139-OR:一项实用的随机对照试验(EMPOWER-T2D):在雇主环境下，以肥胖为中心的方法与常规护理方法相比，使用或不使用抗肥胖药物来管理肥胖和2型糖尿病患者

IF 9.3 1区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes Pub Date : 2023-06-20 DOI:10.2337/db23-139-or

K. Pantalone, Bruce Rogen, James F Bena, Huijun Xiao, Gretchen Barnard, Elena Borukh, S. Peechakara, Marcio L. Griebeler, B. Burguera

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引用次数: 0

摘要

目的:在t2dm合并肥胖的患者中，比较单用OCA或常规护理(UC)联合抗肥胖药物(AOM)与基于雇主的综合体重管理方案[以肥胖为中心的方法(OCA) + AOM]对体重和HbA1c的影响。方法:在克利夫兰诊所(CC)进行一项为期1年的开放标签、随机、实用的临床试验。参与者是参加CC员工健康计划的t2dm (HbA1c >7.5%)和BMI≥30 kg/m2的成年人。参与者按1:1:1随机分为OCA+ AOM、OCA单独或UC。OCA+AOM组的参与者开始使用美国fda批准的5种AOM中的1种进行治疗。采用线性混合效应模型进行分析。结果:共有74名参与者被随机分配(24名OCA+AOM, 26名OCA和24名UC)。参与者主要为女性(59%)，中位年龄为53.5(47,60)岁，68%为白种人，基线中位BMI和HbA1c分别为37.4(34.2,42.7)和8.8%(7.9,10.4)。1年后，单独接受UC, OCA和OCA + AOM的患者的平均体重变化百分比(90%置信区间，CI)分别为-4.48%(-6.52至-2.45)，-6.68%(-8.71至-4.65)和-8.74%(-10.64至-6.74)，平均HbA1c变化(90% CI)分别为-1.65%(-2.09至-1.22)，-2.22%(-2.65至-1.79)和-2.18%(-2.61至-1.74)。只有OCA + AOM治疗在体重减轻变化方面不逊于UC入路(P=0.004)。OCA + AOM治疗在体重减轻变化方面也优于UC入路(P=0.022)。在HbA1c变化方面，OCA+AOM和单独OCA均不逊于常规护理(p0.05)。结论:与UC相比，OCA +AOM方法治疗T2D与额外体重减轻和非低度A1C降低相关。需要更大规模的长期研究来评估以肥胖为中心的T2D管理方法。K.M.Pantalone:顾问;阿斯利康、拜耳、concept Therapeutics、Diasome、礼来、默克、诺和诺德、赛诺菲、研究支持;拜耳公司、默克公司、诺和诺德公司、Twin Health公司、议长局;阿斯利康，概念治疗，默克公司，诺和诺德。B.Rogen:没有。J.F.Bena:没有。H.Xiao:没有。G.Barnard:没有。E.Borukh:没有。S.Peechakara:没有。M.L.Griebeler:没有。B.Burguera:研究支持;诺和诺德公司。

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139-OR: An Obesity-centric Approach With and Without Antiobesity Medications Compared with the Usual-Care Approach to Management of Patients with Obesity and Type 2 Diabetes in an Employer Setting—A Pragmatic Randomized Controlled Trial (EMPOWER-T2D)

Objective: Among patients with T2D and obesity, determine the effect of combining anti-obesity medications (AOM) with a comprehensive employer-based weight management program [obesity-centric approach (OCA) + AOM] compared with OCA alone, or usual care (UC) on weight and HbA1c. Methods: A 1-year open-label, randomized, pragmatic clinical trial was conducted at the Cleveland Clinic (CC). Participants were adults with T2D (HbA1c >7.5%) and BMI ≥ 30 kg/m2 enrolled in the CC Employee Health Plan. Participants were randomized 1:1:1 to OCA+ AOM, OCA alone, or UC. Participants in the OCA+AOM group initiated treatment with 1 of 5 US FDA-approved AOMs according to standard practice. Linear mixed effect models were conducted for analysis. Results: A total of 74 participants were randomized (24 OCA+AOM, 26 OCA, and 24 UC). Participants were predominantly female (59%), median age 53.5 (47, 60) years, 68% Caucasian, with baseline median BMI and HbA1c of 37.4 (34.2, 42.7) and 8.8% (7.9, 10.4), respectively. At 1 year, patients that received UC, OCA alone, and OCA + AOM had their mean % weight change (90% confidence interval, CI) by -4.48% (-6.52 to -2.45), -6.68% (-8.71 to -4.65), and -8.74% (-10.64 to -6.74) and mean HbA1c change (90% CI) by -1.65% (-2.09 to -1.22), -2.22% (-2.65 to -1.79), and -2.18% (-2.61 to -1.74), respectively. Only OCA + AOM treatment was found to be non-inferior (P=0.004) to UC approach in weight loss change. OCA + AOM treatment was also found to be superior to UC approach in weight loss change (P=0.022). OCA+AOM and OCA alone were non-inferior to usual-care in HbA1c change (P <0.05), but neither was superior (P>0.05). Conclusion: An OCA +AOM approach to T2D treatment was associated with additional weight loss with non-inferior A1C reductions vs. UC. Larger long-term studies evaluating obesity-focused approaches to T2D management are needed. K.M.Pantalone: Consultant; AstraZeneca, Bayer Inc., Corcept Therapeutics, Diasome, Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk, Sanofi, Research Support; Bayer Inc., Merck & Co., Inc., Novo Nordisk, Twin Health, Speaker's Bureau; AstraZeneca, Corcept Therapeutics, Merck & Co., Inc., Novo Nordisk. B.Rogen: None. J.F.Bena: None. H.Xiao: None. G.Barnard: None. E.Borukh: None. S.Peechakara: None. M.L.Griebeler: None. B.Burguera: Research Support; Novo Nordisk.

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来源期刊

Diabetes 医学-内分泌学与代谢

CiteScore

12.50

自引率

2.60%

发文量

1968

审稿时长

1 months

期刊介绍： Diabetes is a scientific journal that publishes original research exploring the physiological and pathophysiological aspects of diabetes mellitus. We encourage submissions of manuscripts pertaining to laboratory, animal, or human research, covering a wide range of topics. Our primary focus is on investigative reports investigating various aspects such as the development and progression of diabetes, along with its associated complications. We also welcome studies delving into normal and pathological pancreatic islet function and intermediary metabolism, as well as exploring the mechanisms of drug and hormone action from a pharmacological perspective. Additionally, we encourage submissions that delve into the biochemical and molecular aspects of both normal and abnormal biological processes. However, it is important to note that we do not publish studies relating to diabetes education or the application of accepted therapeutic and diagnostic approaches to patients with diabetes mellitus. Our aim is to provide a platform for research that contributes to advancing our understanding of the underlying mechanisms and processes of diabetes.