Semaglutide for the treatment of glucose intolerance in women with prior gestational diabetes
- Conditions
- prediabetesTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2022-502082-22-00
- Lead Sponsor
- Z Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 252
Participants eligible for inclusion in this Trial must meet all of the following criteria: 1.Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2.Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner. 3.History of GDM (diagnosed with 2013 WHO criteria 24-32 weeks of pregnancy) and glucose intolerance 6-24 weeks postpartum [based on ADA criteria1 (fasting 100-125mg/dl and or 2h value on the 75g OGTT 140-199mg/dl and/or HbA1c 5.7-6.4%), the OGTT needs to be performed after stop breastfeeding to avoid any interaction with result of the OGTT. 4.Needs to be able to understand and speak Dutch, French or English
1.Participant has a history of any type of diabetes or auto-antibodies for type 1 diabetes (GADA, ICA, IA-2, insulin, Znc), history of pancreatitis, family or personal history of medullary or personal history of any other type of thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2), severe psychiatric disorder in the past year, heart failure NYHA class 4, end-stage renal disease (eGFR <15) or dialysis, or history of bariatric surgery 2.Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol 3.Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial 4.Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 5.Participation in an interventional Trial with an investigational medicinal product (IMP) or device 6.Age <18 years, breastfeeding >24 weeks postpartum or HbA1c=6.5% at the time of the OGTT in pregnancy 7.Use of medication with significant impact on glycaemia (such as high dose glucocorticoids or metformin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method