Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311064
Status:
WITHDRAWN
Last Update Posted:
2007-08-21
First Post:
2006-04-04
Brief Title:
Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Overweight
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Only Overweight The Influence of Physical Activity
Status:
WITHDRAWN
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
because of lack of funding and recruitment problems the study has been closed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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 kgm2 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
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 kgm2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None