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

This study has been withdrawn prior to enrollment.
(because of lack of funding and recruitment problems the study has been closed.)
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00311064
First received: April 4, 2006
Last updated: August 20, 2007
Last verified: August 2007
History of Changes
  Purpose

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 Intervention Phase
Inflammation
 Behavioral: physical activity
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Only Overweight. The Influence of Physical Activity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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:
  • delivery by caesarian section
  • induction of labour

Estimated Enrollment: 280
Study Start Date: March 2006
Estimated Study Completion Date: January 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00311064     History of Changes
Other Study ID Numbers: 01 285157
Study First Received: April 4, 2006
Last Updated: August 20, 2007
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Inflammation
Overweight
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013