Use of Liraglutide in Children Aged 6 to 12 Years With Severe Obesity
10. mai 2026 oppdatert av: Louise Cominato, University of Sao Paulo General Hospital
Efficacy, Metabolic and Cardiovascular Effects of Liraglutide in Children Aged 6-12 Years With Severe Obesity: A Randomized Controlled Trial With Advanced Echocardiographic Assessment
This randomized controlled trial evaluates the efficacy, safety, metabolic, and cardiovascular effects of liraglutide in children aged 6 to 12 years with severe obesity.
Participants are randomized to receive liraglutide plus lifestyle intervention or lifestyle intervention alone for 6 months.
In addition to primary outcomes related to weight loss and metabolic improvement, a predefined subgroup analysis evaluates cardiovascular function in participants receiving liraglutide using advanced echocardiographic techniques, including speckle-tracking-derived myocardial deformation parameters.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Intervensjon / Behandling
Detaljert beskrivelse
Childhood obesity is associated with early structural and functional cardiac alterations, including subclinical myocardial dysfunction. Conventional echocardiographic parameters may not detect early changes.
This is a prospective, randomized, controlled, open-label clinical trial including children aged 6-12 years with severe obesity (BMI Z-score ≥ +3). Participants are randomized to receive liraglutide plus lifestyle intervention or lifestyle intervention alone.
Participants are followed for 6 months with clinical, laboratory, imaging, and functional assessments.
In addition to the primary randomized comparison, a predefined longitudinal subgroup analysis is conducted in participants receiving liraglutide to assess cardiovascular effects using advanced echocardiographic techniques, including speckle-tracking analysis of left ventricular global longitudinal strain and left atrial reservoir strain.
This study was registered retrospectively because participant enrollment began prior to trial registration due to administrative reasons. The study protocol and outcomes were defined prior to participant inclusion.
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
São Paulo
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São Paulo, São Paulo, Brasil, 05403-000
- Childrens Institute - University of Sao Paulo
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Children aged 6-12 years
- BMI Z-score ≥ +3
- Previous unsuccessful lifestyle intervention
Exclusion Criteria:
- Severe chronic diseases
- Cardiac disease
- Dermatological contraindication
- Use of interfering medications
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Liraglutide + Lifestyle Intervention
Participants receive liraglutide with dose escalation (0.6 mg to 3.0 mg daily) plus lifestyle intervention. Intervention: Drug: Liraglutide Behavioral: Lifestyle intervention |
Liraglutide administered as a once-daily subcutaneous injection, starting at 0.6 mg and titrated weekly up to 3.0 mg or maximum tolerated dose, for 6 months, combined with lifestyle intervention.
|
|
Ingen inngripen: Lifestyle Intervention Alone
Participants receive standard multidisciplinary lifestyle intervention without pharmacological treatment.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Body Mass Index (BMI)
Tidsramme: 6 months
|
Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²).
BMI will be assessed at baseline and after 6 months using standardized anthropometric measurements.
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6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in left ventricular global longitudinal strain (LV-GLS) measured by two-dimensional speckle-tracking echocardiography
Tidsramme: 6 months
|
LV-GLS will be obtained by transthoracic echocardiography using two-dimensional speckle-tracking analysis according to current American Society of Echocardiography recommendations.
Measurements will be expressed as percentage (%) and evaluated at baseline and after 6 months.
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6 months
|
|
Change in left atrial reservoir strain (LASr) measured by two-dimensional speckle-tracking echocardiography
Tidsramme: 6 months
|
LASr will be obtained from apical four-chamber views using two-dimensional speckle-tracking echocardiography and expressed as percentage (%).
Measurements will be performed at baseline and after 6 months according to current American Society of Echocardiography recommendations
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6 months
|
|
Change in fasting plasma glucose
Tidsramme: Baseline to 6 months
|
Fasting plasma glucose levels will be measured from venous blood samples and expressed in mg/dL.
Changes between baseline and 6 months will be evaluated.
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Baseline to 6 months
|
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Change in fasting insulin levels
Tidsramme: 6 months
|
Fasting insulin levels will be measured from venous blood samples and expressed in µIU/mL.
Changes between baseline and 6 months will be evaluated
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6 months
|
|
Change in triglyceride levels
Tidsramme: 6 months
|
Serum triglyceride levels will be measured from venous blood samples and expressed in mg/dL.
Changes between baseline and 6 months will be evaluated.
|
6 months
|
|
Change in total cholesterol levels
Tidsramme: 6 months
|
Total cholesterol levels will be measured from venous blood samples and expressed in mg/dL.
Changes between baseline and 6 months will be evaluated.
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6 months
|
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Change in HDL cholesterol levels
Tidsramme: 6 months
|
HDL cholesterol levels will be measured from venous blood samples and expressed in mg/dL.
Changes between baseline and 6 months will be evaluated.
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6 months
|
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Change in LDL cholesterol levels
Tidsramme: 6 months
|
LDL cholesterol levels will be measured from venous blood samples and expressed in mg/dL.
Changes between baseline and 6 months will be evaluated.
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6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Louise Cominato, PI, University of Sao Paulo
- Studiestol: Natalia Bernardes, SI, University of Sao Paulo
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Berenson GS, Srinivasan SR, Bao W, Newman WP 3rd, Tracy RE, Wattigney WA. Association between multiple cardiovascular risk factors and atherosclerosis in children and young adults. The Bogalusa Heart Study. N Engl J Med. 1998 Jun 4;338(23):1650-6. doi: 10.1056/NEJM199806043382302.
- Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.
- Kelly AS, Auerbach P, Barrientos-Perez M, Gies I, Hale PM, Marcus C, Mastrandrea LD, Prabhu N, Arslanian S; NN8022-4180 Trial Investigators. A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. N Engl J Med. 2020 May 28;382(22):2117-2128. doi: 10.1056/NEJMoa1916038. Epub 2020 Mar 31.
- Styne DM, Arslanian SA, Connor EL, Farooqi IS, Murad MH, Silverstein JH, Yanovski JA. Pediatric Obesity-Assessment, Treatment, and Prevention: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2017 Mar 1;102(3):709-757. doi: 10.1210/jc.2016-2573.
- Weghuber D, Barrett T, Barrientos-Perez M, Gies I, Hesse D, Jeppesen OK, Kelly AS, Mastrandrea LD, Sorrig R, Arslanian S; STEP TEENS Investigators. Once-Weekly Semaglutide in Adolescents with Obesity. N Engl J Med. 2022 Dec 15;387(24):2245-2257. doi: 10.1056/NEJMoa2208601. Epub 2022 Nov 2.
- Harchali S, Zarrouki M, Elyadari M, Azenoud S, Elmerrouni S, Abdellah E, Berraho A. [Malignant conjunctival melanoma arising from conjunctival melanosis of Reese]. J Fr Ophtalmol. 2017 Nov;40(9):817-818. doi: 10.1016/j.jfo.2017.01.020. Epub 2017 Oct 19. No abstract available. French.
- Provenzano M, Andreucci M, Garofalo C, Faga T, Michael A, Ielapi N, Grande R, Sapienza P, Franciscis S, Mastroroberto P, Serra R. The Association of Matrix Metalloproteinases with Chronic Kidney Disease and Peripheral Vascular Disease: A Light at the End of the Tunnel? Biomolecules. 2020 Jan 17;10(1):154. doi: 10.3390/biom10010154.
- Erdivanli OC, Coskun ZO, Kazikdas KC, Demirci M. Prevalence of Otitis Media with Effusion among Primary School Children in Eastern Black Sea, in Turkey and the Effect of Smoking in the Development of Otitis Media with Effusion. Indian J Otolaryngol Head Neck Surg. 2012 Mar;64(1):17-21. doi: 10.1007/s12070-011-0131-z. Epub 2011 Feb 4.
- Wang HY, Sun LZ, Yue ZH, Yang J, Jiang XY, Mo Y. [Clinical and pathological features of Denys-Drash syndrome: report of 3 cases]. Zhonghua Er Ke Za Zhi. 2012 Nov;50(11):855-8. Chinese.
- Nauck MA, Vilsboll T, Gallwitz B, Garber A, Madsbad S. Incretin-based therapies: viewpoints on the way to consensus. Diabetes Care. 2009 Nov;32 Suppl 2(Suppl 2):S223-31. doi: 10.2337/dc09-S315. No abstract available.
- Caplan LS, Lane DS, Grimson R. The use of cohort vs repeated cross-sectional sample survey data in monitoring changing breast cancer screening practices. Prev Med. 1995 Nov;24(6):553-6. doi: 10.1006/pmed.1995.1088.
- Ferreira SRG, Macotela Y, Velloso LA, Mori MA. Determinants of obesity in Latin America. Nat Metab. 2024 Mar;6(3):409-432. doi: 10.1038/s42255-024-00977-1. Epub 2024 Mar 4.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
30. mars 2024
Primær fullføring (Antatt)
1. april 2027
Studiet fullført (Antatt)
1. april 2028
Datoer for studieregistrering
Først innsendt
22. april 2026
Først innsendt som oppfylte QC-kriteriene
10. mai 2026
Først lagt ut (Faktiske)
15. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Ernæringsforstyrrelser
- Overernæring
- Kroppsvekt
- Overvektig
- Overvekt
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Tegn og symptomer
- Pediatrisk fedme
- Overvekt, sykelig
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Gastrointestinale hormoner
- Glukagonlignende peptider
- Proglucagon
- Glukagonlignende peptid 1
- Liraglutid
Andre studie-ID-numre
- 74225723.4.0000.0068
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
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