Plain English Summary
Background and study aims:
Infants born to mothers with pregnancy diabetes have increased risk of type 2 diabetes later in life. The aim of this study is to examine the extent to which maternal metabolism and habits during pregnancy are related to modifications of genetic material from the fetus during pregnancy. Fetal gene information is collected from the woman's blood during pregnancy using standard blood collection.
Who can participate?:
Scandinavian women aged 25-35 years in early pregnancy. In total, 30 women will be recruited before pregnancy week 12+6. Of these participants, 50% will have a high risk of pregnancy-diabetes while 50% are expected to have a normal pregnancy.
What does the study involve?
This study involves three study visits during pregnancy (all including blood collection from the woman), passive bio-sample collection at delivery (e.g. from the placenta), and one study visit two months after delivery (blood collection from mother and infant). In addition to clinical visits, participating women are followed with continuous monitoring of blood-sugar and physical activity, and report their own weight.
What are the possible benefits and risks of participating?:
There are no direct medical benefits of participating in the study. However, the closer monitoring of blood-sugar in pregnancy could potentially lead to earlier detection of pregnancy-diabetes. The main risk of participating should be potential skin-reactions from devices monitoring blood-sugar and physical activity. Standard blood collection through venipuncture is also associated with a small risk of infection.
Where is the study run from?:
Skåne University Hospital in Lund/Malmö (Sweden)
When is study starting and how long is it expected to run for?:
September 2017 to 2019
Who is the main contact?:
Miss Angela Estampador
angela.estampador@med.lu.se
Trial website
Contact information
Type
Public
Primary contact
Ms Angela Estampador
ORCID ID
Contact details
Genetic and Molecular Epidemiology Unit
Lund University Diabetes Centre
Clinical Research Centre
Box 503 32
Malmö
202 13
Sweden
Type
Scientific
Additional contact
Prof Paul Franks
ORCID ID
Contact details
Genetic and Molecular Epidemiology Unit
Lund University Diabetes Centre
Clinical Research Centre
Box 503 32
Malmö
202 13
Sweden
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.0
Study information
Scientific title
The Diabetogenic Perturbations of the Fetal Methylome Project
Acronym
DIAPRIME
Study hypothesis
We hypothesize that intrauterine exposure to maternal blood glucose during gestation will
correlate with differences in patterns of fetal methylation; fetal methylation patterns will vary by timing and degree of intrauterine exposure to maternal glucose.
Ethics approval
Regional Ethical Review Board in Lund, Sweden, 01/09/2016, ref: 2016/489 with amendment 2016/1098
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Maternal-fetal effects of metabolism in pregnancy
Intervention
Participants attend study visits at three time points in pregnancy (approximately at 12, 26, and 34 gestational weeks) during which maternal blood, questionnaire data on lifestyle, and anthropometry are collected.
Participants are also monitored between study visits with self-reported weight, continuous glucose monitoring and physical activity (wrist accelerometry) from recruitment in early pregnancy to delivery. At delivery, bio-sampling is performed (e.g. placental material and cord blood) and at approximately two months postpartum, additional maternal and infant data is collected, including blood sampling.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Changes in fetal/placental DNA methylation at three time points in pregnancy are measured using cell-free fetal DNA isolated from maternal blood and next generation sequencing at approximately 12, 26, and 34 gestational weeks.
Secondary outcome measures
1. Maternal physical activity as measured by wrist accelerometer from early pregnancy to delivery
2. Maternal blood-glucose as measured by a continuous glucose monitor and OGTT from early pregnancy to delivery
3. Maternal weight gain and body composition (daily weighing using a medical scale and/or clinically measured using the Styku 3D body scanning system) throughout pregnancy and postpartum
Overall trial start date
01/01/2016
Overall trial end date
15/09/2019
Reason abandoned
Eligibility
Participant inclusion criteria
In total, we will recruit around 30 pregnant women:
1. Aged 25-35 before gestational week 12+6
Half of the recruited women (50%) will have a high risk of gestational diabetes mellitus:
1. Family history of diabetes
2. Prior pregnancy affected by diabetes
3. Current obesity
Half of the recruited women (50%) are expected to have a normal pregnancy not complicated by gestational diabetes mellitus (controls).
If a control woman develops gestational diabetes, she will be invited to continue to take part in the study and be monitored as per standard of care; we will then seek to recruit an additional woman to the control arm to ensure an adequate number of participants in the study.
Participant type
Mixed
Age group
Adult
Gender
Female
Target number of participants
30
Participant exclusion criteria
1. Not of Scandinavian origin
2. Use of assisted reproductive technology
3. History of three or more first trimester miscarriages
4. Tobacco use (smoking/snus) in the previous three months
5. Diagnosed PCOS
6. History of gastric bypass surgery
7. Type 1 diabetes
8. Non-Swedish speaker
9. Planned termination of pregnancy or planning to give up infant for adoption
Recruitment start date
20/09/2017
Recruitment end date
15/09/2018
Locations
Countries of recruitment
Sweden
Trial participating centre
Skåne University Hospital
Lund/Malmö
222 41
Sweden
Sponsor information
Organisation
Lund University
Sponsor details
Box 117
Lund
221 00
Sweden
Sponsor type
University/education
Website
Organisation
Skåne University Hospital
Sponsor details
Getingevägen 4
Lund
222 41
Sweden
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
The European Foundation for the Study of Diabetes
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Swedish Heart-Lung Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Novo Nordisk Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in relevant peer-reviewed scientific journal.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/09/2020
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary