Evidence mapPaperPMID 40028615Full record

ArticleObesity pillars2025

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

H E Bays, J D Ard, P M O'Neil, T A Wadden, R F Kushner, J M Jakicic, H R Wyatt, F L Greenway, M Kamar, E Ganon-Elazar and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in Obesity pillars, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04222322 (The Effect of Epitomee Capsule on Body Weight in Patients With Overweight and Obesity With and Without Prediabetes), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04222322 nacompletednot on this map

The Effect of Epitomee Capsule on Body Weight in Patients With Overweight and Obesity With and Without Prediabetes

TypeinterventionalSponsorEpitomee medicalRan2020 to 2023Enrolled279ConditionsOverweight and ObesityArmsEpitomee Capsule, Control-Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

H E BaysLouisville Metabolic and Atherosclerosis Research Center, 3288 Illinois Avenue, Louisville, 40213, Kentucky, USA.
J D ArdDepartment of Epidemiology and Prevention and Department of Medicine, Wake Forest School of Medicine, 525 Vine Street, 5th Floor, Suite 5119, Winston-Salem, 27101, North Carolina, USA.
P M O'NeilWeight Management Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 67 President Street, Suite 410 South, Institute of Psychiatry Building MSC 861, Charleston, SC, 29425, USA.
T A WaddenDepartment of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, 3535 Market Street, Third Floor, Philadelphia, PA, 19104, USA.
R F KushnerDepartment of Medicine, Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, 645 North Michigan Avenue, Suite 530, Chicago, 60611, IL, USA.
J M JakicicDivision of Physical Activity and Weight Management, Department of Internal Medicine, University of Kansas Medical Center, 3901 Rainbow Blvd., MS 7002, Kansas City, 66160, Kansas, USA.
H R WyattDepartment of Nutrition Sciences, The University of Alabama at Birmingham, 1675 University Blvd, Birmingham, 35233, Alabama, USA.
F L GreenwayPennington Biomedical Research Center, Louisiana State University, 6400 Perkins Road, Baton Rouge, 70808, Louisiana, USA.
M KamarDepartment of Acute Care Surgery, Wolfson MC, Sackler School of Medicine Tel- Aviv University, 62 Halochhamim St. Holon, 8100, Israel.
E Ganon-ElazarEpitomee Medical Ltd, Hatochen St. Caesarea Business Park, POB 3088, Caesarea, 3079892, Israel.
L Cohen AsarafEpitomee Medical Ltd, Hatochen St. Caesarea Business Park, POB 3088, Caesarea, 3079892, Israel.
D H RyanPennington Biomedical Research Center, Louisiana State University, 6400 Perkins Road, Baton Rouge, 70808, Louisiana, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 and exploratory endpoints included changes in waist circumference, glycemic parameters, blood pressure, and lipid blood levels; this analysis also assessed percent weight loss in participants with MetS. Results: Waist circumference, systolic and diastolic blood pressure and some measures of glycemia and lipids, improved with both Epitomee and placebo with no significant differences. Participants with prediabetes treated with Epitomee showed significantly greater reductions in HOMA-IR (p < 0.007) and insulin levels (p < 0.003) than the placebo group. Participants with MetS at baseline experienced significantly greater percent change in initial weight when treated with the Epitomee capsule (n = 27) compared to placebo (n = 31), -8.3% vs -5.2 %, respectively (p < 0.0004). Similar percentages of participants with MetS in both groups achieved ≥5 % weight reduction (59.3 % and 54.8 %, in Epitomee and placebo groups respectively). Significantly more participants with MetS treated with Epitomee achieved ≥10 % weight reduction compared with those treated with placebo (40.7 % vs. 6.5 %, respectively, p < 0.002). Conclusion: Treatment with either Epitomee and placebo combined with lifestyle improve cardiometabolic risk factors. Compared to placebo, Epitomee significantly reduced HOMA-IR and insulin levels in participants with prediabetes. Among participants with MetS, Epitomee significantly reduced body weight [ClinicalTrials.gov ID NCT04222322].

Indexed as

Cardiovascular diseaseHydrogelMetabolic syndromeObesityOverweightWeight loss

Identifiers

PMID40028615
PMCPMC11870181

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.