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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

NCT05569772

RecruitingPhase 3

Sponsor: Universitaire Ziekenhuizen KU Leuven

Conditions: Glucose Intolerance After a Recent History of Gestational Diabetes

Interventions: Semaglutide Pen Injector, Semaglutide placebo

Countries: Belgium

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (13)
  • Aalst, Belgium
  • Antwerp, Belgium
  • Antwerp, Belgium
  • Bruges, Belgium
  • Brussels, Belgium
  • Brussels, Belgium
  • Ieper, Belgium
  • Kortrijk, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • Mouscron, Belgium
  • Sint-Niklaas, Belgium
  • Turnhout, Belgium