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)

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2024年4月4日

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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

摘要

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