An Obesity-Centric Approach with and Without Anti-Obesity Medications Compared to 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)

IF 3.8 3区医学 Q2 Medicine

Diabetes Therapy Pub Date : 2024-04-04 DOI:10.1007/s13300-024-01563-0

Kevin M. Pantalone, Bruce Rogen, Patty Zirm, Huijun Xiao, James Bena, Gretchen Barnard, Elena Borukh, Seenia Peechakara, Marcio L. Griebeler, James B. Young, Bartolome Burguera

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Abstract

Introduction

This study aimed to compare weight loss and glycated hemoglobin (HbA_1c)-reduction effects of two obesity-centric, weight-loss management approaches (with or without anti-obesity medication) versus usual glucose-centric care in patients with obesity and type 2 diabetes.

Methods

Single-center, randomized, open-label, 3-armed, parallel-group, pragmatic, noninferiority trial, July 2020 to August 2022. Adults enrolled in the Cleveland Clinic Employee Health Plan (body mass index [BMI] ≥ 30 kg/m², type 2 diabetes diagnosis, HbA_1c > 7.5%) were randomized to usual glucose-centric management (“Usual-Care” group) or one of two obesity-centric management strategies: participation in a weight management program plus anti-obesity medication (“WMP + AOM” group), or WMP participation without anti-obesity medication (“WMP-Only” group). Primary endpoints were changes in weight and HbA_1c, baseline to month 12.

Results

Due to enrollment and retention challenges, largely related to COVID-19, only 74/300 planned participants were randomized and the study was terminated early. Participants were predominantly female (59%), median (interquartile range [IQR]) age 53.5 (47, 60) years, 68% white, with baseline median (IQR) BMI and HbA_1c of 37.4 (34.2, 42.7) kg/m² and 8.8% (7.9%, 10.4%), respectively. At month 12, mean (90% confidence interval [CI]) percentage weight change in the Usual-Care, WMP-Only, and WMP + AOM groups was − 4.5% (− 6.5%, − 2.5%), − 6.7% (− 8.7%, − 4.7%), and − 8.7% (− 10.7%, − 6.8%), respectively; mean (90% CI) HbA_1c change was − 1.7% (− 2.1%, − 1.2%), − 2.2% (− 2.7%, − 1.8%), and − 2.2% (− 2.6%, − 1.7%), respectively. WMP + AOM was superior to Usual-Care for weight change (P = 0.02); both WMP + AOM and WMP-Only were noninferior (P ≤ 0.01) to Usual-Care for change in HbA_1c.

Conclusions

Including anti-obesity medication was associated with superior weight loss with noninferior HbA_1c reductions, warranting further evaluation in larger study populations of obesity-focused approaches to type 2 diabetes management.

Graphical abstract available for this article.

Trial Registration

ClinicalTrials.gov NCT03799198.

Graphical Abstract

Abstract Image

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以肥胖症为中心、使用或不使用抗肥胖症药物的方法与雇主环境中肥胖症和 2 型糖尿病患者的常规护理方法相比：务实的随机对照试验（EMPOWER-T2D）

引言本研究旨在比较两种以肥胖为中心的减肥管理方法（使用或不使用抗肥胖药物）与以血糖为中心的常规护理对肥胖和 2 型糖尿病患者的减肥和糖化血红蛋白 (HbA1c) 降低效果。方法2020 年 7 月至 2022 年 8 月进行的单中心、随机、开放标签、三臂、平行组、实用、非劣效试验。参加克利夫兰诊所员工健康计划的成年人（体重指数[BMI] ≥ 30 kg/m2，确诊为2型糖尿病，HbA1c > 7.5%）被随机分配到以血糖为中心的常规管理（"常规护理 "组）或以肥胖为中心的两种管理策略中的一种：参加体重管理计划并服用抗肥胖药物（"WMP + AOM "组），或参加体重管理计划但不服用抗肥胖药物（"WMP-Only "组）。主要终点是体重和 HbA1c 从基线到第 12 个月的变化。结果由于入组和保留方面的挑战（主要与 COVID-19 有关），只有 74/300 名计划参与者被随机分配，研究提前终止。参与者主要为女性（59%），中位数（四分位数间距 [IQR]）年龄为 53.5（47, 60）岁，68% 为白人，基线中位数（IQR）BMI 和 HbA1c 分别为 37.4（34.2, 42.7）kg/m2 和 8.8%（7.9%, 10.4%）。第 12 个月时，通常护理组、仅 WMP 组和 WMP + AOM 组的平均体重变化百分比（90% 置信区间 [CI]）分别为 - 4.5% (- 6.5%, - 2.5%), - 6.7% (- 8.7%, - 4.7%) 和 - 8.7%（- 10.7%，- 6.8%）；平均（90% CI）HbA1c变化分别为- 1.7%（- 2.1%，- 1.2%）、- 2.2%（- 2.7%，- 1.8%）和- 2.2%（- 2.6%，- 1.7%）。在体重变化方面，WMP + AOM 优于普通护理（P = 0.02）；在 HbA1c 变化方面，WMP + AOM 和单纯 WMP 均不劣于普通护理（P ≤ 0.01）。结论纳入抗肥胖药物与卓越的体重减轻效果相关，但HbA1c降低效果并不差，值得在更大的研究人群中进一步评估以肥胖为重点的2型糖尿病管理方法。

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来源期刊

Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

6.90

自引率

7.90%

发文量

130

审稿时长

6 weeks

期刊介绍： Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.