NCT01559181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
584

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

5.6 years

First QC Date

March 19, 2012

Last Update Submit

May 23, 2018

Conditions

Type 1 Diabetes

Keywords

Offspring of mothers with type 1 diabetesPregnancy and programingIntrauterine hyperglycaemiaStudy focuses on offspring of mothers with type 1 diabetes

Outcome Measures

Primary Outcomes (4)

  • Overweight

    Weight (\> 85-percentile for age and gender)

    0 - 18 years

  • Diabetes/prediabetes

    Assessed by Oral Glucose Tolerance Test

    0 - 18 years

  • Cognitive functions

    Assessed by RIAS-test and Conners' CPT II.

    0 - 18 years

  • Pubertal development

    0 - 18 years

Secondary Outcomes (8)

  • BMI

    0 - 18 years

  • Body composition

    0 - 18 years

  • Blood pressure

    0 - 18 years

  • Dyslipidemia

    0 - 18 years

  • Insulin levels

    0 - 18 years

  • +3 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Offspring of mothers with type one diabetes.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aarhus Universitetshospital

Aarhus, 8000, Denmark

Location

Department of Gynaecology and Obstetrics, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Odense University Hospital, Diabetes Research Center

Odense, 5000, Denmark

Location

Related Publications (6)

  • Jensen RB, Bytoft B, Lohse Z, Johnsen SK, Nielsen MF, Oturai PS, Hojlund K, Damm P, Clausen TD, Jensen DM. Impact of Lean Body Mass and Insulin Sensitivity on the IGF-1-Bone Mass Axis in Adolescence: the EPICOM Study. J Clin Endocrinol Metab. 2021 Jan 23;106(2):e772-e781. doi: 10.1210/clinem/dgaa861.

    PMID: 33236084DERIVED

  • Knorr S, Bytoft B, Lohse Z, Boisen AB, Clausen TD, Jensen RB, Damm P, Beck-Nielsen H, Holst JJ, Hartmann B, Moller HJ, Hojlund K, Gravholt CH, Jensen DM. Fatty Liver Among Adolescent Offspring of Women With Type 1 Diabetes (the EPICOM Study). Diabetes Care. 2019 Aug;42(8):1560-1568. doi: 10.2337/dc19-0571. Epub 2019 Jun 4.

    PMID: 31167890DERIVED

  • Lohse Z, Knorr S, Bytoft B, Clausen TD, Jensen RB, Oturai P, Beck-Nielsen H, Gravholt CH, Damm P, Hojlund K, Jensen DM. Differential effects of age and sex on insulin sensitivity and body composition in adolescent offspring of women with type 1 diabetes: results from the EPICOM study. Diabetologia. 2018 Jan;61(1):210-219. doi: 10.1007/s00125-017-4458-1. Epub 2017 Oct 3.

    PMID: 28971223DERIVED

  • Lohse Z, Bytoft B, Knorr S, Clausen TD, Beck Jensen R, Beck-Nielsen H, Hermann AP, Oturai P, Frystyk J, Damm P, Gravholt CH, Hojlund K, Jensen DM. Abnormal levels of adipokines in adolescent offspring of women with type 1 diabetes - Results from the EPICOM study. Metabolism. 2017 Jul;72:47-56. doi: 10.1016/j.metabol.2017.04.002. Epub 2017 Apr 12.

    PMID: 28641783DERIVED

  • Bytoft B, Knorr S, Vlachova Z, Jensen RB, Mathiesen ER, Beck-Nielsen H, Gravholt CH, Jensen DM, Clausen TD, Mortensen EL, Damm P. Long-term Cognitive Implications of Intrauterine Hyperglycemia in Adolescent Offspring of Women With Type 1 Diabetes (the EPICOM Study). Diabetes Care. 2016 Aug;39(8):1356-63. doi: 10.2337/dc16-0168. Epub 2016 Jun 6.

    PMID: 27271191DERIVED

  • Vlachova Z, Bytoft B, Knorr S, Clausen TD, Jensen RB, Mathiesen ER, Hojlund K, Ovesen P, Beck-Nielsen H, Gravholt CH, Damm P, Jensen DM. Increased metabolic risk in adolescent offspring of mothers with type 1 diabetes: the EPICOM study. Diabetologia. 2015 Jul;58(7):1454-63. doi: 10.1007/s00125-015-3589-5. Epub 2015 Apr 30.

    PMID: 25924986DERIVED

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)

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Dorte Møller Jensen, Associated Professor, PhD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cand. med.

Study Record Dates

First Submitted

March 19, 2012

First Posted

March 21, 2012

Study Start

April 1, 2012

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

May 24, 2018

Record last verified: 2018-05

Locations

DK(3)