Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes
Recruiting · NCT05569772 · Interventional (participants receive a specific treatment) · Lead sponsor: Universitaire Ziekenhuizen KU Leuven
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- include cessation of breastfeeding, no intention to become pregnant within the next year, use of effective contraception and no use of medication affecting glucose metabolism. Written ICF is obtained prior to any study-related procedures.
Exclusion criteria
- include established diabetes, presence of autoantibodies suggestive of type 1 diabetes, normal glucose tolerance, history of pancreatitis, previous bariatric surgery or planned surgery within two years, unable to understand and speak Dutch, French or English and current pregnant or planning to become pregnant within one year after participating in the study.
Where it is running
13 locations listed.
- AZORG - Aalst, Belgium
- UZA - Antwerp, Belgium
- ZAS - 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