Weight and cardiometabolic effects of a novel oral shape-shifting superabsorbent hydrogel capsule: Prespecified and exploratory analysis of the Epitomee capsule RESET study.

ABSTRACT:

Background

Management of obesity potentially improves cardiometabolic risk factors in patients with metabolic syndrome (MetS). The Epitomee capsule is a non-pharmacological, biodegradable device treatment for weight reduction in patients with overweight and obesity.

Methods

This secondary analysis of the Randomized Evaluation of Safety and Efficacy of the Epitomee capsule Trial (RESET) (a randomized, 24-week, multicenter, placebo-controlled, double-blind trial that enrolled 279 adults aged ≥18 years with a BMI of 27-40 kg/m2) evaluated changes in cardiometabolic parameters in participants treated with Epitomee or placebo combined with lifestyle counseling among (a) the entire RESET study population, and (b) participants meeting diagnostic criteria for prediabetes. Predefined

SUBMITTER: Bays HE 

PROVIDER: S-EPMC11870181 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature