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Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity (GLP-BARI-VAN)

3. november 2026 opdateret af: Sebahattin Celik MD, Yuzuncu Yil University

Comparison of Two-Year Weight-Loss Effectiveness of GLP-1 Receptor Agonists and Laparoscopic Sleeve Gastrectomy in the Treatment of Obesity: An Ambispective Propensity Score-Matched Cohort Study

This observational study will compare weight loss over two years in adults receiving GLP-1 receptor agonist medications with weight loss in adults who previously underwent laparoscopic sleeve gastrectomy, an operation that reduces the size of the stomach.

Adults starting GLP-1 medications as part of their usual care will be followed for 24 months. Their results will be compared with existing medical records of adults who underwent sleeve gastrectomy at the same center. Treatment decisions will be made by patients and their treating clinicians as part of routine care, rather than assigned by the study.

The main outcome is the percentage of starting body weight lost at 24 months. The study will also assess weight changes at earlier visits, medication side effects, treatment continuation and reasons for stopping treatment, and changes in weight-related health conditions. The groups will be matched using baseline characteristics to make the comparison more balanced.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Observationel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adults aged 18 years or older receiving treatment for obesity or overweight at the Obesity Center of Van Training and Research Hospital, Türkiye. The prospective cohort will include consecutive eligible patients initiating GLP-1 receptor agonist therapy for weight management as part of routine clinical care. The retrospective cohort will include eligible patients who underwent primary laparoscopic sleeve gastrectomy for obesity at the same center between January 1, 2020, and January 1, 2026. Treatment decisions are made independently of study participation. The cohorts will be matched using propensity scores based on pretreatment demographic and clinical characteristics.

Beskrivelse

Inclusion Criteria:

GLP-1 Receptor Agonist Cohort:

  • Age 18 years or older at treatment initiation.
  • Initiation of a GLP-1 receptor agonist for obesity or overweight as part of routine clinical care.
  • Available baseline height and body weight measurements.
  • Willingness to attend at least one follow-up assessment.
  • Ability to comply with the center's standard follow-up program.
  • Provision of written informed consent.

Laparoscopic Sleeve Gastrectomy Cohort:

  • Age 18 years or older at surgery.
  • Primary laparoscopic sleeve gastrectomy for obesity performed at the study center between January 1, 2020, and January 1, 2026.
  • Available preoperative height, body weight, and body mass index measurements.
  • Available demographic and baseline clinical data.
  • At least one documented postoperative body weight measurement. Availability of a 24-month weight measurement is preferred for the primary comparison.

Exclusion Criteria:

Both Cohorts:

  • Bariatric or metabolic surgery before the index treatment.
  • Revisional bariatric surgery as the index treatment.
  • Active malignancy or a serious systemic disease substantially affecting body weight.
  • Pregnancy or breastfeeding at the index treatment.
  • Uncontrolled endocrine disease that may cause weight loss.
  • Missing baseline height or body weight measurements.
  • Recent participation in another intensive weight-loss program before the index treatment.
  • Concurrent use of another anti-obesity treatment that could substantially affect study outcomes.
  • Inability to reliably verify study data.

GLP-1 Receptor Agonist Cohort:

  • Short-term GLP-1 receptor agonist use for an indication other than weight management.
  • Medication prescribed but never administered.

Laparoscopic Sleeve Gastrectomy Cohort:

  • Sleeve gastrectomy performed concurrently with another bariatric procedure.
  • Sleeve gastrectomy performed for an indication other than primary obesity treatment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: OTHER

Kohorter og interventioner

Gruppe / kohorte

Gruppe / kohorte

En gruppe eller undergruppe af deltagere i et observationsstudie, der vurderes for biomedicinske eller sundhedsmæssige resultater.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
GLP-1 Receptor Agonist Cohort

Adults aged 18 years or older starting a GLP-1 receptor agonist, such as liraglutide or semaglutide, for weight management as part of routine clinical care. Participants will be followed prospectively for 24 months, with assessments at baseline and months 1, 3, 6, 12, and 24. Weight changes, medication use, treatment adherence, adverse events, and treatment discontinuation will be recorded. Medication selection and dosing will be determined by the treating clinician independently of study participation.
Medicin: GLP-1 Receptor Agonist Therapy

GLP-1 receptor agonists, such as liraglutide or semaglutide, prescribed for weight management as part of routine clinical care. Medication selection, dose escalation, dose adjustment, and treatment discontinuation are determined by the treating clinician and are not assigned by the study protocol. Medication use, weight changes, treatment adherence, and adverse events will be recorded during 24 months of prospective follow-up.

Andre navne:
  • Glucagon-Like Peptide-1 Receptor Agonist Therapy
Laparoscopic Sleeve Gastrectomy Cohort

Adults who underwent primary laparoscopic sleeve gastrectomy for obesity at the same center between January 1, 2020, and January 1, 2026, and were aged 18 years or older at surgery. Existing medical records will be reviewed retrospectively for baseline characteristics, postoperative weight measurements through 24 months, and surgical complications. This cohort will be matched with the GLP-1 receptor agonist cohort using propensity scores based on pretreatment characteristics. Surgery was performed as part of routine clinical care independently of this study.
Procedure: Laparoscopic Sleeve Gastrectomy

Primary laparoscopic sleeve gastrectomy performed for obesity as part of routine clinical care between January 1, 2020, and January 1, 2026. The procedure involves removing a large portion of the stomach to create a narrow, sleeve-shaped stomach. Existing medical records will be reviewed retrospectively to assess weight changes and surgical complications through 24 months after surgery.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Total Body Weight change at 24 Months
Tidsramme: 24 months after GLP-1 receptor agonist treatment initiation or sleeve gastrectomy.

Percentage of total body weight loss (%TWL), calculated as [(baseline body weight - body weight at 24 months) / baseline body weight] × 100. Baseline is the date of GLP-1 receptor agonist treatment initiation or sleeve gastrectomy. The outcome will be compared between the propensity score-matched treatment cohorts.
24 months after GLP-1 receptor agonist treatment initiation or sleeve gastrectomy.

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Total Body Weight change at Earlier Follow-Up Visits
Tidsramme: At 1, 3, 6, and 12 months after treatment initiation.

Percentage of total body weight loss (%TWL), calculated as [(baseline body weight - follow-up body weight) / baseline body weight] × 100, compared between the treatment cohorts.
At 1, 3, 6, and 12 months after treatment initiation.
Change in Body Weight
Tidsramme: Baseline to months 1, 3, 6, 12, and 24.

Change in body weight from baseline, measured in kilograms, compared between the treatment cohorts.
Baseline to months 1, 3, 6, 12, and 24.
Change in Body Mass Index
Tidsramme: Baseline to months 1, 3, 6, 12, and 24.

Change in body mass index (BMI) from baseline, calculated as body weight in kilograms divided by height in meters squared, compared between the treatment cohorts.
Baseline to months 1, 3, 6, 12, and 24.
Percentage of Participants Achieving at Least 5% Total Body Weight Loss
Tidsramme: At months 1, 3, 6, 12, and 24.

Percentage of participants losing at least 5% of their baseline body weight, compared between the treatment cohorts.
At months 1, 3, 6, 12, and 24.
Percentage of Participants Achieving at Least 10% Total Body Weight Loss
Tidsramme: At months 1, 3, 6, 12, and 24.

Percentage of participants losing at least 10% of their baseline body weight, compared between the treatment cohorts.
At months 1, 3, 6, 12, and 24.
Percentage of Participants Achieving at Least 15% Total Body Weight Loss
Tidsramme: At months 1, 3, 6, 12, and 24.

Percentage of participants losing at least 15% of their baseline body weight, compared between the treatment cohorts.
At months 1, 3, 6, 12, and 24.
Percentage of Participants Achieving at Least 20% Total Body Weight Loss
Tidsramme: At months 1, 3, 6, 12, and 24.

Percentage of participants losing at least 20% of their baseline body weight, compared between the treatment cohorts.
At months 1, 3, 6, 12, and 24.
Percentage of Participants Achieving at Least 25% Total Body Weight Loss
Tidsramme: At months 1, 3, 6, 12, and 24.

Percentage of participants losing at least 25% of their baseline body weight, compared between the treatment cohorts.
At months 1, 3, 6, 12, and 24.
Percentage of Participants Experiencing Any Adverse Event During GLP-1 Therapy
Tidsramme: From the first medication dose through 24 months.

Percentage of participants in the GLP-1 receptor agonist cohort experiencing at least one adverse event. Event type, onset, severity, and suspected relationship to medication will be recorded.
From the first medication dose through 24 months.
Percentage of Participants Experiencing Gastrointestinal Adverse Events During GLP-1 Therapy
Tidsramme: From the first medication dose through 24 months.

Percentage of participants in the GLP-1 receptor agonist cohort experiencing gastrointestinal adverse events, including nausea, vomiting, diarrhea, constipation, abdominal pain, or reflux/dyspepsia.
From the first medication dose through 24 months.
Percentage of Participants Experiencing Serious Adverse Events During GLP-1 Therapy
Tidsramme: From the first medication dose through 24 months.

Percentage of participants in the GLP-1 receptor agonist cohort experiencing an adverse event resulting in death, a life-threatening condition, inpatient hospitalization or prolonged hospitalization, persistent or significant disability, a congenital anomaly, or another medically important event.
From the first medication dose through 24 months.
Percentage of Participants Requiring GLP-1 Dose Reduction Due to Adverse Events
Tidsramme: From treatment initiation through 24 months.

Percentage of participants in the GLP-1 receptor agonist cohort whose medication dose is reduced because of an adverse event.
From treatment initiation through 24 months.
Percentage of Participants Permanently Discontinuing GLP-1 Therapy Due to Adverse Events
Tidsramme: From treatment initiation through 24 months.

Percentage of participants in the GLP-1 receptor agonist cohort who permanently discontinue medication because of an adverse event.
From treatment initiation through 24 months.
Percentage of Participants Permanently Discontinuing GLP-1 Therapy for Any Reason
Tidsramme: From treatment initiation through 24 months.

Percentage of participants in the GLP-1 receptor agonist cohort who permanently discontinue medication for any reason. Reasons for discontinuation will be recorded.
From treatment initiation through 24 months.
Duration of GLP-1 Treatment Persistence
Tidsramme: From treatment initiation through 24 months.

Time in months from GLP-1 receptor agonist treatment initiation to permanent discontinuation. Participants without permanent discontinuation will be censored at their last known follow-up or the end of the 24-month observation period.
From treatment initiation through 24 months.
Improvement or Remission of Obesity-Related Comorbidities
Tidsramme: At months 3, 6, 12, and 24.

Percentage of participants with improvement or remission of baseline obesity-related comorbidities, including type 2 diabetes, hypertension, and dyslipidemia, assessed separately for each condition using available clinical records, laboratory results, and medication changes.
At months 3, 6, 12, and 24.
Percentage of Participants With Emergency Department Visits
Tidsramme: From treatment initiation through 24 months.

Percentage of participants with at least one emergency department visit during follow-up, assessed in each treatment cohort using available records.
From treatment initiation through 24 months.
Percentage of Participants With Hospital Admissions
Tidsramme: From treatment initiation through 24 months.

Percentage of participants with at least one hospital admission during follow-up, excluding the index admission for sleeve gastrectomy, assessed in each treatment cohort using available records.
From treatment initiation through 24 months.
Percentage of Participants With Early Surgical Complications
Tidsramme: Within 30 days after sleeve gastrectomy.

Percentage of participants in the sleeve gastrectomy cohort experiencing a complication within 30 days after surgery, including bleeding, staple-line leak, or complications requiring reoperation. Complications will be graded using the Clavien-Dindo classification when sufficient information is available.
Within 30 days after sleeve gastrectomy.
Percentage of Participants With Late Surgical Complications
Tidsramme: From postoperative day 31 through 24 months.

Percentage of participants in the sleeve gastrectomy cohort experiencing complications more than 30 days after surgery, including stenosis, gastroesophageal reflux, nutritional deficiencies, or complications requiring revision surgery, as documented in available records.
From postoperative day 31 through 24 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Yuzuncu Yil University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
15. september 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
15. september 2028

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
15. november 2028

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
22. oktober 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
22. oktober 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
28. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
3. november 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • GLP-BARI-VAN

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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