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Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Overweight

Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Only Overweight. The Influence of Physical Activity

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00311064
Enrollment
280
Registered
2006-04-05
Start date
2006-03-31
Completion date
2008-01-31
Last updated
2007-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

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.

Interventions

BEHAVIORALphysical activity

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI \> 30 kg/m2 * BMI \< 45 kg/m2 * Healthy * 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

Design outcomes

Primary

MeasureTime frame
congenital malformations and preeclampsia
preterm delivery
too large infants (> 2 standard deviation [SD])
perinatal mortality
gestational hypertension and gestational diabetes mellitus (GDM)

Secondary

MeasureTime frame
induction of labour
delivery by caesarian section

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026