Actively Recruiting
Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-05
252
Participants Needed
13
Research Sites
324 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
U
University Hospital, Antwerp
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent given before screening
- Use of highly effective birth control methods
- History of gestational diabetes diagnosed by 2013 WHO criteria between 24-32 weeks of pregnancy
- Glucose intolerance present 6-24 weeks postpartum based on ADA criteria
- Ability to understand and speak Dutch, French, or English
You will not qualify if you...
- History of any type of diabetes or type 1 diabetes auto-antibodies
- History of pancreatitis
- Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- Personal history of thyroid carcinoma
- Severe psychiatric disorder in the past year
- Heart failure NYHA class 4
- End-stage renal disease (eGFR <15) or on dialysis
- History of bariatric surgery
- Any disorder that might risk safety or compliance as judged by the Investigator
- Prior or current treatments that might risk safety or affect study integrity
- Pregnant, breastfeeding, intending to become pregnant, or childbearing potential without adequate contraception
- Participation in another interventional trial with an investigational drug or device
- Age under 18 years
- Breastfeeding more than 24 weeks postpartum
- HbA1c 6.5% or higher at time of oral glucose tolerance test in pregnancy
- Use of medications significantly affecting blood sugar such as high dose glucocorticoids or metformin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
OLV-Aalst-Asse
Aalst, Belgium
Actively Recruiting
2
UZA
Antwerp, Belgium
Actively Recruiting
3
ZNA,
Antwerp, Belgium
Actively Recruiting
4
AZ St Jan Brugge
Bruges, Belgium
Actively Recruiting
5
Erasme
Brussels, Belgium
Actively Recruiting
6
UZ Brussel
Brussels, Belgium
Actively Recruiting
7
Jan Yperman
Ieper, Belgium
Actively Recruiting
8
AZ Groeninge Kortrijk
Kortrijk, Belgium
Actively Recruiting
9
UZ Leuven
Leuven, Belgium
Actively Recruiting
10
CHU de Liège
Liège, Belgium
Actively Recruiting
11
Centre Hospitalier Mouscron
Mouscron, Belgium
Actively Recruiting
12
Vitaz
Sint-Niklaas, Belgium
Actively Recruiting
13
AZ Turnhout
Turnhout, Belgium
Actively Recruiting
Research Team
K
Katrien Benhalima, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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