Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Only Overweight. The Influence of Physical Activity
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 280
- Locations
- 2
- Primary Endpoint
- perinatal mortality
Study Overview
Brief Summary
Purpose:
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •BMI > 30 kg/m2
- •BMI < 45 kg/m2
- •Over 18 years of age
- •No earlier preterm delivery (before 37)
- •Singleton pregnancy
- •14 weeks +/- 1 week of gestation
Exclusion Criteria
- •BMI > 45 kg/m2
- •Earlier preterm delivery (before 37)
- •Not singleton pregnancy
- •Medically treated diseases
Outcomes
Primary Outcomes
perinatal mortality
congenital malformations and preeclampsia
gestational hypertension and gestational diabetes mellitus (GDM)
preterm delivery
too large infants (> 2 standard deviation [SD])
Secondary Outcomes
- delivery by caesarian section
- induction of labour