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Study of Offspring of Women With Type 1 Diabetes (EPICOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 Design

Study Type : Observational
Actual Enrollment : 584 participants
Observational Model: Case Control
Time Perspective: Prospective
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
Primary Completion Date : April 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Groups and Cohorts

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.
Control group
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.

Outcome Measures

Primary Outcome Measures :
  1. Overweight [ Time Frame: 0 - 18 years ]
    Weight (> 85-percentile for age and gender)

  2. Diabetes/prediabetes [ Time Frame: 0 - 18 years ]
    Assessed by Oral Glucose Tolerance Test

  3. Cognitive functions [ Time Frame: 0 - 18 years ]
    Assessed by RIAS-test and Conners' CPT II.

  4. Pubertal development [ Time Frame: 0 - 18 years ]

Secondary Outcome Measures :
  1. BMI [ Time Frame: 0 - 18 years ]
  2. Body composition [ Time Frame: 0 - 18 years ]
    % body fat assessed by DEXA scannin

  3. Blood pressure [ Time Frame: 0 - 18 years ]
  4. Dyslipidemia [ Time Frame: 0 - 18 years ]
  5. Insulin levels [ Time Frame: 0 - 18 years ]
  6. Markers of endothelial function [ Time Frame: 0 - 18 years ]
  7. Markers of autoimmunity [ Time Frame: 0 - 18 years ]

  8. PCOS [ Time Frame: 0 - 18 years ]

Biospecimen Retention:   Samples With DNA
Whole blood, serum and plasma. Tissue biopsies from m. vastus lateralis and subcutaneous abdominal fat (only selected subgroup of participants)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Offspring of mothers with type one diabetes.

Inclusion Criteria:

  • Children (diabetes exposed) from the national diabetes birth registry born between 1993 and 1999 (approximately n = 450) The same number of controls from the Central Person Register matched according to gender, age and postcode.

Exclusion Criteria:

  • Offspring with major handicaps or chronic disease will be registered, but will not be examined.
  • Multiple pregnancies and recurrent pregnancies will not be included in the study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559181

Aarhus Universitetshospital
Aarhus, Denmark, 8000
Department of Gynaecology and Obstetrics, Rigshospitalet
Copenhagen, Denmark, 2100
Odense University Hospital, Diabetes Research Center
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Copenhagen
Department of Gynaecology and Obstetrics, Rigshospitalet, Copenhagen
Department of Growth and Reproduction, Rigshospitalet, Copenhagen, Denmark
University of Southern Denmark
University of Aarhus
Aarhus University Hospital
Principal Investigator: Dorte Møller Jensen, Associated Professor, PhD Odense University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zuzana Vlachová, MD, Cand. med., Odense University Hospital
ClinicalTrials.gov Identifier: NCT01559181     History of Changes
Other Study ID Numbers: 2011-41-6044
First Posted: March 21, 2012    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by Zuzana Vlachová, MD, Odense University Hospital:
Offspring of mothers with type 1 diabetes
Pregnancy and programing
Intrauterine hyperglycaemia
Study focuses on offspring of mothers with type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases