Glucose metabolism and systolic ventricular function in newborns of diabetic mothers

Recruiting

• Conditions: I42.9; Cardiomyopathy, unspecified

• Registration Number: DRKS00000202
• Lead Sponsor: Helse Sunnmøre HFSykehus i Aalesund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Pregnancy with insulin dependent Diabetes mellitus in the with
follow up at the obstetric department of the general hospital in
Ålesund / Norway, first appointment with manifested
insulindependent D. mellitus latest at 30+6 wks of gestation
2. full term birth after 37+0 - 42+0 gestational age.
3. documented consent of the parents.
4. A control group will be recruted by including the nextborn
fullterm infant of a non diabetic mother after birth of an infant
from the target group. Documented consent also in this group.
patient group

Exclusion Criteria

1. congenital major malformations or diseases in the newborn
requiring immediate transfer to another hospital, except from
cardiac malformations.
2. No fetal echocardiography from the period 28+0 - 30+6
weeks of gestation. This criterion is not valid for the control
group
3. Down-syndrome in the newborn
4. small for gestational age
5. Prematurity or postmaturity - it means: A Patient that has been
included in the fetal period has to be exluded if pre- or
postmatur at birth

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
frequency of septum hypertrophy, cardiomyopathy and ventricle dysfunction by echocardiography inside 48 hours after birth

Secondary Outcome Measures

Name	Time	Method
Correlation between septumhypertrophy, cardiomyopathy and ventricle dysfunction and clinical symptoms || Correlation between septumhypertrophy, cardiomyopathy, ventricle dysfunction and HbA1c+C-peptide (from the pregnant) C-peptide+insulin (from cord blood) and hypoglycemia of the newborn by gathering of the results from routine blood samples under observation in the NICU || Incident of congenital heart malformation || outcome of septumhypertrophy/ventricle dysfunction/cardiomyopathy by follow up echocardiography at 4 weeks and 3 months