Status:
TERMINATED
Pregnancy Outcomes and Maternal Insulin Sensitivity
Lead Sponsor:
University Medical Center Groningen
Conditions:
Gestational Diabetes
Other "Heavy-For-Dates" Infants
Eligibility:
FEMALE
18-45 years
Brief Summary
The PROMIS study will focus on maternal insulin sensitivity thourghout pregnancy and postpartum in a moderate to high risk population (BMI ≥25 kg/m2) in developing adverse pregnancy outcomes. Next to ...
Detailed Description
The worldwide prevalence of overweight and obesity is rapidly increasing, also affecting women of reproductive age. The prevalence of overweight women between 30-40 years in the Netherlands in 2017 wa...
Eligibility Criteria
Inclusion
- Healthy singleton pregnant women (10-12 weeks of gestation)
- BMI ≥25 kg/m2
- FPG ≤7.0 mmol/l
- Dutch or English speaking
- Written informed consent
Exclusion
- Serious health complications (Hypertension, Hyperlipidemia, Asthma, Haemochromatosis) or medication use that influence the glucose metabolism or fetal growth (e.g. corticosteroids).
- Multiple pregnancy
- pre-existing Diabetes type 1 and 2 defined as FPG ≥7.0 mmol/l or use of diabetes medication
- Participation in any other studies involving the investigation of medication or nutritional products or severe illness or antibiotic use in the two weeks prior to entry into the study
- HIV/Hepatitis
- Expectation of non-compliance to the study protocol, among others, a fear of needles
- Known allergies or intolerances for one or more nutritional ingredients in the MTT
- Psychological dysfunctions
Key Trial Info
Start Date :
February 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 8 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04315545
Start Date
February 6 2020
End Date
July 8 2024
Last Update
March 30 2025
Active Locations (2)
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1
University Medical Centre Groningen
Groningen, Netherlands, 9713 GZ
2
Medical Center Leeuwarden
Leeuwarden, Netherlands, 8984 AD