Trial document





This trial has been registered retrospectively.
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  DRKS00004370

Trial Description

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Title

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

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Trial Acronym

GESA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Infants of women with pregravid obesity and gestational diabetes mellitus (GDM) have an increased risk of obesity and diabetes in later life. Maternal obesity and GDM may independently influence offspring fat mass and disease susceptibility. The aim of this study is to determine changes in the nutrient organ, the placenta, and to examine the body composition within the 1st year in offspring of lean and obese women with normal glucose tolerance and GDM

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Brief Summary in Scientific Language

Offspring from obese and gestational diabetic (GDM) mothers have a higher risk for increased body fat and macrosomia. Moreover, the risk for obesity and diabetes Type 2 in adulthood is higher in offspring from obese and/or GDM women. Higher nutrient and energy supply (e.g. glucose, amino acids, triglycerides) from maternal circulation in obese and diabetic pregnancies is discussed to increase fetal insulin production resulting in increased intrauterine growth. In case of pregravid obesity and GDM, new aspects deal with the impact of chronically inflammatory status on placental gene expression and related epigenetic regulation processes. The GESA study is an observational study comprising the period from third trimester (33-36th week of gestation) until 12 month postpartum. Aim of this human study is to determine the influence of inflammatory uterine environment of obese normoglycemic and obese GDM pregnant women on early childhood obesity. Besides obtaining offspring anthropometric and skin fold thickness data (caliper), ultrasound imaging of subcutaneous and preperitoneal adipose tissue was performed. Especially changes in placental gene expression using microarray analysis were revealed. Furthermore, appropriate target genes were screened for epigenetic regulations (e.g. microRNA, methylation pattern) involved in unfavourable intrauterine status. Additionally, plasma biomarkers in maternal circulation and umbilical cord were examined for correlations with placental changes and fetal adaptation. Therefore, explanations how epigenetic mechanism can influence fetal development reflect a central aspect in prenatal prevention of diabetes type 2 and obesity in the offspring.

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Organizational Data

  •   DRKS00004370
  •   2012/09/24
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  •   yes
  •   Approved
  •   2629/09, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   O24.4 -  Diabetes mellitus arising in pregnancy
  •   E66.9 -  Obesity, unspecified
  •   P08.0 -  Exceptionally large baby
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Interventions/Observational Groups

  •   control group, lean, healthy pregnant women with 18.5 kg/m2< BMI<25 kg/m2 before pregnancy, no gestational diabetes (GDM)
  •   obese pregnant women with BMI> 30 kg/m2 before pregnancy, no gestational diabetes (GDM)
  •   Obese pregnat women with BMI > 30 kg/m2 before pregnancy, Gestationsdiabetes (GDM) with dietary or insulin therapy
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

- 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
- 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
- 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
- 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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2010/02/11
  •   45
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   43   Years
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Additional 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

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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.

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Addresses

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    • Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Lehrstuhl für Ernährungsmedizin
    • Mr.  Univ.-Prof.  Hans  Hauner 
    • Gregor-Mendel-Str.2
    • 85350  Freising
    • Germany
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    • Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Lehrstuhl für Ernährungsmedizin
    • Mr.  Univ.-Prof.  Hans  Hauner 
    • Gregor-Mendel-Str.2
    • 85350  Freising-Weihenstephan
    • Germany
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    • ZIEL- Zentralinstitut für Ernährungs- und Lebensmittelforschung, Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Lehrstuhl für Ernährungsmedizin
    • Ms.  Dipl. Ern.-Wiss  Kirsten  Uebel 
    • Gregor-Mendel-Str.2
    • 85350  Freising-Weihenstephan
    • Germany
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Sources of Monetary or Material Support

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    • Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Lehrstuhl für Ernährungsmedizin
    • Gregor-Mendel-Str.2
    • 85350  Freising
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/02/22
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.