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

Phase 1

Withdrawn

• Conditions: Inflammation

• Registration Number: NCT00311064
• Lead Sponsor: Rigshospitalet, Denmark

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 Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-04-04
• Study First Submitted QC: 2006-04-04
• Study First Posted: 2006-04-05
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-20
• Last Update Posted: 2007-08-21
• Study Completion: 2008-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
delivery by caesarian section
induction of labour

Trial Locations

Locations (1)

Rigshospitalet, Obstetric Clinic, Juliane Marie Centret; 🇩🇰 Copenhagen, Østerbro, Denmark