Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Overweight - Full Text View

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00311064

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 I

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Only Overweight. The Influence of Physical Activity

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, Østerbro
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

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

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Overweight

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009