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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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physical activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Bettina Breitowicz, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet, Obstetric Clinic, Juliane Marie Centret

Copenhagen, Østerbro, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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01 285157

Identifier Type: -

Identifier Source: org_study_id