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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00311064
• Other study ID #: 01 285157
• Status: Withdrawn
• Phase: Phase 1
• First received: April 4, 2006
• Last updated: August 20, 2007
• Start date: March 2006
• Est. completion date: January 2008

Study information

• Verified date: August 2007
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 280
• Est. completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Inflammation

Intervention

Behavioral:
• physical activity

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Obstetric Clinic, Juliane Marie Centret	Copenhagen	Østerbro

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perinatal mortality
Primary	congenital malformations and preeclampsia
Primary	gestational hypertension and gestational diabetes mellitus (GDM)
Primary	preterm delivery
Primary	too large infants (> 2 standard deviation [SD])
Secondary	delivery by caesarian section
Secondary	induction of labour