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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Adults enrolled in the Cleveland Clinic Employee Health Plan (body mass index [BMI] ≥ 30 kg/m<sup>2</sup>, type 2 diabetes diagnosis, HbA<sub>1c</sub> > 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<sub>1c</sub>, baseline to month 12.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>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<sub>1c</sub> of 37.4 (34.2, 42.7) kg/m<sup>2</sup> 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<sub>1c</sub> 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 (<i>P</i> = 0.02); both WMP + AOM and WMP-Only were noninferior (<i>P</i> ≤ 0.01) to Usual-Care for change in HbA<sub>1c</sub>.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>Including anti-obesity medication was associated with superior weight loss with noninferior HbA<sub>1c</sub> reductions, warranting further evaluation in larger study populations of obesity-focused approaches to type 2 diabetes management.</p><p>Graphical abstract available for this article.</p><h3 data-test=\"abstract-sub-heading\">Trial Registration</h3><p>ClinicalTrials.gov NCT03799198.</p><h3 data-test=\"abstract-sub-heading\">Graphical Abstract</h3>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8000,"publicationDate":"2024-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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)\",\"authors\":\"Kevin M. 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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)
Introduction
This study aimed to compare weight loss and glycated hemoglobin (HbA1c)-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, HbA1c > 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 HbA1c, 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 HbA1c 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) HbA1c 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 HbA1c.
Conclusions
Including anti-obesity medication was associated with superior weight loss with noninferior HbA1c reductions, warranting further evaluation in larger study populations of obesity-focused approaches to type 2 diabetes management.
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.
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