Gestational diabetes mellitus, adiposity and early adipose tissue development: A role for epigenetic modulations?

• Conditions: O24.4; E66.9; P08.0; Diabetes mellitus arising in pregnancy; Obesity, unspecified; Exceptionally large baby

• Registration Number: DRKS00004370
• Lead Sponsor: Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Lehrstuhl für Ernährungsmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-24
• Study Completion: 2013-02-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

gestational age < 32th week of gestation
-18.5 < BMI < 40
-age: minimun 18 years and maximun 43 years
-written informed consent
-sufficient German language skills

Exclusion Criteria

- risk pregnancies (multiparae, rhesus incompatibility, hepatitis B infection, HELLP syndrome, pre-eclampsia, more than 4 deliveries )
- hypertension
- pregravid diabetes Type 1 or Type 2 - gastrointestinal disorders accompanied by maldigestion, malabsorption, or elevated energy and nutritional requirements (eg, gluten enteropathy)
- known metabolic defects (eg, phenylketonuria)
- psychiatric diseases
- drug or alcohol abuse.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Offspring adipose tissue development at 1 year postpartum. Measurements are determined by 1.) skin fold thickness (caliper) and 2.) with ultrasound imaging

Secondary Outcome Measures

Name	Time	Method
- maternal and fetal inflammatory status measuring inflammatory markers e.g. TNF-alpha, IL-6, IL-2, INF-gamma, CRP and Adiponektin in maternal and umbilical cord plasma <br>- plasma lipid profiles (triglycerides, total cholesterin, HDL and LDL cholesterol), glucose and insulin concentration, HOMA-Index at recruitment (33.-36.week of gestation), at delivery and 6 weeks postpartal<br>- Analysis of epigenetic modificationens (histone acetylation, DNA-methylation, miRNA-expression) determined in placenta und in peripheral mononuclear Zellen (PBMC) in cord blood as well as in maternal and fetal plasma samples<br>- weight, lenght, head circumference and arm circumference, as well as measurement of skin fold thickness and ultrasound imaging for determination subcutaneous und preperitoneal adipose tissue at time points 1 week, 6 week, 4 month as well as 12 month postpartal.<br>