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121-OR: Safety, Tolerability, and Metabolic Effects of Once-Weekly GL0034 (Utreglutide) in Individuals with Obesity—A Multiple Ascending Dose Study 121-OR: 肥胖症患者每周一次服用GL0034(乌曲鲁肽)的安全性、耐受性和代谢作用--一项多剂量递增研究
IF 7.7 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-07-19 DOI: 10.2337/db24-121-or
RAJAMANNAR THENNATI, VINOD S. BURADE, MUTHUKUMARAN NATARAJAN, PRADEEP SHAHI, RAVISHANKARA NAGARAJA, SUDEEP K. AGRAWAL, THIERRY DUVAUCHELLE, ADOLFO GARCIA-OCANA, GUY A. RUTTER, RICHARD E. PRATLEY, BERNARD THORENS, TINA VILSBØLL
Introduction & Objective: GL0034 (GL), a once weekly glucagon-like peptide 1 receptor agonist, previously demonstrated significant reductions in body weight (BW) up to Day 22 in a single ascending dose study in individuals with obesity. This phase 1 study assessed the safety, tolerability and metabolic effects of GL after multiple ascending doses. Methods: Individuals with BMI ≥28 kg/m2 (N=24) were randomized (9:3) to subcutaneous GL, fixed doses (4 × 680 µg; cohort 1); or increasing doses (680, 900, 1520, 2000 µg; cohort 2) or placebo, once weekly for four weeks. Safety, tolerability and key metabolic parameters were assessed. Results: Most common adverse events (AE) were gastrointestinal (GI) with dose-dependent nausea, decreased appetite and vomiting. One individual with a GI related serious AE rapidly recovered upon treatment with intravenous rehydration. On Day 23, reduction was observed in all parameters from baseline (BL) with significant reductions in glucose area under the curve and HbA1c in both groups. In cohorts 1 & 2, BW reduction versus BL was 2.9 kg and 4.6 kg respectively on Day 29 (Table). Conclusions: In individuals with obesity, once weekly GL dosing for four weeks, demonstrated clinically relevant reductions in glucose, insulin, HbA1c, lipids and BW with an overall good tolerability. Disclosure R. Thennati: None. V.S. Burade: None. M. Natarajan: None. P. Shahi: None. R. Nagaraja: None. S.K. Agrawal: None. T. Duvauchelle: Consultant; Sun Pharmaceutical Industries Ltd. A. Garcia-Ocana: Consultant; Sun Pharmaceutical Industries Ltd. G.A. Rutter: Advisory Panel; Sun Pharmaceutical Industries Ltd. R.E. Pratley: Other Relationship; Bayer AG, Dompé, Endogenex, Inc., Gasherbrum Bio, Inc., Hengrui (USA) Ltd., Intas Pharmaceuticals Ltd., Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk, Novo Nordisk, Pfizer Inc., Rivus Pharmaceuticals Inc., Sun Pharmaceutical Industries Ltd. Consultant; AbbVie Inc., AstraZeneca. Other Relationship; Bayer HealthCare Pharmaceuticals, Inc., Biomea Fusion, Carmot Therapeutics, Inc., Corcept Therapeutics, Fractyl Health, Inc., Genprex. Consultant; Getz Pharma. Other Relationship; Lilly USA LLC, Sanofi. Consultant; Scholar Rock, Inc. B. Thorens: Advisory Panel; Sun Pharmaceutical Industries Ltd. T. Vilsbøll: Consultant; AstraZeneca. Advisory Panel; Boehringer-Ingelheim. Speaker's Bureau; Mundipharma. Advisory Panel; Novo Nordisk, Lilly Diabetes, Sanofi. Speaker's Bureau; Bayer Inc., Gilead Sciences, Inc. Advisory Panel; Sun Pharmaceutical Industries Ltd. Research Support; Lilly Diabetes.
引言& 目的:GL0034 (GL)是一种每周一次的胰高血糖素样肽1受体激动剂,之前在一项针对肥胖症患者的单次递增剂量研究中,该药在第22天之前都能显著降低体重(BW)。这项 1 期研究评估了 GL 在多次升剂量后的安全性、耐受性和代谢效应。研究方法:将体重指数≥28 kg/m2的患者(24 人)随机(9:3)分配到皮下注射 GL,固定剂量(4 × 680 µg;组别 1);或递增剂量(680、9000、1520、2000 µg;组别 2)或安慰剂,每周一次,连续四周。对安全性、耐受性和主要代谢参数进行了评估。结果显示最常见的不良反应(AE)是胃肠道反应(GI),包括剂量依赖性恶心、食欲下降和呕吐。一名患者出现了与胃肠道相关的严重不良反应,经静脉补液治疗后迅速恢复。第 23 天,观察到所有参数都比基线(BL)有所下降,两组的血糖曲线下面积和 HbA1c 都显著降低。第 29 天,第 1 组和第 2 组的体重与基线相比分别减少了 2.9 千克和 4.6 千克(见表)。结论:在肥胖症患者中,每周一次 GL 给药,持续四周,可显著降低血糖、胰岛素、HbA1c、血脂和体重,总体耐受性良好。披露 R. Thennati:无。V.S. Burade:无。M. Natarajan:无。P. Shahi:无:P. Shahi: None.R. Nagaraja: None.S.K. Agrawal:无。T. Duvauchelle:太阳制药工业有限公司顾问。A. Garcia-Ocana:顾问;太阳制药工业有限公司G.A. Rutter:顾问团;太阳制药工业有限公司R.E. Pratley:其他关系;拜耳股份公司、Dompé、Endogenex, Inc.、Gasherbrum Bio, Inc.、恒瑞(美国)有限公司、Intas Pharmaceuticals Ltd.、礼来公司、Merck Sharp & Dohme Corp.、诺和诺德公司、辉瑞公司、Rivus Pharmaceuticals Inc.、太阳制药工业有限公司。顾问;艾伯维公司、阿斯利康公司。其他关系;Bayer HealthCare Pharmaceuticals, Inc.、Biomea Fusion、Carmot Therapeutics, Inc.、Corcept Therapeutics、Fractyl Health, Inc.、Genprex。顾问;Getz Pharma。其他关系;礼来美国有限责任公司、赛诺菲。顾问;Scholar Rock, Inc.B. Thorens:顾问; Sun Pharmaceutical Industries Ltd.T. Vilsbøll:顾问; AstraZeneca.顾问团;勃林格殷格翰公司。Speaker's Bureau; Mundipharma.顾问团;诺和诺德、礼来糖尿病、赛诺菲。Speaker's Bureau; Bayer Inc.、Gilead Sciences, Inc.顾问团;太阳制药工业有限公司研究支持;礼来糖尿病
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引用次数: 0
1113-P: Utilizing a Novel Telemedicine Clinic for Managing Type 2 Diabetes—A Six-Month Pilot Study 1113-P: 利用新型远程医疗诊所管理 2 型糖尿病--为期六个月的试点研究
IF 7.7 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-07-19 DOI: 10.2337/db24-1113-p
FIORELLA SOTOMAYOR, CHIKARA GOTHONG, REYNIER HERNANDEZ, MONICA Y. CHOE, GARRETT I. ASH, WILLIAM H. SCOTT, LILLIAN PINAULT, FERNANDO GOMEZ-PERALTA, LAKSHMI G. SINGH, JOHN D. SORKIN, ILIAS (ELIAS) SPANAKIS
Introduction & Objective: RCT aimed to assess if a Diabetes Advanced Telemedicine (DAT) clinic leads to improvement in glycemic control compared to standard of care (SoC). Methods: Patients with type 2 diabetes (T2D) randomized to DAT or SoC. DAT used continuous glucose monitoring devices, smart insulin pens, telecommunication (i.e. video visits) with physical activity (PA) counseling by an exercise physiologist. SoC used glucometers, traditional insulin pens, in-person visits and PA counseling by providers. Primary outcome was change in HbA1c. Secondary outcomes were time in range (TIR) 70-180 mg/dl, time above range (TAR)>180 mg/dl, TAR>250 mg/dl and time below range (TBR)<70 mg/dl. ANCOVA was used, adjusted for baseline value to determine the relation between group and outcome, and report p-values of the interaction term, group*time. Exercise was evaluated by senior fitness test and assessed by Hedge’s g effect size. Results: Twenty-four patients with T2D completed the trial. Non-statistically significant reductions in glucose metrics were seen. HbA1c decreased by 2.2% (DAT) vs 1.1% (SoC) (-1.1%, [-0.2, -1.8], p=0.076). TIR 70-180 mg/dL increased 17.3% vs 15.4% (+1.9%, [-16.1,15.5], p=0.984), TAR>180 mg/dL decreased 20.5% vs 17.9% (-2.6%, [-21.5,10.5], p=0.756), TAR>250 mg/dL decreased 17.1% vs 6.0% (-11.1%. [-20.3,2.7], p=0.375), TBR changed 0.41% vs -0.88% (+0.47, [-0.16,1.37], p=0.054), DAT vs. SoC, respectively. Fitness tests, completed by 60% of participants, showed improvements in medium strength (bicep curls g=0.90 /p=0.06, chair stands g=0.63/p=0.18), daily physical function (g=0.56/p=0.20), aerobic performance (6min walk test g=0.24/p=0.61), agility/flexibility (timed up and go g=-0.30/p=0.49, back stretch g=-0.51/p=0.26). Conclusions: T2D patients managed by DAT had non-significant improvement in glucose control driven by decreased hyperglycemia > 250 mg/dl. Non-significant modest increase in PA observed. Disclosure F. Sotomayor: None. C. Gothong: None. R. Hernandez: None. M.Y. Choe: None. G.I. Ash: None. W.H. Scott: None. L. Pinault: None. F. Gomez-Peralta: Advisory Panel; Abbott. Speaker's Bureau; Abbott. Advisory Panel; Eli Lilly and Company. Speaker's Bureau; Eli Lilly and Company. Advisory Panel; Insulcloud S.L. Speaker's Bureau; Medtronic. Advisory Panel; Novo Nordisk. Speaker's Bureau; Novo Nordisk. Advisory Panel; Sanofi. L.G. Singh: None. J.D. Sorkin: None. I. Spanakis: Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc.
简介& 目标:研究旨在评估与标准护理(SoC)相比,糖尿病高级远程医疗(DAT)诊所是否能改善血糖控制。研究方法2型糖尿病(T2D)患者随机接受DAT或SoC治疗。DAT使用连续血糖监测设备、智能胰岛素笔、远程通信(即视频访问)以及运动生理学家提供的体育锻炼(PA)咨询。SoC 使用血糖仪、传统胰岛素笔、上门访问和由医疗服务提供者提供的体育锻炼咨询。主要结果是 HbA1c 的变化。次要结果是在范围内的时间(TIR)70-180 mg/dl、高于范围的时间(TAR)>180 mg/dl、TAR>250 mg/dl和低于范围的时间(TBR)<70 mg/dl。采用方差分析,并对基线值进行调整,以确定组别与结果之间的关系,并报告交互项(组别*时间)的 p 值。运动量通过高级体能测试进行评估,并通过 Hedge's g效应大小进行评估。结果24 名糖尿病患者完成了试验。血糖指标的下降无统计学意义。HbA1c 下降了 2.2%(DAT)与 1.1%(SoC)(-1.1%,[-0.2, -1.8], p=0.076)。TIR 70-180 mg/dL 上升 17.3% vs 15.4% (+1.9%, [-16.1,15.5], p=0.984),TAR>180 mg/dL 下降 20.5% vs 17.9% (-2.6%, [-21.5,10.5], p=0.756),TAR>180 mg/dL 下降 20.5% vs 17.9% (-2.6%, [-21.5,10.5], p=0.756)。756),TAR>250 mg/dL 下降了 17.1% vs 6.0% (-11.1%. [-20.3,2.7], p=0.375),TBR 变化了 0.41% vs -0.88% (+0.47, [-0.16,1.37], p=0.054),DAT vs. SoC 分别如此。60%的参与者完成了体能测试,结果显示,他们在中等力量(二头肌卷曲 g=0.90 /p=0.06, 椅子站立 g=0.63/p=0.18)、日常身体功能(g=0.56/p=0.20)、有氧运动能力(6分钟步行测试 g=0.24/p=0.61)、敏捷性/灵活性(定时起立 g=-0.30/p=0.49, 背部伸展 g=-0.51/p=0.26)方面均有所改善。结论通过DAT治疗的T2D患者的血糖控制得到了非显著性改善,这主要归功于高血糖的减少> 250 mg/dl。观察到 PA 略有增加,但不明显。披露 F. Sotomayor:无。C. Gothong:无:C. Gothong: None.R. Hernandez:无。M.Y. Choe:无。G.I. Ash: None.W.H. Scott: None.L. Pinault:无。F. Gomez-Peralta:Advisory Panel; Abbott.Speaker's Bureau; Abbott.顾问团;礼来公司。Speaker's Bureau; Eli Lilly and Company.顾问团;Insulcloud S.L.演讲事务处;美敦力。顾问团;诺和诺德。诺和诺德公司演讲事务处。顾问团;赛诺菲。L.G. Singh:无。J.D. Sorkin:无。I. Spanakis:研究支持;Dexcom, Inc.
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引用次数: 0
345-OR: Beyond Size Matters—The Impact of Pancreatic Volume and Pancreatic Fat on Type 2 Diabetes 345-OR: 大小无关--胰腺体积和胰腺脂肪对 2 型糖尿病的影响
IF 7.7 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-07-19 DOI: 10.2337/db24-345-or
HAJIME YAMAZAKI, SHIN-ICHI TAUCHI, MITSURU DOHKE, NAGISA HANAWA, YOSHIHISA KODAMA, AKIO KATANUMA, SHUNICHI FUKUHARA, KATSIARYNA PRYSTUPA, JULIA HUMMEL, ROBERT WAGNER, MARTIN HENI
Introduction & Objective: Individuals with type 2 diabetes (T2D) are thought to have a smaller pancreas; however, whether this is cause or consequence of T2D is unclear. We investigated the association between pancreas volume and T2D risk and whether this association was modified by pancreatic fat. Methods: Using magnetic resonance imaging from the UK Biobank, 25,389 individuals were classified into four groups based on the median values of pancreas volume (60 cm3) and pancreatic fat (8%). Odds ratios (ORs) for prevalent T2D were estimated using logistic regression. Additionally, we conducted a 6-year case-cohort study in an independent Japanese cohort using computed tomography during health examinations. Hazard ratios (HRs) for incident T2D were estimated using weighted-Cox regression in 658 randomly-selected individuals and 146 incident T2D cases among 2,168 individuals without diabetes. The regression models in both studies were adjusted for age, sex, body mass index, daily alcohol intake, current smoking, liver fat, and visceral fat. Results: In the UK Biobank, individuals who had fat accumulation in a smaller pancreas exhibited the highest likelihood of T2D. Compared with large/low-fat pancreas, the adjusted ORs (95%CI) of T2D were 1.63 (1.36-1.97) in small/high-fat pancreas, 1.09 (0.89-1.33) in large/high-fat pancreas, and 1.08 (0.85-1.37) in small/low-fat pancreas. This finding was prospectively validated in the Japanese cohort with 6.27-year median follow-up. The adjusted HRs (95%CI) of incident T2D were 3.12 (1.40-6.96) in small/high-fat pancreas, 1.00 (0.59-1.69) in large/high-fat pancreas, and 0.74 (0.26-2.14) in small/low-fat pancreas. Conclusion: Fat accumulation in an already smaller pancreas appears to be a key determinant of elevated T2D risk and might therefore be a novel target for preventive interventions. Disclosure H. Yamazaki: Other Relationship; AstraZeneca, Janssen Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma Corporation, Kowa Company, Ltd., Kyorin Pharmaceutical Co. Ltd, Takeda Pharmaceutical Company Limited, Takeda Pharmaceutical Company Limited, Magmitt Pharmaceutical Co. S. Tauchi: None. M. Dohke: None. N. Hanawa: None. Y. Kodama: None. A. Katanuma: None. S. Fukuhara: None. K. Prystupa: None. J. Hummel: None. R. Wagner: Speaker's Bureau; Sanofi. Advisory Panel; Lilly Diabetes. Speaker's Bureau; Boehringer-Ingelheim, Novo Nordisk. M. Heni: Research Support; Boehringer-Ingelheim. Advisory Panel; Amryt Pharma Plc. Speaker's Bureau; Amryt Pharma Plc. Advisory Panel; Boehringer-Ingelheim, Boehringer-Ingelheim. Speaker's Bureau; Lilly Diabetes, Novartis AG, Novo Nordisk, Sanofi. Funding Japan Society for the Promotion of Science KAKENHI grants (JP22K15685); Deutsche Forschungsgemeinschaft (DFG, German Research Foundation: 518749683)
引言& 目的:人们认为2型糖尿病(T2D)患者的胰腺体积较小;然而,这究竟是T2D的原因还是结果尚不清楚。我们研究了胰腺体积与 T2D 风险之间的关系,以及这种关系是否会因胰腺脂肪而改变。研究方法利用英国生物库的磁共振成像,根据胰腺体积(60 立方厘米)和胰腺脂肪(8%)的中位值将 25,389 人分为四组。我们使用逻辑回归法估算了T2D发病率的比值比(ORs)。此外,我们还在一个独立的日本队列中开展了一项为期 6 年的病例队列研究,在健康检查期间使用了计算机断层扫描技术。我们使用加权-Cox 回归估算了 658 名随机抽取的患者和 2,168 名未患糖尿病的患者中 146 个 T2D 发病病例的危险比(HRs)。这两项研究的回归模型都对年龄、性别、体重指数、每日酒精摄入量、当前吸烟情况、肝脏脂肪和内脏脂肪进行了调整。研究结果在英国生物库中,胰腺脂肪堆积较少的人患 T2D 的可能性最高。与大/低脂肪胰腺相比,小/高脂肪胰腺的 T2D 调整 ORs(95%CI)为 1.63(1.36-1.97),大/高脂肪胰腺为 1.09(0.89-1.33),小/低脂肪胰腺为 1.08(0.85-1.37)。这一发现在中位随访 6.27 年的日本队列中得到了前瞻性验证。调整后的 T2D 发生率(95%CI)为:小/高脂胰腺为 3.12(1.40-6.96),大/高脂胰腺为 1.00(0.59-1.69),小/低脂胰腺为 0.74(0.26-2.14)。结论脂肪在已经较小的胰腺中堆积似乎是导致 T2D 风险升高的关键因素,因此可能成为预防干预的新目标。披露 H. Yamazaki:其他关系;阿斯利康、杨森制药公司、三菱田边制药株式会社、Kowa Company, Ltd.、Kyorin Pharmaceutical Co.S. Tauchi:无。M. Dohke:无:M. Dohke:无。N. Hanawa: None.Y. Kodama:无。A. Katanuma:无。S. Fukuhara:S. Fukuhara: None.K. Prystupa:无。J. Hummel:无。R. Wagner:Speaker's Bureau; Sanofi.顾问团;礼来糖尿病。Speaker's Bureau; Boehringer-Ingelheim, Novo Nordisk.M. Heni:研究支持;Boehringer-Ingelheim。顾问团;Amryt Pharma Plc.Speaker's Bureau; Amryt Pharma Plc.Advisory Panel; Boehringer-Ingelheim, Boehringer-Ingelheim.演讲人办公室;礼来糖尿病公司、诺华股份公司、诺和诺德公司、赛诺菲公司。基金资助 日本科学振兴会 KAKENHI 基金 (JP22K15685);德国研究基金会 (DFG,德国研究基金会:518749683)
{"title":"345-OR: Beyond Size Matters—The Impact of Pancreatic Volume and Pancreatic Fat on Type 2 Diabetes","authors":"HAJIME YAMAZAKI, SHIN-ICHI TAUCHI, MITSURU DOHKE, NAGISA HANAWA, YOSHIHISA KODAMA, AKIO KATANUMA, SHUNICHI FUKUHARA, KATSIARYNA PRYSTUPA, JULIA HUMMEL, ROBERT WAGNER, MARTIN HENI","doi":"10.2337/db24-345-or","DOIUrl":"https://doi.org/10.2337/db24-345-or","url":null,"abstract":"Introduction & Objective: Individuals with type 2 diabetes (T2D) are thought to have a smaller pancreas; however, whether this is cause or consequence of T2D is unclear. We investigated the association between pancreas volume and T2D risk and whether this association was modified by pancreatic fat. Methods: Using magnetic resonance imaging from the UK Biobank, 25,389 individuals were classified into four groups based on the median values of pancreas volume (60 cm3) and pancreatic fat (8%). Odds ratios (ORs) for prevalent T2D were estimated using logistic regression. Additionally, we conducted a 6-year case-cohort study in an independent Japanese cohort using computed tomography during health examinations. Hazard ratios (HRs) for incident T2D were estimated using weighted-Cox regression in 658 randomly-selected individuals and 146 incident T2D cases among 2,168 individuals without diabetes. The regression models in both studies were adjusted for age, sex, body mass index, daily alcohol intake, current smoking, liver fat, and visceral fat. Results: In the UK Biobank, individuals who had fat accumulation in a smaller pancreas exhibited the highest likelihood of T2D. Compared with large/low-fat pancreas, the adjusted ORs (95%CI) of T2D were 1.63 (1.36-1.97) in small/high-fat pancreas, 1.09 (0.89-1.33) in large/high-fat pancreas, and 1.08 (0.85-1.37) in small/low-fat pancreas. This finding was prospectively validated in the Japanese cohort with 6.27-year median follow-up. The adjusted HRs (95%CI) of incident T2D were 3.12 (1.40-6.96) in small/high-fat pancreas, 1.00 (0.59-1.69) in large/high-fat pancreas, and 0.74 (0.26-2.14) in small/low-fat pancreas. Conclusion: Fat accumulation in an already smaller pancreas appears to be a key determinant of elevated T2D risk and might therefore be a novel target for preventive interventions. Disclosure H. Yamazaki: Other Relationship; AstraZeneca, Janssen Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma Corporation, Kowa Company, Ltd., Kyorin Pharmaceutical Co. Ltd, Takeda Pharmaceutical Company Limited, Takeda Pharmaceutical Company Limited, Magmitt Pharmaceutical Co. S. Tauchi: None. M. Dohke: None. N. Hanawa: None. Y. Kodama: None. A. Katanuma: None. S. Fukuhara: None. K. Prystupa: None. J. Hummel: None. R. Wagner: Speaker's Bureau; Sanofi. Advisory Panel; Lilly Diabetes. Speaker's Bureau; Boehringer-Ingelheim, Novo Nordisk. M. Heni: Research Support; Boehringer-Ingelheim. Advisory Panel; Amryt Pharma Plc. Speaker's Bureau; Amryt Pharma Plc. Advisory Panel; Boehringer-Ingelheim, Boehringer-Ingelheim. Speaker's Bureau; Lilly Diabetes, Novartis AG, Novo Nordisk, Sanofi. Funding Japan Society for the Promotion of Science KAKENHI grants (JP22K15685); Deutsche Forschungsgemeinschaft (DFG, German Research Foundation: 518749683)","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"48 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141730548","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}
引用次数: 0
229-OR: Orforglipron Improves Markers of Beta-Cell Function and Insulin Sensitivity in Type 2 Diabetes 229-OR: 奥锻利戎能改善 2 型糖尿病患者的 Beta 细胞功能和胰岛素敏感性指标
IF 7.7 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-07-19 DOI: 10.2337/db24-229-or
JULIO ROSENSTOCK, DEBORAH A. ROBINS, KEVIN L. DUFFIN, JONATHAN M. WILSON, KIEREN J. MATHER, HIYA BANERJEE, YANZHU LIN, SARAH EYDE, CHRISTOF M. KAZDA, MANIGE KONIG
Orforglipron (OFG), an oral, non-peptide GLP-1 receptor agonist, demonstrated significantly greater glycemic control and weight loss at doses ≥12 mg vs placebo (PBO) or dulaglutide (DU) 1.5 mg in a 26-week phase 2 study of adults with type 2 diabetes (T2D) (Table). These exploratory analyses investigated mechanisms by which OFG improved glycemic control in T2D by analyzing exploratory biomarkers. Participants with T2D (mean age, 58.9 years; baseline HbA1c, 8.1%; weight, 100.3 kg) treated with diet and exercise, with/without metformin, were randomized to PBO, DU 1.5 mg, or once-daily OFG 3, 12, 24, 36, or 45 mg. Biomarkers of β-cell function and insulin sensitivity were analyzed by mixed model repeated measures, excluding data after study drug discontinuation or rescue drug initiation. Biomarkers of β-cell function were improved by OFG at 26 weeks from baseline (Table). HOMA-B significantly increased with OFG at doses ≥12 mg vs PBO or DU. HOMA-IR (computed with insulin) significantly decreased from baseline with OFG at doses ≥24 mg but was not significantly different vs PBO and DU. Fasting glucose-adjusted glucagon significantly decreased with OFG at doses ≥12 mg vs PBO and with OFG 12, 24, and 45 mg vs DU. These analyses suggest improved glycemic control with OFG vs DU may be partly explained by improved β-cell function and insulin sensitivity. Additional studies are ongoing to understand these mechanisms. Disclosure J. Rosenstock: Research Support; Biomea Fusion, Inc. Other Relationship; Lilly Diabetes. Research Support; Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Corcept Therapeutics. Other Relationship; Novo Nordisk. Research Support; Pfizer Inc. Other Relationship; Sanofi, Boehringer-Ingelheim. Research Support; Shionogi & Co., Ltd. Other Relationship; Structure Therapeutics, Inc. Advisory Panel; Terns Pharmaceuticals, Zealand Pharma A/S. Other Relationship; Applied Therapeutics, Hanmi Pharm. Co., Ltd., Oramed Pharmaceuticals. Advisory Panel; Scholar Rock. D.A. Robins: None. K.L. Duffin: Employee; Eli Lilly and Company. J.M. Wilson: Employee; Eli Lilly and Company. K.J. Mather: Employee; Eli Lilly and Company. H. Banerjee: None. Y. Lin: Stock/Shareholder; Eli Lilly and Company, Pfizer Inc., AstraZeneca. S. Eyde: None. C.M. Kazda: Employee; Eli Lilly and Company. M. Konig: None. Funding Eli Lilly and Company
Oforglipron(OFG)是一种口服、非肽类 GLP-1 受体激动剂,在一项对 2 型糖尿病(T2D)成人患者进行的为期 26 周的 2 期研究中,当剂量≥12 毫克与安慰剂(PBO)或度拉鲁肽(DU)1.5 毫克相比时,OFG 的血糖控制和体重减轻效果明显更好(表)。这些探索性分析通过分析探索性生物标志物,研究了 OFG 改善 T2D 血糖控制的机制。患有 T2D 的参与者(平均年龄 58.9 岁;基线 HbA1c 8.1%;体重 100.3 千克)在接受饮食和运动治疗并服用/不服用二甲双胍后,随机服用 PBO、DU 1.5 毫克或每日一次的 OFG 3、12、24、36 或 45 毫克。β细胞功能和胰岛素敏感性的生物标志物采用混合模型重复测量法进行分析,不包括研究药物停药或开始使用救援药物后的数据。与基线相比,服用 OFG 26 周后,β 细胞功能的生物标志物得到改善(表)。与 PBO 或 DU 相比,OFG 的剂量≥12 毫克时,HOMA-B 明显增加。OFG剂量≥24毫克时,HOMA-IR(用胰岛素计算)比基线明显降低,但与PBO和DU相比无明显差异。OFG剂量≥12毫克与PBO相比,空腹血糖调整后的胰高血糖素明显降低;OFG剂量12、24和45毫克与DU相比,空腹血糖调整后的胰高血糖素明显降低。这些分析表明,OFG 与 DU 相比,血糖控制的改善可能部分归因于 β 细胞功能和胰岛素敏感性的改善。目前正在进行更多研究,以了解这些机制。披露 J. 罗森斯托克:研究支持;Biomea Fusion, Inc.其他关系;礼来糖尿病公司。研究支持;默克公司、诺华制药公司、Corcept Therapeutics。其他关系;诺和诺德公司。研究支持;辉瑞公司。其他关系;赛诺菲、勃林格殷格翰。其他关系;赛诺菲公司、勃林格殷格翰公司。其他关系;Structure Therapeutics, Inc.顾问团;Terns Pharmaceuticals, Zealand Pharma A/S.其他关系;Applied Therapeutics、Hanmi Pharm.Co., Ltd.、Oramed Pharmaceuticals。顾问团;Scholar Rock。D.A. Robins:无。K.L. Duffin:礼来公司雇员。J.M. Wilson:礼来公司雇员。K. J. 马瑟礼来公司雇员H. Banerjee:无。Y. Lin:礼来公司、辉瑞公司、阿斯利康公司股票/股东。S. Eyde:无。C.M. Kazda:礼来公司员工。M. Konig:无。资助礼来公司
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引用次数: 0
1308-P: A Voice-Based AI Algorithm Can Predict Type 2 Diabetes Status—Findings from the Colive Voice Study on U.S. Adult Participants 1308-P: 基于语音的人工智能算法可预测 2 型糖尿病状态--对美国成人参与者进行的 Colive Voice 研究结果
IF 7.7 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-07-19 DOI: 10.2337/db24-1308-p
ABIR ELBEJI, MÉGANE PIZZIMENTI, GLORIA A. AGUAYO, AURELIE FISCHER, HANIN AYADI, FRANCK MAUVAIS-JARVIS, JEAN-PIERRE RIVELINE, VLADIMIR DESPOTOVIC, GUY FAGHERAZZI
Introduction: Reducing undiagnosed type 2 diabetes (T2D) cases worldwide is an urgent public health challenge. Most current screening methods are invasive, lab-based, and costly. Meanwhile, there is a growing focus on noninvasive T2D detection through advanced artificial intelligence (AI) and digital technology. This study explores the feasibility of using a voice-based AI algorithm to predict T2D status in adults, a preliminary step toward innovative screening tools. Objective: To develop and assess the performance of a voice-based AI algorithm for T2D status detection in the adult population in the US. Methods: We analyzed text reading voice recordings from 607 US participants from the Colive Voice study, adhering to the CONSORT AI standards. We trained and cross-validated algorithms with BYOL-S/CvT embeddings for each gender, evaluating them on accuracy, precision, recall, and AUC. Performance of the best models was stratified by age, BMI, and hypertension, and compared to the American Diabetes Association (ADA) score for T2D risk assessment using a Bland-Altman analysis. Results: We analyzed 323 females and 284 males; Females with T2D (age: 49.5 years, BMI: 35.8 kg/m²) vs without (40.0 years, 28.0 kg/m²). Males with T2D (47.6 years, 32.8 kg/m²) vs without (41.6 years, 26.6 kg/m²). The voice-based algorithm achieved good overall predictive capacity (AUC=75% for males, 71% for females) and correctly predicted 71% of male and 66% of female T2D cases. It is enhanced in females aged 60 years (AUC=74%) or older but also with the presence of hypertension for both genders (AUC=75%). We observed an overall agreement above 93% with the ADA risk score. Conclusion: This study demonstrates the feasibility of detecting T2D using exclusively voice features. It is the first step toward using voice analysis as a first-line T2D screening strategy. While the findings are promising, further research and validation are necessary to specifically target early-stage T2D cases. Disclosure A. Elbeji: None. M. Pizzimenti: None. G.A. Aguayo: None. A. Fischer: None. H. Ayadi: None. F. Mauvais-Jarvis: None. J. Riveline: Board Member; Abbott, Novo Nordisk A/S, Sanofi, Eli Lilly and Company, Medtronic, Dexcom, Inc., Insulet Corporation, Air Liquide, AstraZeneca. V. Despotovic: None. G. Fagherazzi: Speaker's Bureau; Sanofi. Advisory Panel; Timkl, SAB Biotherapeutics, Inc., Vitalaire, Roche Diabetes Care.
导言:减少全球未确诊的 2 型糖尿病(T2D)病例是一项紧迫的公共卫生挑战。目前大多数筛查方法都是侵入性的、基于实验室的,而且成本高昂。与此同时,人们越来越关注通过先进的人工智能(AI)和数字技术进行无创 T2D 检测。本研究探讨了使用基于语音的人工智能算法预测成人 T2D 状态的可行性,这是迈向创新筛查工具的第一步。研究目的开发并评估基于语音的人工智能算法在美国成年人群中检测 T2D 状态的性能。方法我们分析了来自 Colive Voice 研究的 607 名美国参与者的文本阅读语音记录,并遵守 CONSORT AI 标准。我们使用 BYOL-S/CvT 嵌入对不同性别的算法进行了训练和交叉验证,并根据准确度、精确度、召回率和 AUC 对其进行了评估。根据年龄、体重指数和高血压对最佳模型的性能进行了分层,并使用布兰-阿尔特曼分析将其与美国糖尿病协会(ADA)的 T2D 风险评估评分进行了比较。结果:我们分析了 323 名女性和 284 名男性;患有 T2D 的女性(年龄:49.5 岁,体重指数:35.8 kg/m²)与未患 T2D 的女性(年龄:40.0 岁,体重指数:28.0 kg/m²)。患有 T2D 的男性(年龄:47.6 岁,体重指数:32.8 kg/m²)与未患有 T2D 的男性(年龄:41.6 岁,体重指数:26.6 kg/m²)。基于语音的算法具有良好的总体预测能力(AUC=男性75%,女性71%),能正确预测71%的男性和66%的女性T2D病例。对于 60 岁(AUC=74%)或以上的女性,该算法的预测能力更强,但对于患有高血压的男性和女性(AUC=75%),该算法的预测能力也更强。我们观察到与 ADA 风险评分的总体一致性超过 93%。结论:这项研究证明了完全使用语音特征检测 T2D 的可行性。这是将语音分析用作 T2D 一线筛查策略的第一步。虽然研究结果很有希望,但仍需进一步研究和验证,以专门针对早期 T2D 病例。披露 A. Elbeji:无。M. Pizzimenti:无。G.A. Aguayo:无。A. Fischer:无。H. Ayadi:无。F. Mauvais-Jarvis:F. Mauvais-Jarvis: None.J. Riveline:董事会成员;雅培、诺和诺德公司、赛诺菲、礼来公司、美敦力、Dexcom 公司、Insulet 公司、液化空气公司、阿斯利康公司。V. Despotovic:无。G. Fagherazzi: Speaker's Bureau; Sanofi.顾问团;Timkl、SAB Biotherapeutics、Inc.、Vitalaire、Roche Diabetes Care。
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引用次数: 0
1928-LB: Feasibility of Calibration-Free Intradermal Glucose Monitoring Using a Sensor Microarray 1928-LB: 使用传感器微阵列进行免校准皮内葡萄糖监测的可行性
IF 7.7 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-07-19 DOI: 10.2337/db24-1928-lb
MARK P. CHRISTIANSEN, NARESH C. BHAVARAJU, REBECCA GOTTLIEB, ALAN CAMPBELL, SIRILAK SATTAYASAMITSATHIT, MARK C. BRISTER, KEITH NOGUEIRA, AMY L. VANDENBERG, RICH YANG, JARED R. TANGNEY
Introduction: Subcutaneous glucose sensors using introducer needles have been well characterized. Robust microsensors are required for a less invasive approach, accessing interstitial glucose in the dermis. Advancements in semiconductor manufacturing have facilitated new sensing technologies using arrays of silicon microsensors on a wearable patch without introducer needles. Several independent electrodes on the microarray chip support redundancy and reliability. The objective of this study was to evaluate the performance of a calibration-free, intradermal glucose sensor, compared to a gold standard. Methods: A 5-day study was conducted at two US sites evaluating the device in persons with Diabetes. Intradermal glucose sensors were placed on the volar forearm or upper arm. All subjects participated in one clinic day on Day 1, 3, or 5 of wear. Venous blood was obtained every 15 minutes for 8 hours and analyzed with the YSI (YSI Inc, Yellow Springs, Ohio) 2300 Stat Plus. A prospective, calibration-free algorithm was used. Results: 19 subjects with Type 1 diabetes ages 19 to 70 were studied. Mean Absolute Relative Difference (MARD) was 10.1% compared to YSI (n=388). 83.2% of paired points were within 20% of YSI and 100% were within Clark Error Grid A+B regions. Conclusion: The intradermal glucose sensor demonstrated accurate tracking and trending of glucose levels compared to the gold standard laboratory analyzer. Disclosure M.P. Christiansen: Research Support; Abbott Diagnostics, Amgen Inc., Biolinq, Boehringer-Ingelheim, Dexcom, Inc., Eli Lilly and Company, Google, Lilly Diabetes, MannKind Corporation, Medtronic, Novo Nordisk, Pfizer Inc., Roche Diabetes Care, REMD Biotherapeutics, ViaCyte, Inc. N.C. Bhavaraju: Employee; Biolinq. R. Gottlieb: Employee; Biolinq. A. Campbell: Employee; Biolinq. S. Sattayasamitsathit: Employee; Biolinq. M.C. Brister: Employee; Biolinq. K. Nogueira: Employee; Biolinq. A.L. VandenBerg: Employee; Biolinq. J.R. Tangney: Employee; Biolinq.
简介:使用导入针的皮下葡萄糖传感器已具有良好的特性。要采用侵入性较小的方法,获取真皮层间隙葡萄糖,就需要坚固耐用的微型传感器。半导体制造技术的进步促进了新的传感技术的发展,在可穿戴贴片上使用硅微型传感器阵列,无需导入针。微阵列芯片上的多个独立电极支持冗余和可靠性。本研究的目的是评估免校准皮内葡萄糖传感器与金标准相比的性能。研究方法在美国的两个地点进行了为期 5 天的研究,对糖尿病患者的设备进行评估。皮内葡萄糖传感器被放置在前臂或上臂。所有受试者都在佩戴后的第 1、3 或 5 天参加了一天的门诊。每 15 分钟采集一次静脉血,连续采集 8 小时,然后用 YSI(YSI Inc,俄亥俄州黄泉市)2300 Stat Plus 进行分析。采用的是一种前瞻性的免校准算法。结果:研究对象为 19 至 70 岁的 1 型糖尿病患者。与 YSI(n=388)相比,平均绝对相对差值(MARD)为 10.1%。83.2%的配对点在 YSI 的 20% 范围内,100% 在克拉克误差网格 A+B 区域内。结论与金标准实验室分析仪相比,皮内葡萄糖传感器能准确跟踪血糖水平并显示其变化趋势。披露 M.P. Christiansen:研究支持;雅培诊断公司、安进公司、Biolinq、勃林格殷格翰公司、Dexcom 公司、礼来公司、谷歌公司、礼来糖尿病公司、MannKind 公司、美敦力公司、诺和诺德公司、辉瑞公司、罗氏糖尿病护理公司、REMD 生物治疗公司、ViaCyte 公司、N.C. Bhavarajad, Inc.N.C. Bhavaraju:雇员;Biolinq.R. Gottlieb:员工;Biolinq.A. Campbell:员工;Biolinq.S. Sattayasamitsathit:S. Sattayasamitsathit: Employee; Biolinq.M.C. Brister:雇员;Biolinq.K. Nogueira: Employee; Biolinq.A.L. VandenBerg:雇员;Biolinq.J.R. Tangney:员工;Biolinq.
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引用次数: 0
1229-P: Blood Glycated Albumin or Fructosamine (GA/Fruc) Rather Than Hemoglobin A1c (A1C) Is Useful for Specifying Individuals Having a Macrosomic Baby—Meta-analysis 1229-P: 血液糖化白蛋白或果糖胺(GA/Fruc)而非血红蛋白 A1c(A1C)有助于鉴别巨型婴儿个体--Meta 分析
IF 7.7 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-07-19 DOI: 10.2337/db24-1229-p
SATORU KODAMA, TAKAHO YAMADA, NORIKO YAGYUDA, KAZUYA FUJIHARA, LAY MON KHIN, MASARU KITAZAWA, MASAHIKO YAMAMOTO, YASUHIRO MATSUBAYASHI, KIMINORI KATO, HIROHITO SONE
Introduction & Objective: Poor glycemic control (GC) increases the risk of various pregnancy complications. Both A1C and GA/Fruc are convenient as they require only one measurement and do not impose fasting. However, GA/Fruc is possibly a better predictor of complications than A1C during pregnancy when GC quickly changes. This meta-analysis compared the predictive ability of pregnancy complications between A1C and GA/Fruc. Methods: We comprehensively searched for studies of prediction of maternal or neonatal adverse outcomes using both A1C and GA/Fruc and for their best cut-off values in each study presenting 2 x 2 data (i.e., true-positive, false-negative, true-negative, and false-positive cases). Results: Of 9 eligible studies, 7 predicted macrosomia and could be meta-analyzed using a hierarchical summary receiver-operating characteristic (HSROC) model. Other complications were impossible to be analyzed because of an insufficient number of data. Pooled specificity (95% confidence interval [CI]) was significantly higher (P=0.02) for GA/Fruc (0.83 [0.70-0.91]) compared with A1C (0.57 [0.35-0.77]) while pooled sensitivity (95% CI) was 0.44 (0.26-0.63) for GA/Fruc and 0.67 (0.50-0.81) for A1C (P for difference, 0.17). Conclusion: Compared with A1C, GA/Fruc is useful for specifying individuals having a macrosomic baby. Disclosure S. Kodama: None. T. Yamada: None. N. Yagyuda: None. K. Fujihara: None. L. Khin: None. M. Kitazawa: None. M. Yamamoto: None. Y. Matsubayashi: None. K. Kato: None. H. Sone: Research Support; Novo Nordisk, Astellas Pharma Inc., Kowa Company, Ltd., Kyowa Kirin Co., Ltd., Eisai Inc., Sumitomo Dainippon Pharma Co., Ltd.
引言& 目的:血糖控制不佳(GC)会增加各种妊娠并发症的风险。A1C 和 GA/Fruc 只需进行一次测量,且无需空腹,因此非常方便。然而,在妊娠期血糖快速变化时,GA/Fruc 可能比 A1C 更能预测并发症。本荟萃分析比较了 A1C 和 GA/Fruc 对妊娠并发症的预测能力。方法:我们全面检索了同时使用 A1C 和 GA/Fruc 预测孕产妇或新生儿不良结局的研究,并检索了每项研究中的最佳临界值,这些研究均提供了 2 x 2 数据(即真阳性、假阴性、真阴性和假阳性病例)。结果:在 9 项符合条件的研究中,7 项研究预测了大畸形,并可使用分层汇总接收者操作特征(HSROC)模型进行元分析。其他并发症因数据数量不足而无法进行分析。与 A1C(0.57 [0.35-0.77])相比,GA/Fruc(0.83 [0.70-0.91])的汇总特异性(95% 置信区间 [CI])明显更高(P=0.02),而 GA/Fruc 的汇总灵敏度(95% CI)为 0.44 (0.26-0.63),A1C 为 0.67 (0.50-0.81)(差异 P 为 0.17)。结论与 A1C 相比,GA/Fruc 可用于确定巨型婴儿的个体。披露 S. Kodama:无。T. Yamada:无。N. Yagyuda: 无:无。K. Fujihara:无。L. Khin:无。M. Kitazawa:无。M. Yamamoto:M. Yamamoto: None.Y. Matsubayashi: None.K. Kato: None.曾根 H:研究资助;诺和诺德、安斯泰来制药公司、Kowa Company, Ltd.、Kyowa Kirin Co.,Ltd.、卫材公司、住友大日本制药株式会社、Novo Nordisk、Astellas Pharma Inc.
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引用次数: 0
240-OR: Longitudinal Assessment of Glycemia and Severe Hypoglycemia among Adults with Type 1 Diabetes—An Online Survey 240-OR: 1 型糖尿病成人血糖和严重低血糖纵向评估--在线调查
IF 7.7 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-07-19 DOI: 10.2337/db24-240-or
JENNIFER L. SHERR, KAITLIN HAGAN, RACHEL BHAK, MEGAN PETER, HUYEN NGUYEN, CHENKUN WANG, TATHABBAI PAKALAPATI, JORDAN SHERWOOD, TINA GUPTA, JASON L. GAGLIA, EMILEE M. CORNELIUS, KATHERINE S.M. CHAPMAN, WENDY WOLF, JEREMY PETTUS
Introduction & Objective: Longitudinal trends of glycemia and severe hypoglycemic events (SHE) among individuals with T1D are not well described, particularly in those using diabetes technologies (i.e., continuous glucose monitors [CGM], automated insulin delivery [AID]). Methods: An online survey recruited adults with T1D through the T1D Exchange Registry or online communities from February-April 2021. Overall, 2,044 individuals completed the survey and eligible participants were invited to complete follow-up survey from April-May 2023. Participants self-reported CGM use, insulin delivery method, HbA1c, impaired awareness of hypoglycemia (IAH), and SHE. Results: Of 1,999 eligible individuals, 1,056 completed the follow-up survey and were eligible for analysis (53% response rate; mean age: 46 y; mean T1D duration: 29 y; 71% female; 97% White). Most reported using CGMs at baseline (91.8%) and follow-up (94.4%), and use of AID increased (baseline: 53.5%; follow-up: 69.0%; Table). At baseline, 61.7% reported HbA1c <7% vs. 67.4% at follow-up. Rates of IAH and SHE in the prior year were similar at both time points. Conclusion: Despite nearly universal CGM usage and increased adoption of AID, one-third of respondents did not achieve HbA1c targets and the proportion of respondents with IAH and SHE did not decline. These results highlight the need for innovative approaches to improve T1D care. Disclosure J.L. Sherr: Consultant; Medtronic. Advisory Panel; Medtronic, Insulet Corporation. Speaker's Bureau; Insulet Corporation. Advisory Panel; Vertex Pharmaceuticals Incorporated, MannKind Corporation, StartUp Health T1D Moonshot, Bigfoot Biomedical, Inc., Cecelia Health. Speaker's Bureau; Zealand Pharma A/S. K. Hagan: Employee; Vertex Pharmaceuticals Incorporated. R. Bhak: Employee; Vertex Pharmaceuticals Incorporated, Novartis Pharmaceuticals Corporation. M. Peter: None. H. Nguyen: None. C. Wang: Employee; Vertex Pharmaceuticals Incorporated. T. Pakalapati: None. J. Sherwood: Employee; Vertex Pharmaceuticals Incorporated. T. Gupta: Employee; Vertex Pharmaceuticals Incorporated. J.L. Gaglia: Consultant; Vertex Pharmaceuticals Incorporated. Stock/Shareholder; Vertex Pharmaceuticals Incorporated. Consultant; Avotres Inc., Imcyse, Diamyd Medical. E.M. Cornelius: None. K.S.M. Chapman: None. W. Wolf: None. J. Pettus: Consultant; Sanofi, Novo Nordisk, Diasome, Carmot Therapeutics, Inc., Kriya Therapeutics, Lilly Diabetes, Provention Bio, Inc. Funding Vertex Pharmaceuticals Incorporated
引言& 目的:对 T1D 患者的血糖和严重低血糖事件(SHE)的纵向趋势还没有很好的描述,尤其是对使用糖尿病技术(即连续血糖监测仪 [CGM]、自动胰岛素输送系统 [AID])的患者。调查方法2021 年 2 月至 4 月期间,通过 T1D Exchange Registry 或在线社区对患有 T1D 的成人进行了在线调查。共有 2044 人完成了调查,并邀请符合条件的参与者在 2023 年 4 月至 5 月期间完成后续调查。参与者自我报告了 CGM 使用情况、胰岛素给药方法、HbA1c、低血糖意识受损 (IAH) 和 SHE。结果:在符合条件的 1,999 人中,1,056 人完成了跟踪调查并符合分析条件(53% 的回复率;平均年龄:46 岁;平均 T1D 病程:29 年;71% 为女性;97% 为白人)。大多数人报告在基线(91.8%)和随访(94.4%)时使用 CGM,AID 的使用有所增加(基线:53.5%;随访:69.0%;表)。基线时,61.7%的人报告 HbA1c &;lt;7%,而随访时为 67.4%。在两个时间点,上一年的 IAH 和 SHE 发生率相似。结论:尽管 CGM 的使用几乎得到普及,AID 的采用率也有所提高,但仍有三分之一的受访者未达到 HbA1c 目标,患有 IAH 和 SHE 的受访者比例并未下降。这些结果凸显了采用创新方法改善 T1D 护理的必要性。披露 J.L. Sherr:顾问;美敦力公司。顾问团;美敦力公司、Insulet 公司。发言人办公室;Insulet 公司。顾问团;Vertex Pharmaceuticals Incorporated、MannKind Corporation、StartUp Health T1D Moonshot、Bigfoot Biomedical, Inc.、Cecelia Health。Zealand Pharma A/S 发言人办公室。K. Hagan:雇员;Vertex Pharmaceuticals Incorporated。R. Bhak:Vertex Pharmaceuticals Incorporated、Novartis Pharmaceuticals Corporation 员工。M. Peter:无。H. Nguyen:H. Nguyen: None.C. Wang:Vertex Pharmaceuticals Incorporated 员工。T. Pakalapati:无。J. Sherwood:Vertex Pharmaceuticals Incorporated: Employee.T. Gupta:Vertex Pharmaceuticals Incorporated 员工。J.L. Gaglia:顾问;Vertex Pharmaceuticals Incorporated。顶点制药公司股票/股东顾问;Avotres Inc.、Imcyse、Diamyd Medical。E.M. Cornelius:无。K.S.M. Chapman:无。W. Wolf:无。J. Pettus:顾问;赛诺菲、诺和诺德、Diasome、Carmot Therapeutics, Inc.、Kriya Therapeutics、礼来糖尿病、Provention Bio, Inc.资助 Vertex 制药公司
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引用次数: 0
155-OR: Genetic Variation and Time to Progression in TN10 (Teplizumab) 155-OR: TN10(替普珠单抗)的基因变异与病情进展时间
IF 7.7 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-07-19 DOI: 10.2337/db24-155-or
DOMINIKA A. MICHALEK, SUNA ONENGUT-GUMUSCU, WEI-MIN CHEN, TODD M. BRUSKO, ANDREA STECK, PETER GOTTLIEB, RICHARD A. ORAM, JEFFREY KRISCHER, HEMANG M. PARIKH, MARIA J. REDONDO, KEVAN C. HEROLD, STEPHEN S. RICH
Introduction & Objective: TN10 Anti-CD3 Prevention (TN10) was a randomized phase 2 clinical trial that showed teplizumab delayed progression to type 1 diabetes (T1D) in high-risk participants. Both HLA and non-HLA variants could influence time to progression. Here, genome-wide analysis identified variants and pathways that influence time to progression in TN10 participants. Methods: In TN10, relatives with stage 2 T1D (i.e., multiple autoantibodies and dysglycemia) received either teplizumab (N = 44) or placebo (N = 32). Samples were genotyped with a genome-wide array followed by imputation. Cox proportional hazards regression models were used to determine the effect of teplizumab, SNPs, and their interaction on time to progression to stage 3 T1D. Thousands of Polygenic Scores (PGSs) from the PGS catalogue were inferred for each of the TN10 samples, and we identified PGS traits that shared common genetic modifiers with time to progression with teplizumab. Results: A genome-wide analysis identified three loci associated with time to progression (p < 5 x 10-6). Two loci contain genes implicated in the inflammatory response (NFKBIZ) and drug metabolism effect (FMO3). SNP-drug interaction analysis identified four known T1D regions that account for progression differences in teplizumab vs placebo: CCR9 (rs34549672), SH2B3 (rs3184504), UBASH3A (rs9984852), and INS (rs3842761). Within the teplizumab group, novel loci (p < 5 x 10-6) were associated with time to progression, including ZNF385D, CCDC38, SHH, ZNF366, ITPKB and RABGAP1L. Traits with similar genetic contribution to teplizumab time to progression were vitamin B12 (AUC = 0.76) and vitamin D (AUC = 0.72). Conclusions: In individuals with stage 2 T1D, variants in inflammatory, immune-relevant, and drug-responsive genes are associated with teplizumab time to progression. Similarity of the teplizumab-responsive polygenic score with other traits implicate novel pathways that could influence teplizumab treatment. Disclosure D.A. Michalek: None. S. Onengut-Gumuscu: None. W. Chen: None. T.M. Brusko: None. A. Steck: None. P. Gottlieb: Other Relationship; IM Therapeutics. Research Support; Imcyse. Advisory Panel; Imcyse. Consultant; Juvenile Diabetes Research Foundation (JDRF). Research Support; Hemsley Charitable Trust, Novartis AG, Provention Bio, Inc., Precigen, Inc. Advisory Panel; ViaCyte, Inc. Research Support; Nova Pharmaceuticals. R.A. Oram: Research Support; Randox R & D. Consultant; Provention Bio, Inc., Sanofi. J. Krischer: None. H.M. Parikh: None. M.J. Redondo: None. K.C. Herold: Consultant; Sanofi. S.S. Rich: None. Funding National Institutes of Health (1R01DK121843-01)
简介& 目的:TN10 抗 CD3 预防(TN10)是一项随机 2 期临床试验,结果表明替普利珠单抗可延缓高风险参与者发展为 1 型糖尿病(T1D)的时间。HLA和非HLA变异都会影响进展时间。在此,我们通过全基因组分析确定了影响 TN10 参与者病情进展时间的变异和途径。方法在 TN10 中,患有 T1D 2 期(即多种自身抗体和血糖异常)的亲属接受了替普利珠单抗(44 例)或安慰剂(32 例)治疗。使用全基因组阵列对样本进行基因分型,然后进行归因。采用 Cox 比例危险回归模型来确定替普利珠单抗、SNPs 及其交互作用对 T1D 进展到 3 期的时间的影响。我们从 PGS 目录中为每个 TN10 样本推断出了数千个多基因评分 (PGS),并确定了与替普利珠单抗治疗进展时间具有共同遗传修饰因子的 PGS 性状。结果全基因组分析发现了三个与进展时间相关的基因位点(p < 5 x 10-6)。其中两个基因位点包含与炎症反应(NFKBIZ)和药物代谢作用(FMO3)有关的基因。SNP-药物相互作用分析确定了四个已知的 T1D 区域,这些区域导致了替普利珠单抗与安慰剂的进展差异:CCR9(rs34549672)、SH2B3(rs3184504)、UBASH3A(rs9984852)和INS(rs3842761)。在替普利珠单抗组中,ZNF385D、CCDC38、SHH、ZNF366、ITPKB和RABGAP1L等新基因位点(p < 5 x 10-6)与疾病进展时间相关。维生素 B12(AUC = 0.76)和维生素 D(AUC = 0.72)等性状对替普利珠单抗的病情进展时间具有相似的遗传贡献。结论在 T1D 2 期患者中,炎症基因、免疫相关基因和药物反应基因的变异与替普利珠单抗的病情进展时间相关。替普利珠单抗反应性多基因评分与其他性状的相似性意味着可能影响替普利珠单抗治疗的新途径。披露 D.A. Michalek:无。S. Onengut-Gumuscu: 无。W. Chen: None.T.M. Brusko:无:无。A. Steck:无。P. Gottlieb:其他关系;IM Therapeutics。研究支持;Imcyse.顾问团;Imcyse.顾问;青少年糖尿病研究基金会 (JDRF)。研究支持;Hemsley 慈善信托基金、诺华股份公司、Provention Bio, Inc.、Precigen, Inc.顾问团;ViaCyte, Inc.研究支持;Nova Pharmaceuticals。R.A. Oram:研究支持;Randox R &;D. 顾问;Provention Bio, Inc.、赛诺菲。J. Krischer:无。H.M. Parikh:无:无。M.J. Redondo:无。K.C. Herold:赛诺菲顾问。S.S. Rich:无。美国国立卫生研究院(1R01DK121843-01)资助
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引用次数: 0
348-OR: Multiancestry Whole Genome Sequencing (WGS) Meta-analysis to Identify Loci Associated with Imaging-Measured Hepatic Steatosis 348-OR: 通过多家畜全基因组测序(WGS)元分析确定与成像测量的肝脏脂肪变性相关的基因位点
IF 7.7 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-07-19 DOI: 10.2337/db24-348-or
NICHOLETTE ALLRED, CHINMAY RAUT, YANHUA CHEN, ANTONINO OLIVERI, JEFFREY O'CONNELL, KATHLEEN RYAN, JEROME I. ROTTER, STEPHEN S. RICH, AARON HAKIM, PATRICIA PEYSER, LAWRENCE F. BIELAK, CHING-TI LIU, JAMES G. TERRY, MYRIAM FORNAGE, LYNNE E. WAGENKNECHT, ELIZABETH K. SPELIOTES, NHLBI TRANS-OMICS FOR PRECISION MEDICINE (TOPMED)PROGRAM, GOLD CONSORTIUM
Introduction and Objective: Steatotic liver disease, formerly called non-alcoholic fatty liver disease (NAFLD), is the most common cause of chronic liver disease worldwide; yet, few effective methods for prevention/treatment exist making it one of the biggest unmet public health needs of our time. To date, genetic studies have been limited to identifying common variants in predominantly European-ancestry populations or focused on surrogate phenotypes, e.g. liver enzymes, identifying association with comorbidities. Here we present a multi-ancestry whole genome sequencing (WGS) association study to discover rare variants associated with imaging-measured hepatic steatosis. Methods: Study-, ancestry- and sex-stratified association analyses were conducted using SAIGEgds in nine studies with imaging-measured hepatic steatosis adjusted for age, sex, alcoholic drinks per week and principal component estimates of admixture. Stratified results were meta-analyzed using a fixed-effects model. Cochran’s Q-test and the I2 metric were used to estimate heterogeneity. Results: Meta-analyses included 23,156 European, African, Hispanic and Chinese ancestry individuals and identified five significant loci (P<5x10-08): PNPLA3, PPP1R3B, HAPLN4, intergenic region on chr14 and F11-AS1. Nine additional variants trended toward association (P<5x10-07). Sex-stratified meta-analyses revealed additional associations in an intergenic region on chr10, RP11-115J16.1 and UBE3B. Variants in RP11-115J16.1 remained significant in European ancestry samples. Significantly associated variants in SLC2A1-AS1 and LINC01684 were novel loci in African Americans. Conclusion: Taken together, multi-ancestry analysis of imaging-measured hepatic steatosis using WGS replicated previously associated loci and identified novel sex- and ancestry-specific loci. Functional studies are underway to determine the biological impact of these findings. Disclosure N. Allred: None. C. Raut: None. Y. Chen: None. A. Oliveri: None. J. O'Connell: None. K. Ryan: None. J.I. Rotter: None. S.S. Rich: None. A. Hakim: None. P. Peyser: None. L.F. Bielak: None. C. Liu: None. J.G. Terry: None. M. Fornage: None. L.E. Wagenknecht: None. E.K. Speliotes: Other Relationship; University of Michigan. Funding National Institute of Diabetes and Digestive Kidney Disease (R01 DK128871)
导言和目标:脂肪肝,以前称为非酒精性脂肪肝(NAFLD),是全球最常见的慢性肝病;然而,几乎没有有效的预防/治疗方法,使其成为当代最大的未满足公共卫生需求之一。迄今为止,遗传学研究仅限于在以欧洲血统为主的人群中确定常见变体,或侧重于替代表型(如肝酶),以确定与合并症的关联。在此,我们介绍一项多安塞斯特全基因组测序(WGS)关联研究,以发现与成像测量的肝脂肪变性相关的罕见变异。研究方法使用 SAIGEgds 对九项影像测量肝脂肪变性的研究进行了研究、祖先和性别分层关联分析,并对年龄、性别、每周酒精饮品量和主成分混杂估计值进行了调整。采用固定效应模型对分层结果进行了元分析。Cochran's Q 检验和 I2 指标用于估计异质性。结果元分析纳入了 23156 名欧洲、非洲、西班牙和中国血统的个体,并确定了五个重要的基因位点(P<5x10-08):PNPLA3、PPP1R3B、HAPLN4、chr14上的基因间区域和F11-AS1。另有 9 个变异具有关联趋势(P<5x10-07)。性别分层荟萃分析表明,在 chr10 上的基因间区域、RP11-115J16.1 和 UBE3B 中存在其他关联。在欧洲血统样本中,RP11-115J16.1 的变异仍然显著。在非裔美国人中,SLC2A1-AS1 和 LINC01684 的显著相关变异是新的位点。结论总之,利用 WGS 对成像测量的肝脂肪变性进行的多种姓分析复制了以前的相关位点,并发现了新的性别和祖先特异性位点。目前正在进行功能研究,以确定这些发现的生物学影响。披露 N. Allred:无。C. Raut:无。Y. Chen: None.A. Oliveri: None.J. O'Connell: None.K. Ryan: None.J.I. Rotter:J.I. Rotter: None.S.S. Rich: None.A. Hakim:无。P. Peyser:无。L.F. Bielak:无。C. Liu: None.J.G. Terry: 无:无。M. Fornage:无。L.E. Wagenknecht:无:无。E.K. Speliotes:其他关系;密歇根大学。资助国家糖尿病和消化性肾病研究所 (R01 DK128871)
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Diabetes
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