Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes
- NCT ID
- NCT05569772
- Registry status
- Recruiting
- Study type
- Not specified in the registry data
- Phase
- Phase 3
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 252 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following eligibility criteria.
Eligible participants are women aged ≥18 years, with a history of GDM diagnosed according to the 2013 WHO criteria (at 24-32 weeks gestation or \<24 weeks for early GDM). Participants must have prediabetes diagnosed between 6 weeks and 12 months postpartum according to ADA criteria (FPG 5.6-6.9 mmol/L, 2-hour OGTT glucose 7.8-11.0 mmol/L and/or HbA1c 39-46 mmol/mol \[5.7-6.4%\]).
Additional 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.
Study locations
13 study locations are listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: Belgium
Sample of listed locations
- AZORG — Aalst, Belgium — Site recruitment status not specified in the registry data
- UZA — Antwerp, Belgium — Site recruitment status not specified in the registry data
- ZAS — Antwerp, Belgium — Site recruitment status not specified in the registry data
- AZ St Jan Brugge — Bruges, Belgium — Site recruitment status not specified in the registry data
- Erasme — Brussels, Belgium — Site recruitment status not specified in the registry data
- UZ Brussel — Brussels, Belgium — Site recruitment status not specified in the registry data
- Jan Yperman — Ieper, Belgium — Site recruitment status not specified in the registry data
- AZ Groeninge Kortrijk — Kortrijk, Belgium — Site recruitment status not specified in the registry data
- UZ Leuven — Leuven, Belgium — Site recruitment status not specified in the registry data
- CHU de Liège — Liège, Belgium — Site recruitment status not specified in the registry data
- Centre Hospitalier Mouscron — Mouscron, Belgium — Site recruitment status not specified in the registry data
- Vitaz — Sint-Niklaas, Belgium — Site recruitment status not specified in the registry data
- AZ Turnhout — Turnhout, Belgium — Site recruitment status not specified in the registry data
Study details
- Start date
- September 14, 2023
- Primary completion date
- March 1, 2030
- First posted
- October 6, 2022
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT05569772
- Registry last updated
- September 15, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT05569772 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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