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Semaglutid til behandling af glukoseintolerance hos kvinder med tidligere svangerskabsdiabetes (SERENA)

11. september 2026 opdateret af: Universitaire Ziekenhuizen KU Leuven

Semaglutid til behandling af glukoseintolerance hos kvinder med tidligere svangerskabsdiabetes: en dobbeltblind RCT

Svangerskabsdiabetes (GDM) er en vigtig bidragyder til den stigende forekomst af type 2-diabetes (T2DM). Kvinder med glukoseintolerans tidligt efter fødslen er en særlig højrisikogruppe med omkring 50 %, som vil udvikle T2DM inden for 5 år efter fødslen. Desuden går kvinder med en historie med GDM hurtigere frem til T2DM sammenlignet med kvinder med tilsvarende forhøjede glucoseniveauer. Tidlig indsats efter indeksgraviditeten er derfor afgørende for at forebygge T2DM. Med SERENA-projektet sigter vi derfor mod at reducere risikoen for at udvikle T2DM med den langtidsvirkende GLP-1-agonist semaglutid hos kvinder med en nyere historie med GDM og glukoseintolerans i tidlig postpartum.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patientpopulation: Kvinder med en nylig historie med svangerskabsdiabetes (GDM) og vedvarende glukoseintolerans i tidlig postpartum er en særlig højrisikogruppe, hvor omkring 50 % udvikler type 2-diabetes (T2DM) inden for 5 år efter fødslen. Semaglutid er en langtidsvirkende glukagon-lignende peptid-1 (GLP-1) agonist med flere gavnlige metaboliske effekter, herunder glukosesænkende effekt, vægttab og kardiovaskulære beskyttende effekter. Vi antager, at hos kvinder med tidligere GDM og glukoseintolerans i tidlig postpartum, vil behandling med semaglutid reducere risikoen for at udvikle T2DM på lang sigt sammenlignet med placebo.

Intervention og sammenligning: Belgisk multicentrisk dobbeltblind RCT med 12 centre til sammenligning af semaglutid (en gang om ugen) med placebo hos kvinder med en nylig historie med GDM og glukoseintolerance [svækket fastende glykæmi (IFG) og/eller nedsat glukosetolerance (IGT) ] 6-24 uger efter fødslen. Deltagerne vil blive 1/1 randomiseret til semaglutid eller placebo på baggrund af livsstilsforanstaltninger. Semaglutid vil blive optitreret til 1 mg/uge over en 8-ugers periode. Deltagerne vil blive fulgt op i 3 år. Deltagerne vil modtage en 75 g oral glukosetolerancetest (OGTT) 3 måneder efter stop af interventionen. Randomisering vil blive stratificeret efter BMI ved det tidlige postpartum besøg (

Resultater: Det primære endepunkt er udviklingen af ​​T2DM defineret af OGTT og/eller HbA1c. Vigtige sekundære endepunkter omfatter behovet for redningsterapi til diabetes, regression til normoglykæmi, vægttab, beta-cellefunktion, insulinresistens og det metaboliske syndrom. For at opnå 80 % effekt planlægger vi en stikprøvestørrelse på 206 for at opdage en estimeret 50 % reduktion i risikoen for at udvikle T2DM mellem begge grupper, forudsat et tab på 30 % til opfølgning under undersøgelsen.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

252

Fase

  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Belgien
      • Aalst, Belgien
        • Rekruttering
        • AZORG
        • Kontakt:
          • Katrien Wierckx
      • Antwerp, Belgien
        • Rekruttering
        • UZA
        • Kontakt:
          • Niels Bochanen
      • Antwerp, Belgien
        • Rekruttering
        • ZAS
        • Kontakt:
          • Ann Verhaegen
      • Bruges, Belgien
      • Brussels, Belgien
        • Rekruttering
        • UZ Brussel
        • Kontakt:
          • Nancy Van Wilder
      • Brussels, Belgien
        • Rekruttering
        • Erasme
        • Kontakt:
          • Maria Lytrivi
      • Ieper, Belgien
        • Rekruttering
        • Jan Yperman
        • Kontakt:
      • Kortrijk, Belgien
        • Rekruttering
        • AZ Groeninge Kortrijk
        • Kontakt:
          • Gertjan Vereecke
      • Leuven, Belgien
        • Rekruttering
        • UZ Leuven
        • Kontakt:
          • Katrien Benhalima
      • Liège, Belgien
        • Rekruttering
        • CHU de Liege
        • Kontakt:
          • JC Philips
      • Mouscron, Belgien
        • Rekruttering
        • Centre Hospitalier Mouscron
        • Kontakt:
          • Philippe Oriot
      • Sint-Niklaas, Belgien
        • Rekruttering
        • Vitaz
        • Kontakt:
          • Peter Coremans
      • Turnhout, Belgien

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

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Der er indhentet frivilligt skriftligt informeret samtykke fra deltageren forud for eventuelle screeningsprocedurer
  2. Brug af yderst effektive præventionsmetoder
  3. Anamnese med GDM (diagnosticeret med 2013 WHO-kriterier 24-32 ugers graviditet) og glukoseintolerans 6-24 uger efter fødslen (baseret på ADA-kriterierne)
  4. Skal kunne forstå og tale hollandsk, fransk eller engelsk

Ekskluderingskriterier:

  • 1. Deltageren har en historie med enhver type diabetes eller autoantistoffer mod type 1 diabetes, historie med pancreatitis, familie eller personlig historie med medullært thyreoideacarcinom eller multipel endokrin neoplasi syndrom type 2, alvorlig psykiatrisk lidelse inden for det seneste år, hjertesvigt NYHA klasse 4, nyresygdom i slutstadiet (eGFR

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: semaglutid
semaglutid SC én gang ugentligt, optitrering over en 2-måneders periode til 1 mg/uge (0,25 mg én gang om ugen, efter 4 uger 0,5 mg én gang om ugen og efter 8 uger vedligeholdelsesdosis på 1 mg én gang om ugen), behandlingsvarighed på max. 3 år
Medicin: Semaglutide Pen Injektor
vedligeholdelsesdosis på 1 mg SC én gang om ugen
Andre navne:
  • Ozempisk
Placebo komparator: placebo
placebo SC én gang om ugen, samme dosis-eskaleringsregime, ved brug af matchende injektioner, behandlingsvarighed på max. 3 år
Medicin: Semaglutid placebo
vedligeholdelsesdosis på 1 mg SC én gang om ugen

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Development of T2DM
Tidsramme: by 160 weeks
Defined by FPG, OGTT, and/or HbA1c according to the ADA criteria
by 160 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Need for glucose-lowering (rescue) therapy
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage need for rescue therapy for diabetes
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Frequency of prediabetes based on FPG, OGTT, and/or HbA1c
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage of prediabetes based on FPG, OGTT, and/or HbA1c
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Regression to normoglycaemia
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage regression to normoglycaemia, based on fasting glycaemia, oral glucose tolerance test and/or HbA1c (ADA criteria)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Change in body weight
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Change in body weight (kg)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
BMI
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Mean BMI (Kg/m2)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Waist circumference
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Mean waist circumference (cm)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Waist-to-hip ratio
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Waist/hip circumference ratio
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Proportion of participants achieving ≥5% weight loss
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage weight loss ≥5%
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Proportion of participants achieving ≥10% weight loss
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage weight loss ≥10%
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Proportion of participants achieving ≥15% weight loss
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage weight loss ≥15%
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Body fat percentage assessed by bioelectrical impedance analysis (Bodystat 1500®)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage body fat measured by bioelectrical impedance analysis
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
β-cell function, assessed by HOMA-B
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Beta-cell function measured by the HOMA-B index
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Insulinogenic index divided by HOMA-IR
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Beta-cell function measured by the by the insulinogenic index divided by HOMA-insulin resistance index
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Insulin secretion-sensitivity index-2
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Beta-cell function measured by theby the insulin-secretion sensitivity-2 index
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Stumvoll index
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Beta-cell function measured by the Stumvoll index
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Insulin sensitivity, assessed by the Matsuda index (reflecting whole body insulin sensitivity)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Whole body Insulin sensitivity measured by the insulin sensitivity index of Matsuda
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
1/HOMA-IR, reflecting primarily hepatic insulin sensitivity
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
The reciprocal of the homeostasis model assessment of insulin resistance (1/HOMA-IR)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Prevalence of the metabolic syndrome
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage of the metabolic syndrome based on the WHO criteria
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Blood pressure (blood pressure ≥140/90 mmHg)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage blood pressure ≥140/90mmHg
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Heart rate
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Mean heart rate
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Lipid profile, including low density lipoprotein-cholesterol (LDL-cholesterol, ≥100 mg/dL or ≥2,6 mmol/L)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage LDL cholesterol ≥100mg/dl or ≥2,6 mmol/L
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Lipid profile, including triglycerides (≥150 mg/dL or ≥1,7 mmol/L)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage triglycerides ≥150mg/dl or ≥1,7 mmol/L
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed by SF-36
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better health-related quality of life
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed by EQ-5D-5L
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale (EQ VAS). Scores range from 0 to 100, with higher scores indicating better perceived health status
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Symptoms of depression (CES-D)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Depressive symptoms assessed using the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). Total scores range from 0 to 60, with higher scores indicating more depressive symptoms
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Symptoms of anxiety (short-form STAI)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Symptoms of anxiety assessed using the 6-item short-form State-Trait Anxiety Inventory (STAI). Total scores range from 20 to 80 after score transformation, with higher scores indicating greater anxiety symptoms
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Treatment satisfaction assessed using a study-specific questionnaire based on the Diabetes Treatment Satisfaction Questionnaire
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Diabetes risk perception assessed using the Diabetes Risk Perception Questionnaire, a validated questionnaire that evaluates perceived risk of developing diabetes
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Sleep quality (Pittsburgh Sleep Quality Index)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Sleep quality assessed using the validated Pittsburgh Sleep Quality Index (PSQI)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Food security (short-form HFSSM)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Food security assessed using the short-form Household Food Security Survey Module (HFSSM). Scores indicate the level of food security, with higher scores reflecting greater food insecurity
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Plasma metabolite concentrations
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Changes in and associations of metabolomic profiles, with cardiometabolic risk and treatment response. Assessed using metabolomic profiling. Blood samples will be collected at baseline and every 6 months during a 3.5-year follow-up period (study visits).
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Quality-adjusted life years (QALYs)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Quality-adjusted life years (QALYs), calculated as the area under the curve of health-related quality of life utility values over time, where higher values indicate better health outcomes
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental costs and incremental cost-effectiveness ratio (ICER) of semaglutide compared with placebo
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental costs and incremental cost-effectiveness ratio (ICER) of semaglutide versus placebo
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental healthcare costs
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental healthcare costs associated with the intervention compared with control, calculated from collected healthcare resource utilization and unit cost data. Currency (e.g., EUR per participant)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)

Samarbejdspartnere og efterforskere

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Samarbejdspartnere

Universitair Ziekenhuis Brussel
University Hospital, Antwerp
Onze Lieve Vrouw Hospital
General Hospital Groeninge
AZ Turnhout
Erasme University Hospital
AZ Sint-Lucas Brugge
Centre Hospitalier Universitaire de Liege
Vitaz
Centre Hospitalier Mouscron
Jan Yperman Ziekenhuis
Ziekenhuis aan de Stroom

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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)

14. september 2023

Primær færdiggørelse (Anslået)

1. marts 2030

Studieafslutning (Anslået)

1. maj 2030

Datoer for studieregistrering

Først indsendt

28. september 2022

Først indsendt, der opfyldte QC-kriterier

3. oktober 2022

Først opslået (Faktiske)

6. oktober 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • S66967
  • 2022-502082-22-00 (Anden identifikator: EU CT number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Individual participant data will be made available upon reasonable request after study completion, database lock, unblinding, and publication of the primary results, subject to applicable ethical, legal, and data protection requirements.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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