred eighty-nine adults (50% women; age: 46.8 ± 6.3 years) with overweight or obesity (body mass index: 32.9 ± 3.5 kg/m2).</p><p><strong>Main outcome measures: </strong>IMAT content in abdominal and mid-thigh regions was measured by magnetic resonance imaging. Mean glucose levels were monitored over 24 hours during 14 days using continuous glucose monitoring devices. We computed a cardiometabolic risk score including fasting high-density lipoprotein cholesterol, triglycerides, glucose, waist circumference, and systolic and diastolic blood pressure.</p><p><strong>Results: </strong>No associations were identified between abdominal IMAT and glucose homeostasis or cardiometabolic risk (all P > .05). In contrast, a positive association of mid-thigh IMAT with 24-hour (β = 0.226; P = .007), diurnal (β = 0.224; P = .008), and nocturnal mean glucose levels (β = 0.233; P = .006) as well as with cardiometabolic risk score (β = 0.324; P < .001) was observed. Participants with greater accumulation of IMAT in the mid-thigh compared to the abdominal region exhibited significantly higher mean glucose levels and cardiometabolic risk (all P < .005).</p><p><strong>Conclusion: </strong>These findings emphasize the importance of distinguishing between adipose tissue depots when evaluating cardiometabolic risk, as specific accumulation patterns-particularly in the mid-thigh region-may significantly influence individual risk profiles.</p>","PeriodicalId":520805,"journal":{"name":"The Journal of clinical endocrinology and metabolism","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144621770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction to: \"Clinical Consequences of Delayed Gastric Emptying With GLP-1 Receptor Agonists and Tirzepatide\".","authors":"","doi":"10.1210/clinem/dgaf387","DOIUrl":"https://doi.org/10.1210/clinem/dgaf387","url":null,"abstract":"","PeriodicalId":520805,"journal":{"name":"The Journal of clinical endocrinology and metabolism","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144610911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sustained HbA1c Improvements Over 36 Months in Youth in the Teamwork, Targets, Technology, and Tight Control (4T) Study.","authors":"Priya Prahalad, Victoria Y Ding, Dessi P Zaharieva, Ananta Addala, Ramesh Johari, David Scheinker, Korey K Hood, Manisha Desai, David M Maahs","doi":"10.1210/clinem/dgaf397","DOIUrl":"10.1210/clinem/dgaf397","url":null,"abstract":"<p><strong>Context: </strong>Youth with type 1 diabetes (T1D) struggle to meet and sustain hemoglobin A1c (HbA1c) targets. Youth enrolled in the Pilot 4T Study improved HbA1c by 0.5%, compared to historical controls at 1-year.</p><p><strong>Objective: </strong>To assess 3 years of glycemic outcomes in the Pilot 4T Study.</p><p><strong>Design: </strong>The Pilot 4T Extension cohort was prospectively followed to determine changes in HbA1c and continuous glucose monitoring (CGM) metrics over 3 years.</p><p><strong>Setting: </strong>Stanford Medicine Children's Health Diabetes Clinic.</p><p><strong>Patients or other participants: </strong>Youth with T1D in the Pilot 4T Study enrolled in the extension phase.</p><p><strong>Intervention: </strong>Youth started CGM in the first month of diabetes diagnosis, received intensified education and remote patient monitoring (RPM) weekly for the first year of diabetes diagnosis and monthly RPM in the extension phase.</p><p><strong>Main outcome measure: </strong>HbA1c and CGM metrics over the first 3 years of diagnosis.</p><p><strong>Results: </strong>In the Pilot 4T cohort, 78.5% (n=102) of participants enrolled in the study extension phase and were followed through 3 years. The adjusted difference in HbA1c at 3 years was 1.2% (95% CI 0.7-1.7%) lower in the Pilot 4T cohort than in the Historical cohort. In the Pilot 4T cohort, 68% and 37% met the <7.5% and <7% HbA1c targets at 3 years, respectively, compared to 37% and 20% in the Historical cohort.</p><p><strong>Conclusions: </strong>Youth with T1D in the Pilot 4T extension phase sustained improvements in HbA1c over 3 years. Focusing resources on intensive management during the first year after T1D diagnosis may impact long-term glycemia.</p>","PeriodicalId":520805,"journal":{"name":"The Journal of clinical endocrinology and metabolism","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144602843","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Challenges and Opportunities for Understanding the Pathogenesis of Type 1 Diabetes: An Endocrine Society Scientific Statement.","authors":"Aaron W Michels, Todd M Brusko, Carmella Evans-Molina, Dirk Homann, Sarah J Richardson, Alvin C Powers","doi":"10.1210/clinem/dgaf267","DOIUrl":"https://doi.org/10.1210/clinem/dgaf267","url":null,"abstract":"<p><p>The discovery of insulin transformed type 1 diabetes (T1D) from a lethal disease to a chronic health condition where individuals can lead long and productive lives. However, T1D is still associated with considerable morbidity and mortality, underscoring the need for disease-modifying therapies to delay clinical onset and preserve residual pancreatic β-cell function in those newly diagnosed with T1D. Notably, the first disease-modifying therapy (teplizumab, a monoclonal antibody targeting CD3+ on T lymphocytes) was approved by the US Food and Drug Administration in November 2022 to delay the clinical onset of T1D, thus opening new avenues to treat T1D as an immunologic disease rather than simply as a metabolic disease with lifelong insulin administration. In this Scientific Statement, we will integrate and summarize information about the pathogenesis of T1D, highlight gaps in current knowledge, and propose future activities that may lead to additional approaches to treat the underlying autoimmunity and β-cell defects in diabetes. Hopefully, these efforts, when combined with other rapidly improving T1D therapeutics including automated insulin delivery and cell replacement therapy, will lead to better long-term outcomes for those living with T1D.</p>","PeriodicalId":520805,"journal":{"name":"The Journal of clinical endocrinology and metabolism","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144593825","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Letter to the Editor from Su and Hasebe: \"Genomic Correlations, Shared Loci, and Drug Targets Between Polycystic Ovary Syndrome and Asthma: Insights From Genome-wide Association Analysis\".","authors":"Chen-Yang Su, Masashi Hasebe","doi":"10.1210/clinem/dgaf388","DOIUrl":"https://doi.org/10.1210/clinem/dgaf388","url":null,"abstract":"","PeriodicalId":520805,"journal":{"name":"The Journal of clinical endocrinology and metabolism","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144593826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Response to Letter to the Editor from Su and Hasebe: Genomic Correlations, Shared Loci, and Drug Targets Between Polycystic Ovary Syndrome and Asthma: Insights From Genome-wide Association Analysis.","authors":"Enting Ji, Min Hu, Hongxia Ma","doi":"10.1210/clinem/dgaf389","DOIUrl":"https://doi.org/10.1210/clinem/dgaf389","url":null,"abstract":"","PeriodicalId":520805,"journal":{"name":"The Journal of clinical endocrinology and metabolism","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144593827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}