Status:
UNKNOWN
Prevention of Gestational Diabetes
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief Summary
Pregnancy is a vulnerable period for both a mother and her developing child. The investigator hypothesizes that diet-induced glucose excursions in the pregnant mother are a key contributor to unfavour...
Eligibility Criteria
Inclusion
- Pregnant women between gestational week 4 and 14 after the last menstruation (proof of b-human choriongonadotropin in urine or proof of pregnancy via ultrasound.)
- Pre-pregnancy overweight (pregravid BMI \> = 27) or positive family history of type 2 diabetes or GDM in first-degree relatives or GDM in previous pregnancy or previous macrosomia (baby with birth weight \> 4000 g) or advanced maternal age \> = 40 years
- Ability to understand and voluntarily sign an informed consent document prior to any study related procedures.
Exclusion
- Age \< 18 years
- Multiple pregnancy
- Pre-pregnancy Diabetes mellitus
- Intake of medication that interferes with glucose-metabolism, such as glucose lowering or increasing drugs at inclusion visit (e.g. Steroids, Antidiabetics, Insulin, Metformin)
- Treatment with drugs with central nervous actions
- Chronic alcohol disease and drug abuse
- Pre-existing cardiac condition
- Mental disorder
- Weight loss \>10% in the previous 6 months
- GFR \< 60 ml/min/1.73 m2
- 2-fold increased transaminase levels in reference to the upper standard
- Any other (clinical) condition that would endanger participant's safety or question scientific success according to a physician's opinion.
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04028089
Start Date
July 15 2019
End Date
November 1 2023
Last Update
March 28 2022
Active Locations (1)
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1
University of Tuebingen, Department of Internal Medicine IV
Tübingen, Germany, 72076