Study of Offspring of Women With Type 1 Diabetes (EPICOM)
|ClinicalTrials.gov Identifier: NCT01559181|
Recruitment Status : Unknown
Verified October 2015 by Zuzana Vlachová, MD, Odense University Hospital.
Recruitment status was: Active, not recruiting
First Posted : March 21, 2012
Last Update Posted : October 14, 2015
There is an increasing trend in the society for developing obesity, type 2 diabetes and cardiovascular diseases. It is therefore important to identify the risk factors behind this tendency. Recent studies have shown that exposure to high blood sugar levels in pregnancy (as in mothers with type 1 diabetes) may play a role in the development of obesity, type 2 diabetes and cardiovascular diseases later in life for the children. Some studies suggest that high blood sugar levels during pregnancy can also affects cognitive function as well as growth and development of puberty. The mechanisms behind this are not sufficiently clarified yet.
In the period 1993-1999, pregnant women with type 1 diabetes in Denmark were followed and information about the course of pregnancy was collected, including the long-term blood sugar level during pregnancy and the children's' condition at birth. The unique opportunities in Denmark to identify and follow the children of these mothers and the possibility to select a comparison group of children of non-diabetic mothers gives a unique opportunity to examine the children of mothers with type 1 diabetes and accurately investigate the effect of blood sugar levels in pregnancy on conditions later in life.
There has not previously been made any study of this size and it is the investigators hope to be able to quantify the effect of blood sugar level during pregnancy on outcomes later in life. This will potentially give the possibility to detect individuals at risk for cardiovascular diseases earlier and to improve prevention targets in children of mothers with diabetes.
|Condition or disease|
|Type 1 Diabetes|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||584 participants|
|Observational Model:||Case Control|
|Official Title:||Environmental Versus Genetic and Epigenetic Influences on Growth, Metabolism and Cognitive Function in Offspring of Mothers With Type 1 Diabetes|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||December 2016|
Exposure to intrauterine hyperglycemia
The study group includes the offspring of women with type 1 diabetes from the national diabetes birth registry (1993-99, n=900) with information of HbA1c prior to conception and/or 1st trimester HbA1c.
The control group including offspring of women without diabetes who delivered during the same period matched with respect to gender and age of offspring and the family's postcode as an indirect marker of the socioeconomic background.
- Overweight [ Time Frame: 0 - 18 years ]Weight (> 85-percentile for age and gender)
- Diabetes/prediabetes [ Time Frame: 0 - 18 years ]Assessed by Oral Glucose Tolerance Test
- Cognitive functions [ Time Frame: 0 - 18 years ]Assessed by RIAS-test and Conners' CPT II.
- Pubertal development [ Time Frame: 0 - 18 years ]
- BMI [ Time Frame: 0 - 18 years ]
- Body composition [ Time Frame: 0 - 18 years ]% body fat assessed by DEXA scannin
- Blood pressure [ Time Frame: 0 - 18 years ]
- Dyslipidemia [ Time Frame: 0 - 18 years ]
- Insulin levels [ Time Frame: 0 - 18 years ]
- Markers of endothelial function [ Time Frame: 0 - 18 years ]
- Markers of autoimmunity [ Time Frame: 0 - 18 years ]GAD-antibodies
- PCOS [ Time Frame: 0 - 18 years ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559181
|Aarhus, Denmark, 8000|
|Department of Gynaecology and Obstetrics, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Odense University Hospital, Diabetes Research Center|
|Odense, Denmark, 5000|
|Principal Investigator:||Dorte Møller Jensen, Associated Professor, PhD||Odense University Hospital|