Pub Date : 2024-11-29DOI: 10.1016/s2213-8587(24)00279-1
Anthony T Zimmermann, Stefanie Lanzinger, Siv Janne Kummernes, Nicolai A Lund-Blix, Reinhard W Holl, Elke Fröhlich-Reiterer, David M Maahs, Osagie Ebekozien, Saketh Rompicherla, Justin T Warner, Saira Pons Perez, Holly Robinson, Maria E Craig, Stephanie Johnson, Karin Akesson, Alexander Thorén, Katarina Eeg-Olofsson, Ajenthen G Ranjan, Mette Madsen, Michael Witsch, Jannet Svensson
<h3>Background</h3>Advances in paediatric type 1 diabetes management and increased use of diabetes technology have led to improvements in glycaemia, reduced risk of severe hypoglycaemia, and improved quality of life. Since 1993, progressively lower HbA<sub>1c</sub> targets have been set. The aim of this study was to perform a longitudinal analysis of HbA<sub>1c</sub>, treatment regimens, and acute complications between 2013 and 2022 using data from eight national and one international paediatric diabetes registries.<h3>Methods</h3>In this longitudinal analysis, we obtained data from the Australasian Diabetes Data Network, Czech National Childhood Diabetes Register, Danish Registry of Childhood and Adolescent Diabetes, Diabetes Prospective Follow-up Registry, Norwegian Childhood Diabetes Registry, England and Wales' National Paediatric Diabetes Audit, Swedish Childhood Diabetes Registry, T1D Exchange Quality Improvement Collaborative, and the SWEET initiative. All children (aged ≤18 years) with type 1 diabetes with a duration of longer than 3 months were included. Investigators compared data from 2013 to 2022; analyses performed on data were pre-defined and conducted separately by each respective registry. Data on demographics, HbA<sub>1c</sub>, treatment regimen, and event rates of diabetic ketoacidosis and severe hypoglycaemia were collected. ANOVA was performed to compare means between registries and years. Joinpoint regression analysis was used to study significant breakpoints in temporal trends.<h3>Findings</h3>In 2022, data were available for 109 494 children from the national registries and 35 590 from SWEET. Between 2013 and 2022, the aggregated mean HbA<sub>1c</sub> decreased from 8·2% (95% CI 8·1–8·3%; 66·5 mmol/mol [65·2–67·7]) to 7·6% (7·5–7·7; 59·4mmol/mol [58·2–60·5]), and the proportion of participants who had achieved HbA<sub>1c</sub> targets of less than 7% (<53 mmol/mol) increased from 19·0% to 38·8% (p<0·0001). In 2013, the aggregate event rate of severe hypoglycaemia rate was 3·0 events per 100 person-years (95% CI 2·0–4·9) compared with 1·7 events per 100 person-years (1·0–2·7) in 2022. In 2013, the aggregate event rate of diabetic ketoacidosis was 3·1 events per 100 person-years (95% CI 2·0–4·8) compared with 2·2 events per 100 person-years (1·4–3·4) in 2022. The proportion of participants with insulin pump use increased from 42·9% (95% CI 40·4–45·5) in 2013 to 60·2% (95% CI 57·9–62·6) in 2022 (mean difference 17·3% [13·8–20·7]; p<0·0001), and the proportion of participants using continuous glucose monitoring (CGM) increased from 18·7% (95% CI 9·5–28·0) in 2016 to 81·7% (73·0–90·4) in 2022 (mean difference 63·0% [50·3–75·7]; p<0·0001).<h3>Interpretation</h3>Between 2013 and 2022, glycaemic outcomes have improved, parallel to increased use of diabetes technology. Many children had HbA<sub>1c</sub> higher than the International Society for Pediatric and Adolescent Diabetes (ISPAD) 2022 target. Reassuringly, despite
{"title":"Treatment regimens and glycaemic outcomes in more than 100 000 children with type 1 diabetes (2013–22): a longitudinal analysis of data from paediatric diabetes registries","authors":"Anthony T Zimmermann, Stefanie Lanzinger, Siv Janne Kummernes, Nicolai A Lund-Blix, Reinhard W Holl, Elke Fröhlich-Reiterer, David M Maahs, Osagie Ebekozien, Saketh Rompicherla, Justin T Warner, Saira Pons Perez, Holly Robinson, Maria E Craig, Stephanie Johnson, Karin Akesson, Alexander Thorén, Katarina Eeg-Olofsson, Ajenthen G Ranjan, Mette Madsen, Michael Witsch, Jannet Svensson","doi":"10.1016/s2213-8587(24)00279-1","DOIUrl":"https://doi.org/10.1016/s2213-8587(24)00279-1","url":null,"abstract":"<h3>Background</h3>Advances in paediatric type 1 diabetes management and increased use of diabetes technology have led to improvements in glycaemia, reduced risk of severe hypoglycaemia, and improved quality of life. Since 1993, progressively lower HbA<sub>1c</sub> targets have been set. The aim of this study was to perform a longitudinal analysis of HbA<sub>1c</sub>, treatment regimens, and acute complications between 2013 and 2022 using data from eight national and one international paediatric diabetes registries.<h3>Methods</h3>In this longitudinal analysis, we obtained data from the Australasian Diabetes Data Network, Czech National Childhood Diabetes Register, Danish Registry of Childhood and Adolescent Diabetes, Diabetes Prospective Follow-up Registry, Norwegian Childhood Diabetes Registry, England and Wales' National Paediatric Diabetes Audit, Swedish Childhood Diabetes Registry, T1D Exchange Quality Improvement Collaborative, and the SWEET initiative. All children (aged ≤18 years) with type 1 diabetes with a duration of longer than 3 months were included. Investigators compared data from 2013 to 2022; analyses performed on data were pre-defined and conducted separately by each respective registry. Data on demographics, HbA<sub>1c</sub>, treatment regimen, and event rates of diabetic ketoacidosis and severe hypoglycaemia were collected. ANOVA was performed to compare means between registries and years. Joinpoint regression analysis was used to study significant breakpoints in temporal trends.<h3>Findings</h3>In 2022, data were available for 109 494 children from the national registries and 35 590 from SWEET. Between 2013 and 2022, the aggregated mean HbA<sub>1c</sub> decreased from 8·2% (95% CI 8·1–8·3%; 66·5 mmol/mol [65·2–67·7]) to 7·6% (7·5–7·7; 59·4mmol/mol [58·2–60·5]), and the proportion of participants who had achieved HbA<sub>1c</sub> targets of less than 7% (<53 mmol/mol) increased from 19·0% to 38·8% (p<0·0001). In 2013, the aggregate event rate of severe hypoglycaemia rate was 3·0 events per 100 person-years (95% CI 2·0–4·9) compared with 1·7 events per 100 person-years (1·0–2·7) in 2022. In 2013, the aggregate event rate of diabetic ketoacidosis was 3·1 events per 100 person-years (95% CI 2·0–4·8) compared with 2·2 events per 100 person-years (1·4–3·4) in 2022. The proportion of participants with insulin pump use increased from 42·9% (95% CI 40·4–45·5) in 2013 to 60·2% (95% CI 57·9–62·6) in 2022 (mean difference 17·3% [13·8–20·7]; p<0·0001), and the proportion of participants using continuous glucose monitoring (CGM) increased from 18·7% (95% CI 9·5–28·0) in 2016 to 81·7% (73·0–90·4) in 2022 (mean difference 63·0% [50·3–75·7]; p<0·0001).<h3>Interpretation</h3>Between 2013 and 2022, glycaemic outcomes have improved, parallel to increased use of diabetes technology. Many children had HbA<sub>1c</sub> higher than the International Society for Pediatric and Adolescent Diabetes (ISPAD) 2022 target. Reassuringly, despite ","PeriodicalId":48790,"journal":{"name":"The Lancet Diabetes & Endocrinology","volume":"10 1","pages":""},"PeriodicalIF":44.5,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142752876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-26DOI: 10.1016/s2213-8587(24)00319-x
Stuart W Flint, Adrian Brown, Verónica Vázquez-Velázquez, Jonathan M Hazlehurst
No Abstract
无摘要
{"title":"Medications for obesity as preventatives: a public and patient safety issue","authors":"Stuart W Flint, Adrian Brown, Verónica Vázquez-Velázquez, Jonathan M Hazlehurst","doi":"10.1016/s2213-8587(24)00319-x","DOIUrl":"https://doi.org/10.1016/s2213-8587(24)00319-x","url":null,"abstract":"No Abstract","PeriodicalId":48790,"journal":{"name":"The Lancet Diabetes & Endocrinology","volume":"182 1","pages":""},"PeriodicalIF":44.5,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142718668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-26DOI: 10.1016/s2213-8587(24)00239-0
Laura M Jacobsen, Mark A Atkinson, Jay M Sosenko, Stephen E Gitelman
In 2015, introduction of a disease staging system offered a framework for benchmarking progression to clinical type 1 diabetes. This model, based on islet autoantibodies (stage 1) and dysglycaemia (stage 2) before type 1 diabetes diagnosis (stage 3), has facilitated screening and identification of people at risk. Yet, there are many limitations to this model as the stages combine a very heterogeneous group of individuals; do not have high specificity for type 1 diabetes; can occur without persistence (ie, reversion to an earlier risk stage); and exclude age and other influential risk factors. The current staging system also infers that individuals at risk of type 1 diabetes progress linearly from stage 1 to stage 2 and subsequently stage 3, whereas such movements are often more complex. With the approval of teplizumab by the US Food and Drug Administration in 2022 to delay type 1 diabetes in people at stage 2, there is a need to refine the definition and accuracy of type 1 diabetes staging. Theoretically, we propose that a type 1 diabetes risk calculator should incorporate any available demographic, genetic, autoantibody, metabolic, and immune data that could be continuously updated. Additionally, we call to action for the field to increase the breadth of knowledge regarding type 1 diabetes risk in non-relatives, adults, and individuals from minority populations.
{"title":"Time to reframe the disease staging system for type 1 diabetes","authors":"Laura M Jacobsen, Mark A Atkinson, Jay M Sosenko, Stephen E Gitelman","doi":"10.1016/s2213-8587(24)00239-0","DOIUrl":"https://doi.org/10.1016/s2213-8587(24)00239-0","url":null,"abstract":"In 2015, introduction of a disease staging system offered a framework for benchmarking progression to clinical type 1 diabetes. This model, based on islet autoantibodies (stage 1) and dysglycaemia (stage 2) before type 1 diabetes diagnosis (stage 3), has facilitated screening and identification of people at risk. Yet, there are many limitations to this model as the stages combine a very heterogeneous group of individuals; do not have high specificity for type 1 diabetes; can occur without persistence (ie, reversion to an earlier risk stage); and exclude age and other influential risk factors. The current staging system also infers that individuals at risk of type 1 diabetes progress linearly from stage 1 to stage 2 and subsequently stage 3, whereas such movements are often more complex. With the approval of teplizumab by the US Food and Drug Administration in 2022 to delay type 1 diabetes in people at stage 2, there is a need to refine the definition and accuracy of type 1 diabetes staging. Theoretically, we propose that a type 1 diabetes risk calculator should incorporate any available demographic, genetic, autoantibody, metabolic, and immune data that could be continuously updated. Additionally, we call to action for the field to increase the breadth of knowledge regarding type 1 diabetes risk in non-relatives, adults, and individuals from minority populations.","PeriodicalId":48790,"journal":{"name":"The Lancet Diabetes & Endocrinology","volume":"24 1","pages":""},"PeriodicalIF":44.5,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142718663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-25DOI: 10.1016/s2213-8587(24)00271-7
Sunil V Badve, Anika Bilal, Matthew M Y Lee, Naveed Sattar, Hertzel C Gerstein, Christian T Ruff, John J V McMurray, Peter Rossing, George Bakris, Kenneth W Mahaffey, Johannes F E Mann, Helen M Colhoun, Katherine R Tuttle, Richard E Pratley, Vlado Perkovic
<h3>Background</h3>GLP-1 receptor agonists reduce the risk of major adverse cardiovascular events (MACE) and can also have kidney benefits. However, whether GLP-1 receptor agonists improve clinically important kidney outcomes remains uncertain. We aimed to comprehensively assess the effects of GLP-1 receptor agonists on kidney and cardiovascular disease outcomes by performing a meta-analysis of randomised controlled trials.<h3>Methods</h3>For this meta-analysis, we searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials for randomised controlled trials that included at least 500 participants with type 2 diabetes, compared a GLP-1 receptor agonist with placebo with at least 12 months of follow-up, and reported a primary clinical kidney or cardiovascular outcome, from database inception to March 26, 2024. Post hoc, we included the SELECT trial (<span><span>NCT03574597</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>), which enrolled participants with cardiovascular disease and a BMI of 27 kg/m<sup>2</sup> or more without diabetes. Study-level summary data were extracted independently by two authors for inclusion in this random-effects analysis. The main kidney outcome was a composite outcome, consisting of kidney failure (kidney replacement therapy or a persistent estimated glomerular filtration rate [eGFR] <15 mL/min per 1·73 m<sup>2</sup>), a sustained reduction in eGFR by at least 50% or the nearest equivalent, or death from kidney failure. The main cardiovascular outcome was MACE, consisting of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. This study is registered with PROSPERO, CRD42024528864.<h3>Findings</h3>Of the 5140 records identified through the literature search, 11 trials, involving 85 373 participants (29 386 female, 55 987 male), were included in the meta-analysis. In participants with type 2 diabetes (67 769), GLP-1 receptor agonists reduced the composite kidney outcome by 18% compared with placebo (hazard ratio [HR] 0·82, 95% CI 0·73–0·93; <em>I</em><sup>2</sup> =26·41%), kidney failure by 16% (HR 0·84, 0·72–0·99; <em>I</em><sup>2</sup> =0%), MACE by 13% (HR 0·87, 0·81–0·93; <em>I</em><sup>2</sup> =49·75%), and all-cause death by 12% (HR 0·88, 0·83–0·93; <em>I</em><sup>2</sup> =0%). The effect on the composite kidney outcome (HR 0·81, 95% CI 0·72–0·92; <em>I</em><sup>2</sup> =23·11%), kidney failure (HR 0·84, 0·72–0·98; <em>I</em><sup>2</sup> =0%), MACE (HR 0·86, 0·80–0·92; <em>I</em><sup>2</sup> =48·9%), and all-cause death (HR 0·87, 0·82–0·91; <em>I</em><sup>2</sup> =0%) was similar when the SELECT trial was included, with no evidence of heterogeneity between this trial and those including participants with type 2 diabetes (p<sub>heterogeneity</sub> >0·05). There was no difference in the risk of serious advers
{"title":"Effects of GLP-1 receptor agonists on kidney and cardiovascular disease outcomes: a meta-analysis of randomised controlled trials","authors":"Sunil V Badve, Anika Bilal, Matthew M Y Lee, Naveed Sattar, Hertzel C Gerstein, Christian T Ruff, John J V McMurray, Peter Rossing, George Bakris, Kenneth W Mahaffey, Johannes F E Mann, Helen M Colhoun, Katherine R Tuttle, Richard E Pratley, Vlado Perkovic","doi":"10.1016/s2213-8587(24)00271-7","DOIUrl":"https://doi.org/10.1016/s2213-8587(24)00271-7","url":null,"abstract":"<h3>Background</h3>GLP-1 receptor agonists reduce the risk of major adverse cardiovascular events (MACE) and can also have kidney benefits. However, whether GLP-1 receptor agonists improve clinically important kidney outcomes remains uncertain. We aimed to comprehensively assess the effects of GLP-1 receptor agonists on kidney and cardiovascular disease outcomes by performing a meta-analysis of randomised controlled trials.<h3>Methods</h3>For this meta-analysis, we searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials for randomised controlled trials that included at least 500 participants with type 2 diabetes, compared a GLP-1 receptor agonist with placebo with at least 12 months of follow-up, and reported a primary clinical kidney or cardiovascular outcome, from database inception to March 26, 2024. Post hoc, we included the SELECT trial (<span><span>NCT03574597</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>), which enrolled participants with cardiovascular disease and a BMI of 27 kg/m<sup>2</sup> or more without diabetes. Study-level summary data were extracted independently by two authors for inclusion in this random-effects analysis. The main kidney outcome was a composite outcome, consisting of kidney failure (kidney replacement therapy or a persistent estimated glomerular filtration rate [eGFR] <15 mL/min per 1·73 m<sup>2</sup>), a sustained reduction in eGFR by at least 50% or the nearest equivalent, or death from kidney failure. The main cardiovascular outcome was MACE, consisting of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. This study is registered with PROSPERO, CRD42024528864.<h3>Findings</h3>Of the 5140 records identified through the literature search, 11 trials, involving 85 373 participants (29 386 female, 55 987 male), were included in the meta-analysis. In participants with type 2 diabetes (67 769), GLP-1 receptor agonists reduced the composite kidney outcome by 18% compared with placebo (hazard ratio [HR] 0·82, 95% CI 0·73–0·93; <em>I</em><sup>2</sup> =26·41%), kidney failure by 16% (HR 0·84, 0·72–0·99; <em>I</em><sup>2</sup> =0%), MACE by 13% (HR 0·87, 0·81–0·93; <em>I</em><sup>2</sup> =49·75%), and all-cause death by 12% (HR 0·88, 0·83–0·93; <em>I</em><sup>2</sup> =0%). The effect on the composite kidney outcome (HR 0·81, 95% CI 0·72–0·92; <em>I</em><sup>2</sup> =23·11%), kidney failure (HR 0·84, 0·72–0·98; <em>I</em><sup>2</sup> =0%), MACE (HR 0·86, 0·80–0·92; <em>I</em><sup>2</sup> =48·9%), and all-cause death (HR 0·87, 0·82–0·91; <em>I</em><sup>2</sup> =0%) was similar when the SELECT trial was included, with no evidence of heterogeneity between this trial and those including participants with type 2 diabetes (p<sub>heterogeneity</sub> >0·05). There was no difference in the risk of serious advers","PeriodicalId":48790,"journal":{"name":"The Lancet Diabetes & Endocrinology","volume":"8 1","pages":""},"PeriodicalIF":44.5,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142713194","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-22DOI: 10.1016/s2213-8587(24)00276-6
Sophie Leboulleux, Claire Bournaud, Cecile N Chougnet, Livia Lamartina, Slimane Zerdoud, Christine Do Cao, Bogdan Catargi, Inna Dygai, Antony Kelly, Marie-Luce Barge, Pierre Vera, Daniela Rusu, Olivier Schneegans, Julie Roux, Perrine Raymond, Danielle Benisvy, Marie-Claude Eberle, Sophie Bidault, Camila Nascimento, Delphine Bastie, Isabelle Borget
Background
ESTIMABL2, a multicentre randomised phase 3 trial in patients with low-risk differentiated thyroid cancer (ie, pT1am or pT1b, N0 [no evidence of regional nodal involvement] or Nx [involvement of regional lymph nodes that cannot be assessed in the absence of neck dissection]), showed the non-inferiority of a follow-up strategy without radioactive iodine (131I) administration compared with a postoperative 131I administration at 3 years post-randomisation. Here, we report a pre-specified analysis after 5 years of follow-up.
Methods
Patients treated with total thyroidectomy with or without prophylactic neck lymph node dissection, without postoperative suspicious findings on neck ultrasonography, were randomly assigned to the no-radioiodine group or to the radioiodine group (1·1 GBq-30 mCi after recombinant human thyrotropin-stimulating hormone). Follow-up consisted of annual thyroglobulin and thyroglobulin antibody determinations during levothyroxine treatment and neck ultrasonography in odd-numbered years. An event was defined as abnormal foci of 131I uptake on the post-treatment whole-body-scan requiring subsequent treatment, abnormal neck ultrasonography, elevated thyroglobulin levels, increasing titres or appearance of thyroglobulin antibody (using the same laboratory assay), or a combination of these definitions. Non-inferiority of the proportion of patients without an event in one group compared with the other at 5 years after randomisation was shown if this proportion and its CI did not differ by more than –5%. This study was registered on ClinicalTrials.gov (NCT01837745) and is completed.
Findings
Of the 776 patients (n=642 [82·7%] female and n=134 [17·3%] male, median age 52·9 years [IQR 42·6–63·1]) enrolled, 698 were evaluable at 5 years. The proportions of patients without events were 93·2% in the no-radioiodine group and 94·8% in the radioiodine group, for a difference of –1·6% (90% CI –4·5 to 1·4). Events consisted of structural or functional abnormalities (n=11) and biological abnormalities (n=31).
Interpretation
The non-inferiority of a follow-up strategy compared with postoperative 131I administration in low risk differentiated thyroid cancer was confirmed at 5 years. There is no loss of opportunity in following these patients without postoperative ablation.
{"title":"Thyroidectomy without radioiodine in patients with low-risk thyroid cancer: 5 years of follow-up of the prospective randomised ESTIMABL2 trial","authors":"Sophie Leboulleux, Claire Bournaud, Cecile N Chougnet, Livia Lamartina, Slimane Zerdoud, Christine Do Cao, Bogdan Catargi, Inna Dygai, Antony Kelly, Marie-Luce Barge, Pierre Vera, Daniela Rusu, Olivier Schneegans, Julie Roux, Perrine Raymond, Danielle Benisvy, Marie-Claude Eberle, Sophie Bidault, Camila Nascimento, Delphine Bastie, Isabelle Borget","doi":"10.1016/s2213-8587(24)00276-6","DOIUrl":"https://doi.org/10.1016/s2213-8587(24)00276-6","url":null,"abstract":"<h3>Background</h3>ESTIMABL2, a multicentre randomised phase 3 trial in patients with low-risk differentiated thyroid cancer (ie, pT1am or pT1b, N0 [no evidence of regional nodal involvement] or Nx [involvement of regional lymph nodes that cannot be assessed in the absence of neck dissection]), showed the non-inferiority of a follow-up strategy without radioactive iodine (<sup>131</sup>I) administration compared with a postoperative <sup>131</sup>I administration at 3 years post-randomisation. Here, we report a pre-specified analysis after 5 years of follow-up.<h3>Methods</h3>Patients treated with total thyroidectomy with or without prophylactic neck lymph node dissection, without postoperative suspicious findings on neck ultrasonography, were randomly assigned to the no-radioiodine group or to the radioiodine group (1·1 GBq-30 mCi after recombinant human thyrotropin-stimulating hormone). Follow-up consisted of annual thyroglobulin and thyroglobulin antibody determinations during levothyroxine treatment and neck ultrasonography in odd-numbered years. An event was defined as abnormal foci of <sup>131</sup>I uptake on the post-treatment whole-body-scan requiring subsequent treatment, abnormal neck ultrasonography, elevated thyroglobulin levels, increasing titres or appearance of thyroglobulin antibody (using the same laboratory assay), or a combination of these definitions. Non-inferiority of the proportion of patients without an event in one group compared with the other at 5 years after randomisation was shown if this proportion and its CI did not differ by more than –5%. This study was registered on <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> (<span><span>NCT01837745</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>) and is completed.<h3>Findings</h3>Of the 776 patients (n=642 [82·7%] female and n=134 [17·3%] male, median age 52·9 years [IQR 42·6–63·1]) enrolled, 698 were evaluable at 5 years. The proportions of patients without events were 93·2% in the no-radioiodine group and 94·8% in the radioiodine group, for a difference of –1·6% (90% CI –4·5 to 1·4). Events consisted of structural or functional abnormalities (n=11) and biological abnormalities (n=31).<h3>Interpretation</h3>The non-inferiority of a follow-up strategy compared with postoperative <sup>131</sup>I administration in low risk differentiated thyroid cancer was confirmed at 5 years. There is no loss of opportunity in following these patients without postoperative ablation.<h3>Funding</h3>Programme de Recherche Hospitalier Clinique.","PeriodicalId":48790,"journal":{"name":"The Lancet Diabetes & Endocrinology","volume":"19 1","pages":""},"PeriodicalIF":44.5,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142690894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-22DOI: 10.1016/s2213-8587(24)00306-1
Frederik A Verburg, Bart de Keizer
No Abstract
无摘要
{"title":"One step closer to the end of postoperative radioactive iodine thyroid remnant ablation","authors":"Frederik A Verburg, Bart de Keizer","doi":"10.1016/s2213-8587(24)00306-1","DOIUrl":"https://doi.org/10.1016/s2213-8587(24)00306-1","url":null,"abstract":"No Abstract","PeriodicalId":48790,"journal":{"name":"The Lancet Diabetes & Endocrinology","volume":"76 1","pages":""},"PeriodicalIF":44.5,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142690895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-15DOI: 10.1016/s2213-8587(24)00287-0
Yair Zloof, Maya Nitecki, Maya Simchoni, Ofek Adar, Avishai M Tsur, Estela Derazne, Dorit Tzur, Jacob Rotschield, Maya Braun, Orit Pinhas-Hamiel, Naomi Fliss Isakov, Hadar Milloh-Raz, Dan Nemet, Dror Dicker, Avi Moyal, Oded Scheuerman, Zivan Beer, Marius Braun, Arnon Afek, Hertzel C Gerstein, Gilad Twig
Background
Morbidities related to obesity are usually associated with its severity and duration. Yet, the onset of serious morbidities in early adulthood among otherwise healthy adolescents with obesity is understudied. We aimed to investigate the association between adolescent BMI and serious morbidities before age 25 years.
Methods
In this nationwide, retrospective cohort study, we included Israeli conscripts aged 17–21 years who underwent pre-recruitment medical evaluation between Jan 1, 1996, and Dec 31, 2017, were deemed medically eligible for military service, and were recruited to the Israeli Defense Forces between 1998 and 2018. Exclusion criteria were missing height or weight or service ineligibility for non-medical or medical reasons. Baseline BMI was converted into age-specific and sex-specific percentiles and classified using the US Centers for Disease Control and Prevention categories. The primary outcome was incidence of serious morbidity disqualifying individuals from completing mandatory service. Participants were followed from enlistment until end of service (3 years for males and 2 years for females), onset of serious morbidity, or Dec 31, 2021. Cox models with adjustment to various socio-economic confounders were applied to calculate the hazard ratio (HR) and 95% CI for serious morbidity for the BMI categories.
Findings
A total of 1 264 355 adolescents aged 16–20 years were assessed for military service. 145 702 were excluded; 144 705 were considered ineligible for service (133 112 for non-medical reasons and 11 593 for medical reasons), and 2867 had missing height or weight data. The study included 1 118 653 individuals (622 989 [55·7%] males and 495 664 [44·3%] females), with 23 347 cases of serious morbidity recorded over 2 534 873 person-years. Incidence of serious morbidity increased across BMI groups in both sexes. Among males, compared with those with normal BMI, the adjusted HRs were 0·89 (95% CI 0·83–0·95) for underweight, 1·21 (1·16–1·27) for overweight, 1·39 (1·32–1·47) for obesity class 1, 2·82 (2·60–3·06) for obesity class 2, and 5·14 (4·37–6·04) for obesity class 3. For females, the respective ratios were HR 0·95 (95% CI 0·84–1·09) for underweight, 1·27 (1·17–1·37) for overweight, 1·63 (1·45–1·82) for obesity class 1, 4·00 (3·46–4·61) for obesity class 2, and 7·30 (5·65–9·43) for obesity class 3. Results persisted in sensitivity analyses restricted to those with unimpaired health at baseline or those in civilian-equivalent office employments.
Interpretation
Obesity in otherwise healthy adolescents was linked with increased risk of serious morbidity before age 25 years. Reducing adolescent obesity will have substantial short-term and long-term health benefits in young adults.
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Pub Date : 2024-11-15DOI: 10.1016/s2213-8587(24)00342-5
Thorkild I A Sørensen
No Abstract
无摘要
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