hypoglycemia low blood sugar
Conditions
Interventions
None listed
Sponsors
Medisch Centrum Leeuwarden
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Pregnant, either after metabolic-bariatric surgery (Roux-en-Y gastric bypass or One anastomosis gastric bypass performed at CON, MCL with pre-surgery BMI >40, and post-BS total weight loss (TWL) of >20%), or without metabolic-bariatric surgery with BMI >40 or BMI between 18.5-24.9. At the time of inclusion, the subject must be between 6-10 weeks pregnant.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Diagnosis with type 1 or type 2 diabetes before the pregnancy, or diagnosis with type 1 or type 2 diabetes or GDM before the BS. - Diagnosis with severe psychiatric or medical comorbidities known to potentially affect fetal growth (e.g. severe depression, lupus, chronic kidney disease). - Continued smoking, alcohol consumption, or substance use throughout the pregnancy. - Allergy for plasters. - Multiple pregnancy. - Pregnancy less than 12 months after bariatric surgery. - Post-bariatric total weight loss of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is the number of hypoglycemic events (fasting and postprandial) during post-bariatric pregnancies and non-bariatric pregnancies (with obese and healthy BMI). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are neonatal birthweight, gestational weight gain, placental weight and histology, micronutrient deficiency, and nu number of hyperglycemic events. Other parameters are data from the patient file (age, ethnicity, comorbidities, pre-bariatric weight). | — |
Countries
Netherlands
Outcome results
None listed