Evidence map›Paper›PMID 39551589›Full record

ArticleBMJ open2024

Protocol for a randomised, double-blinded, controlled trial of youth with childhood-onset obesity treated with semaglutide 2.4 mg/week: the RESETTLE trial.

Sarah Byberg, Joachim Holt, Rasmus Michael Sandsdal, Louise Aas Holm, Lærke Bruun Madsen, Bodil Just Christensen, Simon Birk Kjær Jensen, Torben Hansen, Jens-Christian Holm, Signe Torekov

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
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

10 authors.

Sarah BybergDepartment of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-7363-4595
Joachim HoltDepartment of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Rasmus Michael SandsdalDepartment of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Louise Aas HolmThe Children's Obesity Clinic, Department of Paediatrics, Copenhagen University Hospital Holbæk, Holbaek, Denmark.
Lærke Bruun MadsenDepartment of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Bodil Just ChristensenDepartment of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Simon Birk Kjær JensenDepartment of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-1437-2150
Torben HansenNovo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.
Jens-Christian HolmThe Children's Obesity Clinic, Department of Paediatrics, Copenhagen University Hospital Holbæk, Holbaek, Denmark torekov@sund.ku.dk jhom@regionsjaelland.dk.
Signe TorekovDepartment of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark torekov@sund.ku.dk jhom@regionsjaelland.dk.ORCID 0000-0001-6779-0252

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChildhood-onset obesity poses significant health risks, including early-onset type 2 diabetes, cardiovascular disease, and reduced quality of life. Hospital-based non-pharmacological obesity care can reduce childhood obesity, but 25% of children do not respond. Therefore, this study investigates the effect of the glucagon-like peptide-1 receptor agonist, semaglutide, as an add-on to hospital-based obesity care in youth who still have obesity following hospital-based obesity care as children. Furthermore, biomedical and psychosocial factors linked to treatment response will be investigated, alongside an exercise-based strategy to prevent weight regain and maintain a healthy body composition after semaglutide treatment. METHODS AND ANALYSIS: This is an investigator-initiated, randomised, placebo-controlled, double-blind trial. We will enrol expectedly 180-270 young adults aged 18-28 years based on their previous response to a paediatric obesity management programme and their current body mass index (BMI). Participants are categorised into four groups: low treatment response (BMI SD score (SDS) reduction <0.10; BMI ≥30 kg/m ETHICS AND DISSEMINATION: The trial has been approved by the Danish Medicines Agency and the Ethical Committee of the Capital Region of Denmark (H-20039422). The trial will be conducted in accordance with the Declaration of Helsinki and follow the guidelines for Good Clinical Practice. Results will be presented at international scientific conferences and published in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: EudraCT 2019-002274-31.

Indexed as

Glucagon-Like PeptidesPediatric ObesityAdolescentAdultBody Mass IndexDouble-Blind MethodFemaleHumansMaleRandomized Controlled Trials as TopicSemaglutideTreatment OutcomeWeight LossYoung AdultGlucagon-Like PeptidesSemaglutideBody Mass IndexObesityRandomized Controlled Trial

Identifiers

PMID39551589
PMCPMC11574404

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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 OpenQuestion graph.