RecruitingPhase 3NCT05569772

Semaglutide for the Treatment of Glucose Intolerance in Women with Prior Gestational Diabetes

Semaglutide for the Treatment of Glucose Intolerance in Women with Prior Gestational Diabetes: a Double Blind RCT


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

252 participants

Start Date

Sep 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Gestational diabetes (GDM) is an important contributor to the increasing prevalence of type 2 diabetes (T2DM). Women with glucose intolerance in early postpartum are a particularly high-risk group with about 50% who will develop T2DM within 5 years after the delivery. Moreover, women with a history of GDM progress more rapidly to T2DM compared to women with similarly elevated glucose levels. Early intervention after the index pregnancy is therefore crucial to prevent T2DM. With the SERENA project, the investigators aim to reduce the risk to develop T2DM with the long-acting GLP-1 agonist semaglutide in women with a recent history of GDM and glucose intolerance in early postpartum.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether semaglutide — a medication commonly used for type 2 diabetes and weight loss — can prevent or delay the development of full diabetes in women who had gestational diabetes (diabetes during pregnancy) and still show impaired blood sugar levels after giving birth. **You may be eligible if...** - You previously had gestational diabetes diagnosed during weeks 24–32 of pregnancy - You were found to have impaired glucose tolerance (pre-diabetes) 6 to 24 weeks after giving birth - You are not pregnant or breastfeeding and are using effective birth control - You can speak Dutch, French, or English **You may NOT be eligible if...** - You have been diagnosed with type 1 or type 2 diabetes - You have a personal or family history of medullary thyroid cancer or a related genetic syndrome (MEN2) - You have a history of pancreatitis - Your HbA1c was 6.5% or higher during the OGTT in pregnancy (indicating full diabetes) - You are breastfeeding beyond 24 weeks postpartum - You are currently taking medications that significantly affect blood sugar (such as high-dose steroids or metformin) - You have severe kidney disease, heart failure (NYHA class 4), or a serious psychiatric disorder in the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSemaglutide Pen Injector

maintenance dose of 1mg SC once weekly

DRUGSemaglutide placebo

maintenance dose of 1mg SC once weekly


Locations(13)

OLV-Aalst-Asse

Aalst, Belgium

UZA

Antwerp, Belgium

ZNA,

Antwerp, Belgium

AZ St Jan Brugge

Bruges, Belgium

Erasme

Brussels, Belgium

UZ Brussel

Brussels, Belgium

Jan Yperman

Ieper, Belgium

AZ Groeninge Kortrijk

Kortrijk, Belgium

UZ Leuven

Leuven, Belgium

CHU de Liège

Liège, Belgium

Centre Hospitalier Mouscron

Mouscron, Belgium

Vitaz

Sint-Niklaas, Belgium

AZ Turnhout

Turnhout, Belgium

View Full Details on ClinicalTrials.gov

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NCT05569772