Prenatal Programming of Childhood Obesity and Cardio Metabolic Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age11-55
SponsorHelsinki University Central Hospital
About this trial
This is a prospective 11-17 -years follow-up of two existing pregnancy cohort (PREDO) and prevention (RADIEL) studies. The main objective is to investigate the associations between maternal overweight, obesity, hypertensive disorders in pregnancy, gestational diabetes, and maternal-fetal metabolome, child's birth outcomes, and overweight and obesity and cardio metabolic health outcomes in childhood and adolescence. During this follow-up study, the mothers and their 11-17-year-old children are invited for a study visit and their cardio metabolic health is studied by many different methods.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
all mothers participated originally in the PREDO or the RADIEL studies during pregnancy and with delivery during this index pregnancy
Disqualifiers
None
Trial population
The study population comprises two Finnish pregnancy cohort /prevention studies, in which mother-child pairs have already been followed from early pregnancy until the threshold of adolescence. Women for the PREDO study were enrolled at 12-14 gestational weeks and for the RADIEL study before conception or at 10-12 gestational weeks. They gave birth to a singleton live infant between 2006-2010 (PREDO) and 2008-2014 (RADIEL).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
750 Participants
are grouped into 2 trial groupsGroup A: Prevention of Pre-eclampsia and Intrauterine Growth Restriction (PREDO)
Group B: Finnish Gestational Diabetes Prevention (RADIEL)
Trial outcomes
Primary outcomes
1
Body fat percentage
Measured by Inbody 720 (bioimpedance)
Time frame
one measure at follow-up study visit:11-17 years after pregnancySecondary outcomes
1
Blood pressure
Both systolic and diastolic pressures are measured by Omron HBP-1320
Time frame
2-3 measurements at follow-up study visit: 11-17 years after pregnancy2
Body mass index
weight (kg) / height (m)2
Time frame
one measure at follow-up study visit: 11-17 years after pregnancy3
Pulse wave velocity
Measured by Complior Analyse, Alarm Medical
Time frame
one measure at follow-up study visit: 11-17 years after pregnancy4
Time in target he percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l)
Dexcom G6 CGM (continuous glucose monitoring)
Time frame
10 days measurements related to the 11-17 years follow-up study visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Helsinki University Central Hospital
Lead sponsor
University of Helsinki
Collaborator
University of Oulu
Collaborator
University of Edinburgh
Collaborator
Source ClinicalTrials.gov