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

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ClinicalTrials.gov Identifier: NCT00311064
Recruitment Status : Withdrawn (because of lack of funding and recruitment problems the study has been closed.)
First Posted : April 5, 2006
Last Update Posted : August 21, 2007
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Study Description
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.


Condition or disease Intervention/treatment Phase
Inflammation Behavioral: physical activity Phase 1

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  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Only Overweight. The Influence of Physical Activity
Study Start Date : March 2006
Estimated Study Completion Date : January 2008

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. perinatal mortality
  2. congenital malformations and preeclampsia
  3. gestational hypertension and gestational diabetes mellitus (GDM)
  4. preterm delivery
  5. too large infants (> 2 standard deviation [SD])

Secondary Outcome Measures :
  1. delivery by caesarian section
  2. induction of labour

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311064


Locations
Denmark
Rigshospitalet, Obstetric Clinic, Juliane Marie Centret
Copenhagen, Østerbro, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Bettina Breitowicz, MD Rigshospitalet, Denmark
More Information

ClinicalTrials.gov Identifier: NCT00311064     History of Changes
Other Study ID Numbers: 01 285157
First Posted: April 5, 2006    Key Record Dates
Last Update Posted: August 21, 2007
Last Verified: August 2007

Additional relevant MeSH terms:
Inflammation
Overweight
Pathologic Processes
Body Weight
Signs and Symptoms