Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Overweight
The purpose of this study is to determine if disturbances in cytokines or factors of the metabolic syndrome, can predict complications in pregnancy, birth, and the perinatal period in pregnant women with type 2 diabetes or who are overweight. At the same time we, the investigators at Rigshospitalet, want to determine if physical activity in the overweight pregnant woman can influence these factors in a favourable way and, with that, improve the progress of pregnancy and birth.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
|Official Title:||Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Only Overweight. The Influence of Physical Activity|
- perinatal mortality
- congenital malformations and preeclampsia
- gestational hypertension and gestational diabetes mellitus (GDM)
- preterm delivery
- too large infants (> 2 standard deviation [SD])
- delivery by caesarian section
- induction of labour
|Study Start Date:||March 2006|
|Estimated Study Completion Date:||January 2008|
Material and Method:
This study falls in two fields:
First 80 pregnant women with type 2 diabetes are followed with determination of cytokines and factors of the metabolic syndrome throughout the pregnancy. The correlation between these variables and the pregnancy and delivery progress is evaluated.
280 overweight (body mass index [BMI] > 30 kg/m2) pregnant women with no medical conditions are examined in the same way. The women are randomized in week 14 to either continue their habitual physical activity or to elevate it by participating in a training program with other pregnant women 3 times weekly.
Both groups will get blood samples taken during fasting approximately 50 ml 3-4 times during the pregnancy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311064
|Rigshospitalet, Obstetric Clinic, Juliane Marie Centret|
|Copenhagen, Østerbro, Denmark, 2100|
|Principal Investigator:||Bettina Breitowicz, MD||Rigshospitalet, Denmark|